RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)

RotaTeq
(rotavirus vaccine, live, oral, pentavalent) Oral Solution

DRUG DESCRIPTION

RotaTeq (rotavirus vaccine, live, oral, pentavalent) is a live, oral pentavalent vaccine that contains 5 live reassortant rotaviruses. The rotavirus parent strains of the reassortants were isolated from human and bovine hosts. Four reassortant rotaviruses express one of the outer capsid proteins (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (serotype P7) from the bovine rotavirus parent strain. The fifth reassortant virus expresses the attachment protein, P1A (genotype P[8]), herein referred to as serotype P1A[8], from the human rotavirus parent strain and the outer capsid protein of serotype G6 from the bovine rotavirus parent strain (see Table 7).

Table 7

Name of
Reassortant
Human Rotavirus
Parent Strains and Outer Surface Protein Compositions
Bovine Rotavirus
Parent Strain and Outer Surface Protein Composition
Reassortant
Outer Surface Protein Composition (Human Rotavirus Componentin Bold)
Minimum Dose Levels
(106 infectious units)
G1 WI79 - G1P1A[8] WC3 - G6, P7[5] G1P7[5] 2.2
G2 SC2 - G2P2[6] G2P7[5] 2.8
G3 WI78 - G3P1A[8] G3P7[5] 2.2
G4 BrB - G4P2[6] G4P7[5] 2.0
P1A[8] WI79 - G1P1A[8] G6P1A[8] 2.3

The reassortants are propagated in Vero cells using standard cell culture techniques in the absence of antifungal agents.

The reassortants are suspended in a buffered stabilizer solution. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum.

RotaTeq (rotavirus vaccine, live, oral, pentavalent) contains no preservatives. RotaTeq (rotavirus vaccine, live, oral, pentavalent) is a pale yellow clear liquid that may have a pink tint.

What are the possible side effects of rotavirus oral vaccine (Rotarix, RotaTeq)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the...

Read All Potential Side Effects and See Pictures of RotaTeq »

What are the precautions when taking rotavirus vaccine, live, oral, pentavalent (RotaTeq)?

Before your child takes this vaccine, tell the doctor or pharmacist if your child is allergic to it; or to latex (which may be found in the packaging of some brands); or if he/she has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this vaccine, tell your doctor or pharmacist your child's medical history, especially of: current fever/illness, current vomiting/diarrhea, stomach/intestinal problems (such as blockage, intussusception), not gaining weight/growing as expected, blood cancer (such as leukemia, lymphoma), blood disorders (such as hemophilia), immune system problems (such as HIV/AIDS, SCID).

Family or household members with cancer or...

Read All Potential Precautions of RotaTeq »

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

RotaTeq (rotavirus vaccine, live, oral, pentavalent) 1 is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) should be administered between 6 and 12 weeks of age [see DOSAGE AND ADMINISTRATION].

DOSAGE AND ADMINISTRATION

FOR ORAL USE ONLY. NOT FOR INJECTION.

The vaccination series consists of three ready-to-use liquid doses of RotaTeq (rotavirus vaccine, live, oral, pentavalent) administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age [see Clinical Studies].

There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Do not mix the RotaTeq (rotavirus vaccine, live, oral, pentavalent) vaccine with any other vaccines or solutions. Do not reconstitute or dilute [see DOSAGE AND ADMINISTRATION].

For storage instructions [see How Supplied/Storage and Handling].

Each dose is supplied in a container consisting of a squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch [see DOSAGE AND ADMINISTRATION].

Use with Other Vaccines

In clinical trials, RotaTeq (rotavirus vaccine, live, oral, pentavalent) was administered concomitantly with other licensed pediatric vaccines [see ADVERSE REACTIONS , DRUG INTERACTIONS, and Clinical Studies].

Instructions For Use

To administer the vaccine:

Tear open the pouch and remove the dosing tube.

Instructions For Use - Illustration 1

Clear the fluid from the dispensing tip by holding tube vertically and tapping cap.

Instructions For Use - Illustration 2

Open the dosing tube in 2 easy motions:

1. Puncture the dispensing tip by screwing cap clockwise until it becomes tight.

Instructions For Use - Illustration 3

2. Remove cap by turning it counterclockwise.

Instructions For Use - Illustration 4

Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.)

If for any reason an incomplete dose is administered (e.g., infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series.

Discard the empty tube and cap in approved biological waste containers according to local regulations.

Instructions For Use - Illustration 5

HOW SUPPLIED

Dosage Forms And Strengths

RotaTeq (rotavirus vaccine, live, oral, pentavalent) , 2 mL for oral use, is a ready-to-use solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A[8] which contains a minimum of 2.0 - 2.8 x 106 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 106 IU per aggregate dose.

Each dose is supplied in a container consisting of a squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch.

Storage And Handling

No. 4047 - RotaTeq (rotavirus vaccine, live, oral, pentavalent) , 2 mL, a solution for oral use, is a pale yellow clear liquid that may have a pink tint. It is supplied as follows:

NDC 0006-4047-31 package of 1 individually pouched single-dose tube

NDC 0006-4047-41 package of 10 individually pouched single-dose tubes.

Storage and Handling

Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq (rotavirus vaccine, live, oral, pentavalent) should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.

Protect from light.

RotaTeq (rotavirus vaccine, live, oral, pentavalent) should be discarded in approved biological waste containers according to local regulations.

The product must be used before the expiration date.

REFERENCES

3. Parashar UD et al. Global illness and deaths caused by rotavirus disease in children. Emerg Infect Dis 2003;9(5):565-572.

4. Parashar UD, Holman RC, Clarke MJ, Bresee JS, Glass RI. Hospitalizations associated with rotavirus diarrhea in the United States, 1993 through 1995: surveillance based on the new ICD-9-CM rotavirus-specific diagnostic code. J Infect Dis 1998;177:13-7.

1Registered trademark of MERCK & CO., Inc., Whitehouse Station, New Jersey 08889 USA COPYRIGHT © 2006, 2007 MERCK & CO., Inc. All rights reserved

Issued April 2008. MERCK & Co., Inc., Whitehouse Station, NJ, 08889, USA. FDA rev date: 04/30/08

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Clinical Studies Experience

71,725 infants were evaluated in 3 placebo-controlled clinical trials including 36,165 infants in the group that received RotaTeq (rotavirus vaccine, live, oral, pentavalent) and 35,560 infants in the group that received placebo. Parents/guardians were contacted on days 7, 14, and 42 after each dose regarding intussusception and any other serious adverse events. The racial distribution was as follows: White (69% in both groups); Hispanic-American (14% in both groups); Black (8% in both groups); Multiracial (5% in both groups); Asian (2% in both groups); Native American (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 2%, placebo 1%); and Other ( < 1% in both groups). The gender distribution was 51% male and 49% female in both vaccination groups.

Because clinical trials are conducted under conditions that may not be typical of those observed in clinical practice, the adverse reaction rates presented below may not be reflective of those observed in clinical practice.

Serious Adverse Events

Serious adverse events occurred in 2.4% of recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) when compared to 2.6% of placebo recipients within the 42-day period of a dose in the phase 3 clinical studies of RotaTeq (rotavirus vaccine, live, oral, pentavalent) . The most frequently reported serious adverse events for RotaTeq (rotavirus vaccine, live, oral, pentavalent) compared to placebo were:

bronchiolitis (0.6% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.7% Placebo),
gastroenteritis (0.2% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.3% Placebo),
pneumonia (0.2% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.2% Placebo),
fever (0.1% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.1% Placebo), and
urinary tract infection (0.1% RotaTeq (rotavirus vaccine, live, oral, pentavalent) vs. 0.1% Placebo).

Deaths

Across the clinical studies, 52 deaths were reported. There were 25 deaths in the RotaTeq (rotavirus vaccine, live, oral, pentavalent) recipients compared to 27 deaths in the placebo recipients. The most commonly reported cause of death was sudden infant death syndrome, which was observed in 8 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) and 9 placebo recipients.

Intussusception

In REST, 34,837 vaccine recipients and 34,788 placebo recipients were monitored by active surveillance to identify potential cases of intussusception at 7, 14, and 42 days after each dose, and every 6 weeks thereafter for 1 year after the first dose.

For the primary safety outcome, cases of intussusception occurring within 42 days of any dose, there were 6 cases among RotaTeq (rotavirus vaccine, live, oral, pentavalent) recipients and 5 cases among placebo recipients (see Table 1). The data did not suggest an increased risk of intussusception relative to placebo.

Table 1: Confirmed cases of intussusception in recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) as compared with placebo recipients during REST

  RotaTeq (n=34,837) Placebo
(n=34,788)
Confirmed intussusception cases within 42 days of any dose
Relative risk (95% CI) *
6 5
1.6 (0.4, 6.4)
Confirmed intussusception cases within 365 days of dose 1
Relative risk (95% CI)
13 15
0.9 (0.4, 1.9)
*Relative risk and 95% confidence interval based upon group sequential design stopping criteria employed in REST.

Among vaccine recipients, there were no confirmed cases of intussusception within the 42-day period after the first dose, which was the period of highest risk for the rhesus rotavirus-based product (see Table 2).

Table 2: Intussusception cases by day range in relation to dose in REST

Day Range Dose1 Dose 2 Dose 3 Any Dose
RotaTeq Placebo RotaTeq Placebo RotaTeq Placebo RotaTeq Placebo
1-7 0 0 1 0 0 0 1 0
1-14 0 0 1 0 0 1 1 1
1-21 0 0 3 0 0 1 3 1
1-42 0 1 4 1 2 3 6 5

All of the children who developed intussusception recovered without sequelae with the exception of a 9-month-old male who developed intussusception 98 days after dose 3 and died of post-operative sepsis. There was a single case of intussusception among 2,470 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in a 7-month-old male in the phase 1 and 2 studies (716 placebo recipients).

Hematochezia

Hematochezia reported as an adverse experience occurred in 0.6% (39/6,130) of vaccine and 0.6% (34/5,560) of placebo recipients within 42 days of any dose. Hematochezia reported as a serious adverse experience occurred in < 0.1% (4/36,150) of vaccine and < 0.1% (7/35,536) of placebo recipients within 42 days of any dose.

Seizures

All seizures reported in the phase 3 trials of RotaTeq (rotavirus vaccine, live, oral, pentavalent) (by vaccination group and interval after dose) are shown in Table 3.

Table 3: Seizures reported by day range in relation to any dose in the phase 3 trials of RotaTeq (rotavirus vaccine, live, oral, pentavalent)

Day range 1-7 1-14 1-42
RotaTeq 10 15 33
Placebo 5 8 24

Seizures reported as serious adverse experiences occurred in < 0.1% (27/36,150) of vaccine and < 0.1% (18/35,536) of placebo recipients (not significant). Ten febrile seizures were reported as serious adverse experiences, 5 were observed in vaccine recipients and 5 in placebo recipients.

Kawasaki Disease

In the phase 3 clinical trials, infants were followed for up to 42 days of vaccine dose. Kawasaki disease was reported in 5 of 36,150 vaccine recipients and in 1 of 35,536 placebo recipients with unadjusted relative risk 4.9 (95% CI 0.6, 239.1).

Most Common Adverse Events

Solicited Adverse Events

Detailed safety information was collected from 11,711 infants (6,138 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) ) which included a subset of subjects in REST and all subjects from Studies 007 and 009 (Detailed Safety Cohort). A Vaccination Report Card was used by parents/guardians to record the child's temperature and any episodes of diarrhea and vomiting on a daily basis during the first week following each vaccination. Table 4 summarizes the frequencies of these adverse events and irritability.

Table 4: Solicited adverse experiences within the first week after doses 1, 2, and 3 (Detailed Safety Cohort)

Adverse experience
Dose 1 Dose 2 Dose 3
RotaTeq
n=5,616
Placebo
n=5,077
RotaTeq
n=5,215
Placebo
n=4,725
RotaTeq
n=4,865
Placebo
n=4,382
Elevated temperature* 17.1% 16.2% 20.0% 19.4% 18.2% 17.6%
n=6,130 n=5,560 n=5,703 n=5,173 n=5,496 n=4,989
Vomiting 6.7% 5.4% 5.0% 4.4% 3.6% 3.2%
Diarrhea 10.4% 9.1% 8.6% 6.4% 6.1% 5.4%
Irritability 7.1% 7.1% 6.0% 6.5% 4.3% 4.5%
*Temperature ≥ 100.5°F [38.1°C] rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures

Other Adverse Events

Parents/guardians of the 11,711 infants were also asked to report the presence of other events on the Vaccination Report Card for 42 days after each dose.

Fever was observed at similar rates in vaccine (N=6,138) and placebo (N=5,573) recipients (42.6% vs. 42.8%). Adverse events that occurred at a statistically higher incidence (i.e., 2-sided p-value < 0.05) within the 42 days of any dose among recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) as compared with placebo recipients are shown in Table 5.

Table 5: Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) as compared with placebo recipients

Adverse event RotaTeq (rotavirus vaccine, live, oral, pentavalent)
N=6,138
n (%)
Placebo
N=5,573
n (%)
Diarrhea 1,479 (24.1%) 1,186 (21.3%)
Vomiting 929 (15.2%) 758 (13.6%)
Otitis media 887 (14.5%) 724 (13.0%)
Nasopharyngitis 422 (6.9%) 325 (5.8%)
Bronchospasm 66 (1.1%) 40 (0.7%)

Safety in Pre-Term Infants

RotaTeq (rotavirus vaccine, live, oral, pentavalent) or placebo was administered to 2,070 pre-term infants (25 to 36 weeks gestational age, median 34 weeks) according to their age in weeks since birth in REST. All pre-term infants were followed for serious adverse experiences; a subset of 308 infants was monitored for all adverse experiences. There were 4 deaths throughout the study, 2 among vaccine recipients (1 SIDS and 1 motor vehicle accident) and 2 among placebo recipients (1 SIDS and 1 unknown cause). No cases of intussusception were reported. Serious adverse experiences occurred in 5.5% of vaccine and 5.8% of placebo recipients. The most common serious adverse experience was bronchiolitis, which occurred in 1.4% of vaccine and 2.0% of placebo recipients. Parents/guardians were asked to record the child's temperature and any episodes of vomiting and diarrhea daily for the first week following vaccination. The frequencies of these adverse experiences and irritability within the week after dose 1 are summarized in Table 6.

Table 6: Solicited adverse experiences within the first week of doses 1, 2, and 3 among pre-term infants

Adverse event Dose 1 Dose 2 Dose 3
RotaTeq
N=127
Placebo
N=133
RotaTeq
N=124
Placebo
N=121
RotaTeq
N=115
Placebo
N=108
Elevated temperature* 18.1% 17.3% 25.0% 28.1% 14.8% 20.4%
N=154 N=154 N=137 N=137 N=135 N=129
Vomiting 5.8% 7.8% 2.9% 2.2% 4.4% 4.7%
Diarrhea 6.5% 5.8% 7.3% 7.3% 3.7% 3.9%
Irritability 3.9% 5.2% 2.9% 4.4% 8.1% 5.4%
*Temperature 100.5°F [38.1°C] rectal equivalent obtained by adding 1 degree F to otic and oral temperatures and 2 degrees F to axillary temperatures

Post-Marketing Experience

The following adverse events have been identified during post-approval use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) from reports to the Vaccine Adverse Event Reporting System (VAERS).

Reporting of adverse events following immunization to VAERS is voluntary, and the number of doses of vaccine administered is not known; therefore, it is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to vaccine exposure using VAERS data.

In post-marketing experience, the following adverse events have been reported in infants who have received RotaTeq (rotavirus vaccine, live, oral, pentavalent) :

Gastrointestinal disorders

Intussusception (including death)
Hematochezia

Skin and subcutaneous tissue disorders

Urticaria

Infections and infestations

Kawasaki disease

Reporting Adverse Events

Parents or guardians should be instructed to report any adverse reactions to their health care provider.

Health care providers should report all adverse events to the U.S. Department of Health and Human Services' Vaccine Adverse Events Reporting System (VAERS).

VAERS accepts all reports of suspected adverse events after the administration of any vaccine, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine reporting form, call the VAERS toll-free number at 1-800-822-7967 or report on line to www.vaers.hhs.gov.2

Read the RotaTeq (rotavirus vaccine, live, oral, pentavalent) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Immunosuppressive therapies including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.

Concomitant Vaccine Administration

In clinical trials, RotaTeq (rotavirus vaccine, live, oral, pentavalent) was administered concomitantly with diphtheria and tetanus toxoids and acellular pertussis (DTaP), inactivated poliovirus vaccine (IPV), H. influenzae type b conjugate (Hib), hepatitis B vaccine, and pneumococcal conjugate vaccine [see Clinical Studies]. The safety data available are in the ADVERSE REACTIONS section [see ADVERSE REACTIONS].

There was no evidence for reduced antibody responses to the diphtheria or tetanus toxoid components of DTaP or to the other vaccines that were concomitantly administered with RotaTeq (rotavirus vaccine, live, oral, pentavalent) . However, insufficient immunogenicity data are available to confirm lack of interference of immune responses when RotaTeq (rotavirus vaccine, live, oral, pentavalent) is concomitantly administered with childhood vaccines to prevent pertussis.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Immunocompromised Populations

No safety or efficacy data are available for the administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to infants who are potentially immunocompromised including:

  • Infants with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system.
  • Infants on immunosuppressive therapy (including high-dose systemic corticosteroids). RotaTeq (rotavirus vaccine, live, oral, pentavalent) may be administered to infants who are being treated with topical corticosteroids or inhaled steroids.
  • Infants with primary and acquired immunodeficiency states, including HIV/AIDS or other clinical manifestations of infection with human immunodeficiency viruses; cellular immune deficiencies; and hypogammaglobulinemic and dysgammaglobulinemic states. There are insufficient data from the clinical trials to support administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to infants with indeterminate HIV status who are born to mothers with HIV/AIDS.
  • Infants who have received a blood transfusion or blood products, including immunoglobulins within 42 days.

No data are available regarding potential vaccine virus transmission from vaccine recipient to non-vaccinated household or other contacts [see WARNINGS AND PRECAUTIONS].

Gastrointestinal Illness

No safety or efficacy data are available for administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to infants with a history of gastrointestinal disorders including infants with active acute gastrointestinal illness, infants with chronic diarrhea and failure to thrive, and infants with a history of congenital abdominal disorders, abdominal surgery, and intussusception. Caution is advised when considering administration of RotaTeq (rotavirus vaccine, live, oral, pentavalent) to these infants.

Intussusception

Following administration of a previously licensed live rhesus rotavirus-based vaccine, an increased risk of intussusception was observed.1 In the Rotavirus Efficacy and Safety Trial [REST] (n=69,625), the data did not show an increased risk of intussusception for RotaTeq (rotavirus vaccine, live, oral, pentavalent) when compared to placebo. In post-marketing experience, cases of intussusception have been reported in temporal association with RotaTeq. [See ADVERSE REACTIONS.]

Shedding and Transmission

Shedding was evaluated among a subset of subjects in REST 4 to 6 days after each dose and among all subjects who submitted a stool antigen rotavirus positive sample at any time. RotaTeq (rotavirus vaccine, live, oral, pentavalent) was shed in the stools of 32 of 360 [8.9%, 95% CI (6.2%, 12.3%)] vaccine recipients tested after dose 1; 0 of 249 [0.0%, 95% CI (0.0%, 1.5%)] vaccine recipients tested after dose 2; and in 1 of 385 [0.3%, 95% CI ( < 0.1%, 1.4%)] vaccine recipients after dose 3. In phase 3 studies, shedding was observed as early as 1 day and as late as 15 days after a dose. Transmission was not evaluated.

Caution is advised when considering whether to administer RotaTeq (rotavirus vaccine, live, oral, pentavalent) to individuals with immunodeficient close contacts such as:

  • Individuals with malignancies or who are otherwise immunocompromised; or
  • Individuals receiving immunosuppressive therapy.

RotaTeq (rotavirus vaccine, live, oral, pentavalent) is a solution of live reassortant rotaviruses and can potentially be transmitted to persons who have contact with the vaccine. The potential risk of transmission of vaccine virus should be weighed against the risk of acquiring and transmitting natural rotavirus.

Febrile Illness

Febrile illness may be reason for delaying use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) except when, in the opinion of the physician, withholding the vaccine entails a greater risk. Low-grade fever ( ≤ 100.5°F [38.1°C]) itself and mild upper respiratory infection do not preclude vaccination with RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Incomplete Regimen

The clinical studies were not designed to assess the level of protection provided by only one or two doses of RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Limitations of Vaccine Effectiveness

RotaTeq (rotavirus vaccine, live, oral, pentavalent) may not protect all vaccine recipients against rotavirus.

Post-Exposure Prophylaxis

No clinical data are available for RotaTeq (rotavirus vaccine, live, oral, pentavalent) when administered after exposure to rotavirus.

Patient Counseling Information

[See FDA-Approved Patient Labeling .]

Information for Parents/Guardians

Parents or guardians should be given a copy of the required vaccine information and be given the “Patient Information” appended to this insert. Parents and/or guardians should be encouraged to read the patient information that describes the benefits and risks associated with the vaccine and ask any questions they may have during the visit. See PRECAUTIONS and PATIENT INFORMATION.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

RotaTeq (rotavirus vaccine, live, oral, pentavalent) has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with RotaTeq (rotavirus vaccine, live, oral, pentavalent) . It is also not known whether RotaTeq (rotavirus vaccine, live, oral, pentavalent) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RotaTeq (rotavirus vaccine, live, oral, pentavalent) is not indicated in women of child-bearing age and should not be administered to pregnant females.

Pediatric Use

Safety and efficacy have not been established in infants less than 6 weeks of age or greater than 32 weeks of age.

Data are available from clinical studies to support the use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in pre-term infants according to their age in weeks since birth [see ADVERSE REACTIONS].

Data are available from clinical studies to support the use of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in infants with controlled gastroesophageal reflux disease.

1. Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564-572.

2. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). MMWR 2002;51(RR-2):1-35.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

A demonstrated history of hypersensitivity to any component of the vaccine.

Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) should not receive further doses of RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Rotavirus is a leading cause of severe acute gastroenteritis in infants and young children, with over 95% of these children infected by the time they are 5 years old.3 The most severe cases occur among infants and young children between 6 months and 24 months of age.4

Mechanism of Action

The exact immunologic mechanism by which RotaTeq (rotavirus vaccine, live, oral, pentavalent) protects against rotavirus gastroenteritis is unknown [see Clinical Studies]. RotaTeq (rotavirus vaccine, live, oral, pentavalent) is a live viral vaccine that replicates in the small intestine and induces immunity.

Clinical Studies

Overall, 72,324 infants were randomized in 3 placebo-controlled, phase 3 studies conducted in 11 countries on 3 continents. The data demonstrating the efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in preventing rotavirus gastroenteritis come from 6,983 of these infants from the US (including Navajo and White Mountain Apache Nations) and Finland who were enrolled in 2 of these studies: REST and Study 007. The third trial, Study 009, provided clinical evidence supporting the consistency of manufacture and contributed data to the overall safety evaluation.

The racial distribution of the efficacy subset was as follows: White (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 68%, placebo 69%); Hispanic-American (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 10%, placebo 9%); Black (2% in both groups); Multiracial (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 4%, placebo 5%); Asian ( < 1% in both groups); Native American (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 15%, placebo 14%); and Other ( < 1% in both groups). The gender distribution was 52% male and 48% female in both vaccination groups.

The efficacy evaluations in these studies included: 1) Prevention of any grade of severity of rotavirus gastroenteritis; 2) Prevention of severe rotavirus gastroenteritis, as defined by a clinical scoring system; and 3) Reduction in hospitalizations due to rotavirus gastroenteritis.

The vaccine was given as a three-dose series to healthy infants with the first dose administered between 6 and 12 weeks of age and followed by two additional doses administered at 4- to 10-week intervals. The age of infants receiving the third dose was 32 weeks of age or less. Oral polio vaccine administration was not permitted; however, other childhood vaccines could be concomitantly administered. Breast-feeding was permitted in all studies.

The case definition for rotavirus gastroenteritis used to determine vaccine efficacy required that a subject meet both of the following clinical and laboratory criteria: (1) greater than or equal to 3 watery or looser-than-normal stools within a 24-hour period and/or forceful vomiting; and (2) rotavirus antigen detection by enzyme immunoassay (EIA) in a stool specimen taken within 14 days of onset of symptoms. The severity of rotavirus acute gastroenteritis was determined by a clinical scoring system that took into account the intensity and duration of symptoms of fever, vomiting, diarrhea, and behavioral changes.

The primary efficacy analyses included cases of rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 that occurred at least 14 days after the third dose through the first rotavirus season post vaccination.

Analyses were also done to evaluate the efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 at any time following the first dose through the first rotavirus season postvaccination among infants who received at least one vaccination (Intent-to-treat, ITT).

Rotavirus Efficacy and Safety Trial

Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 74.0% (95% CI: 66.8, 79.9) and the ITT efficacy was 60.0% (95% CI: 51.5, 67.1). Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 98.0% (95% CI: 88.3, 100.0), and ITT efficacy was 96.4% (95% CI: 86.2, 99.6). See Table 8.

Table 8: Efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against any grade of severity of and severe* G1-4 rotavirus gastroenteritis through the first rotavirus season postvaccination in REST

  Per Protocol Intent-to-Treat†
RotaTeq Placebo RotaTeq Placebo
Subjects vaccinated 2,834 2,839 2,834 2,839
  Gastroenteritis cases
Any grade of severity 82 315 150 371
Severe* 1 51 2 55
  Efficacy estimate % and (95% confidence interval)
Any grade of severity 74.0 60.0
(66.8, 79.9) (51.5,67.1)
Severe* 98.0 96.4
(88.3, 100.0) (86.2,99.6)
*Severe gastroenteritis defined by a clinical scoring system based on the intensity and duration of symptoms of fever, vomiting, diarrhea, and behavioral changes
ITT analysis includes all subjects in the efficacy cohort who received at least one dose of vaccine.

The efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against severe disease was also demonstrated by a reduction in hospitalizations for rotavirus gastroenteritis among all subjects enrolled in REST. RotaTeq (rotavirus vaccine, live, oral, pentavalent) reduced hospitalizations for rotavirus gastroenteritis caused by serotypes G1, G2, G3, and G4 through the first two years after the third dose by 95.8% (95% CI: 90.5, 98.2). The ITT efficacy in reducing hospitalizations was 94.7% (95% CI: 89.3, 97.3) as shown in Table 9.

Table 9: Efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in reducing G1-4 rotavirus-related hospitalizations in REST

  Per Protocol Intent-to-Treat*
RotaTeq Placebo RotaTeq Placebo
Subjects vaccinated 34,035 34,003 34,035 34,003
Number of hospitalizations 6 144 10 187
Efficacy estimate % and (95% confidence interval) 95.8
(90.5, 98.2)
  94.7
(89.3, 97.3)
 
*ITT analysis includes all subjects who received at least one dose of vaccine.

Study 007

Primary efficacy against any grade of severity of rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 72.5% (95% CI: 50.6, 85.6) and the ITT efficacy was 58.4% (95% CI: 33.8, 74.5). Primary efficacy against severe rotavirus gastroenteritis caused by naturally occurring serotypes G1, G2, G3, or G4 through the first rotavirus season after vaccination was 100% (95% CI: 13.0, 100.0) and ITT efficacy against severe rotavirus disease was 100%, (95% CI: 30.2, 100.0) as shown in Table 10.

Table 10: Efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against any grade of severity of and severe* G1-4 rotavirus gastroenteritis through the first rotavirus season postvaccination in Study 007

  Per Protocol Intent-to-Treat†
RotaTeq Placebo RotaTeq Placebo
Subjects vaccinated 650 660 650 660
Gastroenteritis cases        
Any grade of severity 15 54 27 64
Severe* 0 6 0 7
Efficacy estimate % and (95% confidence interval)
Any grade of severity 72.5 58.4
(50.6, 85.6) (33.8, 74.5)
Severe* 100.0 100.0
(13.0, 100.0) (30.2, 100.0)
*Severe gastroenteritis defined by a clinical scoring system based on the intensity and duration of symptoms of fever, vomiting, diarrhea, and behavioral change
ITT analysis includes all subjects in the efficacy cohort who received at least one dose of vaccine.

Multiple Rotavirus Seasons

The efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) through a second rotavirus season was evaluated in a single study (REST). Efficacy against any grade of severity of rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, and G4 through the two rotavirus seasons after vaccination was 71.3% (95% CI: 64.7, 76.9). The efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in preventing cases occurring only during the second rotavirus season postvaccination was 62.6% (95% CI: 44.3, 75.4). The efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) beyond the second season postvaccination was not evaluated.

Rotavirus Gastroenteritis Regardless of Serotype

The rotavirus serotypes identified in the efficacy subset of REST and Study 007 were G1P1A[8]; G2P1[4]; G3P1A[8]; G4P1A[8]; and G9P1A[8].

In REST, the efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against any grade of severity of naturally occurring rotavirus gastroenteritis regardless of serotype was 71.8% (95% CI: 64.5, 77.8) and efficacy against severe rotavirus disease was 98.0% (95% CI: 88.3, 99.9). The ITT efficacy starting at dose 1 was 50.9% (95% CI: 41.6, 58.9) for any grade of severity of rotavirus disease and was 96.4% (95% CI: 86.3, 99.6) for severe rotavirus disease.

In Study 007, the primary efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against any grade of severity of rotavirus gastroenteritis regardless of serotype was 72.7% (95% CI: 51.9, 85.4) and efficacy against severe rotavirus disease was 100% (95% CI: 12.7, 100). The ITT efficacy starting at dose 1 was 48.0% (95% CI: 21.6, 66.1) for any grade of severity of rotavirus disease and was 100% (95% CI: 30.4, 100.0) for severe rotavirus disease.

Rotavirus Gastroenteritis by Serotype

The efficacy against any grade of severity of rotavirus gastroenteritis by serotype in the REST efficacy cohort is shown in Table 11.

Table 11: Serotype-specific efficacy of RotaTeq (rotavirus vaccine, live, oral, pentavalent) against any grade of severity of rotavirus gastroenteritis among infants in the REST efficacy cohort through the first rotavirus season postvaccination (Per Protocol)

Serotype identified by PCR Number of cases  
RotaTeq
(N=2,834)
Placebo
(N=2,839)
% Efficacy
(95% Confidence Interval)
Serotypes present in RotaTeq
  G1P1A[8] 72 286 74.9 (67.3, 80.9)
  G2P1[4] 6 17 63.4 (2.6, 88.2)
  G3P1A[8] 1 6 NS
  G4P1A[8] 3 6 NS
Serotypes not present in RotaTeq
  G9P1A[8] 1 3 NS
Unidentified* 11 15 NS
N=number vaccinated
NS=not significant
*Includes rotavirus antigen-positive samples in which the specific serotype could not be identified by PCR

In a separate post hoc analysis of health care utilization data from 68,038 infants (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 34,035 and placebo 34,003) in REST, using a case definition that included culture confirmation, hospitalization and emergency departments visits due to G9P1A[8] rotavirus gastroenteritis were reduced (RotaTeq (rotavirus vaccine, live, oral, pentavalent) 0 cases: placebo 14 cases) by 100% (95% CI: 69.6%, 100.0%).

Immunogenicity

A relationship between antibody responses to RotaTeq (rotavirus vaccine, live, oral, pentavalent) and protection against rotavirus gastroenteritis has not been established. In phase 3 studies, 92.9% to 100% of 439 recipients of RotaTeq (rotavirus vaccine, live, oral, pentavalent) achieved a 3-fold or more rise in serum anti-rotavirus IgA after a three-dose regimen when compared to 12.3%-20.0% of 397 placebo recipients.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

RotaTeq (rotavirus vaccine, live, oral, pentavalent) ®
(pronounced "R -tuh-tek")
rotavirus vaccine, live, oral, pentavalent

Read this information carefully before your child receives each dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in case any information about the vaccine changes. Your child will need 3 doses of the vaccine over the course of a few months. This leaflet is a summary of certain information about RotaTeq (rotavirus vaccine, live, oral, pentavalent) and does not take the place of talking with your child's doctor, who can give you more complete information written for health care professionals.

What is RotaTeq (rotavirus vaccine, live, oral, pentavalent) and How Does it Work?

RotaTeq (rotavirus vaccine, live, oral, pentavalent) helps protect against an infection that nearly all children get called rotavirus. Rotavirus can cause fever, vomiting, and diarrhea which may be severe and can lead to loss of body fluids (dehydration), hospitalization and even death in some children. RotaTeq (rotavirus vaccine, live, oral, pentavalent) may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them.

What should I tell the doctor before my child gets RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

Tell your doctor if your child:

  • Has illness with fever. A mild fever or cold by itself is not reason to delay taking the vaccine.
  • Has diarrhea or has been vomiting.
  • Has not been gaining weight or is not growing as expected.
  • Has a blood disorder.
  • Has any type of cancer.
  • Has a weak immune system because of a disease (this includes HIV/AIDS).
  • Gets treatment or takes medicines that may weaken the immune system (such as high doses of steroids) or has received a blood transfusion or blood products within the past 42 days.
  • Was born with gastrointestinal problems, or has had a blockage or abdominal surgery.
  • Has regular close contact with a member of family or household who has a weak immune system such as someone with cancer or someone taking medicines that weaken their immune system.

What other important information should I know?

Call your child's doctor right away if, following any dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) , your child has vomiting, diarrhea, severe stomach pain, blood in their stool or change in their bowel movements as these may be signs of intussusception. Intussusception is a serious and life-threatening event that occurs when a part of the intestine gets blocked or twisted and it requires immediate medical attention. Intussusception can occur when no vaccine has been given and the cause is usually unknown.

Since FDA approval, reports of infants with intussusception have been received by Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some of these infants required hospitalization and surgery on their intestine or a special enema to treat this problem. Death due to intussusception has also occurred.

Before FDA approval, RotaTeq (rotavirus vaccine, live, oral, pentavalent) was studied in 35,000 infants and no increased risk of intussusception was found compared to 35,000 infants who did not receive RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Contact your doctor if your child has any symptoms of intussusception, even if it has been several weeks since the last vaccine dose.

Who should not receive RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

Your child should not get the vaccine if:

  • He or she had an allergic reaction after getting a dose of this vaccine.
  • He or she is allergic to any of the ingredients of the vaccine. A list of ingredients can be found at the end of this leaflet.

What are the possible side effects of RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

The most common side effects reported after taking RotaTeq (rotavirus vaccine, live, oral, pentavalent) were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection.

Other reported side effects include hives.

These are NOT all the possible side effects of RotaTeq (rotavirus vaccine, live, oral, pentavalent) . You can ask your doctor or health care provider for a more complete list.

If your child seems to be having any side effects that are not mentioned in this leaflet, please call your doctor or other health care provider. If the condition continues or worsens, you should seek medical attention.

You, as a parent or guardian, may also report any adverse reactions to your child's health care provider or directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

Can RotaTeq (rotavirus vaccine, live, oral, pentavalent) be given with other vaccines?

Your child may get RotaTeq (rotavirus vaccine, live, oral, pentavalent) at the same time as other childhood vaccines.

How is RotaTeq (rotavirus vaccine, live, oral, pentavalent) given?

The vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

Your health care provider will gently squeeze the vaccine into your child's mouth (see Figure 1). Your infant may spit out some or all of it. If this happens, the dose does not need to be given again during that visit.

Figure 1:

Your health care provider will gently squeeze the vaccine into your child’s mouth - Illustration 1

What do I do if my child misses a dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your health care provider will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your health care provider for advice.

What else should I know about RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

This leaflet gives a summary of certain information about the vaccine. If you have any questions or concerns about RotaTeq (rotavirus vaccine, live, oral, pentavalent) , talk to your health care provider. You can also visit www.rotateq (rotavirus vaccine, live, oral, pentavalent) .com.

What are the ingredients in RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

Active Ingredient: 5 live rotavirus strains (G1, G2, G3, G4, and P1).

Inactive Ingredients: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

RotaTeq (rotavirus vaccine, live, oral, pentavalent) ®
(pronounced "R -tuh-tek")
rotavirus vaccine, live, oral, pentavalent

Read this information carefully before your child receives each dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) in case any information about the vaccine changes. Your child will need 3 doses of the vaccine over the course of a few months. This leaflet is a summary of certain information about RotaTeq (rotavirus vaccine, live, oral, pentavalent) and does not take the place of talking with your child's doctor, who can give you more complete information written for health care professionals.

What is RotaTeq (rotavirus vaccine, live, oral, pentavalent) and How Does it Work?

RotaTeq (rotavirus vaccine, live, oral, pentavalent) helps protect against an infection that nearly all children get called rotavirus. Rotavirus can cause fever, vomiting, and diarrhea which may be severe and can lead to loss of body fluids (dehydration), hospitalization and even death in some children. RotaTeq (rotavirus vaccine, live, oral, pentavalent) may not fully protect all children that get the vaccine, and if your child already has the virus it will not help them.

What should I tell the doctor before my child gets RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

Tell your doctor if your child:

  • Has illness with fever. A mild fever or cold by itself is not reason to delay taking the vaccine.
  • Has diarrhea or has been vomiting.
  • Has not been gaining weight or is not growing as expected.
  • Has a blood disorder.
  • Has any type of cancer.
  • Has a weak immune system because of a disease (this includes HIV/AIDS).
  • Gets treatment or takes medicines that may weaken the immune system (such as high doses of steroids) or has received a blood transfusion or blood products within the past 42 days.
  • Was born with gastrointestinal problems, or has had a blockage or abdominal surgery.
  • Has regular close contact with a member of family or household who has a weak immune system such as someone with cancer or someone taking medicines that weaken their immune system.

What other important information should I know?

Call your child's doctor right away if, following any dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) , your child has vomiting, diarrhea, severe stomach pain, blood in their stool or change in their bowel movements as these may be signs of intussusception. Intussusception is a serious and life-threatening event that occurs when a part of the intestine gets blocked or twisted and it requires immediate medical attention. Intussusception can occur when no vaccine has been given and the cause is usually unknown.

Since FDA approval, reports of infants with intussusception have been received by Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred days and sometimes weeks after vaccination. Some of these infants required hospitalization and surgery on their intestine or a special enema to treat this problem. Death due to intussusception has also occurred.

Before FDA approval, RotaTeq (rotavirus vaccine, live, oral, pentavalent) was studied in 35,000 infants and no increased risk of intussusception was found compared to 35,000 infants who did not receive RotaTeq (rotavirus vaccine, live, oral, pentavalent) .

Contact your doctor if your child has any symptoms of intussusception, even if it has been several weeks since the last vaccine dose.

Who should not receive RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

Your child should not get the vaccine if:

  • He or she had an allergic reaction after getting a dose of this vaccine.
  • He or she is allergic to any of the ingredients of the vaccine. A list of ingredients can be found at the end of this leaflet.

What are the possible side effects of RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

The most common side effects reported after taking RotaTeq (rotavirus vaccine, live, oral, pentavalent) were diarrhea, vomiting, fever, runny nose and sore throat, wheezing or coughing, and ear infection.

Other reported side effects include hives.

These are NOT all the possible side effects of RotaTeq (rotavirus vaccine, live, oral, pentavalent) . You can ask your doctor or health care provider for a more complete list.

If your child seems to be having any side effects that are not mentioned in this leaflet, please call your doctor or other health care provider. If the condition continues or worsens, you should seek medical attention.

You, as a parent or guardian, may also report any adverse reactions to your child's health care provider or directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-822-7967 or report online to www.vaers.hhs.gov.

Can RotaTeq (rotavirus vaccine, live, oral, pentavalent) be given with other vaccines?

Your child may get RotaTeq (rotavirus vaccine, live, oral, pentavalent) at the same time as other childhood vaccines.

How is RotaTeq (rotavirus vaccine, live, oral, pentavalent) given?

The vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of age.

Your health care provider will gently squeeze the vaccine into your child's mouth (see Figure 1). Your infant may spit out some or all of it. If this happens, the dose does not need to be given again during that visit.

Figure 1:

Your health care provider will gently squeeze the vaccine into your child’s mouth - Illustration 1

What do I do if my child misses a dose of RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your health care provider will tell you when your child should come for the follow-up doses. It is important to keep those appointments. If you forget or are not able to go back at the planned time, ask your health care provider for advice.

What else should I know about RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

This leaflet gives a summary of certain information about the vaccine. If you have any questions or concerns about RotaTeq (rotavirus vaccine, live, oral, pentavalent) , talk to your health care provider. You can also visit www.rotateq (rotavirus vaccine, live, oral, pentavalent) .com.

What are the ingredients in RotaTeq (rotavirus vaccine, live, oral, pentavalent) ?

Active Ingredient: 5 live rotavirus strains (G1, G2, G3, G4, and P1).

Inactive Ingredients: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80 and also fetal bovine serum.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

RotaTeq Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ROTAVIRUS VACCINE - ORAL

(roe-TUH VYE-russ)

COMMON BRAND NAME(S): Rotateq

USES: This medication is a vaccine. It is used to prevent a certain virus infection (rotavirus) in infants and young children. Rotavirus can cause fever, vomiting, and diarrhea. Although nearly all children become infected with this virus before they are 5 years old, some severe cases can lead to a dangerous (rarely fatal) loss of body fluids (dehydration). Most severe cases occur in children between 6 to 24 months old. This vaccine helps the body produce immunity (protection) to prevent infection with rotavirus or to lessen the severity of an infection. Like any vaccine, it may not fully protect your child from rotavirus, and it will not help if your child already has the virus. This vaccine does not prevent fever, vomiting, or diarrhea from other causes.

HOW TO USE: Read the Vaccine Information Statement available from your health care provider before receiving the vaccine. If you have any questions, consult your health care provider.

This vaccine is given by mouth by a health care professional, usually in 2 or 3 separate doses (depending on the brand). The doses are given at least 4 to 10 weeks apart. For the best protection, it is important to receive all scheduled doses.

This vaccine is usually given at the same time as other vaccines.

Disclaimer

RotaTeq Consumer (continued)

SIDE EFFECTS: Mild fever/diarrhea/vomiting may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor immediately if any of these unlikely but serious side effects occur: sudden abdominal pain (persistent crying, especially when abdomen is touched), bloody stools, persistent/high fever greater than 102 degrees F.

A very serious allergic reaction to this vaccine is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

Read the RotaTeq (rotavirus vaccine, live, oral, pentavalent) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before your child takes this vaccine, tell the doctor or pharmacist if your child is allergic to it; or to latex (which may be found in the packaging of some brands); or if he/she has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this vaccine, tell your doctor or pharmacist your child's medical history, especially of: current fever/illness, current vomiting/diarrhea, stomach/intestinal problems (such as blockage, intussusception), not gaining weight/growing as expected, blood cancer (such as leukemia, lymphoma), blood disorders (such as hemophilia), immune system problems (such as HIV/AIDS, SCID).

Family or household members with cancer or weakened immune systems may rarely become infected with this virus if they have regular close contact with a child who takes this vaccine. People in close contact with your child should practice good hygiene such as washing hands thoroughly after diaper changes and feedings. Consult the doctor for more details.

This vaccine is not used in adults. Therefore, it is unlikely to be used during pregnancy or by a mother while breast-feeding. Consult the doctor if you have any questions about this vaccine.

Disclaimer

RotaTeq Consumer (continued)

DRUG INTERACTIONS: The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring your child for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this vaccine, tell the doctor or pharmacist of all prescription and nonprescription/herbal products your child may use, especially of: corticosteroids taken by mouth or given by injection (such as dexamethasone), drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy), recent blood transfusion or use of blood products (such as immunoglobulins).

This document does not contain all possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products your child uses. Keep a list of the medications with you, and share the list with the doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Keep all regular medical and laboratory appointments.

MISSED DOSE: It is important that your child receives each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember. If an appointment is missed, contact the doctor for advice.

STORAGE: Refrigerate between 36-46 degrees F (2-8 degrees C). Do not freeze. Discard the product if it has been frozen. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult the pharmacist or local waste disposal company for more details about how to safely discard this product.

Information last revised July 2011. Copyright(c) 2011 First Databank, Inc.

RotaTeq Patient Information Including Side Effects

Brand Names: Rotarix, RotaTeq

Generic Name: rotavirus vaccine, live (oral) (Pronunciation: ROE ta vye ris VAX een)

What is rotavirus oral vaccine (RotaTeq)?

Rotavirus oral vaccine contains up to five strains of rotavirus. It is made from both human and animal sources.

Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness.

The rotavirus oral vaccine is used to help prevent this disease in children.

This vaccine works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Rotavirus oral vaccine is for use in children between the ages of 6 weeks and 32 weeks old.

Like any vaccine, the rotavirus oral vaccine may not provide protection from disease in every person.

What are the possible side effects of rotavirus oral vaccine (RotaTeq)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects. Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if the child has a serious side effect such as:

  • seizure (black-out or convulsions);
  • severe or ongoing diarrhea;
  • dark red stools;
  • fever, chills, cough with yellow or green mucus;
  • stabbing chest pain, chest tightness, wheezing, feeling short of breath;
  • stomach pain, weakness, loss of appetite, vomiting;
  • ear pain, swelling, or drainage;
  • runny or stuffy nose, sore throat;
  • pain or burning when you urinate; or
  • high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips.

Other less serious side effects are more likely to occur, such as crying or mild irritability.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

Read the RotaTeq (rotavirus vaccine, live, oral, pentavalent) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about rotavirus oral vaccine (RotaTeq)?

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, or if the child has severe combined immunodeficiency disease (SCID). This vaccine should not be given if the child has a history of an intestinal problem called intussusception (in-tuh-suh-SEP-shun).

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Before your child receives this vaccine, tell the doctor if your child has recently had a fever. Also tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives a booster dose, you will need to tell the doctor if the previous dose caused any side effects.

Be sure your child receives all recommended doses of this vaccine. Your child may not be protected from rotavirus if the doses aren't given within 4 to 10 weeks of each other, or if the child does not receive the full series of vaccines.

Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

Call your doctor as soon as possible if your child (after receiving a rotavirus oral vaccine) has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.

Becoming infected with rotavirus is much more dangerous to your child's health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

Side Effects Centers

RotaTeq Patient Information including How Should I Take

What should I discuss with my health care provider before receiving rotavirus oral vaccine (RotaTeq)?

Your child should not receive this vaccine if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, or if the child has severe combined immunodeficiency disease (SCID).

If your child has any of these other conditions, this vaccine may need to be postponed or not given at all:

  • HIV or AIDS;
  • a current stomach illness or diarrhea;
  • a congenital stomach disorder or recent stomach surgery;
  • leukemia or other blood disease;
  • if the child is allergic to latex rubber; or
  • if the child has recently received a blood transfusion.

Rotavirus oral vaccine may cause intussusception in some people. Intussusception is when a section of the intestine folds over into itself, creating an obstruction in the bowel. Call your doctor as soon as possible if your child has stomach pain or bloating, vomiting (especially if it is golden-brown to green in color), bloody stools, grunting or excessive crying, and eventually weakness and shallow breathing.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving this vaccine.

Tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving treatments that can weaken the immune system (such as radiation, chemotherapy, or steroids).

How is rotavirus oral vaccine given (RotaTeq)?

Your child will receive this vaccine in a clinic, hospital, or doctor's office. The rotavirus oral vaccine is given as an oral (by mouth) liquid.

The RotaTeq brand of rotavirus oral vaccine is given in a series of 3 doses. The first dose is usually given when the child is 6 to 12 weeks old. The booster doses are then given at 4-week to 10-week intervals before the child reaches 32 weeks of age.

The Rotarix brand of rotavirus oral vaccine is given in a series of 2 doses. The first dose is usually given when the child is 6 weeks old. The second dose is then given at least 4 weeks after the first dose, but before the child reaches 24 weeks of age.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Tell your doctor if your child spits up or vomits within 1 or 2 hours after receiving rotavirus oral vaccine. The child may need to receive a replacement dose to be fully protected from rotavirus.

Always wash your hands after handling the diapers of a child who has been given the rotavirus oral vaccine. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

Side Effects Centers

RotaTeq Patient Information including If I Miss a Dose

What happens if I miss a dose (RotaTeq)?

Contact your doctor if you miss a booster dose or if you get behind schedule. Your child may not be protected from rotavirus if the doses aren't given within 10 weeks of each other. Be sure your child receives all recommended doses of this vaccine.

What happens if I overdose (RotaTeq)?

An overdose of this vaccine is unlikely to occur.

What should I avoid after receiving rotavirus oral vaccine (RotaTeq)?

Avoid receiving the doses of this vaccine in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect rotavirus oral vaccine (RotaTeq)?

Before receiving this vaccine, tell the doctor about all other vaccines your child has received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • chemotherapy or radiation;
  • medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, such as azathioprine (Imuran), efalizumab (Raptiva), etanercept (Enbrel), leflunomide (Arava), and others; or
  • medicines to treat or prevent organ transplant rejection, such as basiliximab (Simulect), cyclosporine (Sandimmune, Neoral, Gengraf), muromonab-CD3 (Orthoclone), mycophenolate mofetil (CellCept), sirolimus (Rapamune), or tacrolimus (Prograf).

If your child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete and other drugs may interact with this vaccine. Tell your doctor about all medications your child receives. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about this vaccine. Additional information is available from your local health department or the Centers for Disease Control and Prevention.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 6.01. Revision date: 8/12/2011.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com