Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)
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Daptacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

DAPTACEL
(diphtheria and tetanus toxoids and acellular pertussis Vaccine Adsorbed) Suspension for Intramuscular Injection

DRUG DESCRIPTION

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is a sterile isotonic suspension of pertussis antigens and diphtheria and tetanus toxoids adsorbed on aluminum phosphate, for intramuscular injection.

Each 0.5 mL dose contains diphtheria and tetanus toxoids and acellular pertussis antigens (detoxified PT, FHA, PRN and FIM). [See Dosage Forms and Strengths.]

Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg of aluminum) as the adjuvant, ≤ 5 µg residual formaldehyde, < 50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The vial stopper is composed of dry natural latex rubber.

The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (3) modified by the addition of casamino acids and dimethyl-beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. The FIM components are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde. FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed separately onto aluminum phosphate.

Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (5) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.

The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection.

Both diphtheria and tetanus toxoids induce at least 2 units of antitoxin per mL in the guinea pig potency test. The potency of the acellular pertussis vaccine components is determined by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) ® is a vaccine indicated for active immunization against diphtheria, tetanus and pertussis as a five-dose series in infants and children 6 weeks through 6 years of age (prior to seventh birthday).

DOSAGE AND ADMINISTRATION

Immunization Series

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is to be administered as a 5 dose series at 2, 4 and 6 months of age (at intervals of 6-8 weeks), at 15-20 months of age and at 4-6 years of age. The first dose may be given as early as 6 weeks of age. Four doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine constitute a primary immunization course for pertussis. The fifth dose is a booster for pertussis immunization. Three doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine constitute a primary immunization course for diphtheria and tetanus. The fourth and fifth doses are boosters for diphtheria and tetanus immunization. [See Clinical Studies.]

Data are not available on the safety and immunogenicity of using mixed sequences of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine and DTaP vaccines from different manufacturers for successive doses of the DTaP vaccination series. DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine may be used to complete the immunization series in infants who have received 1 or more doses of whole-cell pertussis DTP. However, the safety and efficacy of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in such infants have not been fully demonstrated.

If a decision is made to withhold any recommended dose of pertussis vaccine, [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS], Diphtheria and Tetanus Toxoids Adsorbed For Pediatric Use (DT) should be administered.

Administration

Just before use, shake the vial well, until a uniform, white, cloudy suspension results. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, the product should not be administered.

When withdrawing a dose from a rubber-stoppered vial, do not remove either the rubber stopper or the metal seal holding it in place.

Each 0.5 mL dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is to be administered intramuscularly. In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine should not be combined through reconstitution or mixed with any other vaccine.

HOW SUPPLIED

Dosage Forms And Strengths

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is a suspension for injection in 0.5 mL single dose vials. Each 0.5 mL dose contains 15 Lf diphtheria toxoid, 5 Lf tetanus toxoid and acellular pertussis antigens [10 µg detoxified pertussis toxin (PT), 5 µg filamentous hemagglutinin (FHA), 3 µg pertactin (PRN), and 5 µg fimbriae types 2 and 3 (FIM)]. [See DESCRIPTION]

Vial, 1 Dose (1 per package) - NDC No. 49281-286-01
Vial, 1 Dose (5 per package) - NDC No. 49281-286-05
Vial, 1 Dose (10 per package) - NDC No. 49281-286-10

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine should be stored at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product which has been exposed to freezing should not be used. Do not use after expiration date shown on the label.

Manufactured by: Sanofi Pasteur Limited, Toronto, Ontario, Canada. Distributed by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA. Product information as of March 2008.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Data from Clinical Studies

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

A total of 17,577 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine have been administered to infants and children in 8 clinical studies. In all, 4,998 children received 3 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 1,725 of these children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, and 485 of these children received 5 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

In a randomized, double-blinded pertussis vaccine efficacy trial, the Sweden I Efficacy Trial, conducted in Sweden during 1992-1995, the safety of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was compared with DT and a whole-cell pertussis DTP vaccine. A standard diary card was kept for 14 days after each dose and follow-up telephone calls were made 1 and 14 days after each injection. Telephone calls were made monthly to monitor the occurrence of severe events and/or hospitalizations for the 2 months after the last injection. There were fewer of the solicited common local and systemic reactions following DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine than following the whole-cell pertussis DTP vaccine. As shown in Table 1, the 2,587 infants who received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4 and 6 months of age had similar rates of reactions within 24 hours as recipients of DT and significantly lower rates than infants receiving whole-cell pertussis DTP.

Table 1: Percentage of Infants from Sweden I Efficacy Trial with Local or Systemic Reactions within 24 Hours Post-Dose 1, 2 and 3 of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine compared with DT and Whole-Cell Pertussis DTP Vaccines

EVENT Dose 1
(2 MONTHS)
Dose 2
(4 MONTHS)
Dose 3
(6 MONTHS)
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,587
DT
N =2,574
DTP
N =2,102
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,563
DT
N =2,555
DTP
N =2,040
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,549
DT
N =2,538
DTP
N =2,001
Local
  Tenderness (Any) 8.0* 8.4 59.5 10.1* 10.3 60.2 10.8* 10.0 50.0
  Redness ≥ 2 cm 0.3* 0.3 6.0 1.0* 0.8 5.1 3.7* 2.4 6.4
  Swelling ≥ 2 cm 0.9* 0.7 10.6 1.6* 2.0 10.0 6.3* 3.9 10.5
Systemic
  Fever 7.8* 7.6 72.3 19.1* 18.4 74.3 23.6* 22.1 65.1
   ≥ 38°C (100.4°F) Fretfulness§ 32.3 33.0 82.1 39.6 39.8 85.4 35.9 37.7 73.0
  Anorexia 11.2* 10.3 39.2 9.1* 8.1 25.6 8.4* 7.7 17.5
  Drowsiness 32.7* 32.0 56.9 25.9* 25.6 50.6 18.9* 20.6 37.6
  Crying ≥ 1 hour 1.7* 1.6 11.8 2.5* 2.7 9.3 1.2* 1.0 3.3
  Vomiting 6.9* 6.3 9.5 5.2** 5.8 7.4 4.3 5.2 5.5
DT: Swedish National Biologics Laboratories DTP: Sanofi Pasteur Inc.
N = Number of evaluable subjects
* p < 0.001: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine versus whole-cell pertussis DTP
p < 0.0001: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine versus DT
Rectal temperature
§ Statistical comparisons were not made for this variable
** p < 0.003: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine versus whole-cell pertussis DTP

The incidence of serious and less common selected systemic events in the Sweden I Efficacy Trial is summarized in Table 2.

Table 2: Selected Systemic Events: Rates Per 1,000 Doses after Vaccination at 2, 4 and 6 Months of Age in Sweden I Efficacy Trial

EVENT Dose 1
(2 MONTHS)
Dose 2
(4 MONTHS)
Dose 3
(6 MONTHS)
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,587
DT
N =2,574
DTP
N =2,102
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,565
DT
N =2,556
DTP
N =2,040
DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed)
vaccine
N = 2,551
DT
N =2,539
DTP
N =2,002
Rectal temperature ≥ 40°C (104°F) within 48 hours of vaccination 0.39 0.78 3.33 0 0.78 3.43 0.39 1.18 6.99
Hypotonic-hypo-responsive episode within 24 hours of vaccination 0 0 1.9 0 0 0.49 0.39 0 0
Persistent crying ≥ 3 hours within 24 hours of vaccination 1.16 0 8.09 0.39 0.39 1.96 0 0 1.0
Seizures within 72 hours of vaccination 0 0.39 0 0 0.39 0.49 0 0.39 0
N = Number of evaluable subjects

In the Sweden I Efficacy Trial, one case of whole limb swelling and generalized symptoms, with resolution within 24 hours, was observed following dose 2 of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. No episodes of anaphylaxis or encephalopathy were observed. No seizures were reported within 3 days of vaccination with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. Over the entire study period, 6 seizures were reported in the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine group, 9 in the DT group and 3 in the whole-cell pertussis DTP group, for overall rates of 2.3, 3.5 and 1.4 per 1,000 vaccinees, respectively. One case of infantile spasms was reported in the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine group. There were no instances of invasive bacterial infection or death.

In a US study, children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4, 6, and 15-17 months of age. A total of 1,454 children received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine and were included in the safety analyses. Of these, 51.7% were female, 77.2% Caucasian, 6.3% Black, 6.5% Hispanic, 0.9% Asian and 9.1% other races. In a subsequent study, a non-random subset of 485 of these children received a fifth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 4-6 years of age. The children included in the fifth dose study were representative of all children who received four doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the earlier study with regard to frequencies of solicited local and systemic adverse events following the fourth dose. At 2, 4, and 6 months of age, DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with Haemophilus influenzae type b (Hib) conjugate vaccine (tetanus toxoid conjugate) (sanofi pasteur, SA), inactivated poliovirus vaccine (IPV) (sanofi pasteur, SA), and 7-valent pneumococcal conjugate vaccine (Wyeth Pharmaceuticals Inc.). Infants had received the first dose of hepatitis B vaccine at 0 months of age. At 2 and 6 months of age, hepatitis B vaccine (recombinant) (Merck & Co., Inc.) was also administered concomitantly with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. Based on random assignment, the fourth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered either alone; concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine; or concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine, 7-valent pneumococcal conjugate vaccine, measles, mumps, rubella (MMR) vaccine (Merck & Co., Inc.), and varicella vaccine (Merck & Co., Inc.). The fifth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with IPV and MMR vaccine.

In the US studies, the occurrence of solicited local and systemic adverse events listed in Table 3 was recorded daily by parents or guardians for Days 0-7 following vaccination. For Days 0 and 1 following the first three doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, signs and symptoms of HHE also were solicited. Periodic telephone calls were made to inquire about adverse events. Serious adverse events were monitored during the two studies, through 6 months following the fourth and fifth doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, respectively.

The incidence and severity of selected solicited local and systemic adverse events that occurred within 3 days following each dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine are shown in Table 3. The incidence of redness, tenderness and swelling at the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) injection site increased with the fourth and fifth doses, with the highest rates reported after the fifth dose.

Table 3: Number (Percentage) of Children from US Studies with Selected Solicited Local and Systemic Adverse Events by Severity Occurring Between 0 to 3 Days after Each Dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Vaccine

  Dose 1* Dose 2* Dose 3* Dose 4* Dose 5*
N = 1390-1406
%
N = 1346-1360
%
N = 1301-1312
%
N = 1118-1144
%
N = 473-481
%
Injection Site Reactions (DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine injection site)
Redness
   > 5 mm 6.2 7.1 9.6 17.3 35.8
  25 - 50 mm 0.6 0.5 1.9 6.3 10.4
   > 50 mm 0.4 0.1 0.0 3.1 15.8
Swelling
   > 5 mm 4.0 4.0 6.5 11.7 23.9
  25 - 50 mm 1.2 0.6 1.0 3.2 5.8
   > 50 mm 0.4 0.1 0.1 1.6 7.7
Tenderness
  Any 48.8 38.2 40.9 49.5 61.5
  Moderate 16.5 9.9 10.6 12.3 11.2
  Severe 4.1 2.3 1.7 2.2 1.7
Increase in Arm Circumference
   > 5 mm       30.1 38.3
  20 - 40 mm - - - 7.0 14.0
   > 40 mm       0.4 1.5
Interference with Normal Activity of the Arm§
  Any - - - - 20.4
  Moderate         5.6
  Severe         0.4
Systemic Reactions
Fever**
   ≥ 38.0°C 9.3 16.1 15.8 10.5 6.1
   > 38.5-39.5°C 1.5 3.9 4.8 2.7 2.1
   > 39.5°C 0.1 0.4 0.3 0.7 0.2
Decreased Activity/Lethargy††
  Any 51.1 37.4 33.2 25.3 21.0
  Moderate 23.0 14.4 12.1 8.2 5.8
  Severe 1.2 1.4 0.6 1.0 0.8
Inconsolable Crying‡‡
  Any 58.5 51.4 47.9 37.1 14.1
  Moderate 14.2 12.6 10.8 7.7 3.5
  Severe 2.2 3.4 1.4 1.5 0.4
Fussiness/Irritability§§
  Any 75.8 70.7 67.1 54.4 34.9
  Moderate 27.7 25.0 22.0 16.3 7.5
  Severe 5.6 5.5 4.3 3.9 0.4
* In one U.S. study, children received four doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. A non-random subset of these children received a fifth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in a subsequent study.
Doses 1-4 - Moderate: subject cries when site is touched; Severe: subject cries when leg or arm is moved. Dose 5 - Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
The circumference of the DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine-injected arm at the level of the axilla was monitored following the fourth and fifth doses only. Increase in arm circumference was calculated by subtracting the baseline circumference pre-vaccination (Day 0) from the circumference post-vaccination
§ Moderate: decreased use of arm, but did not require medical care or absenteeism; Severe: incapacitating, refusal to move arm, may have/or required medical care or absenteeism.
** For Doses 1-3, 53.7% of temperatures were measured rectally, 45.1% were measured axillary, 1.0% were measured orally, and 0.1% were measured by an unspecified route. For Dose 4, 35.7% of temperatures were measured rectally, 62.3% were measured axillary, 1.5% were measured orally, and 0.5% were measured by an unspecified route. For Dose 5, 0.2% of temperatures were measured rectally, 11.3% were measured axillary, 88.4% were measured orally. Fever is based upon actual temperatures recorded with no adjustments to the measurement for route.
†† Dose 1-4 - Moderate: interferes with and limits daily activity, less interactive; Severe: disabling (not interested in usual daily activity, subject cannot be coaxed to interact with caregiver). Dose 5 - Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
‡‡ Doses 1-4 - Moderate: 1 to 3 hours inconsolable crying; Severe: > 3 hours inconsolable crying. Dose 5 - Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.
§§ Doses 1-4: Moderate: Irritability for 1 to 3 hours; Severe: irritability for > 3 hours. Dose 5: Moderate: interfered with activities, but did not require medical care or absenteeism; Severe: incapacitating, unable to perform usual activities, may have/or required medical care or absenteeism.

In the US study in which children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, of 1,454 subjects who received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 5 (0.3%) subjects experienced a seizure within 60 days following any dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. One seizure occurred within 7 days post-vaccination: an infant who experienced an afebrile seizure with apnea on the day of the first vaccination. Three other cases of seizures occurred between 8 and 30 days post-vaccination. Of the seizures that occurred within 60 days post-vaccination, 3 were associated with fever. In this study, there were no reported cases of HHE following DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. There was one death due to aspiration 222 days post-vaccination in a subject with ependymoma. Within 30 days following any dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 57 (3.9%) subjects reported at least one serious adverse event. During this period, the most frequently reported serious adverse event was bronchiolitis, reported in 28 (1.9%) subjects. Other serious adverse events that occurred within 30 days following DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine include three cases of pneumonia, two cases of meningitis and one case each of sepsis, pertussis (post-dose 1), irritability and unresponsiveness.

In the 5th dose study of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the US, within 30 days following the 5th dose consecutive dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, 1 (0.2%) subject reported 2 serious adverse events (bronchopasm and hypoxia).

In another study (Sweden II Efficacy Trial), 3 DTaP vaccines and a whole-cell pertussis DTP vaccine, none of which are licensed in the US, were evaluated to assess relative safety and efficacy. This study included HCPDT, a vaccine made of the same components as DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine but containing twice the amount of detoxified PT and four times the amount of FHA (20 µg detoxified PT and 20 µg FHA). HHE was observed following 29 (0.047%) of 61,220 doses of HCPDT; 16 (0.026%) of 61,219 doses of an acellular pertussis vaccine made by another manufacturer; and 34 (0.056%) of 60,792 doses of a whole-cell pertussis DTP vaccine. There were 4 additional cases of HHE in other studies using HCPDT vaccine for an overall rate of 33 (0.047%) in 69,525 doses.

Data from Post-Marketing Experience

The following adverse events have been spontaneously reported during the post-marketing use of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the US and other countries. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association to DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

  • Cardiac disorders

Cyanosis

  • Gastro-intestinal disorders

Nausea, diarrhea

  • General disorders and administration site conditions:

Local reactions: injection site pain, injection site rash, injection site nodule, injection site mass, extensive swelling of injected limb (including swelling that involves adjacent joints).

  • Infections and infestations

Injection site cellulitis, cellulitis, injection site abscess

  • Immune system disorders

Hypersensitivity, allergic reaction, anaphylactic reaction (edema, face edema, swelling face, pruritus, rash generalized) and other types of rash (erythematous, macular, maculo-papular)

  • Nervous system disorders

Convulsions: febrile convulsion, grand mal convulsion, partial seizures. HHE, hypotonia, somnolence

  • Psychiatric disorders Screaming

Read the Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Concomitant Administration with Other Vaccines

In clinical trials, DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly with one or more of the following U.S. licensed vaccines: Hib conjugate vaccine, IPV, hepatitis B vaccine, pneumococcal conjugate vaccine, MMR vaccine, and varicella vaccine. [See ADVERSE REACTIONS and Clinical Studies.] When DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is given at the same time as another injectable vaccine(s), the vaccine should be administered with different syringes.

Immunosuppressive Treatments

Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Latex Allergy

The stopper of the vial contains dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.

Management of Acute Allergic Reactions

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Adverse Reactions Following Prior Pertussis Vaccination

If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine should be based on careful consideration of potential benefits and possible risks. (1) [See DOSAGE AND ADMINISTRATION.]

  • Temperature of ≥ 40.5°C (105°F) within 48 hours, not attributable to another identifiable cause.
  • Collapse or shock-like state (hypotonic-hyporesponsive episode (HHE)) within 48 hours.
  • Persistent, inconsolable crying lasting ≥ 3 hours within 48 hours.
  • Seizures with or without fever within 3 days.

Guillain-Barré Syndrome and Brachial Neuritis

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (2) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. (1)

Infants and Children with a History of Previous Seizures

For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever. (1)

Limitations of Vaccine Effectiveness

Vaccination with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine may not protect all individuals.

Altered Immunocompetence

If DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Immunosuppressive Treatments.]

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. It is also not known whether DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

Pediatric Use

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is not indicated for infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in these age groups have not been established.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Hypersensitivity

A severe allergic reaction (eg, anaphylaxis) after a previous dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine or any other tetanus toxoid, diphtheria toxoid, or pertussis-containing vaccine, or any other component of this vaccine is a contraindication to administration of DAPTACEL vaccine. [See DESCRIPTION.] Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

Encephalopathy

Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause is a contraindication to administration of any pertussis-containing vaccine (1), including DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

Progressive Neurologic Disorder

Progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy is a contraindication to administration of any pertussis-containing vaccine (1) including DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine. Pertussis vaccine should not be administered to individuals with such conditions until a treatment regimen has been established and the condition has stabilized. (1)

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Diphtheria

Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. (6) Levels of 1.0 IU/mL have been associated with long-term protection. (7)

Tetanus

Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level. (6) (8) A tetanus antitoxin level ≥ 0.1 IU/mL as measured by the ELISA used in clinical studies of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is considered protective.

Pertussis

Pertussis (whooping cough) is a respiratory disease caused by B pertussis. This Gram-negative coccobacillus produces a variety of biologically active components, though their role in either the pathogenesis of, or immunity to, pertussis has not been clearly defined.

Clinical Studies

Diphtheria

In a US study in which children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4, 6 and 15-17 months of age, after the third dose, 100% (N = 1,099) achieved diphtheria antitoxin levels of ≥ 0.01 IU/mL and 98.5% achieved diphtheria antitoxin levels of ≥ 0.10 IU/mL. Among a random subset of children who received the fourth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 15-16 months of age, 96.5% (N = 659) achieved diphtheria antitoxin levels of ≥ 1.0 IU/mL after the fourth dose.

Tetanus

In a US study in which children received 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4, 6 and 15-17 months of age, after the third dose, 100% (N = 1,037) achieved tetanus antitoxin levels of ≥ 0.10 IU/mL. Among a random subset of children who received the fourth dose of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 15-16 months of age, 98.8% (N = 681) achieved tetanus antitoxin levels of ≥ 1.0 IU/mL after the fourth dose.

Pertussis

A randomized, double-blinded, placebo-controlled efficacy and safety study was conducted in Sweden during 1992-1995 (Sweden I Efficacy Trial) under the sponsorship of the National Institute of Allergy and Infectious Diseases. A total of 9,829 infants received 1 of 4 vaccines: DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine (N = 2,587); another investigational acellular pertussis vaccine (N = 2,566); whole-cell pertussis DTP vaccine (N = 2,102); or DT vaccine as placebo (Swedish National Bacteriological Laboratory, N = 2,574). Infants were immunized at 2, 4 and 6 months of age. The mean length of follow-up was 2 years after the third dose of vaccine. The protective efficacy of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine against pertussis after 3 doses using the World Health Organization (WHO) case definition ( ≥ 21 consecutive days of paroxysmal cough with culture or serologic confirmation or epidemiologic link to a confirmed case) was 84.9% (95% confidence interval [CI] 80.1 to 88.6). The protective efficacy of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine against mild pertussis ( ≥ 1 day of cough with laboratory confirmation) was 77.9% (95% CI 72.6 to 82.2). Protection against pertussis by DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was sustained for the 2-year follow-up period.

In order to assess the antibody response to the pertussis antigens of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in the US population, 2 lots of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, including the lot used in the Sweden I Efficacy Trial, were administered to US infants in the US Bridging Study. In this study, antibody responses following 3 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine given to US children at 2, 4 and 6 months of age were compared to those from a subset of the infants enrolled in the Sweden I Efficacy Trial. Assays were performed in parallel on the available sera from the US and Swedish infants. Antibody responses to all the antigens were similar except for those to the PRN component. For both lots of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, the geometric mean concentration (GMC) and percent response to PRN in US infants (Lot 006, N = 107; Lot 009, N = 108) were significantly lower after 3 doses of vaccine than in Swedish infants (N = 83). In separate US and Canadian studies in which children received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4 and 6 months of age, with a fourth dose at either 17-20 months (Canadian study) or 15-16 months (random subset from US study) of age, antibody responses to each pertussis antigen following the fourth dose (Canadian study N = 275; US study N = 237-347) were at least as high as those seen in the Swedish infants after 3 doses. While a serologic correlate of protection for pertussis has not been established, the antibody response to all antigens in North American infants after 4 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4, 6 and 15-20 months of age was comparable to that achieved in Swedish infants in whom efficacy was demonstrated after 3 doses of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine at 2, 4 and 6 months of age.

Concomitantly Administered Vaccines

In the US Bridging study, DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was given concomitantly with Hib conjugate vaccine (sanofi pasteur, SA) according to local practices. Anti-PRP immune response was evaluated in 261 infants who received 3 doses of Hib conjugate vaccine. One month after the third dose, 96.9% achieved anti-PRP antibody levels of at least 0.15 µg/mL and 82.7% achieved antibody levels of at least 1.0 µg/mL.

In the US study in which infants received DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine concomitantly with Hib conjugate (tetanus toxoid conjugate) vaccine, IPV, 7-valent pneumococcal conjugate vaccine, and hepatitis B vaccine [see ADVERSE REACTIONS], at 7 months of age, 100.0% of subjects (N = 1,050-1,097) had protective neutralizing antibody levels ( ≥ 1:8 1/dil) for poliovirus types 1, 2 and 3; and 92.4% (N = 998) achieved anti-hepatitis B surface antigen levels ≥ 10.0 mIU/mL. Although there is no established serologic correlate of protection for any of the pneumococcal serotypes, at 7 months of age 91.3%-98.9% (N = 1,027-1,029) achieved anti-pneumococcal polysaccharide levels ≥ 0.5 µg/mL for serotypes 4, 9V, 14, 18C, 19F and 23F and 80.7% (N = 1,027) achieved an anti-pneumococcal polysaccharide level ≥ 0.5 µg/mL for serotype 6B. The mumps seroresponse rate was lower when DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine was administered concomitantly (86.6%; N = 307) vs. non-concomitantly (90.1%; N = 312) with the first dose of MMR vaccine [upper limit of 90% confidence interval for difference in rates (non-concomitant minus concomitant) > 5%]. There was no evidence for interference in the immune response to the measles, rubella, and varicella antigens or to the fourth dose of the 7-valent pneumococcal conjugate vaccine with concomitant administration of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine.

REFERENCES

1. CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

2. Stratton KR, et al. editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington D.C.: National Academy Press. 1994. p. 67-117.

3. Stainer DW, Scholte MJ. A simple chemically defined medium for the production of phase I Bordetella pertussis. J Gen Microbiol 1970;63:211-20.

4. Stainer DW. Production of diphtheria toxin. In: Manclark CR, editor. Proceedings of an informal consultation on the World Health Organization requirements for diphtheria, tetanus, pertussis and combined vaccines. United States Public Health Service, Bethesda, MD. DHHS 91-1174. 1991. p. 7-11.

5. Mueller JH, Miller PA. Variable factors influencing the production of tetanus toxin. J Bacteriol 1954;67(3):271-7.

6. Department of Health and Human Services, Food and Drug Administration. Biological products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Federal Register 1985;50(240):51002-117.

7. Wharton M, et al. Diphtheria Toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W. B. Saunders 2004 p. 211-28.

8. Wassilak SGF, et al. Tetanus Toxoid. In: Plotkin SA, Orenstein WA, editors. Vaccines. 4th ed. Philadelphia, PA: W. B. Saunders 2004 p. 745-81.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Before administration of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, health-care personnel should inform the parent or guardian of the benefits and risks of the vaccine and the importance of completing the immunization series unless a contraindication to further immunization exists. The health-care provider should inform the parent or guardian about the potential for adverse reactions that have been temporally associated with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine and other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VIS) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. The parent or guardian should be instructed to report adverse reactions to their health-care provider.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

Before administration of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine, health-care personnel should inform the parent or guardian of the benefits and risks of the vaccine and the importance of completing the immunization series unless a contraindication to further immunization exists. The health-care provider should inform the parent or guardian about the potential for adverse reactions that have been temporally associated with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine and other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VIS) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. The parent or guardian should be instructed to report adverse reactions to their health-care provider.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

Daptacel Patient Information Including Side Effects

Brand Names: Acel-Imune, Certiva, Daptacel, Infanrix, Tripedia

Generic Name: diphtheria, tetanus, and pertussis (DTaP) vaccines (Pronunciation: DIF thee ree ah, TET ah nus, per TUH sis)

What are diphtheria, tetanus, and pertussis vaccines (Daptacel)?

Diphtheria, tetanus, and pertussis are serious diseases caused by bacteria.

Diphtheria causes a thick coating in the nose, throat, and airway. It can lead to breathing problems, paralysis, heart failure, and even death.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to "locking" of the jaw so the victim cannot open his mouth or swallow. Tetanus leads to death in about 1 out of 10 cases.

Pertussis (whooping cough) causes coughing so severe that it is hard for infants to eat, drink, or breathe. These spells can last for weeks. It can lead to pneumonia, seizures (convulsions), brain damage, and death.

Diphtheria and pertussis are spread from person to person. Tetanus enters the body through cuts or wounds. Vaccines for these diseases expose the individual to a small amount of the bacteria, helping the body develop immunity to the disease.

Diphtheria, tetanus, and pertussis vaccine (DTaP) can help prevent these diseases. Most children who are vaccinated with DTaP will be protected throughout childhood.

What are the possible side effects of diphtheria, tetanus, and pertussis vaccines (Daptacel)?

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine, can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

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

Call your doctor at once if the child has any of the following serious side effects:

  • loss of consciousness;
  • seizure (black-out or convulsions);
  • high fever, over 105 degrees; or
  • non-stop crying for 3 hours or more.

Other less serious side effects may be more likely to occur. Talk to your doctor if your child has:

  • mild fever;
  • redness, pain, tenderness, or swelling where the shot was given;
  • fussiness for 1-3 days after the shot;
  • tiredness or poor appetite for 1-3 days after the shot; or
  • vomiting for 1-3 days after the shot.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

To help reduce fever and pain, your doctor may recommend giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil). This may be given at the time of the shot and over the next 24 hours. Your doctor will tell you the correct dose to use. Controlling fever is especially important if the child has a history of seizures.

Read the Daptacel (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about diphtheria, tetanus, and pertussis vaccines (Daptacel)?

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Keep track of any and all side effects your child has after receiving this vaccine. When the child receives the next booster dose, you will need to tell the doctor if the first shot caused any side effects. Getting diphtheria, tetanus, or pertussis disease is much riskier than getting DTaP vaccine. However, like any medicine, this vaccine can cause side effects. The risk of DTaP vaccine causing a serious side effect is extremely small.

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose.

Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

Side Effects Centers

Daptacel Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving diphtheria, tetanus, and pertussis vaccines (Daptacel)?

Any child who had a life-threatening allergic reaction after a dose of DTaP should not receive another dose.

Any child who has had encephalitis (brain swelling) or a brain or nervous system disease within 7 days after a dose of DTaP should not receive another dose.

Before receiving DTaP vaccine, talk to your doctor if your child:

  • had a seizure or collapsed after a dose of DTaP;
  • cried non-stop for 3 hours or more after a dose of DTaP;
  • had a fever over 105 degrees after a dose of DTaP;
  • developed Guillian-Barre syndrome within 6 weeks after a prior tetanus shot;
  • has HIV or AIDS or another disease that affects the immune system;
  • is taking a medication that affects the immune system (steroids, anti-rejection medications after a transplant);
  • has a bleeding disorder or takes blood thinners (such as warfarin or Coumadin);
  • has cancer; or
  • is receiving cancer treatment with x-rays, radiation, or medication.

If the child has any of these conditions, he or she may not be able to receive DTaP.

Children with a cold or fever can still be vaccinated. Children who are moderately or severely ill should usually wait until they recover before getting DTaP vaccine.

FDA pregnancy category C: This medication may be harmful to an unborn baby and should not be given to a woman who is pregnant.

How are diphtheria, tetanus, and pertussis vaccines administered (Daptacel)?

This vaccine is given as an injection into a muscle. A doctor, nurse, or other healthcare provider will give this injection.

Children should get 5 doses of DTaP vaccine, one dose at each of the following ages: 2 months, 4 months, 6 months, 15 to 18 months, and 4 to 6 years. The series should be completed before the child's seventh birthday.

Your doctor may recommend reducing fever and pain by giving the child an aspirin-free pain reliever such as acetaminophen (Tylenol, Tempra, others) or ibuprofen (Motrin, Advil, others) when the shot is given and for the next 24 hours. Your healthcare provider can tell you the appropriate dosages of these medications. Controlling fever is especially important for children who have had seizures for any reason, or if a family member has had seizures.

Side Effects Centers

Daptacel Patient Information including If I Miss a Dose

What happens if I miss a dose (Daptacel)?

Contact your doctor if a dose of DTaP vaccine is missed.

What happens if I overdose (Daptacel)?

An overdose of DTaP vaccine is unlikely to occur.

What should I avoid before or after getting diphtheria, tetanus, and pertussis vaccines (Daptacel)?

There are no restrictions on food, beverages, or activity before or after receiving DTaP vaccine unless your doctor has told you otherwise.

What other drugs will affect diphtheria, tetanus, and pertussis vaccines (Daptacel)?

Before receiving the DTaP vaccine, tell the doctor if the child is using any of the following medications:

  • an oral, nasal, inhaled, or injectable steroid medicine;
  • cancer chemotherapy or radiation;
  • azathioprine (Imuran);
  • basiliximab (Simulect);
  • cyclosporine (Sandimmune, Neoral, Gengraf);
  • etanercept (Enbrel);
  • leflunomide (Arava);
  • muromonab-CD3 (Orthoclone);
  • mycophenolate mofetil (CellCept);
  • sirolimus (Rapamune); or
  • tacrolimus (Prograf).

There may be other drugs not listed that can affect the DTaP vaccine. Tell your doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

Where can I get more information?

Your doctor or pharmacist may have additional information or suggest additional resources regarding DTaP vaccine.


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

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