Ofatumumab Injection (Arzerra)
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Ofatumumab Injection (Arzerra)

ARZERRA
(ofatumumab)

DRUG DESCRIPTION

ARZERRA (ofatumumab) is an IgG1ê human monoclonal antibody with a molecular weight of approximately 149 kDa. The antibody was generated via transgenic mouse and hybridoma technology and is produced in a recombinant murine cell line (NS0) using standard mammalian cell cultivation and purification technologies.

ARZERRA is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate for intravenous administration. ARZERRA is supplied at a concentration of 20 mg/mL in single-use vials. Each single-use vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution.

Inactive ingredients include: 10 mg/mL arginine, diluted hydrochloric acid, 0.019 mg/mL edentate disodium, 0.2 mg/mL polysorbate 80, 6.8 mg/mL sodium acetate, 2.98 mg/mL sodium chloride, and Water for Injection, USP. The pH is 5.5.

What are the possible side effects of ofatumumab (Arzerra)?

Some people receiving a ofatumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing. These reactions can occur during the injection or within 24 hours afterward..

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

Read All Potential Side Effects and See Pictures of Arzerra »

What are the precautions when taking ofatumumab injection (Arzerra)?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction to it; or if you have 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 medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as chronic obstructive pulmonary disease - COPD, asthma), liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), immune system problems (such as HIV).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities...

Read All Potential Precautions of Arzerra »

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ARZERRA® (ofatumumab) is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab.

The effectiveness of ARZERRA is based on the demonstration of durable objective responses [see Clinical Studies]. No data demonstrate an improvement in disease-related symptoms or increased survival with ARZERRA.

DOSAGE AND ADMINISTRATION

Recommended Dosage Regimen

  • Do not administer as an intravenous push or bolus.
  • Premedicate before each infusion.
  • Administer with an in-line filter set supplied with product.

The recommended dosage and schedule is 12 doses administered as follows:

  • 300 mg initial dose (Dose 1), followed 1 week later by
  • 2,000 mg weekly for 7 doses (Doses 2 through 8), followed 4 weeks later by
  • 2,000 mg every 4 weeks for 4 doses (Doses 9 through 12)

Administration

Prepare all doses in 1,000 mL of 0.9% Sodium Chloride Injection, USP.

  • Dose 1: Initiate infusion at a rate of 3.6 mg/hour (12 mL/hour).
  • Dose 2: Initiate infusion at a rate of 24 mg/hour (12 mL/hour).
  • Doses 3 through 12: Initiate infusion at a rate of 50 mg/hour (25 mL/hour).

In the absence of infusional toxicity, the rate of infusion may be increased every 30 minutes as described in Table 1. Do not exceed the infusion rates in Table 1.

Table 1: Infusion Rates for ARZERRA

Interval After Start of Infusion (min) Dose 1a (mL/hour) Dose 2b (mL/hour) Doses 3-12b (mL/hour)
0-30 12 12 25
31-60 25 25 50
61-90 50 50 100
91-120 100 100 200
> 120 200 200 400
a Dose 1 = 300 mg (0.3 mg/mL).
b Doses 2 and 3-12 = 2,000 mg (2 mg/mL).

Dose Modification

Interrupt infusion for infusion reactions of any severity [see WARNINGS AND PRECAUTIONS].

  • For Grade 4 infusion reactions, do not resume the infusion.
  • For Grade 1, 2, or 3 infusion reaction, if the infusion reaction resolves or remains less than or equal to Grade 2, resume infusion with the following modifications according to the initial Grade of the infusion reaction.
    • Grade 1 or 2: Infuse at one-half of the previous infusion rate.
    • Grade 3: Infuse at a rate of 12 mL/hour.
  • After resuming the infusion, the infusion rate may be increased according to Table 1 above, based on patient tolerance.

Premedication

  • Premedicate 30 minutes to 2 hours prior to each dose with oral acetaminophen 1,000 mg (or equivalent), oral or intravenous antihistamine (cetirizine 10 mg or equivalent), and intravenous corticosteroid (prednisolone 100 mg or equivalent).
  • Do not reduce corticosteroid dose for Doses 1, 2, and 9.
  • Corticosteroid dose may be reduced as follows for Doses 3 through 8 and 10 through 12:
    • Doses 3 through 8: Gradually reduce corticosteroid dose with successive infusions if a Grade 3 or greater infusion reaction did not occur with the preceding dose.
    • Doses 10 through 12: Administer prednisolone 50 mg to 100 mg or equivalent if a Grade 3 or greater infusion reaction did not occur with Dose 9.

Preparation and Administration

  • Do not shake product.
  • Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. ARZERRA should be a clear to opalescent, colorless solution and may contain a small amount of visible translucent-to-white, amorphous, ofatumumab particles. The solution should not be used if discolored or cloudy, or if foreign particulate matter is present.
Preparation of Solution
  • 300-mg dose: Withdraw and discard 15 mL from a 1,000-mL bag of 0.9% Sodium Chloride Injection, USP. Withdraw 5 mL from each of 3 single-use 100 mg vials of ARZERRA and add to the bag. Mix diluted solution by gentle inversion.
  • 2,000-mg dose: Withdraw and discard 100 mL from a 1,000-mL bag of 0.9% Sodium Chloride Injection, USP. Withdraw 50 mL from each of 2 single-use 1,000 mg vials of ARZERRA and add to the bag. Mix diluted solution by gentle inversion.
  • Store diluted solution between 2° to 8°C (36° to 46°F).
  • No incompatibilities between ARZERRA and polyvinylchloride or polyolefin bags and administration sets have been observed.
Administration Instructions
  • Do not mix ARZERRA with, or administer as an infusion with, other medicinal products.
  • Administer using an infusion pump with an administration set and the provided in-line filter set.
  • Flush the intravenous line with 0.9% Sodium Chloride Injection, USP before and after each dose.
  • Start infusion within 12 hours of preparation.
  • Discard prepared solution after 24 hours.

HOW SUPPLIED

Dosage Forms And Strengths

  • 100 mg/5 mL single-use vial.
  • 1,000 mg/50 mL single-use vial.

Storage And Handling

ARZERRA (ofatumumab) is a sterile, clear to opalescent, colorless, preservative-free liquid concentrate (20 mg/mL) for dilution and intravenous administration provided in single-use glass vials with a latex-free rubber stopper and an aluminum overseal. Each vial contains either 100 mg ofatumumab in 5 mL of solution or 1,000 mg ofatumumab in 50 mL of solution.

ARZERRA is available as follows:

Carton Contents NDC
3 single-use 100 mg/5 mL vials with 2 in-line filter sets Vial: NDC 0173-0821-02
Carton of 3 vials: NDC 0173-0821-33
1 single-use 1,000 mg/50 mL vial with 2 in-line filter sets Vial and Carton: NDC 0173-0821-01

Store ARZERRA refrigerated between 2° to 8°C (36° to 46°F). Do not freeze. Vials should be protected from light.

Manufactured by: Glaxo Group Limited, Greenford, Middlesex, UB6 0NN, United Kingdom. Distributed by: GlaxoSmithKline, Research Triangle Park, NC 27709. September 2011

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The following serious adverse reactions are discussed in greater detail in other sections of the labeling:

The most common adverse reactions ( ≥ 10%) in Study 1 were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnea, rash, nausea, bronchitis, and upper respiratory tract infections.

The most common serious adverse reactions in Study 1 were infections (including pneumonia and sepsis), neutropenia, and pyrexia. Infections were the most common adverse reactions leading to drug discontinuation in Study 1.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of monotherapy with ARZERRA was evaluated in 181 patients with relapsed or refractory CLL in 2 open-label, non-randomized, single-arm studies. In these studies, ARZERRA was administered at 2,000 mg beginning with the second dose for 11 doses (Study 1 [n = 154]) or 3 doses (Study 2 [n = 27]).

The data described in Table 2 and other sections below are derived from 154 patients in Study 1. All patients received 2,000 mg weekly from the second dose onward. Ninety percent of patients received at least 8 infusions of ARZERRA and 55% received all 12 infusions. The median age was 63 years (range: 41 to 86 years), 72% were male, and 97% were White.

Table 2: Incidence of All Adverse Reactions Occurring in ≥ 5% of Patients in Study 1 and in the Fludarabine- and Alemtuzumab-Refractory Subset of Study 1 (MedDRA 9.0)

Body System/Adverse Event Total Population
(n =154)
Fludarabine and Alemtuzumab Refractory
(n =59)
All Grades % Grade ≥ 3 % All Grades % Grade ≥ 3 %
Infections and infestations
  Pneumoniaa 23 14 25 15
  Upper respiratory tract infection 11 0 3 0
  Bronchitis 11 < 1 19 2
  Sepsisb 8 8 10 10
  Nasopharyngitis 8 0 8 0
  Herpes zoster  6 1 7 2
  Sinusitis 5 2 3 2
Blood and lymphatic system disorders
  Anemia 16 5 17 8
Psychiatric disorders
  Insomnia 7 0 10 0
Nervous system disorders
  Headache 6 0 7 0
Cardiovascular disorders
  Hypertension 5 0 8 0
  Hypotension 5 0 3 0
  Tachycardia 5 <1 7 2
Respiratory, thoracic, and mediastinal disorders
  Cough 19 0 19 0
  Dyspnea 14 2 19 5
Gastrointestinal disorders
  Diarrhea 18 0 19 0
  Nausea 11 0 12 0
Skin and subcutaneous tissue disorders
  Rashc 14 <1 17 2
  Urticaria 8 0 5 0
  Hyperhidrosis 5 0 5 0
Musculoskeletal and connective tissue disorders
  Back pain 8 1 12 2
  Muscle spasms 5 0 3 0
General disorders and administration site conditions
  Pyrexia 20 3 25 5
  Fatigue 15 0 15 0
  Edema peripheral 9 < 1 8 2
  Chills 8 0 10 0
a Pneumonia includes pneumonia, lung infection, lobar pneumonia, and bronchopneumonia.
b Sepsis includes sepsis, neutropenic sepsis, bacteremia, and septic shock.
c Rash includes rash, rash macular, and rash vesicular.

Infusion Reactions

Infusion reactions occurred in 44% of patients on the day of the first infusion (300 mg), 29% on the day of the second infusion (2,000 mg), and less frequently during subsequent infusions.

Infections

A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced ??Grade 3 infections, of which 19 (12%) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%.

Neutropenia

Of 108 patients with normal neutrophil counts at baseline, 45 (42%) developed ≥ Grade 3 neutropenia. Nineteen (18%) developed Grade 4 neutropenia. Some patients experienced new onset Grade 4 neutropenia > 2 weeks in duration.

Immunogenicity

There is a potential for immunogenicity with therapeutic proteins such as ofatumumab. Serum samples from patients with CLL in Study 1 were tested by enzyme-linked immunosorbent assay (ELISA) for anti-ofatumumab antibodies during and after the 24-week treatment period. Results were negative in 46 patients after the 8th infusion and in 33 patients after the 12th infusion.

Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of incidence of antibodies to ARZERRA with the incidence of antibodies to other products may be misleading.

Read the Arzerra (ofatumumab injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No formal drug-drug interaction studies have been conducted with ARZERRA.

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Infusion Reactions

ARZERRA can cause serious infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac ischemia/infarction, back pain, abdominal pain, pyrexia, rash, urticaria, and angioedema. Infusion reactions occur more frequently with the first 2 infusions [see ADVERSE REACTIONS].

Premedicate with acetaminophen, an antihistamine, and a corticosteroid [see DOSAGE AND ADMINISTRATION]. Interrupt infusion for infusion reactions of any severity. Institute medical management for severe infusion reactions including angina or other signs and symptoms of myocardial ischemia [see DOSAGE AND ADMINISTRATION].

In a study of patients with moderate to severe chronic obstructive pulmonary disease, an indication for which ARZERRA is not approved, 2 of 5 patients developed Grade 3 bronchospasm during infusion.

Cytopenias

Prolonged ( ≥ 1 week) severe neutropenia and thrombocytopenia can occur with ARZERRA. Monitor complete blood counts (CBC) and platelet counts at regular intervals during therapy, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias.

Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML), including fatal PML, can occur with ARZERRA. Consider PML in any patient with new onset of or changes in pre-existing neurological signs or symptoms. Discontinue ARZERRA if PML is suspected, and initiate evaluation for PML including consultation with a neurologist, brain MRI, and lumbar puncture.

Hepatitis B Infection and Reactivation

Fulminant and fatal hepatitis B virus (HBV) infection and reactivation can occur in patients following treatment with ARZERRA. Screen patients at high risk of HBV infection before initiation of ARZERRA. Closely monitor carriers of hepatitis B for clinical and laboratory signs of active HBV infection during treatment with ARZERRA and for 6 to 12 months following the last infusion of ARZERRA. Discontinue ARZERRA in patients who develop viral hepatitis or reactivation of viral hepatitis, and institute appropriate treatment. Insufficient data exist regarding the safety of administration of ARZERRA in patients with active hepatitis.

Intestinal Obstruction

Obstruction of the small intestine can occur in patients receiving ARZERRA. Perform a diagnostic evaluation if obstruction is suspected.

Immunizations

The safety of immunization with live viral vaccines during or following administration of ARZERRA has not been studied. Do not administer live viral vaccines to patients who have recently received ARZERRA. The ability to generate an immune response to any vaccine following administration of ARZERRA has not been studied.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenicity studies of ofatumumab have been conducted. In a repeat-dose toxicity study, no tumorigenic or unexpected mitogenic responses were noted in cynomolgus monkeys treated for 7 months with up to 3.5 times the human dose of ofatumumab. Effects on male and female fertility have not been evaluated in animal studies.

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate or well-controlled studies of ofatumumab in pregnant women. A reproductive study in pregnant cynomolgus monkeys that received ofatumumab at doses up to 3.5 times the recommended human dose of ofatumumab did not demonstrate maternal toxicity or teratogenicity. Ofatumumab crossed the placental barrier, and fetuses exhibited depletion of peripheral B cells and decreased spleen and placental weights. ARZERRA should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

There are no human or animal data on the potential short- and long-term effects of perinatal B-cell depletion in offspring following in utero exposure to ofatumumab. Ofatumumab does not bind normal human tissues other than B lymphocytes. It is not known if binding occurs to unique embryonic or fetal tissue targets. In addition, the kinetics of B-lymphocyte recovery are unknown in offspring with B-cell depletion [see Nonclinical Toxicology].

Nursing Mothers

It is not known whether ofatumumab is secreted in human milk; however, human IgG is secreted in human milk. Published data suggest that neonatal and infant consumption of breast milk does not result in substantial absorption of these maternal antibodies into circulation. Because the effects of local gastrointestinal and limited systemic exposure to ofatumumab are unknown, caution should be exercised when ARZERRA is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of ARZERRA have not been established in children.

Geriatric Use

Clinical studies of ARZERRA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects [see CLINICAL PHARMACOLOGY].

Renal Impairment

No formal studies of ARZERRA in patients with renal impairment have been conducted [see CLINICAL PHARMACOLOGY].

Hepatic Impairment

No formal studies of ARZERRA in patients with hepatic impairment have been conducted.

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No data are available regarding overdosage with ARZERRA.

CONTRAINDICATIONS

None.

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Mechanism of Action

Ofatumumab binds specifically to both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is expressed on normal B lymphocytes (pre-B- to mature B-lymphocyte) and on B-cell CLL. The CD20 molecule is not shed from the cell surface and is not internalized following antibody binding.

The Fab domain of ofatumumab binds to the CD20 molecule and the Fc domain mediates immune effector functions to result in B-cell lysis in vitro. Data suggest that possible mechanisms of cell lysis include complement-dependent cytotoxicity and antibody-dependent, cell-mediated cytotoxicity.

Pharmacodynamics

In patients with CLL refractory to fludarabine and alemtuzumab, the median decrease in circulating CD19-positive B cells was 91% (n = 50) with the 8th infusion and 85% (n = 32) with the 12th infusion. The time to recovery of lymphocytes, including CD19-positive B cells, to normal levels has not been determined.

Pharmacokinetics

Pharmacokinetic data were obtained from 146 patients with refractory CLL who received a 300-mg initial dose followed by 7 weekly and 4 monthly infusions of 2,000 mg. The Cmax and AUC(0-∞) after the 8th infusion in Study 1 were approximately 40% and 60% higher than after the 4th infusion in Study 2. The mean volume of distribution at steady-state (Vss) values ranged from 1.7 to 5.1 L. Ofatumumab is eliminated through both a target-independent route and a B cell-mediated route. Ofatumumab exhibited dose-dependent clearance in the dose range of 100 to 2,000 mg. Due to the depletion of B cells, the clearance of ofatumumab decreased substantially after subsequent infusions compared to the first infusion. The mean clearance between the 4th and 12th infusions was approximately 0.01 L/hr and exhibited large inter-subject variability with CV% greater than 50%. The mean t1/2 between the 4th and 12th infusions was approximately 14 days (range: 2.3 to 61.5 days).

Special Populations

Cross-study analyses were performed on data from patients with a variety of conditions, including 162 patients with CLL, who received multiple infusions of ARZERRA (ofatumumab injection) as a single agent at doses ranging from 100 to 2,000 mg. The effects of various covariates (e.g., body size [weight, height, body surface area], age, gender, baseline creatinine clearance) on ofatumumab pharmacokinetics were assessed in a population pharmacokinetic analysis.

Body Weight: Volume of distribution and clearance increased with body weight. However, this increase was not clinically significant. No dosage adjustment is recommended based on body weight.

Age: Age did not significantly influence ofatumumab pharmacokinetics in patients ranging from 21 to 86 years of age. No pharmacokinetic data are available in pediatric patients.

Gender: Gender had a modest effect on ofatumumab pharmacokinetics (14% to 25% lower clearance and volume of distribution in female patients compared to male patients) in a cross-study population analysis (41% of the patients in this analysis were male and 59% were female). These effects are not considered clinically important, and no dosage adjustment is recommended.

Renal Impairment: Creatinine clearance at baseline did not have a clinically important effect on ofatumumab pharmacokinetics in patients with calculated creatinine clearance values ranging from 33 to 287 mL/min.

Reproductive and Developmental Toxicology

Pregnant cynomolgus monkeys dosed with 0.7 or 3.5 times the human dose of ofatumumab weekly during the period of organogenesis (gestation days 20 to 50) had no maternal toxicity or teratogenicity. Both dose levels of ofatumumab depleted circulating B cells in the dams, with signs of initial B cell recovery 50 days after the final dose. Following Caesarean section at gestational day 100, fetuses from ofatumumab-treated dams exhibited decreases in mean peripheral B-cell counts (decreased to approximately 10% of control values), splenic B-cell counts (decreased to approximately 15 to 20% of control values), and spleen weights (decreased by 15% for the low-dose and by 30% for the high-dose group, compared to control values). Fetuses from treated dams exhibiting anti-ofatumumab antibody responses had higher B cell counts and higher spleen weights compared to the fetuses from other treated dams, indicating partial recovery in those animals developing anti-ofatumumab antibodies. When compared to control animals, fetuses from treated dams in both dose groups had a 10% decrease in mean placental weights. A 15% decrease in mean thymus weight compared to the controls was also observed in fetuses from dams treated with 3.5 times the human dose of ofatumumab. The biological significance of decreased placental and thymic weights is unknown.

The kinetics of B-lymphocyte recovery and the potential long-term effects of perinatal B-cell depletion in offspring from ofatumumab-treated dams have not been studied in animals.

Clinical Studies

Study 1 was a single-arm, multicenter study in 154 patients with relapsed or refractory CLL. ARZERRA (ofatumumab injection) was administered by intravenous infusion according to the following schedule: 300 mg (Week 0), 2,000 mg weekly for 7 infusions (Weeks 1 through 7), and 2,000 mg every 4 weeks for 4 infusions (Weeks 12 through 24). Patients with CLL refractory to fludarabine and alemtuzumab (n = 59) comprised the efficacy population. Drug refractoriness was defined as failure to achieve at least a partial response to, or disease progression within 6 months of, the last dose of fludarabine or alemtuzumab. The main efficacy outcome was durable objective tumor response rate. Objective tumor responses were determined using the 1996 National Cancer Institute Working Group (NCIWG) Guidelines for CLL.

In patients with CLL refractory to fludarabine and alemtuzumab, the median age was 64 years (range: 41 to 86 years), 75% were male, and 95% were White. The median number of prior therapies was 5; 93% received prior alkylating agents, 59% received prior rituximab, and all received prior fludarabine and alemtuzumab. Eighty-eight percent of patients received at least 8 infusions of ARZERRA (ofatumumab injection) and 54% received 12 infusions.

The investigator-determined overall response rate in patients with CLL refractory to fludarabine and alemtuzumab was 42% (99% CI: 26, 60) with a median duration of response of 6.5 months (95% CI: 5.8, 8.3). There were no complete responses. Anti-tumor activity was also observed in additional patients in Study 1 and in a multicenter, open-label, dose-escalation study (Study 2) conducted in patients with relapsed or refractory CLL.

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

Advise patients to contact a healthcare professional for any of the following:

Advise patients of the need for:

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

Advise patients to contact a healthcare professional for any of the following:

Advise patients of the need for:

Last reviewed on RxList: 9/28/2011
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Arzerra 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.

OFATUMUMAB - INJECTION

(oh-fuh-TOO-muh-mab)

COMMON BRAND NAME(S): Arzerra

USES: Ofatumumab is used to treat a certain type of leukemia (CLL - chronic lymphocytic leukemia) in patients who have not responded to other cancer chemotherapy drugs (such as fludarabine, alemtuzumab). Ofatumumab belongs to a class of drugs known as monoclonal antibodies. This medication works by stopping the growth of cancer cells.

HOW TO USE: This medication is given by injection into a vein by a health care professional. It is usually given once a week for the first 8 doses, then once every 4 weeks for the last 4 doses or as directed by your doctor.

The dosage is based on your medical condition and response to treatment. To prevent side effects, your doctor may prescribe other medications before each treatment, including acetaminophen, an antihistamine (such as diphenhydramine), and a corticosteroid (such as methylprednisolone).

This medication may cause very serious (rarely fatal) infusion-related reactions during or up to 24 hours after treatment. These reactions occur more often during the first and second treatments. Your doctor will monitor you closely and increase your dose slowly to reduce the chances of these serious side effects. If you have a reaction, your treatment will be temporarily stopped. Tell your doctor or nurse immediately if any of these effects occur: chest pain, flushing, wheezing, trouble breathing, dizziness, fainting, pounding/irregular heartbeat, fever, chills, back/stomach pain, or rash/itching.

Disclaimer

Arzerra Consumer (continued)

SIDE EFFECTS: See also How to Use section.

Nausea, vomiting, diarrhea, tiredness, swelling of hands/ankles/feet, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Your doctor will order blood tests to check for this side effect. It is important to keep all medical/lab test appointments. Tell your doctor immediately if you develop any of the following symptoms: easy bruising/bleeding, pale skin, unusual tiredness, signs of infection (such as fever, chills, cough, persistent sore throat).

Ofatumumab may rarely cause serious (possibly fatal) liver disease in people exposed to hepatitis B virus. Your doctor may order blood tests and watch for symptoms during treatment and for 6 to 12 months after your last treatment. Seek immediate medical attention if you have any symptoms of liver damage, including: persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin.

Ofatumumab increases your risk of getting a rare but very serious (sometimes fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Tell your doctor immediately if any of these rare but very serious side effects occur: loss of balance/dizziness, confusion, difficulty walking or talking, seizure, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Arzerra (ofatumumab injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction to it; or if you have 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 medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as chronic obstructive pulmonary disease - COPD, asthma), liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), immune system problems (such as HIV).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ofatumumab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Disclaimer

Arzerra Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: If overdose is suspected, contact a 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: Laboratory and/or medical tests (such as complete blood count, platelets, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Keep all regular medical and laboratory appointments.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).

Information last revised June 2010. Copyright(c) 2010 First Databank, Inc.

Arzerra Patient Information Including Side Effects

Brand Names: Arzerra

Generic Name: ofatumumab (Pronunciation: OH fa TOO mue mab)

What is ofatumumab (Arzerra)?

Ofatumumab is a monoclonal antibody that affects the actions of the body's immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.

Ofatumumab is used in to treat chronic lymphocytic leukemia.

Ofatumumab is usually given after other medications have been tried without successful treatment of symptoms.

Ofatumumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ofatumumab (Arzerra)?

Some people receiving a ofatumumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing. These reactions can occur during the injection or within 24 hours afterward..

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

Call your doctor at once if you have any of these serious side effects:

  • change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms, mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
  • easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • confusion, weakness on one side of the body, loss of balance or coordination; or
  • severe constipation.

Less serious side effects may include:

  • mild nausea, diarrhea;
  • swelling in your hands or feet.
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • tired feeling; or
  • mild skin rash.

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 side effects to FDA at 1-800-FDA-1088.

Read the Arzerra (ofatumumab injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about ofatumumab (Arzerra)?

Ofatumumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.

Before you receive ofatumumab, tell your doctor if you have hepatitis or severe COPD.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested for several months, even after you stop using ofatumumab. Do not miss any follow-up visits to your doctor.

Call your doctor at once if you develop any symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

You should also call your doctor right away if you develop any signs of infection such as fever, chills, body aches, flu symptoms, mouth and throat ulcers, easy bruising or bleeding, or cough with mucus and stabbing chest pain.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection. Do not receive a "live" vaccine while you are being treated with ofatumumab.

Side Effects Centers

Arzerra Patient Information including How Should I Take

What should I discuss with my healthcare provider before receiving ofatumumab (Arzerra)?

Ofatumumab increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • hepatitis;
  • severe COPD (chronic obstructive pulmonary disease);

FDA pregnancy category C. It is not known whether ofatumumab is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ofatumumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is ofatumumab given (Arzerra)?

Ofatumumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and one dose can take up to several hours to complete.

Ofatumumab is usually given in a series of 12 doses. The first 8 doses are given 1 week apart. The last 4 doses are given 4 weeks apart. Your dosing schedule may be different. Follow your doctor's instructions.

You will be given other IV or oral (by mouth) medications to prevent certain side effects of ofatumumab. You may need to start using these medications up to 2 hours before the start of your ofatumumab infusion.

To be sure this medication is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested on a regular basis. Ofatumumab can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function at regular visits for several months after you stop using ofatumumab. Do not miss any scheduled appointments.

Side Effects Centers

Arzerra Patient Information including If I Miss a Dose

What happens if I miss a dose (Arzerra)?

Contact your doctor if you miss an appointment for your ofatumumab injection.

What happens if I overdose (Arzerra)?

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of a ofatumumab overdose are unknown.

What should I avoid while receiving ofatumumab (Arzerra)?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with ofatumumab. The live vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What other drugs will affect ofatumumab (Arzerra)?

There may be other drugs that can interact with ofatumumab. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about ofatumumab.


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: 1.02. Revision date: 12/15/2010.

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.

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