Arzerra

What is Arzerra?

• Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody used for the treatment of chronic lymphocytic leukemia (CLL).

Ofatumumab

Ofatumumab 3GIZ

What are the uses of this medicine?

Arzerra (ofatumumab) is used:

• in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
• in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL.
• for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
• for the treatment of patients with CLL refractory to fludarabine and alemtuzumab.

How does this medicine work?

• Ofatumumab (oh” fa toom’ ue mab) is a human monoclonal IgG1 antibody to the cell surface antigen CD20 (also known as human B lymphocyte restricted differentiation antigen: Bp35), which is found on mature B cells as well as 90% of neoplastic B cell such as occur in chronic lymphocytic leukemia.
• CD20 is not present on pro-B cells, hematopoietic stem cells, normal plasma cells or other normal lymphocytes, circulating cells or tissues.
• Engagement of ofatumumab with CD20 leads to B cell lysis and depletion of circulating and tissue B cells for an extended period, up to 6 to 8 months.
• There is an accompanying mild decrease in IgM, but no change in IgG or IgA levels.

Who Should Not Use this medicine ?

• This medicine have no usage limtations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Arzerra.

Is this medicine FDA approved?

• Ofatumumab was approved for use in previously treated, resistant chronic lymphocyte leukemia United States in 2009.

How should this medicine be used?

• Pre-medicate with acetaminophen, antihistamine, and corticosteroid.

Recommended dosage: Previously untreated CLL in combination with chlorambucil recommended dosage and schedule is:

• 300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
• 1,000 mg on Day 1 of subsequent 28-day cycles for a minimum of 3 cycles until best response or a maximum of 12 cycles.

Relapsed CLL in combination with fludarabine and cyclophosphamide recommended dosage and schedule is:

• 300 mg on Day 1 followed by 1,000 mg on Day 8 (Cycle 1)
• 1,000 mg on Day 1 of subsequent 28-day cycles for a maximum of 6 cycles.

Extended treatment in CLL recommended dosage and schedule is:

• 300 mg on Day 1 followed by
• 1,000 mg 1 week later on Day 8, followed by
• 1,000 mg 7 weeks later and every 8 weeks thereafter for up to a maximum of 2 years.

Refractory CLL recommended dosage and schedule is:

• 300 mg initial dose, followed 1 week later by
• 2,000 mg weekly for 7 doses, followed 4 weeks later by
• 2,000 mg every 4 weeks for 4 doses.

Administration:

• Dilute and administer as an intravenous infusion according to the following schedules.
• Do not administer as an intravenous push or bolus or as a subcutaneous injection.
• Administer where facilities to adequately monitor and treat infusion reactions are available.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 100 mg/5 mL single-use vial for intravenous infusion.
• 1,000 mg/50 mL single-use vial for intravenous infusion.

This medicine is available in fallowing brand namesː

• Arzerra

What side effects can this medication cause?

The most common side effects of this medicine include: In Previously Untreated CLL:

• infusion reactions
• neutropenia

In Relapsed CLL:

• infusion reactions
• neutropenia
• leukopenia
• febrile neutropenia

In Extended Treatment in CLL:

• infusion reactions
• neutropenia
• upper respiratory tract infection

In Refractory CLL:

• neutropenia
• pneumonia
• pyrexia
• cough
• diarrhea
• anemia
• fatigue
• dyspnea
• rash
• nausea
• bronchitis
• upper respiratory tract infections

What special precautions should I follow?

• Arzerra can cause serious, including fatal, infusion reactions manifesting as bronchospasm, dyspnea, laryngeal edema, pulmonary edema, flushing, hypertension, hypotension, syncope, cardiac events (e.g., myocardial ischemia/infarction, acute coronary syndrome, arrhythmia, bradycardia), back pain, abdominal pain, pyrexia, rash, urticaria, angioedema, cytokine release syndrome, and anaphylactoid/anaphylactic reactions. Pre-medicate with corticosteroid, acetaminophen, and an antihistamine. Monitor patients during infusions. Interrupt infusion if infusion reactions occur.
• Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, has occurred in patients treated with Arzerra. In patients who develop reactivation of HBV while receiving Arzerra, immediately discontinue Arzerra and any concomitant chemotherapy, and institute appropriate treatment.
• Fatal infection due to hepatitis B in patients who have not been previously infected has been observed with Arzerra. Monitor patients for clinical and laboratory signs of hepatitis.
• Progressive multifocal leukoencephalopathy (PML) resulting in death has occurred with Arzerra. If PML is suspected, discontinue Arzerra and initiate evaluation for PML including neurology consultation.
• Tumor lysis syndrome (TLS), including the need for hospitalization, has occurred in patients treated with Arzerra. Anticipate TLS in high-risk patients; pre-medicate with anti-hyperuricemics and hydration.
• Severe cytopenias, including neutropenia, thrombocytopenia, and anemia, can occur with Arzerra. Monitor complete blood counts at regular intervals.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Arzerra may cause fetal B-cell depletion based on findings from animal studies and the drug’s mechanism of action.
• There are no data on Arzerra use in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• Safety and effectiveness of Arzerra have not been established in children.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• OFATUMUMAB

Inactive ingredients:

• ARGININE
• HYDROCHLORIC ACID
• EDETATE DISODIUM
• POLYSORBATE 80
• SODIUM ACETATE
• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Novartis Pharmaceuticals Corporation
• East Hanover, New Jersey
• At
• Glaxo Group Ltd
• Brentford, Middlesex,

What should I know about storage and disposal of this medication?

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

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• Dailymed label info on Arzerra
• FDA Arzerra

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