Arzerra 1000mg Solution for Infusion

Product Description

1. Technical Specifications

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2. Product Description

Arzerra (ofatumumab) is a fully human monoclonal antibody directed against the CD20 antigen on B lymphocytes. It is an immunotherapy used in the treatment of chronic lymphocytic leukemia (CLL), including cases refractory to fludarabine and alemtuzumab. By binding strongly to a unique epitope on CD20, it mediates B-cell lysis via complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC).

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3. Product Highlights

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4. Therapeutic Uses

• Treatment of chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab

• In combination therapy for previously untreated or relapsed CLL in some regimens

• Investigated in other B-cell malignancies (off-label in some settings)

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5. Dosage & Administration

• Typical dosing (CLL):

  • Initial cycle: 300 mg IV on Day 1, followed by 1000 mg IV on Day 8

  • Subsequent cycles: 1000 mg IV on Day 1 of each 28-day cycle

  • Total: Usually up to 612 cycles depending on indication and response

• Infusion time: Start at a slow rate; increase gradually if tolerated

• Premedication required: Corticosteroid, antihistamine, and antipyretic to reduce infusion-related reactions

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6. Side Effects

Common:

• Infusion reactions (fever, chills, rash, pruritus, dyspnea, hypotension)

• Infections (upper respiratory, urinary tract)

• Fatigue, nausea, diarrhea

• Neutropenia, anemia, thrombocytopenia

Serious:

• Severe infusion-related reactions (rarely life-threatening)

• Progressive multifocal leukoencephalopathy (PML) due to JC virus reactivation

• Hepatitis B virus reactivation (may be fatal)

• Serious bacterial, viral, or opportunistic infections

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7. Precautions & Monitoring

• Screen for Hepatitis B prior to initiation; monitor during and after treatment

• Monitor for infusion-related reactions (especially first infusion)

• Regular CBC for cytopenias

• Monitor for neurological changes (risk of PML)

• Use with caution in immunocompromised patients

• Pregnancy & lactation: Contraindicated; use effective contraception during therapy and for several months afterward

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8. Handling & Disposal

• Prepare under aseptic conditions using cytotoxic handling precautions

• Dilute only in 0.9% sodium chloride IV infusion bag

• Use in-line filter during administration

• Dispose of unused portion and materials as per cytotoxic waste guidelines

Purpose and Application

Arzerra 1000mg Solution for Infusion is designed for intravenous administration in adult patients. It is important that a licensed healthcare professional prescribes and supervises its use. Arzerra plays a critical role in specific medical treatments, underlining the importance of correct dosage and protocol adherence.


Storage and Handling Guidance

Maintain Arzerra in a cool and dry place, as per the storage instructions, to preserve its efficacy. Proper storage minimizes the risk of contamination or degradation of the solution. Medical staff and facility managers must ensure these conditions are consistently met during storage and handling.