Medicine Information

Gazyva

Name: Gazyva
Brand: Gazyva
Rating: 4.5 (117 reviews)

Solution for intravenous infusion1000 mgAntineoplastic agents, Monoclonal antibodiesATC: L01XC14

Generic Name

Obinutuzumab

Manufacturer

Genentech, Inc. (a member of the Roche Group)

Country

USA

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
gazyva 1000 mg injection	৳ 128,000.00	N/A

Description

Overview of the medicine

Gazyva (obinutuzumab) is a CD20-directed cytolytic antibody used to treat certain types of blood cancers, including chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). It works by targeting the CD20 protein on the surface of B-cells, leading to their destruction.

Uses & Indications

Chronic Lymphocytic Leukemia (CLL) in combination with chlorambucil, in previously untreated patients.

Follicular Lymphoma (FL) in combination with bendamustine, followed by Gazyva monotherapy, in patients who did not respond to or whose disease progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Follicular Lymphoma (FL) in combination with chemotherapy (e.g., CHOP, CVP, or bendamustine), followed by Gazyva monotherapy, in previously untreated patients.

Dosage

Adults

Dosage varies by indication: CLL: Cycle 1: Day 1: 100 mg, Day 2: 900 mg; Day 8: 1000 mg; Day 15: 1000 mg. Cycles 2-6: Day 1: 1000 mg. Administered with chlorambucil. FL (Relapsed/Refractory): 1000 mg on Day 1, 8, 15 of Cycle 1; then 1000 mg on Day 1 of Cycles 2-6 (with bendamustine), followed by maintenance every 2 months for 2 years. FL (Previously Untreated): 1000 mg on Day 1, 8, 15 of Cycle 1; then 1000 mg on Day 1 of Cycles 2-6/8 (with chemotherapy), followed by maintenance every 2 months for 2 years.

Elderly

No specific dose adjustment is generally required, but close monitoring for adverse events is recommended.

Renal_impairment

No specific dose adjustment is recommended for mild-to-moderate renal impairment. Limited data available for severe impairment.

How to Take

For intravenous infusion only. Must be diluted prior to infusion. Requires pre-medication (acetaminophen, antihistamine, corticosteroid) to reduce infusion-related reactions. Infusion rate carefully monitored, especially during initial doses.

Mechanism of Action

Obinutuzumab is a humanized monoclonal antibody that selectively binds to the CD20 antigen on malignant B-cells and normal B-lymphocytes. It mediates B-cell lysis primarily through direct cell death induction, antibody-dependent cellular cytotoxicity (ADCC), and antibody-dependent cellular phagocytosis (ADCP). It also enhances complement-dependent cytotoxicity (CDC) to a lesser extent.

Pharmacokinetics

Onset

B-cell depletion generally observed after the first infusion.

Excretion

Mainly through catabolic pathways; not significantly eliminated via kidney or liver as intact antibody.

Half life

Terminal half-life is approximately 25-30 days.

Absorption

Administered intravenously, resulting in 100% bioavailability.

Metabolism

Primarily cleared by catabolism (protein degradation).

Side Effects

Contraindications

Known severe hypersensitivity to obinutuzumab or any excipients.

Drug Interactions

Live attenuated vaccines

Avoid during and after Gazyva treatment until B-cell recovery due to potential for reduced immune response and increased risk of infection.

Other immunosuppressants

Potential for increased immunosuppression and risk of infection when co-administered.

Storage

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

Overdose

There is no specific antidote for Gazyva overdose. Management involves symptomatic and supportive care.

Pregnancy & Lactation

Pregnancy: May cause fetal B-cell depletion. Use only if potential benefit justifies potential risk to the fetus. Lactation: Not known if excreted in human milk. Advise mothers not to breastfeed during treatment and for 6 months after the last dose.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

1000 mg/40 mL single-use vial

Shelf Life

Varies by specific product and storage conditions, typically 2-3 years for unopened vials.

Availability

Hospital pharmacies, Specialty pharmacies

Approval Status

FDA approved

Patent Status

Patented

Clinical Trials

Extensive clinical trials (e.g., CLL11, GADOLIN, GALLIUM) have demonstrated efficacy and safety in chronic lymphocytic leukemia and follicular lymphoma. Ongoing studies continue to explore its use in other B-cell malignancies.

Lab Monitoring

Complete blood counts (CBC) including platelets (prior to each cycle and regularly during treatment)
Hepatitis B virus (HBV) screening (before treatment initiation)
Renal function tests (baseline and as clinically indicated)
Electrolyte monitoring (especially for patients at risk of tumor lysis syndrome)

Doctor Notes

Close monitoring for infusion-related reactions is crucial, especially during the first infusion and dose escalation.
Prophylaxis against Hepatitis B virus reactivation and tumor lysis syndrome is recommended for at-risk patients.
Assess for delayed-onset neutropenia and manage as appropriate, as this can occur months after treatment completion.
Educate patients on symptoms of PML and advise to seek immediate medical attention if they occur.

Patient Guidelines

Report any signs of infection (e.g., fever, chills, sore throat) or unusual bleeding/bruising immediately to your doctor.
Inform your doctor about any new or worsening neurological symptoms (e.g., changes in vision, confusion, weakness, speech difficulties).
Ensure you receive all pre-medications as instructed before each Gazyva infusion.
Avoid live vaccines during and for a period after Gazyva treatment.

Missed Dose Advice

If a planned dose is missed, contact your healthcare provider immediately to reschedule. Do not wait for the next scheduled dose.

Driving Precautions

Gazyva may cause fatigue or dizziness, which could impair the ability to drive or operate machinery. Patients should be advised to exercise caution.

Lifestyle Advice

Maintain good hygiene, including frequent handwashing, to reduce the risk of infection.
Stay well-hydrated.
Avoid contact with people who are sick, especially those with infections like chickenpox or measles.