Gazyva

OBINUTUZUMAB

Manufacturer: Genentech, Inc.

Score: 141.0

Quick Summary

Gazyva (Obinutuzumab) is a humanized anti-CD20 monoclonal antibody used for the treatment of previously untreated chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). It works by targeting the CD20 antigen on B cells, leading to their depletion. The drug has shown efficacy in clinical trials, with common adverse reactions including infusion-related reactions, neutropenia, and infections. Important safety information includes warnings about hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. Dosing recommendations vary depending on the condition being treated, with initial dosing and titration details provided for CLL and FL. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Treatment of previously untreated chronic lymphocytic leukemia (CLL)
Treatment of follicular lymphoma (FL)
Depletion of B cells through targeting of the CD20 antigen

Important Safety Information

Warning

Hepatitis B virus reactivation and progressive multifocal leukoencephalopathy

Contraindications

Known hypersensitivity reactions to obinutuzumab or any of the excipients
Serum sickness with prior obinutuzumab use

Adverse Reactions

Infusion-related reactions
Neutropenia
Infections
Thrombocytopenia
Tumor lysis syndrome

Dosing Recommendations

General Guidance

Dose modifications may be necessary for patients experiencing adverse reactions

Chronic Lymphocytic Leukemia (CLL)

Adult Dose

100 mg on day 1 and 900 mg on day 2 of Cycle 1, 1,000 mg on day 8 and 15 of Cycle 1, and 1,000 mg on day 1 of Cycles 2–6

Pediatric Dose

Not established

Follicular Lymphoma (FL)

Adult Dose

1,000 mg on day 1, 8 and 15 of Cycle 1, 1,000 mg on day 1 of Cycles 2-6 or Cycles 2-8, and then 1,000 mg every 2 months for up to 2 years

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Based on findings from animal studies and its mechanism of action, Gazyva can cause fetal B-cell depletion
Advise pregnant women of the potential risk to the fetus

Nursing Mothers

The effects of Gazyva on milk production and breastfed infants are not known
Caution should be exercised when administering Gazyva to a nursing woman

Pediatric Use

The safety and effectiveness of Gazyva in pediatric patients have not been established

Geriatric Use

Of 336 patients with previously untreated CLL who received Gazyva in combination with chlorambucil, 81% were 65 years and older
No significant differences in efficacy were observed between younger and older patients

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