Gazyva 1000 mg/40 ml (Injection)

Indications

• Chronic Lymphocytic Leukemia (CLL) treatment
• Follicular Lymphoma (FL) treatment
• Combination therapy with chlorambucil
• Combination therapy with chemotherapy
• Maintenance therapy
• Treatment for previously untreated diseases
• Treatment for diseases not responsive to rituximab
• Treatment for diseases progressing after rituximab
• Targeted therapy for CD20 antigen
• Mediation of B-cell lysis
• Engagement of immune effector cells
• Activation of intracellular death signaling pathways
• Activation of the complement cascade
• Antibody-dependent cellular cytotoxicity (ADCC)
• Antibody-dependent cellular phagocytosis

Composition

• Clear, colorless to slightly brownish liquid
• Supplied as a single 1000 mg dose
• Sterile and preservative free
• Nonpyrogenic 50 ml glass vial
• 40 ml liquid concentrate (25 mg/ml)

Pharmacology

• Monoclonal antibody targeting CD20 antigen
• B-cell depletion
• Greater ADCC activity compared to rituximab
• Increased ability to induce direct cell death compared to rituximab
• Binds to FcγRIII with higher affinity than rituximab
• Binds to overlapping epitopes on CD20

Interaction

• No formal drug-drug interaction studies conducted
• Limited drug interaction sub-studies undertaken
• No effect on pharmacokinetics of bendamustine, FC, chlorambucil or CHOP
• No apparent effects of bendamustine, FC, chlorambucil or CHOP on the pharmacokinetics of Gazyva
• Potential risk for interactions with concomitantly used medicinal products

Contraindications

• Known hypersensitivity to obinutuzumab or excipients

Side Effects

• Hepatitis B reactivation
• Progressive multifocal leukoencephalopathy
• Infusion reactions
• Tumor lysis syndrome
• Infections
• Neutropenia
• Thrombocytopenia

Pregnancy & Lactation

• Likely fetal B-cell depletion
• Risk of transplacental transfer
• Unknown risk of major birth defects and miscarriage
• Unknown presence in human milk
• Potential effects on the breastfed child
• Consideration of developmental and health benefits of breastfeeding

Precautions & Warnings

• Improvement of traceability of biological medicinal products
• Record of trade name and batch number in patient file

Use in Special Populations

• Unestablished safety and efficacy in children below 18 years
• Safety and efficacy data for geriatric use
• Increased adverse events and deaths in elderly patients
• No significant differences in efficacy observed in elderly patients
• Increased serious adverse events in older patients with Non-Hodgkin Lymphoma (NHL)

Therapeutic Class

• Anti neoplastic preparations

Storage Conditions

• Refrigeration at 2°C-8°C
• Protection from light
• Avoid freezing and shaking

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