Finished product reference
Obinutuzumab
Injection, Solution, Concentrate · Parenteral · 25 mg/1 mL · 40 mL
- List code
- 53748
- Pharmacologic class
- Antineoplastic; glycoengineered type II anti-CD20 monoclonal antibody
What it is and how it works
Obinutuzumab binds CD20 on B lymphocytes and induces direct cell death and enhanced antibody-dependent cellular cytotoxicity and phagocytosis, depleting normal and malignant B cells.
Indications
Previously untreated chronic lymphocytic leukaemia (with chlorambucil or venetoclax); follicular lymphoma, first-line with chemotherapy followed by maintenance, and rituximab-refractory disease with bendamustine.
Dosage and administration (summary)
Intravenous infusion, typically 1000 mg on days 1, 8 and 15 of cycle 1 and on day 1 of subsequent cycles (in CLL the first dose is split over days 1 and 2), followed by maintenance every 2 months in follicular lymphoma; premedication is required.
Contraindications
Hypersensitivity to obinutuzumab.
Warnings and precautions
Infusion-related reactions are common, especially with the first infusion. Tumour lysis syndrome, neutropenia, thrombocytopenia and serious infections may occur; screen for hepatitis B before treatment because of reactivation risk. Progressive multifocal leukoencephalopathy has been reported, and live vaccines should be avoided.
Pregnancy
Avoid; it may cause B-cell depletion in the infant, and contraception is recommended during and for 18 months after treatment.
Storage and supply
Store at 2–8 °C in a refrigerator; do not freeze; protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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