Besponsa 1mg Injection

Product Description

1. Technical Specifications

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2. Product Description

Besponsa contains Inotuzumab Ozogamicin, an antibody-drug conjugate (ADC) that combines a monoclonal antibody targeting CD22 with a cytotoxic agent (calicheamicin).

• The antibody binds to CD22-positive B-cells, is internalized, and releases calicheamicin, which causes DNA double-strand breaks and induces apoptosis.

• It is specifically designed for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

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3. Product Highlights

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4. Therapeutic Uses

• Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults.

• Being studied for other CD22-positive B-cell malignancies (investigational).

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5. Side Effects

Common:

• Nausea, vomiting

• Fatigue, fever

• Headache, dizziness

• Anemia, thrombocytopenia, neutropenia

• Elevated liver enzymes (AST, ALT, bilirubin)

• Abdominal pain, diarrhea

Serious / Severe:

• Hepatotoxicity (including VOD/SOS veno-occlusive disease / sinusoidal obstruction syndrome, especially post stem cell transplant)

• Severe cytopenias (risk of infections, bleeding)

• Infusion-related reactions

• QT prolongation (cardiac risk)

• Secondary malignancies (rare, long-term risk)

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6. Precautions

• Liver Monitoring: Regular LFTs (AST, ALT, bilirubin, alkaline phosphatase) before and during therapy.

• VOD Risk: Higher if patient undergoes stem cell transplant monitor closely.

• CBC Monitoring: Weekly monitoring of blood counts due to risk of cytopenias.

• Cardiac Monitoring: Monitor ECG for QT prolongation, especially with other QT-prolonging drugs.

• Pregnancy & Breastfeeding: Contraindicated teratogenic and toxic.

• Drug Interactions: Use caution with hepatotoxic drugs and QT-prolonging agents.

• Infusion Reactions: Premedication with corticosteroids, antihistamines, and antipyretics recommended.

Effective Cancer Therapy

Besponsa 1mg Injection is a prescription medication used primarily to treat adults with relapsed or refractory acute lymphoblastic leukemia. Its main component, Inotuzumab Ozogamicin, targets specific cancer cells to improve treatment outcomes.


Safe Storage and Shelf Life

To ensure Besponsa 1mg Injection maintains its potency, it should be kept in a cool, dry place away from direct sunlight. The injection has a shelf life of one year from the date of manufacture, supporting extended usability within clinical settings.


Quality and Distribution

Originating from India, this injection is produced using high-quality, 100% yeast-based ingredients. It is readily available through a network of distributors, exporters, suppliers, traders, and wholesalers in India, ensuring reliable access for healthcare providers.