उत्पाद विवरण
1. Technical Specifications
| Attribute |
Details |
| Brand Name |
Besponsa Injection |
| Generic Name |
Inotuzumab Ozogamicin |
| Strength |
1 mg per vial |
| Dosage Form |
Injection (Lyophilized powder for IV infusion) |
| Packaging Size |
Single-use vial |
| Packaging Type |
Glass vial with sterile powder |
| Medicine Type |
Anticancer Antibody-Drug Conjugate (ADC) |
| Manufacturer |
Pfizer Inc. |
| Distributed By |
Authorized oncology distributors / specialty pharmacies |
2. Product Description
Besponsa contains Inotuzumab Ozogamicin, an antibody-drug conjugate (ADC) that combines a monoclonal antibody targeting CD22 with a cytotoxic agent (calicheamicin).
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The antibody binds to CD22-positive B-cells, is internalized, and releases calicheamicin, which causes DNA double-strand breaks and induces apoptosis.
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It is specifically designed for relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
3. Product Highlights
| Attribute |
Details |
| Therapeutic Category |
Anticancer ADC targeting CD22 |
| Application Area |
Hematologic malignancies (B-cell ALL) |
| Mechanism of Action |
Monoclonal antibody targets CD22 internalization release of calicheamicin DNA breaks cancer cell death |
| Administration |
Intravenous infusion (cycle-based treatment) |
| Storage Conditions |
Store in refrigerator (28C); protect from light; do not freeze |
4. Therapeutic Uses
5. Side Effects
Common:
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Nausea, vomiting
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Fatigue, fever
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Headache, dizziness
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Anemia, thrombocytopenia, neutropenia
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Elevated liver enzymes (AST, ALT, bilirubin)
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Abdominal pain, diarrhea
Serious / Severe:
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Hepatotoxicity (including VOD/SOS veno-occlusive disease / sinusoidal obstruction syndrome, especially post stem cell transplant)
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Severe cytopenias (risk of infections, bleeding)
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Infusion-related reactions
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QT prolongation (cardiac risk)
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Secondary malignancies (rare, long-term risk)
6. Precautions
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Liver Monitoring: Regular LFTs (AST, ALT, bilirubin, alkaline phosphatase) before and during therapy.
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VOD Risk: Higher if patient undergoes stem cell transplant monitor closely.
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CBC Monitoring: Weekly monitoring of blood counts due to risk of cytopenias.
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Cardiac Monitoring: Monitor ECG for QT prolongation, especially with other QT-prolonging drugs.
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Pregnancy & Breastfeeding: Contraindicated teratogenic and toxic.
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Drug Interactions: Use caution with hepatotoxic drugs and QT-prolonging agents.
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Infusion Reactions: Premedication with corticosteroids, antihistamines, and antipyretics recommended.
Effective Cancer TherapyBesponsa 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 LifeTo 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 DistributionOriginating 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.
FAQs of Besponsa 1mg Injection:
Q: How should Besponsa 1mg Injection be stored to ensure maximum effectiveness?
A: Besponsa 1mg Injection should be stored in a cool and dry place, away from sunlight and moisture. Follow the storage instructions to preserve its quality and efficacy throughout its one-year shelf life.
Q: What is the main ingredient in Besponsa 1mg Injection and what is its purpose?
A: The injection contains Inotuzumab Ozogamicin (1mg), which is used to target and treat certain types of cancer cells, especially in patients with relapsed or refractory acute lymphoblastic leukemia.
Q: When should Besponsa 1mg Injection be administered?
A: Administration of Besponsa 1mg Injection should always be under the supervision of a qualified medical professional, who will determine the appropriate timing and dosing based on the patients specific condition.
Q: Where can I purchase Besponsa 1mg Injection in India?
A: Besponsa 1mg Injection is available through authorized distributors, exporters, suppliers, traders, and wholesalers across India. Always ensure you obtain it from a reputable source.
Q: What is the recommended process for using Besponsa 1mg Injection?
A: This medication must be prepared and administered by healthcare professionals via an injection. Self-administration is not recommended, and dosing should strictly follow the doctors prescription.
Q: What are the key benefits of using Besponsa 1mg Injection?
A: The main benefit lies in its targeted action against certain cancer cells, offering an effective treatment option for individuals with relapsed or refractory acute lymphoblastic leukemia.