Medical Use
Besponsa is a CD22-targeted antibody-drug conjugate (ADC) used to treat adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Recommended Dosage: Pre-medicate patients before each dose.
First Cycle: The total recommended dose is 1.8 mg/m² per cycle, divided into three doses: 0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8, and 0.5 mg/m² on Day 15. The first cycle lasts 21 days (three weeks), but can be extended to four weeks if the patient achieves complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), or to allow for recovery from toxicity.
Subsequent Cycles:
- For patients achieving CR/CRi, the total recommended dose is 1.5 mg/m² per cycle, divided into three doses: 0.5 mg/m² on Day 1, 0.5 mg/m² on Day 8, and 0.5 mg/m² on Day 15. These cycles last 28 days (four weeks).
- For patients not achieving CR/CRi, the total recommended dose remains 1.8 mg/m² per cycle, divided into three doses: 0.8 mg/m² on Day 1, 0.5 mg/m² on Day 8, and 0.5 mg/m² on Day 15. These cycles also last four weeks. If CR/CRi is not achieved within three cycles, treatment should be interrupted or discontinued.
For Patients Proceeding to Hematopoietic Stem Cell Transplant (HSCT): The recommended treatment duration is two cycles. A third cycle may be considered for patients who do not achieve CR/CRi and minimal residual disease (MRD) negativity after two cycles.
For Patients Not Proceeding to HSCT: Additional cycles of Besponsa treatment, up to a maximum of six cycles, may be administered.
Warning & Precautions
Premedication: Before starting the dose, premedicate with an antipyretic, corticosteroid, and antihistamine. Observe patients throughout the infusion and for at least 60 minutes afterward for any signs of infusion-related reactions.
Cytoreduction: For patients with circulating lymphoblasts, reduce the peripheral blast count to ≤10,000/mm³ using steroids, hydroxyurea, or vincristine before the first dose.
VOD Risk: The risk of veno-occlusive disease (VOD) may increase in patients who undergo HSCT after Besponsa treatment. Monitor for signs of VOD, such as rapid weight gain, elevated total bilirubin, hepatomegaly, and ascites. For those proceeding to HSCT, closely monitor liver tests during the first month post-HSCT and less frequently thereafter.
Liver Monitoring: In all patients, monitor liver tests, including AST, ALT, total bilirubin, and alkaline phosphatase, before and after each dose of Inotuzumab Ozogamicin. Dose adjustments or discontinuation may be necessary if liver test elevations occur.
Post-HSCT Mortality: Clinical trials have shown a higher post-HSCT non-relapse mortality rate in patients treated with Besponsa compared to those receiving standard chemotherapy. Monitor for post-HSCT toxicities, including infections and VOD.
Myelosuppression: Myelosuppression has been observed in patients receiving Inotuzumab Ozogamicin. Monitor complete blood counts (CBCs) before each dose and watch for signs of bleeding, infection, or other myelosuppression effects throughout treatment.
QTc Prolongation: Administer Besponsa with caution in patients with a history of QTc prolongation, those on QT-prolonging medications, and those with electrolyte imbalances. Obtain ECGs and electrolytes before starting treatment, after initiating any QT-prolonging medication, and periodically as needed.
Embryo-Fetal Harm: Besponsa can cause harm to a fetus if administered to a pregnant woman. Women of reproductive age should use effective contraception during treatment and for at least 8 months after the final dose. Women should contact their healthcare provider if they become pregnant or suspect pregnancy during treatment.
Documentation Availability
Documents required to import BESPONSA to India?
BESPONSA (inotuzumab ozogamicin) injection can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- (i)2 ID proofs along with PAN card details along with attested scanned copies
- (ii)Valid doctor prescription scanned copy
- (iii)Doctor’s MCI number
- (iv)Doctor’s mobile number
- (v)Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- (i)The above-mentioned documents and drug availability.
- (ii)Import permit if applicable.
Sourcing & Delivery
The Rx4U team has extensive experience in sourcing BESPONSA (Cancer Treatment Medicines) from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.
FAQ
What is the Generic Name for Besponsa®?
The generic name for Besponsa® is Inotuzumab Ozogamicin.
Who manufactures Besponsa®?
Besponsa® is manufactured by Pfizer Inc.
Is Besponsa® FDA approved?
Yes, Besponsa® was approved by the FDA on August 17, 2017.
What is the dosage and form of Besponsa®?
Besponsa® is available as a 0.9 mg lyophilized powder in a single-dose vial for reconstitution and further dilution for intravenous administration.
What are the most common side effects of Besponsa®?
Common side effects include fatigue, thrombocytopenia, neutropenia, abdominal pain, febrile neutropenia, infection, leukopenia, hemorrhage, fever, nausea, headache, increased transaminases, increased gamma-glutamyltransferase, anemia, and hyperbilirubinemia.
How much does Besponsa® cost in India?
The cost of Besponsa® in India is relatively low and can vary. For authentic procurement, you can reach out to Rx4u team.
What are the storage conditions for Besponsa®?
Store Besponsa® vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. As it is a cytotoxic drug, follow all applicable special handling and disposal procedures.
Is it safe to buy Besponsa® online in India?
Yes, you can safely purchase Besponsa® online in India through https://rx4u.in/.
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