Besponsa (Inotuzumab Ozogamicin)
Besponsa (Inotuzumab Ozogamicin)
- Medicine Name: Besponsa
- Generic Name: Inotuzumab Ozogamicin
- Dosage Form & Strength: For Injection: 0.9 mg as a white to off-white lyophilized powder in a single-dose vial for reconstitution
- Manufactured By: Pfizer Inc.
Besponsa is a CD22-directed antibody-drug conjugate (ADC) used for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
Recommended Dosage: Pre-medicate all the respective patients prior to each dose.
For the first cycle: The recommended total dose of Besponsa injection for all patients is 1.8 mg/m2 per cycle, given as three divided doses on Day 1’st (0.8 mg/m2), Day 8’th (0.5 mg/m2), and Day 15’th (0.5 mg/m2). Cycle-1 is 21 days (three weeks) in duration, but may be extended to four weeks in case the respective patient achieves a CR (complete remission) or complete remission (CR) with incomplete hematologic recovery (CRi), or to enable recovery from toxicity.
For subsequent cycles: In those who achieve a CR/CRi, the recommended total dose is 1.5 mg/m2 per cycle, administered as 3 divided doses on Day-1’st (0.5 mg/m2), Day-8’th (0.5 mg/m2), and Day-15’th (0.5 mg/m2). Subsequent cycles are 28 days (four weeks) in duration.
In those who do not achieve a CR/CRi, the recommended total dose is 1.8 mg/m2 per cycle given as 3 divided doses on Day 1’st (0.8 mg/m2), Day 8’th (0.5 mg/m2), and Day 15’th (0.5 mg/m2). Subsequent cycles are 4 weeks in duration. Those who do not achieve a CR/CRi within three cycles should interrupt or discontinue treatment.
For those proceeding to hematopoietic stem cell transplant (HSCT), the recommended duration of treatment is 2 cycles. A 3’rd cycle may be considered for those who do not achieve CR/CRi and minimal residual disease (MRD) negativity after two cycles.
For those not proceeding to HSCT, additional cycles of treatment with Besponsa, up to a maximum of six cycles, may be administered.
- Premedication with an antipyretic, corticosteroid, and antihistamine is required before starting the dose. Patients must be observed throughout and for at least 60 minutes after the end of infusion for signs/symptoms of infusion related reactions.
- For those with circulating lymphoblasts, cytoreduction with a combination of steroids, hydroxyurea, or vincristine to a peripheral blast count of less than or equal to 10,000/mm3 is recommended before the initial/first dose.
- A probability of VOD may increase in those who underwent HSCT after Besponsa 0.9 mg treatment. Monitor precisely for signs/symptoms of VOD; these may include rapid weight gain, elevations in total bilirubin, hepatomegaly, and ascites. For those who proceed to HSCT, assess liver tests precisely during the initial month post-HSCT, then less frequently thereafter, as per standard medical practice.
- In all respective patients, monitor liver tests, including AST, ALT, total bilirubin, and alkaline phosphatase, before and after each dose of Inotuzumab Ozogamicin. Elevations of liver tests may need dose reduction, dosing interruption, or permanent discontinuation of treatment.
- In clinical trials, higher post-HSCT non-relapse mortality rate was noted in those receiving Besponsa treatment compared to the Investigator’s choice of chemotherapy arm. Assess precisely for toxicities post-HSCT, including signs/symptoms of infection as well as VOD.
- In clinical trials, myelosuppression was noted in those receiving Inotuzumab Ozogamicin 0.9mg. Monitor complete blood counts (CBCs) prior to each dose and monitor for signs/symptoms of bleeding/hemorrhage, infection, or other effects of myelosuppression throughout treatment with Inotuzumab Ozogamicin.
- Besponsa must be administered with caution in those who have a history of or predisposition for QTc prolongation, who are on medicinal products that are known to prolong QT interval, and in those with electrolyte disturbances. Obtain ECGs and electrolytes before start of treatment, after initiation of any medicine known to prolong QTc, and periodically monitor as clinically required throughout the treatment.
- Besponsa can cause embryo-fetal harm if administered to a pregnant woman. Females of reproductive age should consider effective contraception during therapy and for at least 8 months after the final dose. Women should contact their health specialist if they become pregnant or in case pregnancy is suspected during therapy.
What documents are required to import BESPONSA to India?
BESPONSA (inotuzumab ozogamicin) injection can be imported by patients or government hospitals on the name of the patients only.
The following documentation required to import the product:
- Valid prescription from a qualified doctor.
- Patients diagnostic reports
- Patients Identity Proof (issued by government of India)
How does order be confirmed?
The order will be confirmed only after the receipt of:
- Valid prescription of Doctor
- Import permit if applicable
Is BESPONSA available in India?
BESPONSA (inotuzumab ozogamicin injection) is a (prescription drug, prescription medication or prescription medicine) pharmaceutical drug that legally requires a medical prescription to be dispensed.
IPN (Indian Pharma Network) helps import cancer medicines on the named patient supply (NPS). Indian Pharma Network is facilitator providing input
- On availability of Besponsa in India (Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore and Pune etc.)
- Medicine Price.
- Finding Genuine and reliable source from Canada, Europe, USA and Australia
- Ensuring 100% transparency.
BESPONSA can be made available to patients, doctors and hospitals at Mumbai, Kolkata, Hyderabad, Chennai, Ahmedabad, Delhi, Bangalore, Srinagar, Jammu, Jaipur, Chandigarh, Ludhiana, Noida, Gurgaon, Lucknow and Pune and other cities in India. The order will be confirmed only after the receipt of a valid prescription from the doctor and import permit.
IPN (Indian Pharma Network) can facilitate the supply of BESPONSA (prescription medicines) to all locations in the world and in India after fulfilling the legal requirement (if applicable).
Please contact +91-9310090915 | Toll-Free Number: 1800-889-1064 or write us at info@indianpharmanetwork.in for Besponsa price in India.
We take guarantee of quality and delivery anywhere in the world as per the buyer’s requirements.
Indian Pharma Network is able to source the BESPONSA (Cancer Treatment Medicines) from across the globe, and has the ability to supply. Indian Pharma Network offers its customers worldwide access to the best available treatment.
Indian Pharma Network is able to dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.
What is the Generic Name for the trade name drug Besponsa®?
Inotuzumab Ozogamicin is Generic Name for the trade name drug Besponsa®.
What is the Manufacturer Name of Besponsa®?
Besponsa® is manufactured by Pfizer Inc.
Is Besponsa® approved by the FDA?
Yes, Besponsa is approved by the FDA. Date of first/initial approval: August 17, 2017.
Where can I get Besponsa® at the best price in India?
To get the best BESPONSA- inotuzumab ozogamicin price in India, kindly contact Indian Pharma Network (a WHO GDP & ISO 9001:2008 authorized Company). For Besponsa, a valid medical prescription is required from your treating doctor.
What is the dosage and form of Besponsa® supplied?
Besponsa is supplied as injection: 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 with Besponsa®?
The most common side effects with Besponsa® include: fatigue, thrombocytopenia, neutropenia, abdominal pain, febrile neutropenia, infection, leukopenia, hemorrhage, pyrexia, nausea, headache, transaminases increased, gamma-glutamyltransferase increased, anemia, and hyperbilirubinemia.
How much does Besponsa® cost in India?
Besponsa cost in India is less and can vary. In order to buy or procure this ALL medication authentically, you can Call or WhatsApp +91-9310090915 or send mail to info@indianpharmanetwork.in.
What are the storage conditions of Besponsa®?
Refrigerate vials of Besponsa at 2°C to 8°C; 36°F to 46° and store in the original carton to protect from light. Do not freeze. It is a cytotoxic drug. Follow all the applicable special handling and disposal procedures.
Is it safe to buy Besponsa® online from India?
Yes, You can buy Besponsa (inotuzumab ozogamicin) online at the best price from the Indian Pharma Network (IPN) if Besponsa® has not been approved or is not available in your country.
What are the Highlights of prescribing information for Besponsa®?
Click Here to download full Besponsa prescribing information.
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