Medical uses:
Columvi (glofitamab-gxbm) is a bispecific CD20-directed CD3 T-cell engager used to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that have relapsed or are refractory to previous treatments, and who have undergone at least two prior therapies.
Recommended Dosage: Columvi is administered as an intravenous (IV) infusion. Patients will receive 12 treatment cycles, each lasting 21 days. Treatment begins with a low dose, which is gradually increased to the full dose. The typical schedule is as follows:
Cycle 1: This includes pre-treatment with obinutuzumab and two low doses of Columvi over 21 days:
- Day 1: Pre-treatment with 1,000 mg of obinutuzumab IV, 7 days before starting Columvi
- Day 8: Initial low dose of 2.5 mg of Columvi
- Day 15: Second low dose of 10 mg of Columvi
Cycles 2 to 12: Patients receive one dose of Columvi every 21 days:
- Day 1: Full dose of 30 mg of Columvi
The first infusion is administered over four hours, with careful monitoring for 10 hours afterward to check for signs or symptoms of cytokine release syndrome (CRS).
Continue treatment for up to 12 cycles (including the step-up dosing in Cycle 1) or until disease progression or unacceptable toxicity occurs, whichever comes first.
Warnings & Precautions:
Cytokine Release Syndrome (CRS): Columvi 2.5 mg or 10 mg can cause severe and potentially fatal CRS. Administer this medication in a facility equipped to manage and monitor CRS. Follow the Columvi step-up dosing schedule to reduce the risk of CRS, administer pretreatment medications, and ensure adequate hydration.
Neurologic Toxicity: Columvi can cause severe and potentially fatal neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity (ICANS). Monitor patients for signs and symptoms of neurologic toxicity, provide supportive care, and withhold or permanently discontinue treatment based on the severity.
Infections: Columvi can lead to severe or fatal infections. Do not administer to patients with an active infection. Administer antimicrobial prophylaxis according to guidelines. Monitor patients for infections before and during treatment, and treat as necessary.
Tumor Flare: Glofitamab 2.5 mg or 10 mg can cause significant tumor flare. Patients with bulky tumors or tumors near airways or vital organs should be closely monitored during initial therapy. Assess for signs of compression or obstruction due to tumor flare and provide appropriate treatment.
Pregnancy: Columvi may cause fetal harm if administered to a pregnant woman. Women of reproductive potential should use effective contraception during treatment and for 30 days after the final dose.
Documentation & Availability :
Documents required to import COLUMVI to India?
COLUMVI (glofitamab-gxbm) injection can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:
- 2 ID proofs along with PAN card details along with attested scanned copies
- Valid doctor prescription scanned copy
- Doctor’s MCI number
- Doctor’s mobile number
- Patients diagnostic reports
How is the order confirmed?
The order will be confirmed only after the receipt of:
- The above-mentioned documents and drug availability.
- Import permit if applicable.
Sourcing & Delivery:
The Rx4U team has extensive experience in sourcing COLUMVI (Cancer Treatment Medicines) 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 Columvi®?
The generic name for Columvi® is glofitamab-gxbm.
Who manufactures Columvi®?
Columvi® is manufactured by Genentech, Inc.
Is Columvi® FDA approved?
Yes, Columvi® was approved by the FDA on June 15, 2023.
What is the dosage form of Columvi®?
Columvi® is available as injections: 2.5 mg/2.5 mL (1 mg/mL) and 10 mg/10 mL (1 mg/mL) in single-dose vials for intravenous use.
What are the common side effects of Columvi®?
Common side effects include cytokine release syndrome (CRS), rash, muscle and bone pain, and fatigue.
How much does Columvi® cost in India?
The cost of Columvi® in India can vary. To purchase it legally, you can reach out to the Rx4u team.
How should Columvi® be stored?
Store Columvi® refrigerated at 2-8°C (36-46°F) in its original carton to protect from light. Do not freeze or shake the vials.
How to order Columvi® online in India?
Columvi® can be ordered online in India through https://rx4u.in/.
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