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Belantamab mafodotin achieved an overall response rate (ORR) of 32% (97.5% confidence interval [CI]: 22–44) with a median duration of response (DoR) of 11 months (95% CI: 4.2 to not reached). Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment.
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Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Belantamab mafodotin (GSK2857916); is an antibody-drug conjugate (ADC) containing humanized anti-BCMA monoclonal antibody (mAb). This is a phase I/II, randomized, open-label, platform study designed to evaluate the effects of belantamab mafodotin in combination with other anti-cancer drugs in participants with relapsed/refractory multiple myeloma.
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Call your doctor to find out what to do. How do I store and/or throw out this drug? If you need to store this drug at home, talk with your doctor, nurse, or Belantamab Mafodotin 4/6 dilute in a 250-mL infusion bag of 0.9% Sodium Chloride Injection, USP, to a final concentration of 0.2 mg/mL to 2 mg/mL.
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Copy link to Tweet; Embed Tweet. FDA följde ODAC och godkände Belantamab trots ögon Local Anesthetic Infusion Via Catheters for Control of Peri-Operative Pain in Nuss Patients Belantamab Mafodotin-Blmf. INJECTABLE;INTRAVENOUS. Indikationen för belantamab mafodotin är recidiverande eller Doseringen är 2,5 mg/kg som intravenös infusion under minst 30 minuter var. /18.6099bd3a174afc870ff3191e/1600865660713/Belantamab-mafodotin-vid- .se/images/18.3e7cbd461677d8d7b5c9cb06/1545124278466/infusion.png L01XC39 belantamab mafodotin belantamab mafodotin (Blenprep) Inplanterbart port- och katetersystem för intravenös injektion/infusion.
Reduction in dose may be required based on symptoms and experienced side effects. The recommended dose reduction for adverse events is: 1
Do not mix or administer BLENREP as an infusion with other products. The product does not contain a preservative. 3 DOSAGE FORMS AND STRENGTHS For injection: 100 mg of belantamab mafodotin-blmf as a white to yellow lyophilized powder in a
Belantamab mafodotin was granted PRIME designation in 2017 and the Conditional Marketing Authorisation Application was reviewed under European Medicines Agency’s accelerated assessment procedure, which is given if the EMA’s Committee for Medicinal Products for Human Use determines the treatment is of major interest from a public health perspective and represents a therapeutic innovation.
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It is given as an infusion into a vein over a period of time. What do I do if I miss a dose? Call your doctor to find out what to do. How do I store and/or throw out this drug?
Myeloma. The recommended dosage of Blenrep is 2.5 mg/kg of actual body weight given as an intravenous infusion over approximately
The Ambulatory Infusion Center, in the Beverly Building, provides therapeutic, intravenous infusions to outpatients.
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Belantamab mafodotin exhibited dose-proportional pharmacokinetics, with a gradual decrease in clearance over time. The time to reach steady-state was ~70 days.
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BLENREP - FASS Allmänhet
2020-07-22 Grade 4 Withhold belantamab until platelet count improves to Grade 3 or better. Consider resuming at a reduced dose of 1.9 mg/kg.