Bendamustine is an alkylating drug sold in the U.S. under 4 brand and generic names, for lymphoid leukemia and non-hodgkin lymphoma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Vivimusta (application NDA212209). Other bendamustine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For CLL : • 100 mg/m 2 infused intravenously over 20 minutes on Days 1 and 2 of a 28 day cycle, up to 6 cycles ( 2.1 ) For NHL : • 120 mg/m 2 infused intravenously over 20 minutes on Days 1 and 2 of a 21 day cycle, up to 8 cycles ( 2.2 ) 2.1 Dosing Instructions for CLL Recommended Dosage The recommended dosage is 100 mg/m 2 administered intravenously over 20 minutes on Days 1 and 2 of a 28-day cycle for up to 6 cycles. Dose Delays, Dose Modifications and Re-initiation of Therapy for CLL Delay VIVIMUSTA for Grade 4 hematologic toxicity or clinically significant Grade 2 or greater non-hematologic toxicity. Once non-hematologic toxicity has recovered to less than or equal to Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10 9 /L and platelets greater than or equal to 75 x 10 9 /L], reinitiate VIVIMUSTA at the discretion of the healthcare provider. In addition, consider dose reduction [ see Warnings and Precautions ( 5.1 )] Dose modifications for hematologic toxicity: for Grade 3 or greater toxicity, reduce the dose to 50 mg/m 2 on Days 1 and 2 of each cycle; if Grade 3 or greater toxicity recurs, reduce the dose to 25 mg/m 2 on Days 1 and 2 of each cycle. Dose modifications for non-hematologic toxicity: for clinically significant Grade 3 or greater toxicity, reduce the dose to 50 mg/m 2 on Days 1 and 2 of each cycle.…
The following clinically significant adverse reactions are described elsewhere in the labelling: • Myelosuppression [see Warnings and Precautions ( 5.1 )] • Infections [see Warnings and Precautions ( 5.2 )] • Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] • Anaphylaxis and Infusion-Related Reactions [see Warnings and Precautions ( 5.4 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.5 )] • Skin Reactions [see Warnings and Precautions ( 5.6 )] • Hepatotoxicity [see Warnings and Precautions ( 5.7 )] • Other Malignancies [see Warnings and Precautions ( 5.8 )] • Extravasation Injury [see Warnings and Precautions ( 5.9 )] • Adverse reactions (> 5%) during infusion and within 24 hours post-infusion are nausea, and fatigue. ( 6.1 ) • Most common adverse reactions (≥15%) for CLL are anemia, thrombocytopenia, neutropenia, lymphopenia, leukopenia, hyperbilirubinemia, pyrexia, nausea, vomiting. ( 6.1 ) • Most common adverse reactions (≥15%) for NHL are lymphopenia, leukopenia, anemia neutropenia, thrombocytopenia, nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased dyspnea, rash, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Injectable | — | — | View → | |
| 2 | 54/100 | Prescription | Injectable | — | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
VIVIMUSTA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol [see Warnings and Precautions ( 5.4 )] History of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol. Reactions to bendamustine hydrochloride have included anaphylaxis and anaphylactoid reactions. ( 4 , 5.4 )
Consider alternative therapies that are not CYP1A2 inducers or inhibitors during treatment with VIVIMUSTA. ( 7.1 ) 7.1 Effect of Other Drugs on VIVIMUSTA CYP1A2 Inhibitors The coadministration of VIVIMUSTA with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with VIVIMUSTA [see Clinical Pharmacology ( 12.3 )]. Consider alternative therapies that are not CYP1A2 inhibitors during treatment with VIVIMUSTA. CYP1A2 Inducers The coadministration of VIVIMUSTA with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of VIVIMUSTA [see Clinical Pharmacology ( 12.3 )]. Consider alternative therapies that are not CYP1A2 inducers during treatment with VIVIMUSTA.
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| 3 | Not yet rated | Prescription | Injectable | — | — | View → |
| 4 | Not yet rated | Prescription | Injectable | — | — | View → |