Drugplain

VIVIMUSTA 25 mg/mL

BENDAMUSTINE HYDROCHLORIDE · INJECTION · Slayback Pharma LLC

No Recall History
Plain English

VIVIMUSTA is a injection containing bendamustine hydrochloride at 25 mg/mL, taken intravenous. Manufactured by Slayback Pharma LLC.

Key Facts

Brand Name
VIVIMUSTA
Generic Name
BENDAMUSTINE HYDROCHLORIDE
NDC Code (Product)
71225-120
Manufacturer
Slayback Pharma LLC
Strength
25 mg/mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA212209
Marketing Start
12/07/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use986 reports
pyrexia550 reports
disease progression511 reports
covid-19403 reports
product use in unapproved indication399 reports
drug ineffective387 reports
febrile neutropenia364 reports
malignant neoplasm progression357 reports
neutropenia345 reports
neutrophil count decreased337 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & USAGE VIVIMUSTA is an alkylating drug indicated for treatment of patients with: • Chronic lymphocytic leukemia (CLL). Efficacy relative to first line therapies other than chlorambucil has not been established. ( 1.1 ) • Indolent B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. ( 1.2 ) 1.1 Chronic Lymphocytic Leukemia (CLL) VIVIMUSTA is indicated for the treatment of adult patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) VIVIMUSTA is indicated for the treatment of adult patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

Dosage & Administration

2 DOSAGE & ADMINISTRATION 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, …

Contraindications

4 CONTRAINDICATIONS 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 )

Drug Interactions

7 DRUG INTERACTIONS 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.

Adverse Reactions

6 ADVERSE REACTIONS 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, ra…

Frequently Asked Questions

What is VIVIMUSTA used for?

VIVIMUSTA contains BENDAMUSTINE HYDROCHLORIDE. It is a injection taken intravenous. Consult your doctor for specific uses.

Is VIVIMUSTA a controlled substance?

VIVIMUSTA is not classified as a controlled substance by the DEA.

What is the generic name for VIVIMUSTA?

The generic name for VIVIMUSTA is BENDAMUSTINE HYDROCHLORIDE. There are 10 other brand versions of BENDAMUSTINE HYDROCHLORIDE.

What is the NDC code for VIVIMUSTA 25 mg/mL?

The NDC (National Drug Code) for VIVIMUSTA 25 mg/mL is 71225-120, listed by Slayback Pharma LLC.

Product NDC

71225-120

Package NDC

71225-120-01

Other VIVIMUSTA Dosages

Other Bendamustine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)