vivimusta™
(bendamustine hydrochloride injection)
A 20-minute infusion of bendamustine indicated for adults chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin lymphoma (NHL) patients
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VIVIMUSTA™ is an alkylating drug indicated for treatment of patients with:
Contraindications: History of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol
Myelosuppression: Delay or reduce dose, and restart treatment based on ANC and platelet count recovery [See Warnings and Precautions (Section 5.1)].
Infections: Monitor for fever and other signs of infection or reactivation of infections and treat promptly [See Warnings and Precautions (Section 5.2)].
Progressive multifocal leukoencephalopathy (PML): Monitor for new or worsening neurological, cognitive or behavioral signs or symptoms suggestive of PML [See Warnings and Precautions (Section 5.3)].
Anaphylaxis and Infusion-Related Reactions: Severe anaphylactic reactions have occurred. Monitor clinically and discontinue drug for severe reactions. Pre-medicate in subsequent cycles for milder reactions [See Warnings and Precautions (Section 5.4)].
Tumor Lysis Syndrome: May lead to acute renal failure and death; anticipate and use supportive measures in patients at high risk [See Warnings and Precautions (Section 5.5)].
Skin Reactions: Discontinue for severe skin reactions. Cases of SJS, DRESS and TEN, some fatal, have been reported [See Warnings and Precautions (Section 5.6)].
Hepatotoxicity: Monitor liver chemistry tests prior to and during treatment [See Warnings and Precautions (Section 5.7)].
Other Malignancies: Pre-malignant and malignant diseases have been reported [See Warnings and Precautions (Section 5.8)].
Extravasation Injury: Take precautions to avoid extravasation, including monitoring intravenous infusion site during and after administration [See Warnings and Precautions (Section 5.9)].
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use an effective method of contraception [See Warnings and Precautions (Section 5.10, Section 8.1)].
Adverse Reactions: Adverse reactions (> 5%) during infusion and within 24 hours post-infusion are nausea, and fatigue. Most common adverse reactions (≥15%) for CLL are anemia, thrombocytopenia, neutropenia, lymphopenia, leukopenia, hyperbilirubinemia, pyrexia, nausea, vomiting.
TO REPORT ADVERSE REACTIONS, contact Slayback Pharma LLC at 1-844-566-2505 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
VIV-1207-25 December 2022
0.9% sodium chloride injection USP or 2.5% dextrose/0.45% sodium chloride injection USP
(2C˚ to 8C˚ or 36F˚ to 46F˚) OR 3 hours when stored at room temperature (15C˚ to 30C˚ or 59F˚ to 86F˚) and room light
Recommended VIVIMUSTA™ dosage is 100 mg/m2 administered intravenously
Recommended VIVIMUSTA™ dosage is 120 mg/m2 administered intravenously
1 Please refer to the VIVIMUSTA™ Prescribing Information for full dosing, dosing adjustments, preparation, administration, and storage information.
Vial not pictured to actual size
71225-0120-01
J9999 Not otherwise classified, antineoplastic drugs
96413 Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
VIVIMUSTA™ is available at major wholesalers and specialty pharmacies:
10274789
5818448
2660058
193797
10275244
5013789
5013789
For more information, visit www.CONNECTdocsign.com or call 1.844.4SBCNCT (1.844.472.2628)
Timings: Monday through Friday (8 am to 6 pm) ET
VIVIMUSTA™ is an alkylating drug indicated for treatment of patients with:
Contraindications: History of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, dehydrated alcohol, or monothioglycerol
Myelosuppression: Delay or reduce dose, and restart treatment based on ANC and platelet count recovery [See Warnings and Precautions (Section 5.1)].
Infections: Monitor for fever and other signs of infection or reactivation of infections and treat promptly [See Warnings and Precautions (Section 5.2)].
Progressive multifocal leukoencephalopathy (PML): Monitor for new or worsening neurological, cognitive or behavioral signs or symptoms suggestive of PML [See Warnings and Precautions (Section 5.3)].
Anaphylaxis and Infusion-Related Reactions: Severe anaphylactic reactions have occurred. Monitor clinically and discontinue drug for severe reactions. Pre-medicate in subsequent cycles for milder reactions [See Warnings and Precautions (Section 5.4)].
Tumor Lysis Syndrome: May lead to acute renal failure and death; anticipate and use supportive measures in patients at high risk [See Warnings and Precautions (Section 5.5)].
Skin Reactions: Discontinue for severe skin reactions. Cases of SJS, DRESS and TEN, some fatal, have been reported [See Warnings and Precautions (Section 5.6)].
Hepatotoxicity: Monitor liver chemistry tests prior to and during treatment [See Warnings and Precautions (Section 5.7)].
Other Malignancies: Pre-malignant and malignant diseases have been reported [See Warnings and Precautions (Section 5.8)].
Extravasation Injury: Take precautions to avoid extravasation, including monitoring intravenous infusion site during and after administration [See Warnings and Precautions (Section 5.9)].
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of the potential risk to a fetus and to use an effective method of contraception [See Warnings and Precautions (Section 5.10, Section 8.1)].
Adverse Reactions: Adverse reactions (> 5%) during infusion and within 24 hours post-infusion are nausea, and fatigue. Most common adverse reactions (≥15%) for CLL are anemia, thrombocytopenia, neutropenia, lymphopenia, leukopenia, hyperbilirubinemia, pyrexia, nausea, vomiting.
TO REPORT ADVERSE REACTIONS, contact Slayback Pharma LLC at 1-844-566-2505 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
VIV-1207-25 December 2022
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