Bendamustine Hydrochloride 25 mg/mL

Bendamustine Hydrochloride · INJECTION, SOLUTION · Apotex Corp

No Recall History

Plain English

Bendamustine Hydrochloride is a injection, solution containing bendamustine hydrochloride at 25 mg/mL, taken intravenous. Manufactured by Apotex Corp.

Key Facts

Brand Name: Bendamustine Hydrochloride
Generic Name: Bendamustine Hydrochloride
NDC Code (Product): 60505-6228
Manufacturer: Apotex Corp
Strength: 25 mg/mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA215033
Marketing Start: 04/26/2023

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 indication398 reports

drug ineffective387 reports

febrile neutropenia364 reports

malignant neoplasm progression357 reports

neutropenia344 reports

neutrophil count decreased337 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Non-Hodgkin Lymphoma (NHL) Bendamustine hydrochloride injection 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. Bendamustine hydrochloride injection is an alkylating drug indicated for treatment of adult patients with: • 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 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For NHL : • 120 mg/m 2 infused intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles ( 2.1 ) 2.1 Dosing Instructions for NHL Recommended Dosage: The recommended dosage is 120 mg/m 2 administered intravenously over 60 minutes on Days 1 and 2 of a 21-day cycle, up to 8 cycles. Dose Delays, Dosage Modifications and Reinitiation of Therapy for NHL: Delay bendamustine hydrochloride injection administration in the event of a Grade 4 hematologic toxicity or clinically significant greater or equal to Grade 2 non-hematologic toxicity. Once non-hematologic toxicity has recovered to ≤ Grade 1 and/or the blood counts have improved [Absolute Neutrophil Count (ANC) ≥ 1 x 10 9 /L, platelets ≥ 75 x 10 9 /L], reinitiate bendamustine hydrochloride injection at the discretion of the treating physician. In addition, consider dose reduction. [ see Warnings and Precautions ( 5.1 )] Dosage modifications for hematologic toxicity: for Grade 4 toxicity, reduce the dose to 90 mg/m 2 on Days 1 and 2 of each cycle; if Grade 4 toxicity recurs, reduce the dose to 60 mg/m 2 on Days 1 and 2 of each cycle. Dosage modifications for non-hematologic toxicity: for G…

Contraindications

4 CONTRAINDICATIONS Bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, absolute ethanol, sodium hydroxide and monothioglycerol. [see Warnings and Precautions ( 5.4 )] Bendamustine hydrochloride injection is contraindicated in patients with a history of a hypersensitivity reaction to bendamustine, polyethylene glycol 400, absolute ethanol, sodium hydroxide and 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 bendamustine hydrochloride injection. ( 7.1 ) 7.1 Effect of Other Drugs on Bendamustine Hydrochloride Injection CYP1A2 Inhibitors The coadministration of bendamustine hydrochloride injection with CYP1A2 inhibitors may increase bendamustine plasma concentrations and may result in increased incidence of adverse reactions with bendamustine hydrochloride injection [see Clinical Pharmacology ( 12.3 )]. Consider alternative therapies that are not CYP1A2 inhibitors during treatment with bendamustine hydrochloride injection. CYP1A2 Inducers The coadministration of bendamustine hydrochloride injection with CYP1A2 inducers may decrease bendamustine plasma concentrations and may result in decreased efficacy of bendamustine hydrochloride injection [see Clinical Pharmacology ( 12.3 )]. Consider alternative therapies that are not CYP1A2 inducers during treatment with bendamustine hydrochloride injection.

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant serious adverse reactions are discussed in greater detail in other sections of the prescribing information. 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 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 (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue. ( 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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fd…

Frequently Asked Questions

What is Bendamustine Hydrochloride used for?

Bendamustine Hydrochloride contains Bendamustine Hydrochloride. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Bendamustine Hydrochloride a controlled substance?

Bendamustine Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Bendamustine Hydrochloride?

The generic name for Bendamustine Hydrochloride is Bendamustine Hydrochloride. There are 12 other brand versions of Bendamustine Hydrochloride.

What is the NDC code for Bendamustine Hydrochloride 25 mg/mL?

The NDC (National Drug Code) for Bendamustine Hydrochloride 25 mg/mL is 60505-6228, listed by Apotex Corp.

Product NDC

60505-6228

Package NDC

60505-6228-0

Other Bendamustine Brands

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

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