BELRAPZO 100 mg/4mL

bendamustine hydrochloride · INJECTION · Eagle Pharmaceuticals, Inc

No Recall History

Plain English

BELRAPZO is a injection containing bendamustine hydrochloride at 100 mg/4mL, taken intravenous. Manufactured by Eagle Pharmaceuticals, Inc.

Key Facts

Brand Name: BELRAPZO
Generic Name: bendamustine hydrochloride
NDC Code (Product): 42367-521
Manufacturer: Eagle Pharmaceuticals, Inc
Strength: 100 mg/4mL
Dosage Form: INJECTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA205580
Marketing Start: 06/03/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use987 reports

pyrexia550 reports

disease progression512 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 BELRAPZO 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) BELRAPZO is indicated for the treatment of patients with chronic lymphocytic leukemia. Efficacy relative to first line therapies other than chlorambucil has not been established. 1.2 Non-Hodgkin Lymphoma (NHL) BELRAPZO is indicated for the treatment of 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 AND ADMINISTRATION For CLL : 100 mg/m 2 infused intravenously over 30 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 60 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 30 minutes on Days 1 and 2 of a 28-day cycle, up to 6 cycles. Dose Delays, Dosage Modifications and Reinitiation of Therapy for CLL: Delay BELRAPZO administration in the event of 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) ≥ 1 x 10 9 /L, platelets ≥ 75 x 10 9 /L], reinitiate BELRAPZO 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 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/…

Contraindications

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

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 CLL are anemia, thrombocytopenia, neutropenia, lymphopenia, leukopenia, hyperbilirubinemia, pyrexia, nausea, vomiting. ( 6.1 , 6.2 ) Most common adverse reactions (≥15%) for NHL are lymphopenia, leukopenia, anemia, neutropenia, thrombocytopenia, nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight…

Frequently Asked Questions

What is BELRAPZO used for?

BELRAPZO contains bendamustine hydrochloride. It is a injection taken intravenous. Consult your doctor for specific uses.

Is BELRAPZO a controlled substance?

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

What is the generic name for BELRAPZO?

The generic name for BELRAPZO is bendamustine hydrochloride. There are 11 other brand versions of bendamustine hydrochloride.

What is the NDC code for BELRAPZO 100 mg/4mL?

The NDC (National Drug Code) for BELRAPZO 100 mg/4mL is 42367-521, listed by Eagle Pharmaceuticals, Inc.

Product NDC

42367-521

Package NDC

42367-521-25

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

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