Bleomycin 30 [USP'U]/1

Bleomycin · POWDER, FOR SOLUTION · NorthStar Rx LLC

4 Recalls on RecordCurrently in Shortage

Plain English

Bleomycin is a chemotherapy medication used to treat certain cancers, including testicular cancer, lymphomas, and squamous cell cancers. It is administered by injection into the muscle and works by damaging cancer cell DNA to slow or stop their growth.

Key Facts

Brand Name: Bleomycin
Generic Name: Bleomycin
NDC Code (Product): 16714-908
Manufacturer: NorthStar Rx LLC
Strength: 30 [USP'U]/1
Dosage Form: POWDER, FOR SOLUTION
Route: INTRAMUSCULAR, INTRAPLEURAL, INTRAVENOUS, SUBCUTANEOUS
Marketing Status
Application #: ANDA205030
Marketing Start: 12/01/2018

Recall History

4 Recalls on Record

Class I12/21/2023

PFIZER

Presence of particulate matter: glass

OngoingVoluntary: Firm initiated

Class II11/01/2013

Natures Pharmacy & Compounding Center

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

TerminatedVoluntary: Firm initiated

Class III08/05/2021

Hikma Pharmaceuticals USA Inc.

Labeling: Not elsewhere classified: Mislabeling

TerminatedVoluntary: Firm initiated

Class II06/12/2019

Infusion Options, Inc.

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

febrile neutropenia820 reports

off label use788 reports

neutropenia594 reports

drug ineffective500 reports

pyrexia459 reports

pulmonary toxicity410 reports

vomiting368 reports

nausea366 reports

anaemia355 reports

thrombocytopenia350 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Bleomycin for Injection, USP should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva. The response to Bleomycin for Injection, USP is poorer in patients with previously irradiated head and neck cancer. Lymphomas: Hodgkin's disease, non-Hodgkin's lymphoma. Testicular Carcinoma: Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin for Injection, USP has also been shown to be useful in the management of: Malignant Pleural Effusion: Bleomycin for Injection, USP is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions.

Dosage & Administration

DOSAGE AND ADMINISTRATION Because of the possibility of an anaphylactoid reaction, lymphoma patients should be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed. The following dose schedule is recommended: Squamous cell carcinoma, non-Hodgkin's lymphoma, testicular carcinoma – 0.25 to 0.50 units/kg (10 to 20 units/m 2 ) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. Hodgkin's Disease – 0.25 to 0.50 units/kg (10 to 20 units/m 2 ) given intravenously, intramuscularly, or subcutaneously weekly or twice weekly. After a 50% response, a maintenance dose of 1 unit daily or 5 units weekly intravenously or intramuscularly should be given. Pulmonary toxicity of bleomycin for injection appears to be dose-related with a striking increase when the total dose is over 400 units. Total doses over 400 units should be given with great caution. Note: When bleomycin for injection is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses. Improvement of Hodgkin's disease and testicular tumors is prompt and noted within 2 weeks. If no improvement i…

Warnings

WARNINGS Patients receiving bleomycin must be observed carefully and frequently during and after therapy. It should be used with extreme caution in patients with significant impairment of renal function or compromised pulmonary function. Pulmonary toxicities occur in 10% of treated patients. In approximately 1%, the nonspecific pneumonitis induced by bleomycin progresses to pulmonary fibrosis and death. Although this is age and dose related, the toxicity is unpredictable. Frequent roentgenograms are recommended (see ADVERSE REACTIONS: Pulmonary ). A severe idiosyncratic reaction (similar to anaphylaxis) consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with bleomycin. Since these reactions usually occur after the first or second dose, careful monitoring is essential after these doses (see ADVERSE REACTIONS: Idiosyncratic Reactions ). Renal or hepatic toxicity, beginning as a deterioration in renal or liver function tests, have been reported. These toxicities may occur at any time after initiation of therapy. Usage in Pregnancy Pregnancy “Category D” Bleomycin can cause fetal harm when administ…

Contraindications

CONTRAINDICATIONS Bleomycin for injection is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.

Drug Interactions

Drug Interactions Drugs that Can Affect Renal Clearance Because bleomycin is eliminated predominantly through renal excretion, the administration of nephrotoxic drugs with bleomycin may affect its renal clearance. Specifically, in one report of 2 children receiving concomitant cisplatin with bleomycin, total body clearance of bleomycin decreased from 39 to 18 mL/min/m 2 as the cumulative dose of cisplatin exceeded 300 mg/m 2 . Terminal half-life of bleomycin also increased from 4.4 to 6 hours. Fatal bleomycin pulmonary toxicity has been reported in a patient with unrecognized cisplatin-induced oliguric renal failure.

Adverse Reactions

ADVERSE REACTIONS Pulmonary The most serious side effects are pulmonary adverse reactions, occurring in approximately 10% of treated patients. The most frequent presentation is pneumonitis occasionally progressing to pulmonary fibrosis. Approximately 1% of patients treated have died of pulmonary fibrosis. Pulmonary toxicity is both dose and age related, being more common in patients over 70 years of age and in those receiving over 400 units total dose. This toxicity, however, is unpredictable and has been seen in young patients receiving low doses. Some published reports have suggested that the risk of pulmonary toxicity may be increased when bleomycin is used in combination with G-CSF (filgrastim) or other cytokines. However, randomized clinical studies completed to date have not demonstrated an increased risk of pulmonary complications in patients treated with bleomycin and G-CSF. Because of lack of specificity of the clinical syndrome, the identification of patients with pulmonary toxicity due to bleomycin has been extremely difficult. The earliest symptom associated with bleomycin pulmonary toxicity is dyspnea. The earliest sign is fine rales. Radiographically, bleomycin-induce…

Frequently Asked Questions

What is Bleomycin used for?

Is Bleomycin a controlled substance?

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

What is the generic name for Bleomycin?

The generic name for Bleomycin is Bleomycin. There are no other listed brand versions of Bleomycin.

What is the NDC code for Bleomycin 30 [USP'U]/1?

The NDC (National Drug Code) for Bleomycin 30 [USP'U]/1 is 16714-908, listed by NorthStar Rx LLC.

Product NDC

16714-908

Package NDC

16714-908-01

Other Bleomycin Dosages

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

Data from openFDA · Public domain (CC0 1.0)