BLEOMYCIN injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BLEOMYCIN SULFATE (UNII: 7DP3NTV15T) (BLEOMYCIN - UNII:40S1VHN69B)

Available from:

Hospira, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Bleomycin for Injection 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 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 has also been shown to be useful in the management of: Malignant Pleural Effusion Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. Bleomycin for Injection is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to i

Product summary:

Bleomycin for Injection, USP contains sterile bleomycin sulfate equivalent to 15 units or 30 units of bleomycin. NDC 0409-0332-20 Carton containing 1 single-dose vial 15 units per vial NDC 0409-0323-20 Carton containing 1 single-dose vial 30 units per vial The sterile powder is stable under refrigeration 2°C to 8°C (36°F to 46°F) and should not be used after the expiration date is reached. Bleomycin for Injection should not be reconstituted or diluted with 5% Dextrose Injection or other dextrose containing diluents. When reconstituted in 5% Dextrose Injection and analyzed by HPLC, Bleomycin for Injection demonstrates a loss of A2 and B2 potency that does not occur when Bleomycin for Injection is reconstituted in Sodium Chloride for Injection, 0.9%, USP. Bleomycin for Injection, USP is stable for 24 hours at room temperature in Sodium Chloride.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BLEOMYCIN- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HOSPIRA, INC.
----------
BLEOMYCIN
FOR INJECTION, USP
RX ONLY
WARNING
It is recommended that Bleomycin for Injection be administered under
the
supervision of a qualified physician experienced in the use of cancer
chemotherapeutic agents. Appropriate management of therapy and
complications
is possible only when adequate diagnostic and treatment facilities are
readily
available.
Pulmonary fibrosis is the most severe toxicity associated with
Bleomycin for
Injection.
The most frequent presentation is pneumonitis occasionally progressing
to
pulmonary fibrosis. Its occurrence is higher in elderly patients and
in those
receiving greater than 400 units total dose, but pulmonary toxicity
has been
observed in young patients and those treated with low doses.
A severe idiosyncratic reaction consisting of hypotension, mental
confusion, fever,
chills, and wheezing has been reported in approximately 1% of lymphoma
patients
treated with Bleomycin for Injection.
DESCRIPTION
Bleomycin for Injection, USP is a mixture of cytotoxic glycopeptide
antibiotics isolated
from a strain of_ Streptomyces verticillus_. It is freely soluble in
water.
It is available as a lyophilized powder for intramuscular, intravenous
or subcutaneous
injection. Each vial contains sterile bleomycin sulphate equivalent to
15 units or 30 units
of bleomycin.
Sulfuric acid or Sodium hydroxide used, if necessary to adjust the pH.
Bleomycins are a group of related basic glycopeptides which differ in
the terminal amine
substituent of the common structural unit, bleomycin acid. The main
components of
Bleomycin for Injection are bleomycins A and B . Chemically, bleomycin
A is N -[3-
(dimethylsulfonio)propyl]-bleomycinamide and bleomycin B is N -[4-
(aminoiminomethyl)amino]butyl]-bleomycinamide.
The molecular formula of bleomycin A is C
H
N
O
S and a calculated molecular
weight of 1414. The molecular formula of bleomycin B is C
H
N
O
S and a
calculated molecular weight of 1425. The structural formula of
b