BLEOMYCIN- bleomycin sulfate 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:

Fresenius Kabi USA, LLC

INN (International Name):

BLEOMYCIN SULFATE

Composition:

BLEOMYCIN 30 [USP'U]

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 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 ha

Product summary:

Bleomycin for Injection, USP is available as follows: 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 D 5 W or other dextrose containing diluents.  When reconstituted in D 5 W and analyzed by HPLC, Bleomycin for Injection demonstrates a loss of A 2 and B 2 potency that does not occur when Bleomycin for Injection is reconstituted in Sodium Chloride for Injection, 0.9%, USP. Bleomycin for Injection is stable for 24 hours at room temperature in Sodium Chloride. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BLEOMYCIN - BLEOMYCIN SULFATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
FRESENIUS KABI USA, LLC
----------
BLEOMYCIN FOR INJECTION, USP
Rx only
BOXED WARNING
It is recommended that Bleomycin for Injection, USP 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. 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.
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.
Bleomycin for Injection, USP is provided as a sterile lyophilized
powder for reconstitution containing
15 units per vial and 30 units per vial, which are intended for
intramuscular, intravenous, subcutaneous
or intrapleural administration.
Its chemical name is N’-[3-(dimethylsulphonio)propyl]bleomycin-amide
(bleomycin A
) and N’-[4-
(guaniodobutyl)]bleomycin-amide (bleomycin B
).
(Main component: Bleomycin A
, in which _R _is [CH
]
S
CH
CH
CH
-)
NOTE: A unit of bleomycin is equal to the formerly used milligram
activity. The term milligram activity
is a misnomer and was changed to units to be more precise.
CLINICAL PHARMACOLOGY:
_MECHANISM OF ACTION_
2
2
2
3
2
+
2
2
2
Although the exact mechanism of action of bleomycin is unknown,
available evidence indicates that the
main mode of action is the inhibition of DNA synthesis with