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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

BLEOMYCIN SULFATE

Composition:

BLEOMYCIN 15 [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 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. Hodgkin's disease, non-Hodgkin's lymphoma. Embryonal cell, choriocarcinoma, and teratocarcinoma. Bleomycin for Injection, USP has also been shown to be useful in the management of: Bleomycin is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions. Bleomycin is contraindicated in patients who have demonstrated a hypersensitive or an idiosyncratic reaction to it.

Product summary:

Bleomycin for Injection, USP is available as follows: NDC 0143-9240-01 , 15 units of bleomycin per vial as bleomycin sulfate USP. NDC 0143-9241-01 , 30 units of bleomycin per vial as bleomycin sulfate USP. The sterile powder is stable under refrigeration 2° to 8°C (36° to 46°F) and should not be used after the expiration date is reached. Bleomycin should not be reconstituted or diluted with D5 W or other dextrose containing diluents. When reconstituted in D5 W and analyzed by HPLC, bleomycin demonstrates a loss of A2 and B2 potency that does not occur when bleomycin is reconstituted in Sodium Chloride for Injection, 0.9%. Bleomycin is stable for 24 hours at room temperature in Sodium Chloride. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BLEOMYCIN- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
HIKMA PHARMACEUTICALS USA INC.
----------
BLEOMYCIN FOR INJECTION USP
RX ONLY
WARNING
WARNING
It is recommended that bleomycin 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 is provided as a sterile, white to off-white, lyophilized
cake or powder in vials for
intramuscular, intravenous, or subcutaneous administration. Each 15
unit and 30 unit
vial contains sterile bleomycin sulfate equivalent to 15 or 30 units
of bleomycin,
respectively. The pH range is 4.0 to 6.0 in a solution reconstituted
with Sterile Water for
Injection. Its chemical name is _N_
-[3-(dimethylsulphonio)propyl]bleomycin-amide
(bleomycin A ) and _N_ -4-(guanidobutyl)bleomycinamide (bleomycin B ).
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 is shown
at right:
1
2
1
2
2
55
84
17
21 3
2
55
84
20
21 2
NOTE: A unit of bleomycin is equal to the formerly used milligram
activi