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:

Amneal Pharmaceuticals LLC

INN (International Name):

BLEOMYCIN SULFATE

Composition:

BLEOMYCIN 15000 [iU]

Administration route:

INTRA-ARTERIAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Palliation and treatment adjutant to surgery and radiation therapy of the following neoplasms: - Squamous cell carcinoma of the skin, head and neck, and esophagus (primary indication). - Squamous cell carcinoma of the larynx, penis and uterine cervix. - Squamous cell carcinoma of the bronchus (response infrequent). - Ch0riocarcinoma and embryonal cell carcinoma of the testis. - Advanced Hodgkin’s disease and Other lymphomas. - Mycosis fungoides. Note . Use of bleomycin after radiation therapy is less successful than use before radiation therapy. Bleomycin is bone marrow sparing and may be used when other cytotoxic agents are contraindicated.

Product summary:

Vials (white to cream colored lyophilized powder for reconstitution), equiv. 15,000 IU bleomycin activity: 1's, 10’s. Store at 2-B°C. (Refrigerate. Do not freeze.) Shelf life: 2 years AUST R 157341

Authorization status:

Unapproved drug for use in drug shortage

Summary of Product characteristics

BLEOMYCIN- BLEOMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
AMNEAL PHARMACEUTICALS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
​ BLEO 15K
BLEOMYCIN SULFATE.
BLEOMYCIN SULFATE POWDER FOR INJECTION CONTAINS BLEOMYCIN SULFATE
15,000 IU
PER VIAL
IMPORTANT DRUG INFORMATION
July 5, 2016
Re: Temporary importation of Bleomycin Sulfate Powder for Injection,
15,000
International Units (IU) to address drug shortage issue
Dear Healthcare Professional,
IMPORTANT
NOTE:
EACH VIAL OF
AMNEAL
BIOSCIENCES’
PRODUCT
CONTAINS
15,000 IU OF
BLEOMYCIN
SULFATE
POWDER FOR
INJECTION,
WHICH IS
EQUIVALENT
TO
BLEOMYCIN
SULFATE USP
15 UNITS
(1000 IU OF
BLEOMYCIN
SULFATE
POWDER FOR
INJECTION =
1 UNIT OF
BLEOMYCIN
SULFATE
USP).
PRESCRIBERS
AND
PHARMACISTS
MUST BE
ALERT TO THIS
DIFFERENCE
IN LABELED
UNITS IN
ORDER TO
PREVENT
MEDICATION
ERRORS.
APPROPRIATE
QUALITY
ASSURANCE
MEASURES
SHOULD BE
ENACTED TO
REDUCE THE
RISK OF
MEDICATION
ERRORS.
Due to the current critical shortage of Bleomycin Sulfate for
Injection, USP, 15 units and
30 units per vial in the United States (U.S.) market, Amneal
Biosciences is coordinating
with the U.S. Food and Drug Administration (FDA) to increase the
availability of
Bleomycin Sulfate for Injection, USP, 15 units per vial.
Amneal Biosciences has initiated temporary importation of a non-FDA
approved product,
Bleomycin Sulfate Powder for Injection 15,000 IU per vial to the U.S.
market: lot
numbers GE50604, GE60003, GE60012. The Bleomycin Sulfate Powder for
Injection
15,000 IU product being distributed by Amneal Biosciences was
manufactured by Cipla
Ltd. from its FDA-inspected facility in Verna, Goa, India, for Amneal
Pharma Australia Pty
Ltd and was sold in Australia under the WIllow Pharmaceutical label.
At this time, no other entity except Amneal Biosciences is authorized
by the FDA to
import or distribute Amneal Pharma Australia Pty Ltd.’s Bleomycin