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BUSULFAN- busulfan injection, solution


  1. Patient Information
  2. Manufactured By:
  3. Distributed By:

Patient Information 

Myelosuppression

Advise patients of the possibility of developing low blood cell counts and the need for hematopoietic progenitor cell infusion. Instruct patients to immediately report to their healthcare provider if fever develops [seeWarnings and Precautions (5.1)].

Seizures

Advise patients of the possibility of seizures and that they will be given medication to prevent them. Patients should be asked to report a history of seizure or head trauma [seeWarnings and Precautions (5.2)].

Hepatic Veno-Occlusive Disease (HVOD)

Advise patients of the risks associated with the use of busulfan as well as the plan for regular blood monitoring during therapy. Specifically inform patients of the following: The risk of veno-occlusive liver disease [seeWarnings and Precautions (5.3)].

Embryo-fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [seeWarnings and Precautions (5.4)andUse in Specific Populations (8.1)].

Females of Reproductive Potential

Advise females of reproductive potential to use effective contraception during treatment with busulfan and for 6 months following cessation of therapy [seeUse in Specific Populations (8.3)].

Males of Reproductive Potential

Advise males with female sexual partners of reproductive potential to use effective contraception during treatment with busulfan injection and for 3 months following cessation of therapy [seeUse in Specific Populations (8.3)].

Lactation

Advise females to discontinue breastfeeding during treatment with busulfan injection [seeUse in Specific Populations (8.2)].

Infertility

Advise females and males of reproductive potential that busulfan injection may cause temporary or permanent infertility [seeUse in Specific Populations (8.3)].

Cardiac Tamponade

Advise patients of the risk of cardiac tamponade. Instruct patients to report to their healthcare provider symptoms of abdominal pain and vomiting [seeWarnings and Precautions (5.5)].

Bronchopulmonary Dysplasia

Advise patients of the possibility of bronchopulmonary dysplasia with pulmonary fibrosis with chronic busulfan therapy. Instruct patients to report symptoms of shortness of breath and cough to their healthcare provider. These symptoms could occur several months or years after therapy with busulfan injection [seeWarnings and Precautions (5.6)].

Manufactured By: 


Shilpa Medicare Limited
Jadcherla-509301, INDIA

Distributed By: 


Armas Pharmaceuticals, Inc.
Manalapan, NJ 07726 (USA)

Revised: 05/2019

Rx only

Caution: Cytotoxic agent



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