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AZACITIDINE FOR- azacitidine injection, powder, lyophilized, for solution


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

Patient Information 

Hepatotoxicity in Patients with Severe Pre-Existing Hepatic Impairment

Instruct patients to inform their physician about any underlying liver disease [see Warnings and Precautions (5.2)].

Renal Toxicity

Instruct patients to inform their physician about any underlying renal disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)].

Embryo-Fetal Risk

Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1)].

Advise females of reproductive potential to avoid pregnancy during treatment with Azacitidine for injection. Advise males with female sexual partners of reproductive potential to not father a child and to use effective contraception during treatment with Azacitidine for injection. Advise patients to report pregnancy to their physicians immediately [see Warnings and Precautions (5.5) and Use in Specific Populations (8.3)].

Lactation

Advise patients to avoid breastfeeding while receiving Azacitidine for injection [see Use in Specific Populations (8.2)].

Manufactured By: 

Shilpa Medicare Limited

Jadcherla-509301

INDIA

Revised: 1/2019

Distributed By: 

Cipla USA, Inc.

1560 Sawgrass Corporate Parkway,

Suite 130, Sunrise, FL 33323

Issued: 1/2019



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