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COSMEGEN- dactinomycin injection, powder, lyophilized, for solution


Patient Information

Secondary Malignancy or Leukemia

Advise patients of the increased risk of secondary malignancies[see Warnings and Precautions (5.1)].

Veno-occlusive Disease

Advise patients about the symptoms of VOD and to seek medical attention if they develop new onset jaundice, abdominal distention, or right upper quadrant pain[see Warnings and Precautions (5.2)].

Myelosuppression

Advise patients to contact their healthcare provider for any signs or symptoms of myelosuppression or infection[see Warnings and Precautions (5.4)].

Severe Mucocutaneous Reactions

Advise patients of the risk of severe mucocutaneous reactions and to contact their health care provided for new skin lesions, mouth sores or oropharyngeal lesions[see Warnings and Precautions (5.5)].

Renal Toxicity or Hepatotoxicity

Advise patients of the need for periodic laboratory testing to monitor for renal toxicity and hepatotoxicity[see Warnings and Precautions (5.7,5.8)].

Potentiation of Radiation Toxicity and Radiation Recall

Advise patients of the risk of increased radiation-induced gastrointestinal, myelosuppression and skin toxicity[see Warnings and Precautions (5.9)].

Embryo-Fetal Toxicity

Advise females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy[see Warnings and Precautions (5.10), Use in Specific Populations (8.1)].

Advise females of reproductive potential to use effective contraception during treatment with COSMEGEN and for 6 months after final dose[see Use in Specific Populations (8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment with COSMEGEN and for 3 months after final dose[see Use in Specific Populations (8.3)].

Lactation

Advise females not to breastfeed during treatment with COSMEGEN and for 14 days after the final dose[see Use in Specific Populations (8.2)].

Manufactured by: Baxter Oncology GmbH, 33790 Halle/Westfalen, Germany

Manufactured for: Recordati Rare Diseases Inc., Lebanon, NJ 08833, U.S.A.

COSMEGEN is a registered trademark of Recordati Rare Diseases Inc.

PX 2092/5



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