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About Purixan™

Warnings and Precautions

Myelosupression
The most consistent dose-related toxicity of PURIXAN is bone marrow suppression.

Hepatotoxicity
Mercaptopurine is hepatotoxic. There are reports of deaths attributed to hepatic necrosis associated with the administration of mercaptopurine. Hepatic injury can occur with any dosage, but seems to occur with greater frequency when the recommended dosage is exceeded.

Immunosuppression
Mercaptopurine is immunosuppressive and may impair the immune response to infectious agents or vaccines.

Embryo-Fetal Toxicity
PURIXAN can cause fetal harm when administered to pregnant women. If PURIXAN is used during pregnancy or if the patient becomes pregnant while taking PURIXAN, she should be apprised of the risk to the fetus.

Treatment-Related Malignancies
Cases of hepatosplenic T-cell lymphoma have been reported in patients treated with mercaptopurine for inflammatory bowel disease, for which mercaptopurine is not approved. Mercaptopurine is mutagenic in animals and humans, carcinogenic in animals, and may increase the risk of second primary malignancies.

Laboratory Tests
Monitor the following laboratory tests in patients receiving PURIXAN:
• Complete blood counts
• Transaminases
• Bilirubin
Evaluate TPMT status in patients with clinical or laboratory evidence of severe bone marrow toxicity or repeated episodes of myelosuppression.

Adverse Reactions

Myelosuppression
Including anemia, neutropenia, lymphopenia, and thrombocytopenia:
>20% Occurrence in ALL Trials

Anorexia, nausea, vomiting, diarrhea, malaise, and rash:
5 to 20% Occurrence in ALL Trials

Urticaria, hyperuricemia, oral lesions,a elevated transaminases, hyperbilirubinemia, hyperpigmentation, and pancreatitis:
<5% Occurrence in ALL Trials

Delayed or Late Toxicities
Including hepatic fibrosis, hyperbilirubinemia, alopecia, pulmonary fibrosis, oligospermia, and secondary malignancies.

INDICATION

PURIXAN® (mercaptopurine) is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as a component of a combination maintenance therapy regimen.

Warnings and Precautions

Myelosuppression
Monitor complete blood count (CBC) and adjust the dose of PURIXAN for excessive myelosuppression. Consider testing in patients with severe myelosuppression or repeated episodes of myelosuppression for thiopurine S-methyltransferase (TPMT) or nucleotide diphosphatase (NUDT15) deficiency. Patients with homozygous-TPMT or homozygous-NUDT15 deficiency may require a dose reduction.

Hepatotoxicity
Monitor transaminases, alkaline phosphatase and bilirubin. Withhold PURIXAN at onset of hepatotoxicity.

Immunosuppression
Response to all vaccines may be diminished and there is a risk of infection with live virus vaccines. Consult immunization guidelines for immunocompromised pediatrics.

Treatment Related Malignancies
Aggressive and fatal cases of hepatosplenic T-cell lymphoma have occurred.

Macrophage Activation Syndrome
Monitor for and treat promptly; discontinue PURIXAN.

Embryo-Fetal Toxicity
Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception.

 

Adverse Reactions

Adverse Reactions – Clinical Studies Experience
The most common adverse reaction occurring in > 20% of patients was myelosuppression, including anemia, neutropenia, lymphopenia and thrombocytopenia. Adverse reactions occurring in 5% to 20 % of patients included anorexia, nausea, vomiting, diarrhea, malaise, and rash. Adverse reactions occurring in < 5 % of patients included urticaria, hyperuricemia, oral lesions, elevated transaminases, hyperbilirubinemia, hyperpigmentation, infections, and pancreatitis. Oral lesions resemble thrush rather than antifolic ulcerations. Delayed or late toxicities include hepatic fibrosis, hyperbilirubinemia, alopecia, pulmonary fibrosis, oligospermia and secondary malignancies.

Adverse Reactions – Postmarketing Experience
The following adverse reactions have been identified during postapproval use of PURIXAN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions include: photosensitivity, hypoglycemia, and portal hypertension.

See Full Prescribing Information

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