MERCAPTOPURINE
Generic: MERCAPTOPURINE
Basic Information
Manufacturer
Nova Laboratories, Ltd
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
9c6fc66b-522f-499d-961a-cde6ca0ec2e5
Indications & Usage
1 INDICATIONS AND USAGE MERCAPTOPURINE is a nucleoside metabolic inhibitor indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.( 1.1 ) 1.1 Acute Lymphoblastic Leukemia MERCAPTOPURINE is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reaction (> 20%) is myelosuppression including anemia, neutropenia, lymphopenia and thrombocytopenia.
Adverse reactions occurring in 5% to 20% of patients include anorexia, nausea, vomiting, diarrhea, malaise and rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Immunosuppression [see Warnings and Precautions (5.3) ] Treatment Related Malignancies [see Warnings and Precautions (5.4) ] Macrophage Activation Syndrome [see Warnings and Precautions (5.5) ]
Adverse reactions occurring in 5% to 20% of patients include anorexia, nausea, vomiting, diarrhea, malaise and rash.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Rare Disease Therapeutics, Inc., at 1-844-472-7389 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Immunosuppression [see Warnings and Precautions (5.3) ] Treatment Related Malignancies [see Warnings and Precautions (5.4) ] Macrophage Activation Syndrome [see Warnings and Precautions (5.5) ]