Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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) ]
5 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.
( 2.2, 5.1 ) Hepatotoxicity : Monitor transaminases, alkaline phosphatase and bilirubin.
Withhold PURIXAN at onset of hepatotoxicity.
Like all medications, Purixan can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: