PURIXAN 20 mg/mL
Purixan · SUSPENSION · Nova Laboratories, Ltd
Purixan is an oral suspension containing 20 mg/mL used to treat acute lymphoblastic leukemia. This prescription medication is taken by mouth and helps prevent the return of leukemia after initial treatment.
Key Facts
- Brand Name
- PURIXAN
- Generic Name
- Purixan
- NDC Code (Product)
62484-0020- Manufacturer
- Nova Laboratories, Ltd
- Strength
- 20 mg/mL
- Dosage Form
- SUSPENSION
- Route
- ORAL
- Marketing Status
- Application #
- NDA205919
- Marketing Start
- 04/28/2014
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE PURIXAN 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 PURIXAN is indicated for the treatment of patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended starting dosage of PURIXAN is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of a combination chemotherapy maintenance regimen. Adjust dose to maintain desirable absolute neutrophil count and for excessive myelosuppression.( 2.1 ) Renal Impairment : Use the lowest recommended starting dose or increase the dosing interval. ( 2.3, 8.6 ) Hepatic Impairment : Use the lowest recommended starting dose. ( 2.3, 8.7 ) 2.1 Recommended Dosage The recommended starting dose of PURIXAN is 1.5 mg/kg to 2.5 mg/kg (50 mg/m 2 to 75 mg/m 2 ) orally once daily as part of combination chemotherapy maintenance regimen. Take PURIXAN either consistently with or without food. After initiating PURIXAN, monitor complete blood counts (CBC) and adjust the dose to maintain absolute neutrophil count (ANC) at a desirable level and for excessive myelosuppression. Evaluate the bone marrow in patients with prolonged myelosuppression or repeated episodes of myelosuppression to assess leukemia status and marrow cellularity. Evaluate thiopurine S-methyltransferase (TPMT) and nucleotide diphosphatase (NUDT15) status in patients with severe myelosuppr…
Contraindications
4 CONTRAINDICATIONS None None.
Drug Interactions
7 DRUG INTERACTIONS Allopurinol : Reduce the dose of PURIXAN when co-administered with allopurinol. ( 2.4 , 7.1 ) Warfarin : PURIXAN may decrease the anticoagulant effect. ( 7.2 ) See FDA approved patient labeling and
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) ]
Frequently Asked Questions
What is PURIXAN used for?
Purixan is an oral suspension containing 20 mg/mL used to treat acute lymphoblastic leukemia. This prescription medication is taken by mouth and helps prevent the return of leukemia after initial treatment.
Is PURIXAN a controlled substance?
PURIXAN is not classified as a controlled substance by the DEA.
What is the generic name for PURIXAN?
The generic name for PURIXAN is Purixan. There are no other listed brand versions of Purixan.
What is the NDC code for PURIXAN 20 mg/mL?
The NDC (National Drug Code) for PURIXAN 20 mg/mL is 62484-0020, listed by Nova Laboratories, Ltd.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)