"The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
CLL is a rare blood and bone marrow disease"...
Acute Lymphatic Leukemia
PURIXAN (mercaptopurine) is indicated for the treatment of patients with acute lymphoblastic leukemia as part of a combination regimen.
DOSAGE AND ADMINISTRATION
The starting dose of PURIXAN in multi-agent combination chemotherapy maintenance regimens is 1.5 to 2.5mg/kg (50 to 75 mg/m² ) as a single daily dose.
After initiating PURIXAN, continuation of appropriate dosing requires periodic monitoring of absolute neutrophil count (ANC) and platelet count to assure sufficient drug exposure (that is to maintain ANC at a desirable level) and to adjust for excessive hematological toxicity.
Dosage In TPMT-deficient Patients
Patients with inherited little or no thiopurine S-methyltransferase (TPMT) activity are at increased risk for severe mercaptopurine toxicity from conventional doses of mercaptopurine and generally require dose reduction. Testing for TPMT gene polymorphism should be considered in patients who experience severe bone marrow toxicities [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Homozygous deficient patients may require up to a 90% dosage reduction (10% of the standard PURIXAN dose). Most patients with heterozygous TPMT deficiency tolerated recommended mercaptopurine doses, but some require dose reduction based on toxicities.
The bottle should be shaken vigorously for at least 30 seconds to ensure the oral suspension is well mixed. PURIXAN is a pink to brown viscous oral suspension.
Once opened, PURIXAN should be used within 6 weeks. Dosing devices are not included with the product. The pharmacist should provide a commercially available oral syringe and suitable adaptor (if available), based on the dosing requirement for an individual patient.
If the syringe is intended for multiple use, instruct patients and caregivers to: wash the syringe with warm 'soapy' water and rinse well; hold the syringe under water and move the plunger up and down several times to make sure the inside of the syringe is clean; ensure the syringe is completely dry before use of the syringe again for dosing; and store the syringe in a hygienic place with the medicine.
PURIXAN is a cytotoxic drug. Follow special handling and disposal procedures.1
Dosage Forms And Strengths
Oral Suspension: 2000 mg/100 mL (20 mg/mL) -pink to brown in color.
PURIXAN (mercaptopurine) oral suspension 2000 mg/100 mL (20 mg/mL) is a pink to brown viscous liquid supplied in amber glass multiple-dose bottles with a child resistant closure.
100 mL bottle NDC #62484-0020-1.
Storage And Handling
Store between 15 to 25°C (59° to 77°F) in a dry place.
PURIXAN is a cytotoxic drug. Follow special handling and disposal procedures1.
1. OSHA Hazardous Drugs. OSHA. [Accessed on March 28, 2014, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
Manufactured by: Nova Laboratories Ltd Leicester LE18 4YL United Kingdom. Manufactured for: Rare Disease Therapeutics, Inc. 2550 Meridian Blvd., Suite 150 Franklin, Tennessee 37067. www.raretx.com. Distributed by: AnovoRx Distribution, LLC 1710 North Shelby Oaks Drive, Suite 6 Memphis, TN 38134. Revised: April 2014.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/9/2014
Additional Purixan Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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