"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"...
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.
Prior to initiation of Purixan and on each visit to the clinic, train patients or caregivers on proper handling, storage, administration, disposal and clean-up of accidental spillage of the medication. Since Purixan is supplied with 1 mL and 5 mL oral dispensing syringes, provide appropriate instructions regarding which syringe to use and how to administer a specified dose.
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.
A press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided.
The oral dispensing syringe is intended for multiple use: wash the oral dispensing syringe with warm 'soapy' water and rinse well; hold the oral dispensing syringe under water and move the plunger up and down several times to make sure the inside of the oral dispensing syringe is clean; ensure the oral dispensing syringe is completely dry before use of the oral dispensing syringe again for dosing; and store the oral dispensing 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. In addition, a press-in bottle adapter and two oral dispensing syringes (one 1 mL and one 5 mL) are provided.
100 mL bottle NDC #62484-0020-1.
Storage And Handling
- Store PURIXANbetween 59° to 77°F (15°to 25°C), inadryplace. Do not store above 25°C.
- Storethe oral dispensingsyringe inacleanplace, withthe medicine.
- PURIXAN oral suspension should be used within 6 weeks after opening the bottle. Dispose of (throw away) any unused medicine after 6 weeks.
- Do notuse after the expiry date which is stated on the cartonandthe bottleafter 'EXP'.
- Keep the bottle tightlyclosedto preventspoilage ofthemedicineand reduce the riskofaccidental spillage.
- Keep PURIXAN and all medicines out of the reach of children, preferably in a locked cupboard. Accidental ingestion can be lethal for children.
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. Distributed by: AnovoRx Distribution, LLC, 1710 North Shelby Oaks Drive, Suite 6, Memphis, TN 38134. Revised: Dec 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/12/2016
Additional Purixan Information
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