For: Malaria
Krintafel (tafenoquine) is an 8-aminoquinoline derivative antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria. How Supplied
KRINTAFEL tablets contain 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate) and are pink, film?coated, capsule-shaped, and debossed with 'GS J11' on one side. KRINTAFEL is supplied as follows:
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Bottle of 30 tablets with child-resistant closure (NDC 0173-0889-13). Bottles contain a desiccant. Once opened, use within 3 months.
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Unit Dose Pack of 2 tablets in a bottle with child-resistant closure (NDC 0173-0889-39). Bottles contain a desiccant.
Storage
Store at 20�C to 25�C (68�F to 77�F). Temperature excursions are permitted to 15�C to 30�C (59�F to 86�F) [see USP Controlled Room Temperature].
Store in the original package to protect from moisture. Keep the bottle tightly closed and do not remove the desiccant. These highlights do not include all the information needed to use KRINTAFEL safely and effectively. See full prescribing information for KRINTAFEL.
KRINTAFEL (tafenoquine) tablets, for oral use
Initial U.S. Approval: 2018
INDICATIONS AND USAGE
KRINTAFEL is an antimalarial indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection. (1)
Limitation of Use
KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. (1)
DOSAGE AND ADMINISTRATION
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All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing KRINTAFEL. (2.1)
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Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with KRINTAFEL. (2.1)
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The recommended dose of KRINTAFEL in patients aged 16 years and older is a single dose of 300 mg administered as two 150-mg KRINTAFEL tablets taken together. (2.2)
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Coadminister KRINTAFEL on the first or second day of the appropriate antimalarial therapy for the acute P. vivax malaria. (2.2)
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Administer KRINTAFEL with food. (2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 150 mg of tafenoquine (3)
CONTRAINDICATIONS
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G6PD deficiency or unknown G6PD status. (4)
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Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown. (4, 8.2)
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Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL. (4)
WARNINGS AND PRECAUTIONS
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Hemolytic Anemia: G6PD testing must be performed before prescribing KRINTAFEL due to the risk of hemolytic anemia. Monitor patients for clinical signs or symptoms of hemolysis. (5.1)
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G6PD Deficiency in Pregnancy or Lactation: KRINTAFEL may cause hemolytic anemia when administered to a pregnant woman with a G6PD-deficient fetus. KRINTAFEL is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to KRINTAFEL through breast milk. Check infant's G6PD status before breastfeeding begins. (5.2, 8.1, 8.2)
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Methemoglobinemia: Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. (5.3)
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Psychiatric Effects: Serious psychiatric adverse reactions have been observed in patients with a previous history of psychiatric conditions at doses higher than the approved dose. The benefit of treatment with KRINTAFEL must be weighed against the potential risk for psychiatric adverse reactions in patients with a history of psychiatric illness. (5.4)
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Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., angioedema) have been observed with administration of KRINTAFEL. If hypersensitivity reactions occur, institute appropriate therapy. (5.5)
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Due to the long half-life of KRINTAFEL (15 days), psychiatric effects and hypersensitivity reactions may be delayed in onset and/or duration. (5.4, 5.5, 12.3)
ADVERSE REACTIONS
Common adverse reactions (?5%) were dizziness, nausea, vomiting, headache, and decreased hemoglobin. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Avoid coadministration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. (7.1)
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status for 3 months after the dose of KRINTAFEL. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 7/2018