Krintafel
tafenoquine succinate · Tablet, Film Coated · Oral
Uses
1 INDICATIONS AND USAGE KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration ( 2.2 )] . Limitations of Use
• KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria.
• Concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria [see Warnings and Precautions ( 5.6 )] . 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 chloroquine therapy for acute P. vivax infection. ( 1 ) Limitations of Use
• KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. ( 1 )
• The concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria. ( 1 , 5.6 )
Dosage and administration
• All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing KRINTAFEL. ( 2.1 )
• Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with KRINTAFEL. ( 2.1 )
• 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 )
• Coadminister KRINTAFEL on the first or second day of chloroquine therapy for the acute P. vivax malaria. ( 2.2 )
• Administer KRINTAFEL with food. ( 2.2 ) 2.1 Tests to be Performed Prior to Treatment with KRINTAFEL All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing KRINTAFEL [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with KRINTAFEL [see Use in Specific Populations ( 8.1 , 8.3 )] . 2.2 Recommended Dosage and Administration The recommended dose of KRINTAFEL in patients aged 16 years and older is a single dose of 300 mg administered as two 150-mg tablets taken together. Coadminister KRINTAFEL on the first or second day of chloroquine therapy for acute P. vivax malaria [see Clinical Studies ( 14 )] . Administer KRINTAFEL with food to increase systemic absorption [see Clinical Pharmacology ( 12.3 )] . Swallow tablets whole. Do not break, crush, or chew the tablets. In the event of vomiting within 1 hour after dosing, a repeat dose should be given. Re-dosing should not be attempted more than once.
Dosage forms and strengths
3 DOSAGE FORMS AND STRENGTHS KRINTAFEL tablets are pink, film‑coated, capsule-shaped tablets debossed with ‘GS J11’ on one side and contain 150 mg of tafenoquine. Tablets: 150 mg of tafenoquine ( 3 )
Contraindications
4 CONTRAINDICATIONS KRINTAFEL is contraindicated in:
• Patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia [see Warnings and Precautions ( 5.1 )] .
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if the G6PD status of the infant is unknown [see Use in Specific Populations ( 8.2 )].
• Patients with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL [see Warnings and Precautions ( 5.5 )] .
• G6PD deficiency or unknown G6PD status. ( 4 )
• Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if G6PD status is unknown. ( 4 , 8.2 )
• Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL. ( 4 )
Warnings and precautions
• 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 )
• 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 )
• Methemoglobinemia : Asymptomatic elevations in blood methemoglobin have been observed. Initiate appropriate therapy if signs or symptoms of methemoglobinemia occur. ( 5.3 )
• 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 )
• Hypersensitivity Reactions : Serious hypersensitivity reactions (e.g., angioedema) have been observed with administration of KRINTAFEL. If hypersensitivity reactions occur, institute appropriate therapy. ( 5.5 )
• 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 )
• Risk of P. vivax Malaria Recurrence: Lack of efficacy in reducing P. vivax malaria recurrence in patients treated with KRINTAFEL combined with dihydroartemisinin/piperaquine (not approved artemisinin-containing antimalarial) was seen in a clinical trial. Use with antimalarials other than chloroquine is not recommended. ( 1 , 5.6 ) 5.1 Hemolytic Anemia Due to the risk of hemolytic anemia in patients with G6PD deficiency, G6PD testing must be performed before prescribing KRINTAFEL [see Dosage and Administration ( 2.1 )] . Due to the limitations of G6PD tests, physicians need to be aware of residual risk of hemolysis and adequate medical support and follow-up to manage hemolytic risk should be available. Treatment with KRINTAFEL is contraindicated in patients with G6PD deficiency or unknown G6PD status [see Contraindications ( 4 )] . Patients were excluded from clinical trials of KRINTAFEL if they had a G6PD enzyme activity level <70% of the site median value for G6PD normal activity [see Clinical Studies ( 14 )]. In clinical trials, declines in hemoglobin levels were reported in some G6PD-normal patients [see Adverse Reactions ( 6.1 )] . Monitor patients for clinical signs or symptoms of hemolysis. Advise patients to seek medical attention if signs of hemolysis occur. 5.2 G6PD Deficiency in Pregnancy or Lactation Potential Harm to the Fetus The use of KRINTAFEL during pregnancy may cause hemolytic anemia in a G6PD-deficient fetus. Even if a pregnant woman has normal levels of G6PD, the fetus could be G6PD deficient. Advise females of reproductive potential that treatment with KRINTAFEL during pregnancy is not recommended and to avoid pregnancy or use effective contraception for 3 months after the dose of KRINTAFEL [see Use in Specific Populations ( 8.1 , 8.3 )] . Potential Harm to the Breastfeeding Infant A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to KRINTAFEL through breast milk. Infant G6PD status should be checked before breastfeeding begins. KRINTAFEL is contraindicated in breastfeeding women when the infant is found to be G6PD deficient or the G6PD status of the infant is unknown [see Contraindications ( 4 )] . Advise the woman with a G6PD-deficient infant or if the G6PD status of the infant is unknown not to breastfeed for 3 months after the dose of KRINTAFEL [see Use in Specific Populations ( 8.2 )] . 5.3 Methemoglobinemia Asymptomatic elevations in methemoglobin have been observed in the clinical trials of KRINTAFEL [see Adverse Reactions ( 6.1 )]. Institute appropriate therapy if signs or symptoms of methemoglobinemia occur. Carefully monitor individuals with nicotinamide adenine dinucleotide (NADH)-dependent methemoglobin reductase deficiency. Advise patients to seek medical attention if signs of methemoglobinemia occur. 5.4 Psychiatric Effects Psychiatric adverse reactions including anxiety (<1%), abnormal dreams (<1%), and insomnia (3%) have been reported in clinical trials of KRINTAFEL [see Adverse Reactions ( 6.1 )] . Two cases of depression and 2 cases of psychosis have occurred primarily in patients with a history of psychiatric disorders following receipt of single doses of tafenoquine that were higher than the approved 300-mg dose (350 mg to 600 mg). Safety and effectiveness of KRINTAFEL have not been established at doses or regimens other than the approved regimen; use of KRINTAFEL at doses or regimens other than a 300-mg single dose is not approved by FDA. 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. Due to the long half-life of KRINTAFEL (approximately 15 days), signs or symptoms of psychiatric adverse reactions that may occur could be delayed in onset and/or duration [see Clinical Pharmacology ( 12.3 )] . 5.5 Hypersensitivity Reactions Serious hypersensitivity reactions (e.g., angioedema, urticaria) have been observed with administration of KRINTAFEL [see Adverse Reactions ( 6.1 )] . Institute appropriate therapy if hypersensitivity reactions occur. Do not re-administer KRINTAFEL. KRINTAFEL is contraindicated in patients who develop hypersensitivity to tafenoquine or any component of KRINTAFEL or other 8-aminoquinolines [see Contraindications ( 4 )] .
Side effects
The following clinically significant adverse reactions have been observed with KRINTAFEL and are discussed in detail in the Warnings and Precautions section:
• Hemolytic anemia [see Warnings and Precautions ( 5.1 )]
• Methemoglobinemia [see Warnings and Precautions ( 5.3 )]
• Psychiatric effects [see Warnings and Precautions ( 5.4 )]
• Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described below reflect exposure to 4,129 subjects, of whom 810 received a 300-mg single dose of KRINTAFEL. KRINTAFEL was evaluated in patients with P. vivax malaria (n = 483) in 3 randomized, double-blind trials including a placebo-controlled trial comparing KRINTAFEL plus chloroquine (n = 260) with chloroquine alone (Trial 1), a placebo-controlled dose-ranging trial (Trial 2) (n = 57) [see Clinical Studies ( 14 )] , and a hematologic safety trial (Trial 3, NCT02216123) (n = 166). In Trial 1, in patients with P. vivax malaria, the most common adverse reactions reported in ≥5% of patients treated with KRINTAFEL are listed in Table 1 . Patients included in the trial had a mean age of 35 (range: 16 to 79 years), were 75% male and from the following regions: 70% Latin America (Brazil and Peru), 19% Southeast (SE) Asia (Thailand, Cambodia, and the Philippines), and 11% Africa (Ethiopia). Table 1. Selected Adverse Reactions a Reported in ≥5% of Patients with P. vivax Malaria Receiving KRINTAFEL in a Randomized, Active-Controlled Trial (Trial 1) a Adverse reactions reported prior to Day 29 as subsequent adverse reactions can be confounded by recurrence of malaria or retreatment with another agent from the quinoline class. Adverse Reaction Chloroquine KRINTAFEL + Chloroquine (n = 133) (n = 260) % % Dizziness 3 8 Nausea 7 6 Vomiting 5 6 Decreased Hemoglobin 2 5 Headache 7 5 Other Adverse Reactions Reported with KRINTAFEL Clinically significant adverse reactions with KRINTAFEL 300-mg single dose in clinical trials (n = 810) in ≤3% of subjects are listed below: Psychiatric Disorders: Anxiety, insomnia, abnormal dreams. Nervous System Disorders: Somnolence. Laboratory Investigations: Increased blood creatinine, increased blood methemoglobin, increased alanine aminotransferase. Immune System Disorders: Hypersensitivity reactions (e.g., angioedema, urticaria) [see Contraindications ( 4 ), Warnings and Precautions ( 5.5 )] . Eye Disorders: Vortex keratopathy, photophobia.
Drug interactions
Avoid coadministration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. ( 7.1 ) 7.1 Effect of KRINTAFEL on Organic Cation Transporter-2 (OCT2) and Multidrug and Toxin Extrusion (MATE) Substrates The effect of coadministration of tafenoquine on the pharmacokinetics of OCT2 and MATE substrates in humans is unknown. However, in vitro observations suggest the potential for increased concentrations of these substrates [see Clinical Pharmacology ( 12.3 )] which may increase the risk of toxicity of these drugs. Avoid coadministration of KRINTAFEL with OCT2 and MATE substrates (e.g., dofetilide, metformin). If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction if needed based on approved product labeling of the coadministered drug.
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 ) 8.1 Pregnancy Risk Summary The use of KRINTAFEL during pregnancy may cause hemolytic anemia in a fetus who is G6PD deficient. Treatment with KRINTAFEL during pregnancy is not recommended [see Warnings and Precautions ( 5.2 )] . Available data with use of KRINTAFEL in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, there were increased abortions, with and without maternal toxicity, when KRINTAFEL was given orally to pregnant rabbits at and above doses equivalent to about 0.4 times the clinical exposure based on body surface area comparisons. No fetotoxicity was observed at doses equivalent to the clinical exposure (based on body surface area comparisons) in a similar study in rats. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. Data Animal Data: Tafenoquine resulted in dose-related abortions when given orally to pregnant rabbits during organogenesis (Gestation Days 6 to 18) at doses of 7 mg/kg (about 0.4 times the clinical exposure based on body surface area comparisons) and above. Doses higher than 7 mg/kg were also associated with maternal toxicity (mortality and reduced body weight gain). In a similar study in rats, doses of 3, 10, or 30 mg/kg/day resulted in maternal toxicity (enlarged spleen, reduced body weight, and reduced food intake) but no fetotoxicity at the high dose (equivalent to the clinical exposure based on body surface area comparisons). There was no evidence of malformations in either species. In a pre- and postnatal development study in rats, tafenoquine administered throughout pregnancy and lactation produced maternal toxicity and a reversible decrease in offspring body weight gain and decrease in motor activity at 18 mg/kg/day, which is equivalent to about 0.6 times the clinical dose based on body surface area comparisons. 8.2 Lactation Risk Summary A breastfed infant with G6PD deficiency is at risk for hemolytic anemia from exposure to KRINTAFEL. Infant G6PD status should be checked before breastfeeding begins. KRINTAFEL is contraindicated in breastfeeding women when the infant is found to be G6PD deficient or the G6PD status of the infant is unknown [see Contraindications ( 4 ), Clinical Considerations] . There is no information regarding the presence of KRINTAFEL in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. In a breastfed infant with normal G6PD, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for KRINTAFEL and any potential effects on the breastfed infant from KRINTAFEL or from the underlying maternal condition. Clinical Considerations Check the infant’s G6PD status before maternal breastfeeding commences. If an infant is G6PD deficient, exposure to KRINTAFEL during breastfeeding may result in hemolytic anemia in the infant; therefore, advise the woman with an infant who has G6PD deficiency or whose G6PD status is unknown not to breastfeed for 3 months after the dose of KRINTAFEL. 8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating treatment with KRINTAFEL [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )] . Contraception KRINTAFEL may cause hemolytic anemia in a G6PD-deficient fetus [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 )] . Advise females of reproductive potential that treatment with KRINTAFEL during pregnancy is not recommended and to avoid pregnancy or use effective contraception for 3 months after the dose of KRINTAFEL. 8.4 Pediatric Use The safety and effectiveness of KRINTAFEL have been established in pediatric patients aged 16 years and older. Use of KRINTAFEL in these pediatric patients is supported by evidence from adequate and well-controlled studies of KRINTAFEL [see Clinical Studies ( 14 )] . Safety and effectiveness of KRINTAFEL in pediatric patients younger than 16 years have not been established. 8.5 Geriatric Use Clinical trials of KRINTAFEL did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients [see Clinical Pharmacology ( 12.3 )]. 8.6 Renal Impairment The pharmacokinetics of KRINTAFEL have not been studied in patients with renal impairment. If KRINTAFEL is administered to such patients, monitoring for adverse reactions associated with KRINTAFEL is needed [see Warnings and Precautions ( 5 ), Adverse Reactions ( 6 )] . 8.7 Hepatic Impairment The pharmacokinetics of KRINTAFEL have not been studied in patients with hepatic impairment. If KRINTAFEL is administered to such patients, monitoring for adverse reactions associated with KRINTAFEL is needed [see Warnings and Precautions ( 5 ), Adverse Reactions ( 6 )] .
Pregnancy
8.1 Pregnancy Risk Summary The use of KRINTAFEL during pregnancy may cause hemolytic anemia in a fetus who is G6PD deficient. Treatment with KRINTAFEL during pregnancy is not recommended [see Warnings and Precautions ( 5.2 )] . Available data with use of KRINTAFEL in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, there were increased abortions, with and without maternal toxicity, when KRINTAFEL was given orally to pregnant rabbits at and above doses equivalent to about 0.4 times the clinical exposure based on body surface area comparisons. No fetotoxicity was observed at doses equivalent to the clinical exposure (based on body surface area comparisons) in a similar study in rats. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: Malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. Data Animal Data: Tafenoquine resulted in dose-related abortions when given orally to pregnant rabbits during organogenesis (Gestation Days 6 to 18) at doses of 7 mg/kg (about 0.4 times the clinical exposure based on body surface area comparisons) and above. Doses higher than 7 mg/kg were also associated with maternal toxicity (mortality and reduced body weight gain). In a similar study in rats, doses of 3, 10, or 30 mg/kg/day resulted in maternal toxicity (enlarged spleen, reduced body weight, and reduced food intake) but no fetotoxicity at the high dose (equivalent to the clinical exposure based on body surface area comparisons). There was no evidence of malformations in either species. In a pre- and postnatal development study in rats, tafenoquine administered throughout pregnancy and lactation produced maternal toxicity and a reversible decrease in offspring body weight gain and decrease in motor activity at 18 mg/kg/day, which is equivalent to about 0.6 times the clinical dose based on body surface area comparisons.
Pediatric use
8.4 Pediatric Use The safety and effectiveness of KRINTAFEL have been established in pediatric patients aged 16 years and older. Use of KRINTAFEL in these pediatric patients is supported by evidence from adequate and well-controlled studies of KRINTAFEL [see Clinical Studies ( 14 )] . Safety and effectiveness of KRINTAFEL in pediatric patients younger than 16 years have not been established.
Geriatric use
8.5 Geriatric Use Clinical trials of KRINTAFEL did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients [see Clinical Pharmacology ( 12.3 )].
Overdosage
Hemoglobin decline and methemoglobinemia may be encountered in an overdose with KRINTAFEL. Treatment of overdosage consists of institution of appropriate symptomatic and/or supportive therapy.
Description
11 DESCRIPTION KRINTAFEL contains tafenoquine succinate, an antimalarial agent for oral administration. The chemical name of tafenoquine succinate is (±) 8-[(4-amino-1-methylbutyl)amino]-2,6-dimethoxy-4‑methyl-5-[3-(trifluoromethyl)phenoxy]quinoline succinate. The molecular formula of tafenoquine succinate is C 24 H 28 F 3 N 3 O 3
• C 4 H 6 O 4 , and its molecular mass is 581.6 as the succinate salt (463.5 as free base). The structural formula is shown below. Each KRINTAFEL tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate). Inactive ingredients include magnesium stearate, mannitol, and microcrystalline cellulose. The tablet film-coating inactive ingredients include hydroxypropylmethylcellulose, polyethylene glycol, red iron oxide, and titanium dioxide. Tafenoquine succinate chemical structure
Mechanism of action
12.1 Mechanism of Action Tafenoquine is an 8-aminoquinoline antimalarial drug [see Microbiology ( 12.4 )].
How supplied
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:
• 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.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information). G6PD Testing and Hemolytic Anemia Inform patients of the need for testing for G6PD deficiency before starting KRINTAFEL. Advise patients of the symptoms of hemolytic anemia and instruct them to seek medical advice promptly if such symptoms occur. Patients should contact their healthcare provider if they develop dark lips or urine as these may be signs of hemolysis or methemoglobinemia [see Warnings and Precautions ( 5.1 )] . Important Administration Instructions Advise patients to take KRINTAFEL with food to increase absorption [see Dosage and Administration ( 2 )] . Advise patients to swallow the tablet whole and not to break, crush, or chew it. Potential Harm to the Fetus Advise females of reproductive potential of the potential risk of KRINTAFEL to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations 8.1 )]. Advise females of reproductive potential to avoid pregnancy or use effective contraception for 3 months after the dose of KRINTAFEL [see Use in Specific Populations ( 8.3 )]. Lactation Advise women with a G6PD-deficient infant, or if they do not know the G6PD status of their infant, not to breastfeed for 3 months after the dose of KRINTAFEL [see Contraindications ( 4 ), Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.2 )]. Methemoglobinemia Inform patients that methemoglobinemia has occurred with KRINTAFEL. Advise patients of the symptoms of methemoglobinemia and instruct them to seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.3 )]. Psychiatric Symptoms Advise patients with a history of psychiatric illness regarding the potential for new or worsening psychiatric symptoms with KRINTAFEL and instruct them to seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.4 )] . Hypersensitivity Reactions Inform patients that hypersensitivity reactions have occurred with KRINTAFEL. Advise patients of the symptoms of hypersensitivity reactions and instruct them to seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.5 )] . Trademarks are owned by or licensed to the GSK group of companies. GlaxoSmithKline Durham, NC 27701 ©2023 GSK group of companies or its licensor. KFL:4PI
Label text from the FDA structured product label by GlaxoSmithKline LLC (revised Aug 2, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Tafenoquine Succinate in 1 product
Krintafel NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0173-0889 | Tafenoquine Succinate 150 mg/1 Tablet, Film Coated | GlaxoSmithKline LLC | NDA |
Frequently asked questions
What is Krintafel used for?
1 INDICATIONS AND USAGE KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration ( 2.2 )] . Limitations of Use • KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. • Concomitant use of KRINTAFEL with…
What are the side effects of Krintafel?
The following clinically significant adverse reactions have been observed with KRINTAFEL and are discussed in detail in the Warnings and Precautions section: • Hemolytic anemia [see Warnings and Precautions ( 5.1 )] • Methemoglobinemia [see Warnings and Precautions ( 5.3 )] • Psychiatric effects [see Warnings and Precautions ( 5.4 )] • Hypersensitivity reactions [see Warnings and Precautions (… See the full label for the complete list.
Who makes Krintafel?
Krintafel is listed by 1 labeler in the FDA NDC directory, including GlaxoSmithKline LLC.