Tafenoquine Succinate (Krintafel)

Trade Name : Krintafel

GlaxoSmithKline LLC

TABLET, FILM COATED

Strength 150 mg/1

TAFENOQUINE SUCCINATE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tafenoquine Succinate (Krintafel) which is also known as Krintafel and Manufactured by GlaxoSmithKline LLC. It is available in strength of 150 mg/1 per ml. Read more

Tafenoquine Succinate (Krintafel) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

KRINTAFEL is indicated for the radical cure (prevention of relapse) of malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute infection .
Limitation of Use
KRINTAFEL is NOT indicated for the treatment of acute malaria.
KRINTAFEL is an antimalarial indicated for the radical cure (prevention of relapse) of malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute infection. ()
Limitation of Use
KRINTAFEL is NOT indicated for the treatment of acute malaria. ()

No data

P. vivax

KRINTAFEL tablets are pink, filmu2011coated, capsule-shaped tablets debossed with u2018GS J11u2019 on one side and contain 150 mg of tafenoquine.
Tablets: 150 mg of tafenoquine ()

KRINTAFEL is contraindicated in:

4n- 8.2

No data

Hemolytic Anemia
G6PD Deficiency in Pregnancy or Lactation
Methemoglobinemia
Psychiatric Effects
Hypersensitivity Reactions
5.4n- 5.5n- 12.3

The following clinically significant adverse reactions have been observed with KRINTAFEL and are discussed in detail in the Warnings and Precautions section:
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 malaria (nu00a0=u00a0483) in 3 randomized, double-blind trials including a placebo-controlled trial comparing KRINTAFEL plus chloroquine (nu00a0=u00a0260) with chloroquine alone (Trial 1), a placebo-controlled dose-ranging trial (Trial 2) (nu00a0=u00a057) , and a hematologic safety trial (Trial 3, NCT02216123) (nu00a0=u00a0166)n
In Trial 1, in patients with malaria, the most common adverse reactions reported in u22655% of patients treated with KRINTAFEL are listed in . 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).
Other Adverse Reactions Reported with KRINTAFEL
Clinically significant adverse reactions with KRINTAFEL 300-mg single dose in clinical trials (n = 810) in u22643% of subjects are listed below:
Psychiatric Disorders:
Nervous System Disorders:
Laboratory Investigations:
Immune System Disorders:
[see Contraindications (), Warnings and Precautions ()]
Eye Disorders:
Common adverse reactions (u22655%) were dizziness, nausea, vomiting, headache, and decreased hemoglobin. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or n

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 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.
Avoid coadministration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. ()

Lactation
8.2

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.

KRINTAFEL contains tafenoquine succinate, an antimalarial agent for oral administration. The chemical name of tafenoquine succinate is (u00b1) 8-[(4-amino-1-methylbutyl)amino]-2,6-dimethoxy-4u2011methyl-5-[3-(trifluoromethyl)phenoxy]quinoline succinate. The molecular formula of tafenoquine succinate is CH FNOu2022 CHO, 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 188.2u00a0mg 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.

No data

Carcinogenesis
Two-year oral carcinogenicity studies were conducted in rats and mice. Renal cell adenomas and carcinomas were increased in male rats at doses of 1u00a0mg/kg/day and above (3 times the clinical exposure based on AUC comparisons). Tafenoquine was not carcinogenic in mice. Given the single-dose administration of KRINTAFEL, these findings may not represent a carcinogenicity risk to humans.
Mutagenesis
Tafenoquine did not cause mutations or chromosomal damage in 2 definitive in vitro tests (bacterial mutation assay and mouse lymphoma L5178Y cell assay) or in an in vivo oral rat micronucleus test.
Impairment of Fertility
In a rat fertility study, tafenoquine was given orally at 1.5, 5, and 15 mg/kg/day (up to about 0.5 times the human dose based on body surface area comparisons) to males for at least 67 days, including 29 days prior to mating, and to females from 15 days prior to mating through early pregnancy. Tafenoquine resulted in reduced number of viable fetuses, implantation sites, and corpora lutea at 15 mg/kg in the presence of maternal toxicity (mortality, piloerection, rough coat, and reduced body weight).

Trial 1 (NCT01376167) was a double-blind, controlled clinical trial of 522 adults positive for across 3 regions (Asia, Africa, and Latin America). All patients received chloroquine phosphate (600-mg free base on Days 1 and 2 with 300-mg free base on Day 3) to treat the acute infection in addition to either a one-time dose of KRINTAFEL (two 150-mg tablets) on Day 1 or Day 2 (nu00a0=u00a0260), an active control (nu00a0=u00a0129), or placebo (nu00a0=u00a0133) in a 2:1:1 fashion. 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% SE Asia (Thailand, Cambodia, and the Philippines), and 11% Africa (Ethiopia).
Patients were considered recurrence-free at 6 months if they demonstrated initial parasite clearance, took no anti-malarial medications, and were confirmed parasite-free at the 6-month final assessment (i.e., absence of relapse or new infection).
Due to the risk of hemolytic anemia, patients were excluded from the trial if they had a G6PD enzyme activity level <70% of the site median value for G6PD normals (8.2 IU/gHb). In this trial, the minimum G6PD enzyme level of any subject was 5.4 IU/gHb. Patients with severe malaria were excluded from the trial.
The recurrence-free efficacy rates at 6 months among the tafenoquine and placebo groups are presented in . The risk of recurrence for KRINTAFEL plus chloroquine was reduced by 76% compared with placebo plus chloroquine.
In Trial 2 (NCT01376167), a dose-ranging trial with a study design similar to Trial 1, 57 and 54 subjects were randomized to tafenoquine 300-mg single dose plus chloroquine (same dose as in Trial 1) and placebo plus chloroquine groups, respectively. Tafenoquine plus chloroquine demonstrated a statistically significantly higher rate of recurrence-free efficacy at 6 months compared with the placebo plus chloroquine control group (84% versus 39%, with a difference of 45% and 95% CI [29%, 61%]).

How Supplied
KRINTAFEL tablets contain 150 mg of tafenoquine (equivalent to 188.2u00a0mg tafenoquine succinate) and are pink, filmu2011coated, capsule-shaped, and debossed with u2018GS J11u2019 on one side. KRINTAFEL is supplied as follows:
Storage
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). Temperature excursions are permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [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.

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 .
Important Administration Instructions
Advise patients to take KRINTAFEL with food to increase absorption .
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 pregnancyn
Advise females of reproductive potential to avoid pregnancy or use effective contraception for 3 months after the dose of KRINTAFEL n
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 n
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 n
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 .
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 .
Trademark is owned by or licensed to the GSK group of companies.
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92018 GSK group of companies or its licensor.
KFL:1PI

This Patient Information has been approved by the U.S. Food and Drug Administration.u00a0 u00a0Approved: July 2018

PRINCIPAL DISPLAY PANEL
NDC 0173-0889-39
Krintafel
(tafenoquine)
tablets
150 mg
Rx Only
Patients must be tested for glucose-6-phosphate dehydrogenase deficiency before taking this medicine.
2 tablets to be taken as a single one-time dose
2 Tablets
Each tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate).
See prescribing information for dosage information.
Store at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F); excursions permitted to 15u00b0C to 30u00b0C (59u00b0F to 86u00b0F) [See USP controlled Room Temperature].
Store in original package. Protect from moisture. Do not remove desiccant.
Do not break or crush the tablets.
Do not accept if membrane seal under cap is missing or broken.
Manufactured by:
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in India
10000000148541

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Tafenoquine Succinate (Krintafel)

Trade Name : Krintafel

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Tafenoquine Succinate (Krintafel)

Trade Name : Krintafel

TABLET, FILM COATED

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

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