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Krintafel tafenoquine succinate 150 mg Tablet, Film Coated, 2-count — NDC 00173-0889-39 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Krintafel tafenoquine succinate 150 mg Tablet, Film Coated, 2-count — NDC 0173-0889-39 (Billing 00173-0889-39)

by GlaxoSmithKline LLC · 2 TABLET, FILM COATED in 1 BOTTLE

This is a package of 2 tablets of Krintafel tafenoquine succinate 150 mg Tablet, Film Coated from GlaxoSmithKline LLC, marketed since Jan 2019 and currently FDA-listed.

NDC 00173-0889-39
🏷️ FDA NDC (as labeled) 0173-0889-39 billing pads the labeler segment with a zero
This package
Contains2-count Pack sizes2 compare ↓
Also priced by: Part D plans $15.88/unit — full pricing hub ↓
Product page 00173-0889-13 Also comes in: 30 tablets 0173-0889-13
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0173-0889-39 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0173 labeler · 0889 product · 39 package
Package marketed since
Jan 22, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
2 EA per package
Barcode (UPC)
0301730889393
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0173-0889-39
Product NDC 0173-0889
11-digit billing NDC 00173088939
NCPDP billing unit EA — each (per item)
RxCUI 2109233, 2109239
UNII DL5J0B8VSS
UPC 0301730889393
Application # NDA210795
SPL Set ID 5cf989d5-36f5-4561-a30b-9fcb9deb6b6a
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-01-22
Route ORAL
Dosage form TABLET, FILM COATED
Substance TAFENOQUINE SUCCINATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 13000070200320
GCN Seq No 078674
GCN 45043
HICL code 045121
Ingredient (HICL) Tafenoquine Succinate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W4
Therapeutic class — intermediate (HIC2) Antiparasitics
HIC3 code W4A
Therapeutic class — specific (HIC3) Antimalarial Drugs
AHFS code 08:30.08.00
AHFS class Antimalarials
FDB label name KRINTAFEL 150 MG TABLET
FDB brand name Krintafel
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 078674
  • GCN: 45043
  • GPI-14 (Medi-Span): 13000070200320
  • HICL (First Databank): 045121
  • AHFS class code: 08:30.08.00
  • RxCUI (RxNorm): 2109233
Why two NDCs? The FDA registers this code as 0173-0889-39 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00173-0889-39. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Aminoquinolines class.

Drug family (ATC) Aminoquinolines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name KRINTAFEL 150 MG TABLET Ingredient Tafenoquine Succinate
📗 Our plain-language guide HelloPharmacist
  • It depends on the brand. Arakoda and Kodatef are used to prevent malaria when you travel to a malaria area. Krintafel is used with chloroquine to stop P. vivax malaria from coming...
  • Tafenoquine can break down red blood cells in people with G6PD deficiency, causing hemolytic anemia. That is why the G6PD test is required and why you cannot take it if your status...
  • Why do I need a blood test before starting?
  • Take it with food and swallow the tablets whole. Arakoda has a loading phase, a weekly phase and a final dose, so finish the full course. Krintafel is one dose taken with chloroqui...
📖 Read our full Tafenoquine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $15.88 $31.77 / 2 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00173-0889-13 0173-0889-13 Main listing 30 TABLET, FILM COATED in 1 BOTTLE 2019-01-22 — Active
00173-0889-39 You're viewing this 2 TABLET, FILM COATED in 1 BOTTLE 2019-01-22 — Active

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 2-count package — 2 tablet, film coated in 1 bottle.
How does this package differ from NDC 00173-0889-13?
Both are Krintafel tafenoquine succinate 150 mg Tablet, Film Coated — the drug itself is identical. This page's package is the 2-count one, while NDC 00173-0889-13 is the 30 tablets package.
What NDC number is used to bill for this package of Krintafel tafenoquine succinate 150 mg Tablet, Film Coated?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Krintafel 150 mgthis 00173-0889-39 GlaxoSmithKline 2 tablets — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Jan 2019
📍
2026
Currently FDA-listed
7 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color Pink
ShapeCapsule
ImprintGS;J11
Size17 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGlaxoSmithKline LLC
Application holderGLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
FDA applicationNDA210795 (NDA)
Labeler code00173
First marketedJan 2019
Product typeHuman Prescription Drug
Portfolio97 products on file

More NDCs from GlaxoSmithKline LLC labeler code 00173

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 174 words ▾

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 ~1 min read ▾

2 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 )

2.1Tests 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 )] .

2.2Recommended 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 33 words ▾

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 137 words ▾

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 Cautions ~3 min read ▾

5 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 )

5.1Hemolytic 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.

5.2G6PD 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 )] .

5.3Methemoglobinemia Asymptomatic elevations in methemoglobin have been observed in the clinical trials of KR… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS 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.

6.1Clinical 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 124 words ▾

7 DRUG INTERACTIONS Avoid coadministration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters. ( 7.1 )

7.1Effect 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 ~3 min read ▾

8 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 )

8.1Pregnancy 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.

8.2Lactation 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.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status in females of reproductive potential prior to initiating… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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 61 words ▾

8.4Pediatric 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 50 words ▾

8.5Geriatric 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 26 words ▾

10 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.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tafenoquine is an 8-aminoquinoline antimalarial drug [see Microbiology ( 12.4 )].

12.2Pharmacodynamics Cardiac Electrophysiology The effect of tafenoquine on the QTc interval was evaluated in a Phase 1 randomized, single-blind, placebo- and positive-controlled, parallel-group thorough QTc study in 260 healthy adult subjects. At a cumulative dose of 1,200 mg (400 mg/day for 3 days; 4 times the maximum recommended dose), tafenoquine did not prolong the QTc interval to any clinically relevant extent. Exposure-Response Relationships A saturable relationship between tafenoquine exposure (AUC) and clinical response (recurrence-free rate at 6 months) was identified.

Tafenoquine exposures achieved with doses of 300 mg and higher are on the plateau of the exposure-response curve. Use of KRINTAFEL at doses or regimens other than a 300-mg single dose is not approved by the FDA.

12.3Pharmacokinetics Absorption Maximum plasma concentrations were generally observed 12 to 15 hours following oral administration. Food Effect: Plasma tafenoquine AUC increased by 41% and C max increased by 31% when administered as an investigational capsule formulation with a high-calorie, high-fat meal (approximately 1,000 calories with 15% protein, 25% carbohydrate, and 60% fat) compared with the fasted state. Distribution Protein binding of tafenoquine is >99.5%.

The apparent oral volume of distribution is ~1,600 L. Following single- and multiple-oral-dose administration, tafenoquine whole blood concentrations were on average 67% higher than corresponding plasma values. Elimination The apparent oral clearance of tafenoquine is approximately 3 L/h.

The average terminal half-life is approximately 15 days. Metabolism: Tafenoquine undergoes slow metabolism. Unchanged tafenoquine represented the only notable drug-related component in human plasma after a single oral dose of tafenoquine.

Excretion: The full excretion profile of tafenoquine in humans is unknown. Over a 6-day collection period, renal elimination of unchanged tafenoquine was low. Specific Populations Pharmacokinetics of tafenoquine were not significantly impacted by age, sex, ethnicity, and body weight.

The effect of renal or hepatic impairment on tafenoquine pharmacokinetics is unknown. Drug Interaction Studies Clinical Studies: No clinically significant effects on tafenoquine pharmacokinetics were observed following coadministration with chloroquine, dihydroartemisinin-piperaquine, or artemether-lumefantrine in healthy subjects. No clinically significant effects on the pharmacokinetics of dihydroartemisinin, piperaquine, artemether, lumefantrine, or substrates of cytochrome P450 isoenzymes (CYP)1A2 (caffeine), CYP2D6 (desipramine), CYP2C8 (chloroquine), CYP2C9 (flurbiprofen), or CYP3A4 (midazolam, chloroquine) were observed following coadministration of tafenoquine in healthy subjects.

In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically: Tafenoquine inhibited metformin transport via human OCT2, MATE-1, and MATE2-K transporters. Clinical drug interaction studies with tafenoquine and OCT2 and MATE substrates have not been conducted [see Drug Interactions ( 7 )] . The effect of tafenoquine on substrates of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptides 1B1/1B3 (OATP1B1/OATP1B3) is unknown.

12.4Microbiology Mechanism of Action Tafenoquine, an 8-aminoquinoline antimalarial, is active against the liver stages including the hypnozoite (dormant stage) of P. vivax . In addition to its effect on the parasite, tafenoquine causes red blood cell shrinkage in vitro. The molecular target of tafenoquine is not known.

Antimicrobial Activity Tafenoquine is active against pre-erythrocytic (liver) and erythrocytic (asexual) forms as well as gametocytes of P. vivax. The activity of tafenoquine against the pre-erythrocytic liver stages of the parasite prevents the developmen… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Tafenoquine is an 8-aminoquinoline antimalarial drug [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling 102 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING 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.

📋 Description 108 words ▾

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

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING 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

🧬 Pharmacokinetics ~1 min read ▾

12.3Pharmacokinetics Absorption Maximum plasma concentrations were generally observed 12 to 15 hours following oral administration. Food Effect: Plasma tafenoquine AUC increased by 41% and C max increased by 31% when administered as an investigational capsule formulation with a high-calorie, high-fat meal (approximately 1,000 calories with 15% protein, 25% carbohydrate, and 60% fat) compared with the fasted state. Distribution Protein binding of tafenoquine is >99.5%.

The apparent oral volume of distribution is ~1,600 L. Following single- and multiple-oral-dose administration, tafenoquine whole blood concentrations were on average 67% higher than corresponding plasma values. Elimination The apparent oral clearance of tafenoquine is approximately 3 L/h.

The average terminal half-life is approximately 15 days. Metabolism: Tafenoquine undergoes slow metabolism. Unchanged tafenoquine represented the only notable drug-related component in human plasma after a single oral dose of tafenoquine.

Excretion: The full excretion profile of tafenoquine in humans is unknown. Over a 6-day collection period, renal elimination of unchanged tafenoquine was low. Specific Populations Pharmacokinetics of tafenoquine were not significantly impacted by age, sex, ethnicity, and body weight.

The effect of renal or hepatic impairment on tafenoquine pharmacokinetics is unknown. Drug Interaction Studies Clinical Studies: No clinically significant effects on tafenoquine pharmacokinetics were observed following coadministration with chloroquine, dihydroartemisinin-piperaquine, or artemether-lumefantrine in healthy subjects. No clinically significant effects on the pharmacokinetics of dihydroartemisinin, piperaquine, artemether, lumefantrine, or substrates of cytochrome P450 isoenzymes (CYP)1A2 (caffeine), CYP2D6 (desipramine), CYP2C8 (chloroquine), CYP2C9 (flurbiprofen), or CYP3A4 (midazolam, chloroquine) were observed following coadministration of tafenoquine in healthy subjects.

In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically: Tafenoquine inhibited metformin transport via human OCT2, MATE-1, and MATE2-K transporters. Clinical drug interaction studies with tafenoquine and OCT2 and MATE substrates have not been conducted [see Drug Interactions ( 7 )] . The effect of tafenoquine on substrates of P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), and organic anion transporting polypeptides 1B1/1B3 (OATP1B1/OATP1B3) is unknown.

🧬 Pharmacodynamics 118 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effect of tafenoquine on the QTc interval was evaluated in a Phase 1 randomized, single-blind, placebo- and positive-controlled, parallel-group thorough QTc study in 260 healthy adult subjects. At a cumulative dose of 1,200 mg (400 mg/day for 3 days; 4 times the maximum recommended dose), tafenoquine did not prolong the QTc interval to any clinically relevant extent. Exposure-Response Relationships A saturable relationship between tafenoquine exposure (AUC) and clinical response (recurrence-free rate at 6 months) was identified.

Tafenoquine exposures achieved with doses of 300 mg and higher are on the plateau of the exposure-response curve. Use of KRINTAFEL at doses or regimens other than a 300-mg single dose is not approved by the FDA.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Trial 1 (NCT01376167) was a double-blind, controlled clinical trial of 522 adults positive for P. vivax 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 (n = 260), an active control (n = 129), or placebo (n = 133) 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 antimalarial 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

5.4IU/gHb. Patients with severe malaria were excluded from the trial. The recurrence-free efficacy rates at 6 months among the groups receiving KRINTAFEL and placebo are presented in Table 2 .

The risk of recurrence for KRINTAFEL plus chloroquine was reduced by 76% compared with placebo plus chloroquine. Table 2. Recurrence-Free Efficacy Rates of KRINTAFEL in Patients with P. vivax at 6 Months – Trial 1 a a All randomized patients were treated and had a positive parasite smear for P. vivax at baseline. b Odds ratio of the risk of recurrence of KRINTAFEL plus chloroquine versus placebo plus chloroquine using logistic regression model with treatment and region as covariates.

Subjects who did not demonstrate initial clearance, took a concomitant medication with antimalarial activity, or who had a missing Day 180 assessment were considered ‘missing/indeterminate’ and were counted as recurrences in the analysis. KRINTAFEL/ Placebo/ Chloroquine Chloroquine (n = 260) (n = 133) Recurrence-free efficacy 155 (60%) 35 (26%) Recurrence 85 (33%) 88 (66%) Missing/indeterminate outcome 20 (8%) 10 (8%) OR b (95% CI) 0.24 (0.15, 0.38) P value <0.001 In Trial 2 (NCT01376167), a dose-ranging trial with a study design similar to Trial 1, 57 and 54 subjects were randomized to KRINTAFEL 300-mg single dose plus chloroquine (same dose as in Trial 1) and placebo plus chloroquine groups, respectively.

KRINTAFEL 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%]).

🧪 Nonclinical Toxicology 188 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 1 mg/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).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 185 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility 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 1 mg/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).

📄 Patient Package Insert ~3 min read ▾

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PHARMACIST—DETACH HERE AND GIVE PATIENT INFORMATION TO PATIENT _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ PATIENT INFORMATION KRINTAFEL (KRIN-TAH-FELL) (tafenoquine) tablets, for oral use What is KRINTAFEL? • KRINTAFEL is a prescription medicine used to treat malaria caused by a parasite called Plasmodium vivax in patients aged 16 years and older who are also receiving chloroquine to treat acute Plasmodium vivax malaria. • Malaria is a serious disease of the blood that is spread by infected mosquitos.

KRINTAFEL does not work for all types of malaria. • It is not known if KRINTAFEL is safe and effective in children younger than 16 years. Do not use KRINTAFEL if you: • have a blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency (sometimes known as favism) or you have not been tested for G6PD deficiency. KRINTAFEL can cause a breakdown of red blood cells (hemolysis) in people with G6PD deficiency.

Your healthcare provider will test you for G6PD deficiency before you start taking KRINTAFEL. • are breastfeeding a child known to have G6PD deficiency or breastfeeding a child that has not been tested for G6PD deficiency. • are allergic to tafenoquine or any of the ingredients in KRINTAFEL or if you have had an allergic reaction to similar medicines containing 8-aminoquinolines. See the end of this Patient Information leaflet for a complete list of ingredients in KRINTAFEL. Before taking KRINTAFEL, tell your healthcare provider about all of your medical conditions, including if you: • have or have had mental health problems. • are pregnant or plan to become pregnant.

KRINTAFEL can harm an unborn baby who has G6PD deficiency. • are breastfeeding or plan to breastfeed. It is not known if KRINTAFEL passes into breast milk. ○ See “ Do not use KRINTAFEL if you: ” ○ Your healthcare provider should check your child for G6PD deficiency before you start breastfeeding. ○ If you know your child has G6PD deficiency, do not breastfeed while taking KRINTAFEL and for 3 months after your last dose of KRINTAFEL. • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

KRINTAFEL and other medicines may affect each other causing side effects. How should I take KRINTAFEL? • Your healthcare provider will test you for G6PD deficiency before you start taking KRINTAFEL. • KRINTAFEL is given as 2 tablets that you take together as a single dose. • You will take KRINTAFEL on the first or second day of your treatment with chloroquine. • Take KRINTAFEL with food to make sure the right amount of medicine is absorbed into your body. • Swallow KRINTAFEL tablets whole. Do not break, crush, or chew the tablets. • If you vomit within 1 hour of taking KRINTAFEL, call your healthcare provider as you may need to take a second dose of KRINTAFEL.

What are the possible side effects of KRINTAFEL? KRINTAFEL can cause serious side effects, including: • Breakdown of red blood cells (hemolytic anemia). Contact your healthcare provider if you develop signs of hemolytic anemia, which include darkening of the lips or urine, dizziness, confusion, feeling tired, light-headedness, or shortness of breath. • Hemolytic anemia in an unborn baby who has G6PD deficiency. ○ Females who are able to become pregnant should avoid pregnancy or use effective birth control (contraception) for 3 months after the dose of KRINTAFEL.

Talk with your healthcare provider about birth control methods that might be right for you. ○ Your healthcare provider will do a pregnancy test before you start taking KRINTAFEL. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with KRINTAFEL. • Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (m… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 125 words ▾

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 GSK Each tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate). See prescribing information for dosage information.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [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 Durham, NC 27701 Made in India 62000000090897 (A090897) Krintafel 150 mg 2 count label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Krintafel (this brand).

Top reported reactions

Bacteraemia2
Blood Fibrinogen Decreased2
Blood Lactate Dehydrogenase Increased2
Blood Triglycerides Increased2
Candida Infection2
Drug Effective For Unapproved Indication2
Haemolysis2

Reporter sex

10 reports
Male · 33%
Female · 67%

Serious outcomes

Hospitalization5
Death3
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
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Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 tablets (00173-0889-13). Each has its own NDC and its own page — see the package list near the top of this page.
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GlaxoSmithKline LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
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Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 00173-0888-10 · GlaxoSmithKline 00173-0892-01 · GlaxoSmithKline →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.