Arakoda Tafenoquine 100 mg Tablet, Film Coated, 8-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Aminoquinolines class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- You're right that both contain tafenoquine, but they're approved for very different purposes. Arakoda (and Kodatef) are for preventing malaria when you're traveling to or living in...
- What's the difference between Krintafel and Arakoda — they both seem to be the same drug?
- That test checks for something called G6PD deficiency — a genetic condition where your red blood cells lack an enzyme they need to stay healthy under certain stresses. Tafenoquine...
- Why do I have to get a blood test before taking this medication?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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
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💲 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 system | Per each | Per 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 · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Arakoda 100 mgthis 71475-0257-02 | 60 | 8 tablets | — | — | FDA listed | — |
| Kodatef 100 mg 71475-0258-03 | 60 | 1 tablet | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 10342791 ↗ | Method of use | U-2582 | Dec 2, 2035 |
| US 11744828 ↗ | Method of use | U-2582 | Dec 2, 2035 |
| US 10888558 ↗ | Method of use | U-2582 | Dec 2, 2035 |
| US 12616689 ↗ | Method of use | U-2582 | Dec 2, 2035 |
Is there a generic version of ARAKODA 100 MG TABLET?
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71475-0257-01 | 2 BLISTER PACK in 1 CARTON (71475-257-01) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2018-08-20 | Active |
| 71475-0257-02 You're viewing this | 8 TABLET, FILM COATED in 1 BOTTLE (71475-257-02) | 2018-08-20 | Active |
Pack size FAQ
What quantity is in NDC 71475-0257-02?
What NDC number is used to bill for this package of Arakoda Tafenoquine 100 mg Tablet, Film Coated?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| 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 |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing ARAKODA. ( 2.1 ) • Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with ARAKODA. ( 2.1 ) Regimen Name Timing Dosage Loading regimen For each of the 3 days before travel to a malarious area 200 mg (2 of the 100 mg tablets) once daily for 3 days Maintenance regimen While in the malarious area 200 mg (2 of the 100 mg tablets) once weekly – start 7 days after the last loading regimen dose Terminal prophylaxis regimen In the week following exit from the malarious area 200 mg (2 of the 100 mg tablets) one-time 7 days after the last maintenance dose • Administer ARAKODA with food.
( 2.2 ) • See full prescribing information for instructions on how to replace missed doses. ( 2.2 )
2.1Tests to be Performed Prior to ARAKODA Dose Initiation All patients must be tested for glucose-6-phosphate dehydrogenase (G6PD) deficiency prior to prescribing ARAKODA [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )] . Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with ARAKODA [see Use in Specific Populations ( 8.1 and 8.3 )] .
2.2Recommended Dosage and Administration Instructions The recommended dosage of ARAKODA is described in Table 1 below. ARAKODA can be administered for up to 6 months of continuous dosing. Table 1: Recommended Dosage of ARAKODA in Patients (18 Years of Age and Older) Regimen Name Timing Dosage Loading regimen For each of the 3 days before travel to a malarious area 200 mg (2 of the 100 mg tablets) once daily for 3 days Maintenance regimen While in the malarious area 200 mg (2 of the 100 mg tablets) once weekly – start 7 days after the last loading regimen dose Terminal prophylaxis regimen In the week following exit from the malarious area 200 mg (2 of the 100 mg tablets) taken one time, 7 days after the last maintenance dose • Administer ARAKODA with food. [see Clinical Pharmacology ( 12.3 )] . • Swallow the tablet whole.
Do not break, crush or chew the tablets. • Complete the full course of ARAKODA including the loading dose and the terminal dose. Table 2: How to Replace Missed Doses of ARAKODA Dose(s) Missed How to Replace Missed Dose(s): 1 Loading dose 1 dose of 200 mg (2 of the 100 mg tablets) so that a total of 3 daily loading doses have been taken. Begin maintenance dose 1 week after the last loading dose.
2 Loading doses 2 doses of 200 mg (2 of the 100 mg tablets) on 2 consecutive days so that a total of 3 daily loading doses have been taken. Begin maintenance dose 1 week after the last loading dose. 1 Maintenance (weekly) dose 1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the next scheduled weekly dose.
2 Maintenance (weekly) doses 1 dose of 200 mg (2 of the 100 mg tablets) on any day up to the time of the next scheduled weekly dose. 3 or more Maintenance (weekly) doses 2 doses of 200 mg (2 of the 100 mg tablets), taken as 200 mg (2 of the 100 mg tablets) once daily for 2 days up to the time of the next weekly dose. Terminal prophylaxis dose 1 dose of 200 mg (2 of the 100 mg tablets) as soon as remembered.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS ARAKODA tablets are dark pink, film-coated, capsule-shaped tablets debossed with ‘TQ100’ on one side containing 100 mg of tafenoquine. Tablets: 100 mg of tafenoquine ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS ARAKODA is contraindicated in: • patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia [see Warnings and Precautions ( 5.2 )] . • 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 Warnings and Precautions ( 5.3 ), Use in Specific Populations ( 8.2 )] . • patients with a history of psychotic disorders or current psychotic symptoms (i.e., hallucinations, delusions, and/or grossly disorganized behavior) [see Warnings and Precautions ( 5.4 )] • patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA [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 ) • Patients with a history of psychotic disorders or current psychotic symptoms ( 4 , 5.4 ) • Known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hemolytic Anemia : G6PD testing must be performed before prescribing ARAKODA due to the risk of hemolytic anemia. Monitor patients for signs or symptoms of hemolysis. ( 5.1 ) • G6PD Deficiency in Pregnancy or Lactation : ARAKODA may cause fetal harm when administered to a pregnant woman with a G6PD-deficient fetus.
ARAKODA is not recommended during pregnancy. A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA 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 psychotic adverse reactions have been observed in patients with a history of psychosis or schizophrenia, at doses different from the approved dose.
If psychotic symptoms (hallucinations, delusions, or grossly disorganized thinking or behavior) occur, consider discontinuation of ARAKODA therapy and, evaluation by a mental health professional as soon as possible. ( 5.4 ) • Hypersensitivity Reactions : Serious hypersensitivity reactions have been observed with administration of ARAKODA. If hypersensitivity reactions occur, institute appropriate therapy.
( 5.5 ) • Delayed Adverse Reactions : Due to the long half-life of ARAKODA (approximately 17 days), psychiatric effects, hemolytic anemia, methemoglobinemia, and hypersensitivity reactions may be delayed in onset and/or duration. ( 5.6 , 12.3 )
5.1Hemolytic Anemia Due to the risk of hemolytic anemia in patients with G6PD deficiency, G6PD testing must be performed before prescribing ARAKODA [see Contraindications ( 4 )] . Due to the limitations with 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 ARAKODA is contraindicated in patients with G6PD deficiency or unknown G6PD status [see Contraindications ( 4 )] .
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 [see Warnings and Precautions ( 5.6 )] . Advise patients to discontinue ARAKODA and seek medical attention if signs of hemolysis occur.
5.2G6PD Deficiency in Pregnancy and Lactation Potential Harm to the Fetus The use of ARAKODA 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 ARAKODA during pregnancy is not recommended and to avoid pregnancy or use effective contraception during treatment and for 3 months after the last dose of ARAKODA.
If a pregnancy is detected during ARAKODA use, discontinue ARAKODA as soon as possible and switch to an alternative prophylactic drug for malaria during pregnancy [see Use in Specific Populations ( 8.1 and 8.3 )] . Potential Harm to the Breastfeeding Infant A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to ARAKODA through breast milk. Infant G6PD status should be checked before breastfeeding begins.
ARAKODA 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 during treatment with ARAKODA and for 3 months after the final dose [see Use in Specific Populations ( 8.2 )] .
5.3Methemoglobinemia Asymptomatic elevations in methemoglobin have been observed in the clinical trials of ARAKODA [see Adverse Reactions ( 6.1 )] . Institute appropriate therapy if signs or symptoms of methemoglobinemia occur [see Warnings and Precautions ( 5.6 )] . Carefully monitor individ…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions observed with ARAKODA are discussed in detail in the Warnings and Precautions section: • Hemolytic Anemia [see Warnings and Precautions ( 5.2 )] • Methemoglobinemia [see Warnings and Precautions ( 5.3 )] • Psychiatric Effects [see Warnings and Precautions ( 5.4 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (incidence ≥1%) were: headache, dizziness, back pain, diarrhea, nausea, vomiting, increased alanine aminotransferase (ALT), motion sickness, insomnia, depression, abnormal dreams, anxiety.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 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 of tafenoquine was studied in clinical trials at various doses and regimens in 3,184 subjects. The recommended ARAKODA regimen was evaluated in 825 subjects in 5 controlled clinical trials (Trials 1, Trial 2, Trial 3, Trial 4 and Trial 5).
The mean duration of exposure to ARAKODA in these five clinical trials was 21 weeks (range 10-29 weeks). Trial 1, 2 and 4 were conducted in healthy semi-immune volunteers in Ghana or Kenya and were placebo-controlled; a mefloquine arm was included in Trials 2 and 4 as a benchmark. Trial 3, an active comparator (mefloquine) controlled trial was conducted in healthy soldiers deployed in East Timor (Timor Leste).
A placebo-controlled Trial 5 was conducted in healthy volunteers in the United States and United Kingdom. The mean age of the subjects included in the five trials was 29 years (range 17 to 69 years); 84% were male. Adverse Reactions Reported with ARAKODA in Trial 3 and Pooled Trials 1, 2, 4, and 5 Adverse reactions occurring in ≥1% of subjects in the ARAKODA group in the placebo-controlled pooled Trials 1, 2, 3, and 4 are presented in Table 3 .
Table 3: Selected Adverse Reactions Occurring in ≥1% of Subjects Receiving ARAKODA in Pooled Trials 1, 2, 4, and 5 (Non-Deployed Subjects) Adverse Reaction ARAKODA 1 (n=333) % Placebo (n=295) % Mefloquine 2 (n=147) % 1 ARAKODA was administered as 200 mg daily for 3 days, then 200 mg weekly 2 Mefloquine was administered as 250 mg daily for 3 days, then 250 mg weekly 3 Includes headache, sinus headache, migraine and tension headache. 4 Includes dizziness and dizziness postural 5 Includes abnormal dreams, insomnia, nightmares, sleep disorder, and somnambulism.
Nervous system Disorders 35 34 47 Headache 3 32 32 44 Dizziness 4 5 3 10 Musculoskeletal and connective tissue disorders 27 26 37 Back pain 14 9 11 Gastrointestinal disorders 31 33 46 Diarrhea 5 3 1 Nausea 5 2 2 Vomiting 2 2 1 Investigations 8 7 11 Alanine Aminotransferase (ALT) increased/abnormal 4 2 3 Psychiatric disorders 2 1 2 Any sleep symptom 5 1 1 0 Insomnia 1 1 0 Depression/depressed mood 1 0 0 Adverse reactions occurring in ≥1% of subjects in the ARAKODA group in the active-control Trial 3 conducted in military personnel deployed to malaria endemic areas are presented in Table 4 .
Table 4: Selected Adverse Reactions Occurring in ≥1% of Subjects Receiving ARAKODA in Trial 3 (Deployed Subjects) Adverse Reaction ARAKODA 1 (n=492) % Mefloquine 2 (n=162) % 1 ARAKODA was administered as 200 mg daily for 3 days, then 200 mg weekly 2 Mefloquine was administered as 250 mg daily for 3 days, then 250 mg weekly 3 Includes headache, sinus headache, migraine and tension headache. 4 Includes dizziness and dizziness postural 5 Includes motion sickness, vertigo and vertigo positional. 6 Includes abnormal dreams, insomnia, nightmares, sleep disorder, and somnambulism.
7 Includes abnormal dreams, nightmares 8 Includes anxiety disorder…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Avoid co-administration with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters ( 7.1 )
7.1Effect of ARAKODA 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 ARAKODA 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 ▾
8 USE IN SPECIFIC POPULATIONS Lactation : Advise women not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status during treatment and for 3 months after the last dose of ARAKODA. ( 5.2 , 8.2 )
8.1Pregnancy Risk Summary The use of ARAKODA during pregnancy may cause hemolytic anemia in a fetus who is G6PD-deficient. Treatment with ARAKODA during pregnancy is not recommended. If a pregnancy is detected during ARAKODA use, discontinue ARAKODA as soon as possible and switch to an alternative prophylactic drug for malaria during pregnancy [see Warnings and Precautions ( 5.2 )] .
Available data with use of ARAKODA 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 tafenoquine 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 about 1.5 times 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 (about 1.5 times 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 ARAKODA. Infant G6PD status should be checked before breastfeeding begins. ARAKODA 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 ) and Clinical Considerations ] .
There is no information regarding the presence of ARAKODA 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 ARAKODA and any potential effects on the breastfed infant from ARAKODA 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 ARAKODA 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 during t…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary The use of ARAKODA during pregnancy may cause hemolytic anemia in a fetus who is G6PD-deficient. Treatment with ARAKODA during pregnancy is not recommended. If a pregnancy is detected during ARAKODA use, discontinue ARAKODA as soon as possible and switch to an alternative prophylactic drug for malaria during pregnancy [see Warnings and Precautions ( 5.2 )] .
Available data with use of ARAKODA 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 tafenoquine 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 about 1.5 times 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 (about 1.5 times 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 ▾
8.4Pediatric Use Safety and effectiveness of ARAKODA in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical trials of ARAKODA 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 ▾
10 OVERDOSAGE There were no reported cases of ARAKODA overdose. Hemoglobin decline and methemoglobinemia may be encountered in an overdose with ARAKODA. Treatment of overdosage consists of institution of appropriate symptomatic and/or supportive therapy.
🧬 Clinical Pharmacology ▾
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 QT interval was evaluated in a study of healthy adult subjects. In this study, subjects received once daily 400 mg (2 times the approved recommended dosage) doses of tafenoquine for 3 days. The results suggest that the mean increase in the QTcF interval for tafenoquine is less than 20 msec.
12.3Pharmacokinetics Absorption A food effect study was not conducted with the 100 mg ARAKODA tablet. In majority of the clinical trials, tafenoquine was administered under fed conditions. Table 5 provides the pharmacokinetics of tafenoquine following single dose administration of 200 mg ARAKODA (two 100-mg ARAKODA tablets) in 65 healthy adult subjects under fed conditions.
In this study, ARAKODA was administered with a high-calorie, high-fat meal (approximately 1000 calories with 19% protein, 31% carbohydrate, and 50% fat). Table 5. Mean (%CV) Pharmacokinetic Parameters of Tafenoquine Following Single Oral Administration of Two 100-mg ARAKODA Tablets Under Fed Conditions in Healthy Adult Subjects (N=65) Parameter Value a Coefficient of Variance (CV) b Median and (Range) c Plasma tafenoquine AUC inf increased by 41% when tafenoquine was administered as an investigational capsule formulation with a high-calorie, high-fat meal compared with the fasted state.
C max 147 ng/mL (20.7%) a T max 14 hr (6 – 72 hr) b AUC inf 70 hr*mcg/mL (24.6%) a, c Following administration of a single dose of tafenoquine orally under fasted conditions in healthy adult subjects, AUC and C max increased dose proportionally over the dose range from 100 mg to 400 mg. When healthy adult subjects received once-weekly administrations of 200 mg tafenoquine orally for ten weeks without a loading dose under fasting conditions, the mean plasma accumulation ratio of tafenoquine was approximately 4.4. Distribution Tafenoquine is greater than 99.5% bound to protein in humans.
The apparent volume of distribution of tafenoquine in healthy adult subjects is 2470 L [Inter-Individual Variability (IIV): 24.1 %]. Elimination The apparent oral clearance of tafenoquine is approximately
4.2L/hr (IIV: 23.6 %) in healthy adult subjects. The mean terminal half-life following administration of ARAKODA is approximately 16.5 days (range: 10.8 days to 27.3 days) in healthy adult subjects. Metabolism Negligible metabolism of tafenoquine was observed in vitro in human liver microsomes and hepatocytes.
Following administration of tafenoquine orally, once daily for three days to healthy adult subjects, unchanged tafenoquine represented the only notable drug-related component in plasma at approximately 3 days following the first dose of tafenoquine. Excretion The full excretion profile of tafenoquine in humans is unknown. Specific Populations The 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 the pharmacokinetics of substrates of cytochrome P450 isoenzymes (CYP)1A2 (caffeine), CYP2D6 (desipramine), CYP2C9 (flurbiprofen), or CYP3A4 (midazolam) were observed following coadministration with tafenoquine in healthy adult subjects. In Vitro Studies Where Drug Interaction Potential Was Not Further Evaluated Clinically Tafenoquine inhibited metformin transport via human OCT2, MATE1 and MATE2-K transporters [see Drug Interactions ( 7 )] .
Tafenoquine is not an inhibitor of human breast cancer resistance protein (BCRP), P-glycoprotein (P-gp), Organic anion transporter 1/3 (OAT1 or OAT3), Organic anion transporting polypeptide 1B1/1B3 (OATP1B1 or OATP1B3) mediated transport at clinically relevant concentrations. Tafenoquine is also not a substrate of human OATP1B1 or OATP1B3 at cl…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tafenoquine is an 8-aminoquinoline antimalarial drug [see Microbiology ( 12.4 )] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied ARAKODA tablets contain 100 mg of tafenoquine (equivalent to 125.5 mg of tafenoquine succinate) and are dark pink, film-coated, capsule-shaped, and debossed with ‘TQ100’ on one side. ARAKODA tablets are packed in blister packs or bottles. For the blister pack presentation, ARAKODA tablets are packed in polyamide aluminum and PVC formable laminate backed blisters with a polyethylene terephthalate aluminum foil cover.
Each blister card contains 8 tablets. Each package contains 2 blister cards (16 tablets) housed in a contiguous outer paperboard child-resistant carton component (NDC 71475-257-01). For the bottle presentation, ARAKODA tablets are packed in 40 cc, 33 mm white high-density polyethylene bottles with a 33 mm polypropylene screw-top child resistant cap with an induction seal liner.
Each bottle contains 8 tablets (NDC 71475-257-02). Storage Store at less than 30°C (86°F). Protect from moisture.
Dispense only in the original carton or bottle.
📋 Description ▾
11 DESCRIPTION ARAKODA contains tafenoquine succinate, an antimalarial agent for oral administration. The structural formula of tafenoquine succinate is: Figure 1: Tafenoquine Succinate Structure 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 weight is 581.6 as the succinate salt (463.49 as free base).
Each ARAKODA tablet contains 100 mg of tafenoquine (equivalent to 125.5 mg of tafenoquine succinate). Inactive ingredients include magnesium stearate, mannitol, and microcrystalline cellulose. The tablet film coating inactive ingredients include: hypromellose, iron oxide red, macrogol/polyethylene glycol and titanium dioxide.
Figure 1: Tafenoquine Succinate Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). G6PD Testing and Hemolytic Anemia Inform patients of the need for testing for G6PD deficiency before starting ARAKODA. Advise patients on the symptoms of hemolytic anemia and instruct them to seek medical advice promptly if such symptoms occur.
Patients should contact their health care provider if they have darker 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 ARAKODA with food. • Advise patients to swallow the tablet whole and not to break, crush or chew it. • Advise patients to complete the full course of ARAKODA including the loading dose, maintenance dose and terminal dose. Potential Harm to the Fetus Advise females of reproductive potential of the potential risk of ARAKODA to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 )] .
Advise females of reproductive potential to avoid pregnancy or use effective contraception during treatment with ARAKODA and for 3 months after the final dose [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 during treatment with ARAKODA and for 3 months after the final dose [see Contraindication ( 4 ), Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.2 )] . Methemoglobinemia Inform patients that methemoglobinemia has occurred with ARAKODA.
Advise patients on 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 who experience hallucinations, delusions, or confused thinking while taking ARAKODA to seek medical attention as soon as possible. Other psychiatric symptoms, such as changes in mood, anxiety, insomnia, and nightmares, should be promptly evaluated by a medical professional if they last more than three days or severe [see Warnings and Precautions ( 5.4 )] .
Hypersensitivity Reactions Inform patients that hypersensitivity reactions have occurred with ARAKODA. Advise patients on the symptoms of hypersensitivity reactions and instruct them to seek medical advice promptly if such symptoms occur [see Warnings and Precautions ( 5.5 )] . Manufactured For: 60 Degrees Pharmaceuticals INC, 1025 Connecticut Avenue NW, Suite 1000, Washington DC 20036 1217a
💬 Medication Guide ▾
Medication Guide MEDICATION GUIDE ARAKODA (AIR-uh-KOH-duh) (tafenoquine) tablets, for oral use What is the most important information I should know about ARAKODA? ARAKODA can cause serious side effects including : • Breakdown of red blood cells (hemolytic anemia). See “ Do not take ARAKODA if you :” ARAKODA can cause a breakdown of red blood cells (hemolysis) in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Your healthcare provider will test you for G6PD deficiency before you start taking ARAKODA. Signs of hemolytic anemia may not happen right away (delayed reaction).Tell your healthcare provider or get emergency medical help right away if you develop signs of hemolytic anemia which include darkening of the urine, dizziness, confusion, feeling tired, light-headedness, or shortness of breath, pale skin or yellowing of the skin and whites of the eyes. • Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia) .
Signs and symptoms of methemoglobinemia may not happen right away (delayed reaction). Get medical help right away if you have bluish coloring of the lips or skin, headache, fatigue, shortness of breath, or lack of energy. • Mental health (psychiatric) symptoms . See “ Do not take ARAKODA if you :” Sleep problems, depression, anxiety and psychosis have happened while taking ARAKODA.
Psychiatric symptoms may not happen right away (delayed reaction). Get emergency medical help right away if you develop hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), or if you get confused or have problems thinking while taking ARAKODA. Call your healthcare provider if you develop changes in your mood, anxiety, trouble sleeping (insomnia), or nightmares for 3 days or longer while taking ARAKODA. • ARAKODA can have other serious side effects.
See “ What are the possible side effects of ARAKODA? ” What is ARAKODA? • ARAKODA is a prescription medicine used to help prevent malaria in people 18 years of age and older. • Malaria is a serious disease of the blood that is spread by infected mosquitos. • It is not known if ARAKODA is safe and effective in children. Do not take ARAKODA if you : • have G6PD deficiency. • are breastfeeding a child known to have G6PD deficiency or breastfeeding a child that has not been tested for G6PD deficiency. • have a history of psychotic disorders, or you currently have psychotic symptoms including hallucinations (seeing or hearing things that are not really there), delusions (false or strange thoughts or beliefs), or disorganized thinking or behavior. • are allergic to tafenoquine, other 8-aminoquinolines, or any of the ingredients in ARAKODA.
See the end of this Medication Guide for a complete list of ingredients in ARAKODA. Before taking ARAKODA, tell your health care provider about all your medical conditions, including if you : • have nicotinamide adenine dinucleotide (NADH) reductase deficiency. People with NADH reductase deficiency have a higher risk for methemoglobinemia if they take ARAKODA. • have or have had mental health problems. • are pregnant or plan to become pregnant.
ARAKODA can harm an unborn baby who has G6PD deficiency. o You should not become pregnant during treatment with ARAKODA. o Females who are able to become pregnant should use effective birth control (contraception) during treatment with ARAKODA. Talk with your healthcare provider about birth control methods that may be right for you. o Your healthcare provider may suggest you take a pregnancy test before you start taking ARAKODA. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ARAKODA. • are breastfeeding or plan to breastfeed.
It is not known if ARAKODA passes into breast milk. See “ Do not take ARAKODA if you :” o Your healthcare provider should check your child for G6PD deficiency before you start breastfeeding. o If you know your…