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Generic Name
Tafenoquine
Brand Names
Arakoda, Kodatef, Krintafel
FDA approval date: August 20, 2018
Form: Tablet
What is Arakoda (Tafenoquine)?
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.
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Brand Information
Arakoda (Tafenoquine)
1INDICATIONS AND USAGE
ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older.
2DOSAGE FORMS AND STRENGTHS
ARAKODA tablets are dark pink, film-coated, capsule-shaped tablets debossed with ‘TQ100’ on one side containing 100 mg of tafenoquine.
3CONTRAINDICATIONS
ARAKODA is contraindicated in:
- patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia
- breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if the G6PD status of the infant is unknown
- patients with a history of psychotic disorders or current psychotic symptoms (i.e., hallucinations, delusions, and/or grossly disorganized behavior)
- patients with known hypersensitivity reactions to tafenoquine, other 8-aminoquinolines, or any component of ARAKODA
4ADVERSE REACTIONS
The following clinically significant adverse reactions observed with ARAKODA are discussed in detail in the Warnings and Precautions section:
- Hemolytic Anemia
- Methemoglobinemia
- Psychiatric Effects
- Hypersensitivity Reactions
4.1Clinical 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
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
Clinically Significant Adverse Reactions in Trials 1 to 5 (Overall Safety Population)
Clinically significant adverse reactions with ARAKODA (200 mg daily for 3 days, followed by 200 mg weekly) in Trials 1 to 5 (n= 825) are described below:
Ocular Adverse Reactions
Vortex keratopathy was reported in 21% to 93% of subjects receiving ARAKODA in the trials which included ophthalmic evaluations (Trials 3, 5, and Trial 6 (NCT # 01290601, an active-control trial in patients from Thailand with
A total of 7 serious ocular adverse reactions (SARs) were reported in ARAKODA-treated subjects in the trials which included ophthalmic evaluations: 5 reports of keratopathy and two reports of retinal disorders.
Laboratory Abnormalities
Methemoglobinemia: Asymptomatic methemoglobin elevations were observed in 13% of subjects receiving ARAKODA.
Hemoglobin decrease: Hemoglobin decreases of ≥ 3 g/dL were observed in 2.3% of subjects receiving ARAKODA.
Adverse Reactions Reported in < 1% of Subjects Receiving ARAKODA in Trials 1 to 5
The following selected adverse reactions were reported in subjects receiving ARAKODA in Trials 1 to 5 at a rate of less than 1%.
Blood and lymphatic system disorders: hemolytic anemia, anemia, thrombocytopenia
Ear and labyrinth disorders: hyperacusis, Meniere’s disease
Eye disorders: night blindness, photophobia, blurred vision, visual acuity reduced, visual impairment, vitreous floaters
Hepatobiliary disorders: hyperbilirubinemia, jaundice cholestatic
Immune system disorders: hypersensitivity
Investigations: blood bilirubin increased, blood creatinine increased, glomerular filtration rate decreased
Nervous system disorders: amnesia, coordination abnormal, hyperesthesia, hypoesthesia, somnolence, syncope, tremor, visual field defect
Psychiatric disorders: agitation, neurosis
Skin and subcutaneous tissue disorders: urticaria.
5OVERDOSAGE
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.
6DESCRIPTION
ARAKODA contains tafenoquine succinate, an antimalarial agent for oral administration. The structural formula of tafenoquine succinate is:
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
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.
7CLINICAL STUDIES
Clinical Trials 1, 2, and 3
Three double-blind, randomized, controlled studies have been performed to evaluate the efficacy of ARAKODA.
Trial 1 (NCT #02491606) was a Phase IIb, placebo-controlled study conducted in Kenya, an area of holoendemic
Trial 2 (NCT #02488902) was a comparison of tafenoquine to placebo for prophylaxis in healthy semi-immune residents of a malarious region in Ghana. After treating existing parasitemia with quinine/doxycycline/primaquine, subjects were randomized into prophylactic groups including ARAKODA and placebo. Patients were administered a loading regimen of daily drug or placebo for 3 days followed by a maintenance regimen of weekly drug or placebo for 12 weeks. For the ARAKODA and placebo groups, males were 65% of the total population. The mean age was 38.4 years and 53.5 years for males and females, respectively, as women in reproductive ages were excluded from the study. The mean weight was 55.4 kg and 47.5 kg for males and females, respectively. Subjects were evaluated for parasitemia by weekly blood smears. Parasitemia required a blood smear positive for asexual stage of
Trial 3 compared ARAKODA with mefloquine for the prophylaxis of both
Clinical Trial 7
In a randomized, double-blind, placebo-controlled trial (Trial 7) in healthy, non-immune volunteers, ARAKODA was shown to have prophylactic activity directed against blood-stage
8HOW 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.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
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
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
Advise females of reproductive potential to avoid pregnancy or use effective contraception during treatment with ARAKODA and for 3 months after the final dose
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
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
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
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
Manufactured For:
1217a
10Medication Guide
This Medication Guide has been approved by the U.S. Food and Drug Administration
Issued: August 2018
11PRINCIPAL DISPLAY PANEL - Carton Label
Rx only
NDC: 71475-257-01
KEEP OUT OF REACH OF CHILDREN
ATTENTION: Dispense the enclosed
Medication Guide to each patient
Medication Guide to each patient
Arakoda(tafenoquine) tablets,
for oral use
for oral use
100 mg
16 (2 x 8)
Sixty
Each tablet contains 100 mg tafenoquine (equivalent to 125.5 mg
Protect from moisture. Dispense only in the original carton.
See Prescribing Information for Dosage and Administration
Two blister packs are contained in each carton. Each
Manufactured for:60 Degrees Pharmaceuticals, Inc.
1025 Connecticut Ave., NW, Suite 1000
Washington DC 20036
1025 Connecticut Ave., NW, Suite 1000
Washington DC 20036
Country of Origin: India
Sixty
Arakoda
(tafenoquine) tablets,
for oral use
(tafenoquine) tablets,
for oral use
Principal Display Panel - Inner Carton Label
Rx only
NDC: 71475-257-01
KEEP OUT OF REACH OF CHILDREN
ATTENTION: Dispense the enclosed
Medication Guide to each patient
Medication Guide to each patient
Arakoda(tafenoquine) tablets,
for oral use
for oral use
100 mg
16 (2 x 8)
Sixty
Arakoda(tafenoquine) tablets,
for oral use
for oral use
100 mg
Principal Display Panel - Blister Label
CODE: MP/DRUGS/25/10/92
NDC: 71475-257-01
21541667
EM 15572
Sixty
Arakoda
100 mg
Exp:
Principal Display Panel - Bottle Label
Rx only
NDC: 71475-257-02
KEEP OUT OF REACH
ATTENTION: Dispense the attached
Medication Guide to each patient
Medication Guide to each patient
Arakoda(tafenoquine) tablets,
for oral use
for oral use
100 mg
8 Tablets
Sixty
Each tablet contains 100 mg
Protect from moisture.
See Prescribing Information for Dosage
Manufactured for:60 Degrees Pharmaceuticals, Inc.
1025 Connecticut Ave., NW, Suite 1000
Washington DC 20036
1025 Connecticut Ave., NW, Suite 1000
Washington DC 20036
Country of Origin: India
