Arakoda
- Generic Name: tafenoquine tablets
- Brand Name: Arakoda
- Drug Class: Antimalarials, Antimalarials, Aminoquinoline
Arakoda (Tafenoquine Tablets) side effects drug center
- Related Drugs
- headache,
- dizziness,
- back pain,
- diarrhea,
- nausea,
- vomiting,
- increased alanine aminotransferase (ALT),
- motion sickness,
- insomnia,
- depression,
- abnormal dreams, and
- anxiety
- pale or yellowed skin, dark colored urine;
- darkening of your mouth, lips, or fingernails;
- fast heartbeats, shortness of breath;
- a headache, or light-headed feeling (like you might pass out);
- confusion, tiredness; or
- new or worsening mental health problems--anxiety, strange dreams, trouble sleeping.
- nausea, vomiting;
- abnormal hemoglobin tests;
- dizziness; or
- headache.
- Hemolytic Anemia [see WARNINGS AND PRECAUTIONS]
- Methemoglobinemia [see WARNINGS AND PRECAUTIONS]
- Psychiatric Effects [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
What Is Arakoda?
Arakoda (tafenoquine) is an antimalarial indicated for the prevention of malaria in patients aged 18 years and older.
What Are Side Effects of Arakoda?
Common side effects of Arakoda include:
Dosage for Arakoda
The loading dose and regimen of Arakoda is: 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. The maintenance dose and regimen of Arakoda is: While in the malarious area 200 mg (2 of the 100 mg tablets) once weekly– start 7 days after the last loading regimen dose. The preventive dose and regimen of Arakoda is: 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.
What Drugs, Substances, or Supplements Interact with Arakoda?
Arakoda may interact with OCT2 and MATE substrates (e.g., dofetilide, metformin). Tell your doctor all medications and supplements you use.
Arakoda During Pregnancy and Breastfeeding
Arakoda is not recommended for use during pregnancy; it may harm a fetus. Women are advised 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. Consult your doctor before breastfeeding.
Additional Information
Our Arakoda (tafenoquine) tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
Common side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Arakoda (Tafenoquine Tablets)
SIDE EFFECTS
The following clinically significant adverse reactions observed with ARAKODA are discussed in detail in the Warnings and Precautions section:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety 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 | ARAKODA1 (n=333)% | Placebo (n=295) % | Mefloquine2 (n=147) % |
| Nervous system Disorders | 35 | 34 | 47 |
| Headache3 | 32 | 32 | 44 |
| Dizziness4 | 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 symptom5 | 1 | 1 | 0 |
| Insomnia | 1 | 1 | 0 |
| Depression/depressed mood | 1 | 0 | 0 |
| 1ARAKODA was administered as 200 mg daily for 3 days, then 200 mg weekly 2Mefloquine was administered as 250 mg daily for 3 days, then 250 mg weekly 3Includes headache, sinus headache, migraine and tension headache. 4Includes dizziness and dizziness postural 5Includes abnormal dreams, insomnia, nightmares, sleep disorder, and somnambulism. | |||
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 | ARAKODA1 (n=492) % | Mefloquine2 (n=162) % |
| Nervous system Disorders | 22 | 27 |
| Headache3 | 15 | 19 |
| Dizziness4 | 1 | 1 |
| Ear and labyrinth Disorders | 7 | 11 |
| Motion sicknesss5 | 5 | 6 |
| Musculoskeletal and | 29 | 30 |
| connective tissue disorders | ||
| Back pain | 14 | 15 |
| Gastrointestinal disorders | 36 | 41 |
| Diarrhea | 18 | 20 |
| Nausea | 7 | 9 |
| Vomiting | 5 | 6 |
| Psychiatric disorders | 5 | 4 |
| Any sleep symptom6 | 4 | 4 |
| Insomnia | 2 | 1 |
| Abnormal dreams7 | 2 | 2 |
| Anxiety8 | 1 | 0 |
| 1ARAKODA was administered as 200 mg daily for 3 days, then 200 mg weekly 2Mefloquine was administered as 250 mg daily for 3 days, then 250 mg weekly 3Includes headache, sinus headache, migraine and tension headache. 4Includes dizziness and dizziness postural 5Includes motion sickness, vertigo and vertigo positional. 6Includes abnormal dreams, insomnia, nightmares, sleep disorder, and somnambulism. 7Includes abnormal dreams, nightmares 8Includes anxiety disorder, panic attack and stress. | ||
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 P. vivax malaria. The keratopathy did not result in any apparent functional visual changes and resolved within one year after drug cessation in all patients. Retinal abnormalities were noted in less than 1% of subjects receiving ARAKODA.
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.
Read the entire FDA prescribing information for Arakoda (Tafenoquine Tablets)
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