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Arakoda

Last reviewed on RxList: 8/16/2018
Arakoda Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 8/16/2018

Arakoda (tafenoquine) is an antimalarial indicated for the prevention of malaria in patients aged 18 years and older. Common side effects of Arakoda include:

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. Arakoda may interact with OCT2 and MATE substrates (e.g., dofetilide, metformin). Tell your doctor all medications and supplements you use. 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.

TOur Arakoda (tafenoquine) tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Arakoda Consumer Information

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:

  • pale or yellowed skin, dark colored urine;
  • darkening of your mouth, lips, or fingernails;
  • feeling light-headed or short of breath;
  • confusion, tiredness; or
  • new or worsening mental health problems--anxiety, strange dreams, trouble sleeping.

Common side effects may include:

  • nausea, vomiting;
  • abnormal hemoglobin tests;
  • dizziness; or
  • headache.

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)

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Arakoda Professional Information

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 placebocontrolled 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 ARAKODA2
(n=333)
%
Placebo
(n=295)
%
Mefloquine3
(n=147)
%
Nervous system Disorders 35 34 47
Headache4 32 32 44
Dizziness5 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 symptom6 1 1 0
Insomnia 1 1 0
Depression/depressed mood 1 0 0
1 Trials 2 and 4 included mefloquine arm in addition to placebo
2 ARAKODA was administered as 200 mg daily for 3 days, then 200 mg weekly
3 Mefloquine was administered as 250 mg daily for 3 days, then 250 mg weekly
4 Includes headache, sinus headache, migraine and tension headache.
5 Includes dizziness and dizziness postural
6 Includes 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 connective tissue disorders 29 30
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
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, 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 activecontrol 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)

Related Resources for Arakoda

© Arakoda Patient Information is supplied by Cerner Multum, Inc. and Arakoda Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

QUESTION

Bowel regularity means a bowel movement every day. See Answer

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