Arakoda

Last updated on RxList: 11/30/2020
Arakoda Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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.

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.

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Arakoda Consumer Information

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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;
  • 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.

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:

  • Hemolytic Anemia [see WARNINGS AND PRECAUTIONS]
  • Methemoglobinemia [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Effects [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]

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 ReactionARAKODA1
(n=333)%
Placebo
(n=295) %
Mefloquine2
(n=147) %
Nervous system Disorders353447
Headache3323244
Dizziness45310
Musculoskeletal and connective tissue disorders272637
Back pain14911
Gastrointestinal disorders313346
Diarrhea531
Nausea522
Vomiting221
Investigations8711
Alanine Aminotransferase (ALT) increased/abnormal423
Psychiatric disorders212
Any sleep symptom5110
Insomnia110
Depression/depressed mood100
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 ReactionARAKODA1
(n=492) %
Mefloquine2
(n=162) %
Nervous system Disorders2227
Headache31519
Dizziness411
Ear and labyrinth Disorders711
Motion sicknesss556
Musculoskeletal and2930
connective tissue disorders
Back pain1415
Gastrointestinal disorders3641
Diarrhea1820
Nausea79
Vomiting56
Psychiatric disorders54
Any sleep symptom644
Insomnia21
Abnormal dreams722
Anxiety810
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)

© 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.

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