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Krintafel

Generic Name: tafenoquine (ta FEN o kwin)
Brand Names: Arakoda
Arakoda is used for the treatment of Plasmodium vivax malaria. Arakoda information includes news, clinical trial results and side effects.
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Drug Information:
Arakoda (tafenoquine) is an anti-malaria medicine that works by interfering with the growth of parasites in the red blood cells of the human body. Parasites that cause malaria typically enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia. Arakoda is used to treat malaria in people who are also using other anti-malaria medications. Arakoda is for use in people 18 years of age and older. It is not known if Arakoda is safe and effective in children. Learn more

Krintafel Side Effects

Arakoda Side Effects

Note: This document contains side effect information about tafenoquine. Some of the dosage forms listed on this page may not apply to the brand name Arakoda.

For the Consumer

Applies to tafenoquine: oral tablet

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of hemolytic anemia like dark lips or urine, dizziness or passing out, feeling confused, feeling very tired or weak, pale skin, shortness of breath, or yellow skin or eyes.
  • Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
  • Mental, mood, or behavior changes that are new or worse.
  • Strange or odd dreams.
  • Trouble sleeping.
  • Hallucinations (seeing or hearing things that are not there).
  • Feeling confused.
  • Very bad dizziness or passing out.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Headache.
  • Dizziness.
  • Back pain.
  • Diarrhea.
  • Motion sickness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to tafenoquine: oral tablet

General

The recommended regimen for the prophylaxis of malaria was evaluated in 5 clinical trials. The duration of drug exposure in these 5 trials averaged 21 weeks (range: 10 to 29 weeks). Of the 5 trials, 3 were conducted in healthy semi-immune volunteers in Ghana or Kenya, 1 was in healthy soldiers in East Timor (Timor Leste), and 1 was in healthy volunteers in the US and UK.

In clinical trials in patients with Plasmodium vivax malaria, a single dose of this drug was used with chloroquine.

Ocular

For the prophylaxis of malaria:

-Very common (10% or more): Vortex keratopathy (up to 93%)

-Frequency not reported: Retinal abnormalities, retinal disorders, keratopathy, night blindness, photophobia, blurred vision, reduced visual acuity, visual impairment, vitreous floaters

For the radical cure of P vivax malaria:

-Uncommon (0.1% to 1%): Vortex keratopathy, photophobia

In the trials that included ophthalmic evaluations, vortex keratopathy was reported in 21% to 93% of subjects receiving this drug; the keratopathy did not cause any apparent functional visual changes and resolved within 1 year after stopping the drug in all patients.

For the prophylaxis of malaria: Keratopathy (5 reports) and retinal disorders (2 reports) were reported as serious ocular adverse reactions in trials that included ophthalmic evaluations.

Nervous system

For the prophylaxis of malaria:

-Very common (10% or more): Headache (included headache, sinus headache, migraine, tension headache; up to 32%)

-Common (1% to 10%): Dizziness (included dizziness, postural dizziness), motion sickness (included motion sickness, vertigo, positional vertigo)

-Frequency not reported: Hyperacusis, Meniere's disease, amnesia, abnormal coordination, hyperesthesia, hypoesthesia, somnolence, syncope, tremor, visual field defect

For the radical cure of P vivax malaria:

-Common (1% to 10%): Headache, dizziness

-Uncommon (0.1% to 1%): Somnolence

Gastrointestinal

For the prophylaxis of malaria:

-Very common (10% or more): Diarrhea (up to 18%)

-Common (1% to 10%): Nausea, vomiting

For the radical cure of P vivax malaria:

-Common (1% to 10%): Nausea, vomiting

Musculoskeletal

For the prophylaxis of malaria:

-Very common (10% or more): Back pain (14%)

Hematologic

For the prophylaxis of malaria:

-Very common (10% or more): Asymptomatic methemoglobin elevations (13%)

-Common (1% to 10%): Decreased hemoglobin

-Frequency not reported: Hemolytic anemia, anemia, thrombocytopenia

For the radical cure of P vivax malaria:

-Common (1% to 10%): Decreased hemoglobin levels, elevated methemoglobin

-Frequency not reported: Asymptomatic methemoglobin elevations

For the prophylaxis of malaria: Decreased hemoglobin (at least 3 g/dL) was reported in 2.3% of subjects.

Psychiatric

For the radical cure of P vivax malaria: Cases of depression and psychosis (2 each) have been reported primarily in patients with history of psychiatric disorders after receiving single doses that were higher than the approved 300 mg dose (350 to 600 mg).

For the prophylaxis of malaria:

-Common (1% to 10%): Any sleep symptom (included abnormal dreams, insomnia, nightmares, sleep disorder, somnambulism), insomnia, abnormal dreams (included abnormal dreams, nightmares), depression/depressed mood, anxiety (included anxiety disorder, panic attack, stress)

-Frequency not reported: Agitation, neurosis

For the radical cure of P vivax malaria:

-Common (1% to 10%): Insomnia

-Uncommon (0.1% to 1%): Anxiety

-Rare (less than 0.1%): Abnormal dreams

-Frequency not reported: Depression, psychosis

Renal

For the prophylaxis of malaria:

-Frequency not reported: Increased blood creatinine, decreased glomerular filtration rate

For the radical cure of P vivax malaria:

-Common (1% to 10%): Increased blood creatinine

Hepatic

For the prophylaxis of malaria:

-Common (1% to 10%): Increased/abnormal ALT

-Frequency not reported: Hyperbilirubinemia, cholestatic jaundice, increased blood bilirubin

For the radical cure of P vivax malaria:

-Uncommon (0.1% to 1%): Increased ALT

Hypersensitivity

For the prophylaxis of malaria:

-Frequency not reported: Hypersensitivity

For the radical cure of P vivax malaria:

-Rare (less than 0.1%): Hypersensitivity reactions (e.g., angioedema, urticaria)

Dermatologic

For the prophylaxis of malaria:

-Frequency not reported: Urticaria

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Krintafel (www.drugs.com/krintafel.html).