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This medication comes with important safety warnings that highlight potential risks and necessary precautions. Please read the information thoroughly and consult your healthcare provider if you have any questions or concerns.

• Low Red Blood Cells (Hemolytic Anemia): Tafenoquine may cause dangerously low red blood cells in individuals with a genetic condition known as G6PD deficiency. Your healthcare provider will test you for this deficiency before prescribing tafenoquine. If you are capable of becoming pregnant, a pregnancy test may be required before starting the medication. Tafenoquine is not recommended for use during pregnancy or breastfeeding, as it can harm a baby with G6PD deficiency. It is advised to use effective birth control and pause breastfeeding during treatment and for three months after completing your tafenoquine regimen. Seek immediate medical attention if you experience symptoms such as fatigue, shortness of breath, rapid heartbeat, dark urine, or fever, which may indicate hemolytic anemia.

• Methemoglobinemia: Tafenoquine has been associated with a serious blood disorder known as methemoglobinemia, where too much methemoglobin is produced, reducing oxygen delivery to the body. This condition can lead to severe side effects, including skin discoloration, seizures, coma, irregular heart rhythms, and potentially death. The risk increases for individuals with G6PD deficiency or a family history of methemoglobinemia. Prompt medical attention is necessary if symptoms such as pale, blue, or gray skin, headache, fast heartbeat, shortness of breath, or lightheadedness occur.

• Mental Health Changes: Tafenoquine may cause mental health symptoms, including anxiety, abnormal dreams, insomnia, depression, and psychosis. Those with a history of mental health issues are at higher risk. Do not use Arakoda if you have experienced or are currently experiencing psychosis. Be aware that some side effects may not appear until several weeks after starting the medication. Discuss your medical history with your healthcare provider, and report any mood changes, hallucinations, nightmares, or sleep disturbances immediately.

• Malaria Recurrence Risk (Krintafel): Krintafel is effective only when taken with chloroquine. It should be started on the first or second day of chloroquine treatment. Using Krintafel with other malaria medications may reduce its effectiveness and increase the risk of malaria recurrence.

Contraindications:

• Do not use this medication if you have G6PD deficiency.
• Avoid use during breastfeeding if the baby has or may have G6PD deficiency.
• Do not take Arakoda if you have a history of psychotic disorders or symptoms.

Tafenoquine can cause a range of side effects that vary in severity. Common side effects include headaches, which occur in up to 32% of users, along with diarrhea, back pain, nausea, motion sickness, vomiting, and dizziness. These effects are generally mild and often resolve on their own, but if they persist or worsen, consulting a healthcare provider is advisable.

More serious side effects, though less common, require prompt attention. These include mental or mood changes like hallucinations, confusion, or unusual thoughts, as well as physical symptoms such as unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat, severe headaches, or yellowing of the skin or eyes. Additionally, symptoms like dark urine, dizziness, bluish lips or skin, and any vision problems should be addressed immediately.

In rare cases, tafenoquine can cause significant allergic reactions. Warning signs include rash, severe dizziness, swelling of the face, tongue, or throat, and trouble breathing. It's crucial to seek emergency medical help if these symptoms occur. Always remain vigilant for any unusual effects and consult your healthcare provider for guidance.