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This document outlines critical safety information regarding the use of tafenoquine. Please review it carefully and consult your healthcare provider with any concerns.

• Low Red Blood Cells (Hemolytic Anemia): Tafenoquine may lead to dangerously low red blood cells in individuals with G6PD deficiency. Prior to starting tafenoquine, a test for G6PD deficiency is required. If you are capable of becoming pregnant, a pregnancy test might also be necessary. Due to potential risks, tafenoquine is not recommended during pregnancy or breastfeeding, as it could harm a baby with G6PD deficiency. Effective contraception and avoiding breastfeeding are advised during treatment and for three months afterward. 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: This serious blood condition occurs when the body produces excess methemoglobin, reducing oxygen delivery by red blood cells. Symptoms can include bluish or gray skin, seizures, coma, irregular heart rhythms, and even death. Individuals with G6PD deficiency or a family history of methemoglobinemia are at greater risk. Prompt medical assistance is crucial if symptoms like skin color changes, headaches, rapid heart rate, shortness of breath, or dizziness occur.

• Mental Health Changes: Tafenoquine may induce mental health symptoms such as anxiety, unusual dreams, insomnia, depression, or psychosis, especially in those with a history of mental health conditions. Avoid using Arakoda if you have a current or past psychotic disorder. It is important to inform your healthcare provider of any changes in mood, hallucinations, nightmares, or sleep disturbances during treatment.

• Risk of Malaria Recurrence (Krintafel): Krintafel should only be used in conjunction with chloroquine, starting on the first or second day of chloroquine treatment. Using Krintafel with other antimalarial drugs may reduce its effectiveness and increase the risk of malaria recurrence.

Contraindications:

• Individuals with G6PD deficiency.
• During breastfeeding if the baby has, or it is unknown whether the baby has, G6PD deficiency.
• Those with a history of psychotic disorders or symptoms (specific to Arakoda).

It is imperative to consult with your healthcare provider if these conditions apply to you before using tafenoquine.

Tafenoquine, a medication that remains in your body for an extended period, may lead to side effects that are delayed or last longer than anticipated. Common side effects include headaches, affecting 15-32% of users, diarrhea (5-18%), back pain (14%), nausea (5-7%), motion sickness (5%), vomiting (2-5%), and dizziness (1-5%). These symptoms are generally mild, but if they persist or worsen, it is advisable to consult your healthcare provider.

In some cases, individuals may experience other side effects such as anemia, dizziness, nausea, vomiting, or headaches. While these are less common, they still warrant attention if they become severe. The serious side effects are rare but significant and require immediate medical intervention. These include liver damage, trouble sleeping, abnormal dreams, depression, and anxiety. Additionally, be vigilant for symptoms like hallucinations, unusual thoughts or behavior, confusion, unusual tiredness, rapid breathing, pale skin, shortness of breath, fast heartbeat, severe headaches, yellowing of the eyes or skin, dark urine, and bluish lips or skin.

In rare instances, a serious allergic reaction could occur, characterized by rash, itching or swelling, severe dizziness, and difficulty breathing. Prompt medical assistance should be sought if these symptoms appear. While the comprehensive list of side effects may vary, remaining informed and attentive to your body's reactions can help manage and mitigate potential risks.