Tafenoquine

What it is used for

ARAKODA is indicated for the prophylaxis of malaria in patients aged 18 years and older. ARAKODA is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older.

The most important thing to know

ARAKODA can cause serious side effects including: Breakdown of red blood cells (hemolytic anemia). See “

How to take it

Take ARAKODA exactly as your healthcare provider tells you to take it. ARAKODA is given as 2 tablets that you will take together as a single dose. Each ARAKODA tablet has 100 mg of tafenoquine. You will start taking ARAKODA 3 days before you travel to a malaria area. o Take 2 tablets, 1 time each day for 3 days. You will continue to take ARAKODA while you are in the malaria area.

o Take 2 tablets, 1 time each week. o Start taking this dose of ARAKODA 7 days after the last dose of ARAKODA that you took before your travel to the malaria area. You will take your last dose of ARAKODA after you leave the malaria area. o Take 2 tablets. o Take this dose of ARAKODA 7 days after the last dose of ARAKODA that you took while you were in the malaria area.

Take ARAKODA tablets whole. Do not break, crush, or chew the tablets before swallowing. Take ARAKODA with food. It is important that you take the full course of treatment with ARAKODA. Do not stop taking ARAKODA without first talking to your healthcare provider because the medicine may not work as well to prevent malaria.

If you miss 1 or 2 daily doses of ARAKODA before your travel to the malaria area: o 1 daily dose: take 2 tablets (missed dose), and then continue to take your daily dose of ARAKODA until you have taken a total of 3 daily doses before your travel to the malaria area. Start taking your weekly doses or ARAKODA 1 week after your last daily dose.

o 2 daily doses: take 2 tablets (missed dose), 1 time each day for 2 days in a row (consecutive days) so that you have taken a total of 3 daily doses before your travel to the malaria area. Start taking your weekly doses of ARAKODA 1 week after your last daily dose. If you miss any weekly doses of ARAKODA while you are in the malaria area: o 1 weekly dose: take 2 tablets, 1 time on any day up to the time of your next scheduled weekly dose.

o 2 weekly doses: take 2 tablets, 1 time on any day before your next scheduled weekly dose. o 3 or more weekly doses: take 2 tablets, 1 time each day for 2 days up to the time of your next scheduled weekly dose. If you miss taking your last dose of ARAKODA 7 days after the last dose of ARAKODA you took while you were in the malaria area, take this last dose of ARAKODA as soon as you remember.

What are the possible side effects of ARAKODA? ARAKODA may cause serious side effects, including: Allergic (hypersensitivity) reactions. See “ Do not take ARAKODA if you:” Allergic reactions can happen after you take ARAKODA. Signs and symptoms of an allergic reaction may not happen right away (delayed reaction). Get medical help right away if you have any signs or symptoms of an allergic reaction including: o swelling of the face, lips, tongue or throat o itching o trouble breathing or wheezing o vomiting o fainting and feeling lightheaded o rash o hives The most common side effects of ARAKODA include: diarrhea, headache, back pain, nausea, vomiting, dizziness, increased liver enzyme levels in your blood, motion sickness, insomnia, depression, abnormal dreams and anxiety.

Other side effects of ARAKODA include eye problems. Some people who take ARAKODA can have a problem with the cornea of the eye called vortex keratopathy. This problem can be seen during an eye exam. Vortex keratopathy does not cause vision problems and will usually go away after you stop taking ARAKODA. These are not all the possible side effects of ARAKODA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Sixty Degrees Pharmaceuticals, LLC at 1-888-834-0225.

Side effects, and when to stop

” What is ARAKODA? ARAKODA is a prescription medicine used to help prevent malaria in people 18 years of age and older. Malaria is a serious disease of the blood that is spread by infected mosquitos. It is not known if ARAKODA is safe and effective in children. Do not take ARAKODA if you: have G6PD deficiency. are breastfeeding a child known to have G6PD deficiency or breastfeeding a child that has not been tested for G6PD deficiency.

have a history of psychotic disorders, or you currently have psychotic symptoms including hallucinations (seeing or hearing things that are not really there), delusions (false or strange thoughts or beliefs), or disorganized thinking or behavior. are allergic to tafenoquine, other 8-aminoquinolines, or any of the ingredients in ARAKODA.

See the end of this Medication Guide for a complete list of ingredients in ARAKODA. Before taking ARAKODA, tell your health care provider about all your medical conditions, including if you: have nicotinamide adenine dinucleotide (NADH) reductase deficiency. People with NADH reductase deficiency have a higher risk for methemoglobinemia if they take ARAKODA.

have or have had mental health problems. are pregnant or plan to become pregnant. ARAKODA can harm an unborn baby who has G6PD deficiency. o You should not become pregnant during treatment with ARAKODA. o Females who are able to become pregnant should use effective birth control (contraception) during treatment with ARAKODA.

Talk with your healthcare provider about birth control methods that may be right for you. o Your healthcare provider may suggest you take a pregnancy test before you start taking ARAKODA. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with ARAKODA. are breastfeeding or plan to breastfeed.

It is not known if ARAKODA passes into breast milk. See “ Do not take ARAKODA if you:” o Your healthcare provider should check your child for G6PD deficiency before you start breastfeeding. o If you know your child has G6PD deficiency, do not breastfeed during treatment with ARAKODA and for 3 months after your last dose of ARAKODA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARAKODA and other medicines may affect each other causing side effects.

Who should not take it

Do not take ARAKODA if you:” ARAKODA can cause a breakdown of red blood cells (hemolysis) in people with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Your healthcare provider will test you for G6PD deficiency before you start taking ARAKODA. Signs of hemolytic anemia may not happen right away (delayed reaction).Tell your healthcare provider or get emergency medical help right away if you develop signs of hemolytic anemia which include darkening of the urine, dizziness, confusion, feeling tired, light-headedness, or shortness of breath, pale skin or yellowing of the skin and whites of the eyes.

Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). Signs and symptoms of methemoglobinemia may not happen right away (delayed reaction). Get medical help right away if you have bluish coloring of the lips or skin, headache, fatigue, shortness of breath, or lack of energy.

Mental health (psychiatric) symptoms. See “ Do not take ARAKODA if you:” Sleep problems, depression, anxiety and psychosis have happened while taking ARAKODA. Psychiatric symptoms may not happen right away (delayed reaction). Get emergency medical help right away if you develop hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs), or if you get confused or have problems thinking while taking ARAKODA.

Call your healthcare provider if you develop changes in your mood, anxiety, trouble sleeping (insomnia), or nightmares for 3 days or longer while taking ARAKODA. ARAKODA can have other serious side effects. See “

Storing it

Store ARAKODA at room temperature between 68°F to 77°F (20°C to 25°C). Protect tablets from moisture. Keep ARAKODA and all medicines out of the reach of children.