Arakoda 100mg Tablets
It is used to prevent malaria.
Drug Class
Antimalarial
Pharmacologic Class
8-aminoquinoline
Pregnancy Category
Not available
FDA Approved
Jul 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Arakoda is a medication used to prevent malaria, a serious disease spread by mosquitoes. It works by killing the malaria parasites in your body, including those that can cause relapses. It's important to take this medication exactly as prescribed, especially with food, and to complete the full course.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Swallow the tablet whole - do not chew, break, or crush it.
If you are taking this medication to prevent malaria, start taking it before you travel to a high-risk area, as directed by your doctor. It is crucial that you do not miss or skip any doses during your treatment.
Storing and Disposing of Your Medication
Keep your medication in its original container at room temperature.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert for guidance or contact your doctor or pharmacist for advice on what to do next.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with food to help your body absorb it properly. Swallow the tablet whole - do not chew, break, or crush it.
If you are taking this medication to prevent malaria, start taking it before you travel to a high-risk area, as directed by your doctor. It is crucial that you do not miss or skip any doses during your treatment.
Storing and Disposing of Your Medication
Keep your medication in its original container at room temperature.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert for guidance or contact your doctor or pharmacist for advice on what to do next.
Lifestyle & Tips
- Always take Arakoda with food to help your body absorb the medication better.
- Take the tablets at the same time each day (for the loading dose) or week (for the maintenance dose) to maintain consistent levels in your body.
- Continue to use other malaria prevention measures, such as insect repellent, mosquito nets, and protective clothing, even while taking Arakoda.
- Complete the full course of medication, including the 3 weeks after leaving the malaria-endemic area, to ensure full protection and prevent relapses.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Loading: 200 mg once daily for 3 days. Maintenance: 100 mg once weekly, starting 7 days after the last loading dose. Continue for 3 weeks after leaving malaria-endemic area.
Dose Range:
100 - 200 mg
Condition-Specific Dosing:
malaria_prophylaxis_loading:
200 mg (two 100 mg tablets) once daily for 3 days.
malaria_prophylaxis_maintenance:
100 mg (one 100 mg tablet) once weekly, starting 7 days after the last loading dose. Continue for 3 weeks after leaving malaria-endemic area.
Pediatric Dosing
Neonatal:
Not established (Approved for 18 years and older)
Infant:
Not established (Approved for 18 years and older)
Child:
Not established (Approved for 18 years and older)
Adolescent:
Dosing as per adult for individuals 18 years and older.
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
Not available (Limited data, use with caution).
Dialysis:
Not available (Limited data, use with caution).
Hepatic Impairment:
Mild:
No dose adjustment recommended.
Moderate:
No dose adjustment recommended.
Severe:
Not available (Limited data, use with caution).
Pharmacology
Mechanism of Action
Tafenoquine is an 8-aminoquinoline antimalarial. Its exact mechanism of action is not fully elucidated but is thought to involve the formation of reactive oxygen species, interference with parasite mitochondrial function, and inhibition of hemozoin formation. It is active against the pre-erythrocytic (liver) and erythrocytic (blood) stages of Plasmodium falciparum and Plasmodium vivax, and also against the hypnozoites of P. vivax, preventing relapses.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly quantified, but well absorbed.
Tmax:
10-15 hours
FoodEffect:
Increased absorption (approximately 40-50%) when taken with food. Must be taken with food.
Distribution:
Vd:
Approximately 1600 L (suggests extensive tissue distribution)
ProteinBinding:
>99.5%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 15 days
Clearance:
Not explicitly quantified, but slow due to long half-life.
ExcretionRoute:
Primarily fecal (approximately 90%), with a small amount (less than 1%) excreted renally.
Unchanged:
Less than 1% (renal)
Pharmacodynamics
OnsetOfAction:
Not directly applicable for prophylactic use; therapeutic levels are achieved over the loading period.
PeakEffect:
Not directly applicable for prophylactic use; steady-state levels are maintained with weekly dosing.
DurationOfAction:
Due to its long half-life, tafenoquine provides prolonged prophylactic coverage.
Safety & Warnings
BLACK BOX WARNING
Risk of Hemolytic Anemia in Patients with G6PD Deficiency. Tafenoquine can cause hemolytic anemia in patients with G6PD deficiency. G6PD deficiency testing must be performed prior to prescribing Arakoda. Arakoda is contraindicated in patients with G6PD deficiency or unknown G6PD status.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of hemolytic anemia, including:
+ Dark urine or lips
+ Dizziness or fainting
+ Confusion
+ Feeling extremely tired or weak
+ Pale skin
+ Shortness of breath
+ Yellow skin or eyes
Signs of methemoglobinemia, which may include:
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling tired or weak
+ Shortness of breath
New or worsening mental, mood, or behavioral changes
Strange or unusual dreams
Difficulty sleeping
Hallucinations (seeing or hearing things that are not there)
Confusion
Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Upset stomach or vomiting
Dizziness or headache
Back pain
Diarrhea
Motion sickness
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of hemolytic anemia, including:
+ Dark urine or lips
+ Dizziness or fainting
+ Confusion
+ Feeling extremely tired or weak
+ Pale skin
+ Shortness of breath
+ Yellow skin or eyes
Signs of methemoglobinemia, which may include:
+ Blue or gray discoloration of the lips, nails, or skin
+ Abnormal heartbeat
+ Seizures
+ Severe dizziness or fainting
+ Severe headache
+ Excessive sleepiness
+ Feeling tired or weak
+ Shortness of breath
New or worsening mental, mood, or behavioral changes
Strange or unusual dreams
Difficulty sleeping
Hallucinations (seeing or hearing things that are not there)
Confusion
Severe dizziness or fainting
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Upset stomach or vomiting
Dizziness or headache
Back pain
Diarrhea
Motion sickness
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Dark or reddish-brown urine (a sign of hemolytic anemia)
- Pale skin or yellowing of the skin/eyes (jaundice)
- Unusual tiredness, weakness, or shortness of breath (signs of anemia)
- Bluish discoloration of lips, fingernails, or skin (cyanosis, a sign of methemoglobinemia)
- Severe headache, dizziness, or confusion
- Nausea, vomiting, or abdominal pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency or if you have not undergone testing for this condition.
Any history of mental health or behavioral issues.
If you are currently taking dofetilide, metformin, or any medications for the prevention or treatment of malaria.
If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
If you are breastfeeding, particularly if your child has G6PD deficiency or has not been tested for it. You should not breastfeed for 3 months after taking this medication if your child has G6PD deficiency or has not been tested for it.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have been diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency or if you have not undergone testing for this condition.
Any history of mental health or behavioral issues.
If you are currently taking dofetilide, metformin, or any medications for the prevention or treatment of malaria.
If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
If you are breastfeeding, particularly if your child has G6PD deficiency or has not been tested for it. You should not breastfeed for 3 months after taking this medication if your child has G6PD deficiency or has not been tested for it.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
If you have a genetic condition called G6PD deficiency, you may be at a higher risk of experiencing hemolysis, a condition where red blood cells break down. This deficiency is more common in people of African, South Asian, Middle Eastern, and Mediterranean descent. You should not take this medication if you have G6PD deficiency. Before starting this medication, your doctor may recommend screening for G6PD deficiency. If you have any questions or concerns, discuss them with your doctor.
To minimize the risk of malaria, it is crucial to use this medication in combination with other preventive measures, including:
- Using window screens and bed netting
- Applying insect repellent containing 10% to 35% DEET
- Spraying permethrin on clothing and nets
However, avoid spraying insect repellents on children. Additionally, try to reduce your outdoor activities during evening and nighttime hours when mosquitoes are most active.
If you develop a fever while in or after leaving a malaria-endemic area, contact your doctor immediately.
This medication may harm an unborn baby. To ensure your safety, a pregnancy test will be performed before you start taking this medication to confirm that you are not pregnant. If you may become pregnant, you must use effective birth control while taking this medication and for a certain period after the last dose. Your doctor will advise you on how long to continue using birth control. If you become pregnant, notify your doctor right away.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
If you have a genetic condition called G6PD deficiency, you may be at a higher risk of experiencing hemolysis, a condition where red blood cells break down. This deficiency is more common in people of African, South Asian, Middle Eastern, and Mediterranean descent. You should not take this medication if you have G6PD deficiency. Before starting this medication, your doctor may recommend screening for G6PD deficiency. If you have any questions or concerns, discuss them with your doctor.
To minimize the risk of malaria, it is crucial to use this medication in combination with other preventive measures, including:
- Using window screens and bed netting
- Applying insect repellent containing 10% to 35% DEET
- Spraying permethrin on clothing and nets
However, avoid spraying insect repellents on children. Additionally, try to reduce your outdoor activities during evening and nighttime hours when mosquitoes are most active.
If you develop a fever while in or after leaving a malaria-endemic area, contact your doctor immediately.
This medication may harm an unborn baby. To ensure your safety, a pregnancy test will be performed before you start taking this medication to confirm that you are not pregnant. If you may become pregnant, you must use effective birth control while taking this medication and for a certain period after the last dose. Your doctor will advise you on how long to continue using birth control. If you become pregnant, notify your doctor right away.
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe hemolytic anemia
- Methemoglobinemia
- Gastrointestinal disturbances (nausea, vomiting, abdominal pain)
What to Do:
Seek immediate medical attention. Treatment is supportive and symptomatic. Contact a poison control center (e.g., 1-800-222-1222) for specific guidance.
Drug Interactions
Contraindicated Interactions
- Drugs that are known to cause methemoglobinemia (e.g., dapsone, primaquine, sulfonamides, nitrofurantoin) in patients with G6PD deficiency or unknown G6PD status, due to increased risk of hemolytic anemia or methemoglobinemia.
Moderate Interactions
- Strong inhibitors of OATP1B1/1B3 (e.g., rifampin, cyclosporine): May increase tafenoquine plasma concentrations, but clinical significance is unknown. Monitor for adverse effects.
Confidence Interactions
Monitoring
Baseline Monitoring
Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency testing
Rationale: Tafenoquine can cause hemolytic anemia in individuals with G6PD deficiency. Testing is mandatory before prescribing.
Timing: Prior to initiation of tafenoquine.
Pregnancy test (for females of reproductive potential)
Rationale: Tafenoquine is contraindicated in pregnant women with G6PD deficiency or unknown G6PD status.
Timing: Prior to initiation of tafenoquine.
Routine Monitoring
Symptoms of hemolytic anemia (e.g., dark urine, pallor, fatigue, shortness of breath, jaundice)
Frequency: Daily during treatment and for several weeks after the last dose.
Target: Absence of symptoms
Action Threshold: If symptoms occur, discontinue tafenoquine and seek immediate medical attention. Perform complete blood count (CBC) and G6PD testing if not already done.
Symptoms of methemoglobinemia (e.g., cyanosis, headache, dizziness, shortness of breath, fatigue)
Frequency: Daily during treatment and for several weeks after the last dose.
Target: Absence of symptoms
Action Threshold: If symptoms occur, discontinue tafenoquine and seek immediate medical attention. Measure methemoglobin levels.
Symptom Monitoring
- Dark or reddish-brown urine
- Pale skin
- Unusual tiredness or weakness
- Shortness of breath
- Yellowing of skin or eyes (jaundice)
- Bluish discoloration of lips, fingernails, or skin (cyanosis)
- Headache
- Dizziness
- Nausea
- Abdominal pain
Special Patient Groups
Pregnancy
ARAKODA is contraindicated in pregnant women with G6PD deficiency or unknown G6PD status of the mother or fetus due to the risk of hemolytic anemia in the fetus. If G6PD status is normal, use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Risk of hemolytic anemia in G6PD deficient fetus. Limited human data on major birth defects or miscarriage.
Second Trimester:
Risk of hemolytic anemia in G6PD deficient fetus.
Third Trimester:
Risk of hemolytic anemia in G6PD deficient fetus/neonate, especially if exposure occurs near term.
Lactation
ARAKODA is contraindicated in breastfeeding women if the infant is G6PD deficient or if the G6PD status of the infant is unknown, due to the risk of hemolytic anemia in the infant. If the infant's G6PD status is normal, monitor the infant for signs of hemolytic anemia (e.g., jaundice, dark urine).
Infant Risk:
High risk (L5) if infant is G6PD deficient or status is unknown; otherwise, moderate risk (L3) with monitoring.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients less than 18 years of age. Tafenoquine is approved for use in individuals 18 years of age and older for malaria prophylaxis.
Geriatric Use
No specific dose adjustment is recommended based on age. However, elderly patients may have reduced renal or hepatic function, which should be considered. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- **Mandatory G6PD Testing:** Always confirm G6PD status (quantitative test preferred) before prescribing tafenoquine. This is the most critical step to prevent severe hemolytic anemia.
- **Take with Food:** Tafenoquine must be taken with food to ensure adequate absorption.
- **Long Half-Life:** The long half-life (15 days) allows for weekly dosing after the initial loading phase and provides prolonged protection after cessation.
- **Complete the Course:** Patients must complete the full 3-week post-travel course to prevent relapses of *P. vivax*.
- **Not for Acute Treatment:** Tafenoquine is for prophylaxis only and is not indicated for the acute treatment of malaria.
- **Monitor for Hemolysis/Methemoglobinemia:** Educate patients on symptoms of hemolytic anemia (dark urine, pallor, fatigue) and methemoglobinemia (cyanosis, shortness of breath) and advise immediate medical attention if they occur.
Alternative Therapies
- Atovaquone/Proguanil (Malarone)
- Doxycycline
- Mefloquine (Lariam)
- Chloroquine (for sensitive areas)
Cost & Coverage
Average Cost:
Varies, typically $2000-$3000+ per 30 tablets
Insurance Coverage:
Tier 3 or Non-preferred Brand
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the overdose, be prepared to provide details about the medication taken, the quantity, and the time it occurred.