Krintafel

What is Krintafel used for?

Krintafel is a prescription medicine that is used to prevent malaria from coming back.

Description

KRINTAFEL contains tafenoquine succinate, an antimalarial agent for oral administration. The chemical name of tafenoquine succinate is (±) 8-[(4-amino-1-methylbutyl)amino]-2,6-dimethoxy-4‑methyl-5-[3-(trifluoromethyl)phenoxy]quinoline succinate. The molecular formula of tafenoquine succinate is C24H28F3N3O3 •C4H6O4, and its molecular mass is 581.6 as the succinate salt (463.5 as free base). The structural formula is shown below.

Each KRINTAFEL tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate). Inactive ingredients include magnesium stearate, mannitol, and microcrystalline cellulose. The tablet film-coating inactive ingredients include hydroxypropylmethylcellulose, polyethylene glycol, red iron oxide, and titanium dioxide.

Before taking Krintafel, tell your doctor:

• If you are allergic to Krintafel; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have glucose-6-phosphate dehydrogenase (G6PD) deficiency or you have not been tested for it.
• If you have ever had any mental health or behavior problems.
• If you are taking any of these drugs: Dofetilide or metformin.
• If you are pregnant or may be pregnant. Do not take Krintafel if you are pregnant.
• If you are breast-feeding and your child has G6PD deficiency or your child has not been tested for it. Do not breast-feed for 3 months after taking Krintafel if your child has G6PD deficiency or has not been tested for it.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Krintafel with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Krintafel?

• Tell all of your health care providers that you take Krintafel. This includes your doctors, nurses, pharmacists, and dentists.
• People with an enzyme deficiency called G6PD deficiency may have more chance of getting hemolysis. Do not take Krintafel if you have G6PD deficiency. You may need to be screened for G6PD deficiency before taking Krintafel. Talk with your doctor.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Krintafel to show that you are NOT pregnant.
• Women must use birth control while taking Krintafel and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Krintafel best taken?

Use Krintafel as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take Krintafel with food.
• Swallow whole. Do not chew, break, or crush.
• If you throw up within 1 hour of taking Krintafel, call your doctor to find out what to do.

What do I do if I miss a dose?

• Most of the time, 1 dose of Krintafel is needed. If you miss the dose, take it as soon as you think about it with food. If you need to take more than 1 dose of Krintafel, follow what your doctor has told you to do.

What are the side effects of Krintafel that I need to call my doctor about immediately?

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 Krintafel?

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.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Krintafel?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• NDC 0173-0889-39
• Krintafel
• (tafenoquine)
• tablets
• 150 mg
• Rx Only
• Patients must be tested for glucose-6-phosphate dehydrogenase deficiency before taking this medicine.
• 2 tablets to be taken as a single one-time dose
• 2 Tablets
• Each tablet contains 150 mg of tafenoquine (equivalent to 188.2 mg tafenoquine succinate).
• See prescribing information for dosage information.
• Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature].
• Store in original package. Protect from moisture. Do not remove desiccant.
• Do not break or crush the tablets.
• Do not accept if membrane seal under cap is missing or broken.
• Manufactured by:
• GlaxoSmithKline
• Research Triangle Park, NC 27709
• Made in India
• 10000000148541

SRC: NLM .