FDA approves Krintafel to treat malaria

The United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine), an antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria.

What is Krintafel?

Krintafel is a prescription medicine used to treat malaria caused by a parasite called Plasmodium vivax in patients aged 16 years and older who are also receiving a medicine to treat acute Plasmodium vivax malaria such as chloroquine.

Malaria is a serious disease of the blood that is spread by infected mosquitos. Krintafel does not work for all types of malaria.

It is not known if this medicine is safe and effective in children younger than 16 years.

Do not use Krintafel if you:

have a blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency (sometimes known as favism) or you have not been tested for G6PD deficiency. Krintafel can cause a breakdown of red blood cells (hemolysis) in people with G6PD deficiency. Your healthcare provider will test you for G6PD deficiency before you start treatment.

are breastfeeding a child known to have G6PD deficiency or breastfeeding a child that has not been tested for G6PD deficiency.

are allergic to tafenoquine or any of the other ingredients, or if you have had an allergic reaction to similar medicines containing 8-aminoquinolines. See the end of this page for a complete list of ingredients.

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

have or have had mental health problems.

are pregnant or plan to become pregnant. Krintafel can harm an unborn baby who has G6PD deficiency.

are breastfeeding or plan to breastfeed. It is not known if this medicine passes into breast milk.

Your healthcare provider should check your child for G6PD deficiency before you start breastfeeding.

If you know your child has G6PD deficiency, do not breastfeed while taking Krintafel and for 3 months after your last dose.

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

Your healthcare provider will test you for G6PD deficiency before you start taking treatment.

Krintafel is given as two tablets that you take together as a single dose.

You will take Krintafel on the first or second day of your treatment with the antimalarial medicine you have been prescribed.

Take Krintafel tablets with food to make sure the right amount of medicine is absorbed into your body.

Swallow the tablets whole. Do not break, crush, or chew the tablets.

If you vomit within one hour of taking Krintafel, call your healthcare provider as you may need to take a second dose.

Krintafel side effects

Krintafel can cause serious side effects, including:

Breakdown of red blood cells (hemolytic anemia). Contact your healthcare provider if you develop signs of hemolytic anemia, which include darkening of the lips or urine, dizziness, confusion, feeling tired, light-headedness, or shortness of breath.

Hemolytic anemia in an unborn baby who has G6PD deficiency.

Females who are able to become pregnant should avoid pregnancy or use effective birth control (contraception) for 3 months after the dose of Krintafel. Talk with your healthcare provider about birth control methods that might be right for you.

Your healthcare provider will do a pregnancy test before you take Krintafel. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment.

Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). Get medical help right away if you have darkening of the urine, nail beds, lips, or the inside of your mouth.

Allergic (hypersensitivity) reactions. Serious allergic reactions can happen after you take Krintafel. Allergic reactions can sometimes happen hours or days after you take the dose. Tell your healthcare provider or get emergency help right away if you have any signs or symptoms of an allergic reaction including:

swelling of your face, lips, tongue, or throat

itching

trouble breathing

fainting, dizziness, feeling lightheaded

rash

hives

Other side effects include mental health (psychiatric) symptoms. Krintafel can cause new psychiatric symptoms including anxiety, abnormal dreams, and trouble sleeping (insomnia), or make the symptoms you already have worse. Contact your healthcare provider right away if you have new or worsening psychiatric symptoms.

The most common side effects include: dizziness, nausea, vomiting, headache, and changes in laboratory tests for hemoglobin.

These are not all the possible side effects. Call your doctor for medical advice about side effects.

Keep all medicines out of the reach of children and pets.

Active Ingredient: tafenoquine.

Inactive Ingredients: magnesium stearate, mannitol, and microcrystalline cellulose.

 

FDA approves Krintafel to treat malaria

The United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine), an antimalarial for the radical cure (prevention of relapse) of Plasmodium vivax malaria. What is Krintafel? Krintafel is a prescription medicine used to treat malaria caused by a parasite called Plasmodium vivax in patients aged 16 years and older who are also receiving a medicine to treat acute Plasmodium vivax malaria such as chloroquine. Malaria is a serious disease of the blood that is spread by infected mosquitos. Krintafel does not work for all types of malaria. It is not known if this medicine is safe and effective in children younger than 16 years. Do not use Krintafel if you: have a blood problem called glucose-6-phosphate dehydrogenase (G6PD) deficiency (sometimes known as favism) or you have not been tested for G6PD deficiency. Krintafel can cause a breakdown of red blood cells (hemolysis) in people with G6PD deficiency. Your healthcare provider will test you for G6PD deficiency before you start treatment. are breastfeeding a child known to have G6PD deficiency or breastfeeding a child that has not been tested for G6PD deficiency. are allergic to tafenoquine or any of the other ingredients, or if you have had an allergic reaction to similar medicines containing 8-aminoquinolines. See the end of this page for a complete list of ingredients. Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you: have or have had mental health problems. are pregnant or plan to become pregnant. Krintafel can harm an unborn baby who has G6PD deficiency. are breastfeeding or plan to breastfeed. It is not known if this medicine passes into breast milk. Your healthcare provider should check your child for G6PD deficiency before you start breastfeeding. If you know your child has G6PD deficiency, do not breastfeed while taking Krintafel and for 3 months after your last dose. Tell your healthcare provider about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements. Krintafel and other medicines may affect each other causing side effects. Your healthcare provider will test you for G6PD deficiency before you start taking treatment. Krintafel is given as two tablets that you take together as a single dose. You will take Krintafel on the first or second day of your treatment with the antimalarial medicine you have been prescribed. Take Krintafel tablets with food to make sure the right amount of medicine is absorbed into your body. Swallow the tablets whole. Do not break, crush, or chew the tablets. If you vomit within one hour of taking Krintafel, call your healthcare provider as you may need to take a second dose. Krintafel side effects Krintafel can cause serious side effects, including: Breakdown of red blood cells (hemolytic anemia). Contact your healthcare provider if you develop signs of hemolytic anemia, which include darkening of the lips or urine, dizziness, confusion, feeling tired, light-headedness, or shortness of breath. Hemolytic anemia in an unborn baby who has G6PD deficiency. Females who are able to become pregnant should avoid pregnancy or use effective birth control (contraception) for 3 months after the dose of Krintafel. Talk with your healthcare provider about birth control methods that might be right for you. Your healthcare provider will do a pregnancy test before you take Krintafel. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment. Decrease of oxygen in your blood caused by a certain type of abnormal red blood cell (methemoglobinemia). Get medical help right away if you have darkening of the urine, nail beds, lips, or the inside of your mouth. Allergic (hypersensitivity) reactions. Serious allergic reactions can happen after you take Krintafel. Allergic reactions can sometimes happen hours or days after you take the dose. Tell your healthcare provider or get emergency help right away if you have any signs or symptoms of an allergic reaction including: swelling of your face, lips, tongue, or throat itching trouble breathing fainting, dizziness, feeling lightheaded rash hives Other side effects include mental health (psychiatric) symptoms. Krintafel can cause new psychiatric symptoms including anxiety, abnormal dreams, and trouble sleeping (insomnia), or make the symptoms you already have worse. Contact your healthcare provider right away if you have new or worsening psychiatric symptoms. The most common side effects include: dizziness, nausea, vomiting, headache, and changes in laboratory tests for hemoglobin. These are not all the possible side effects. Call your doctor for medical advice about side effects. Keep all medicines out of the reach of children and pets. Active Ingredient: tafenoquine. Inactive Ingredients: magnesium stearate, mannitol, and microcrystalline cellulose.