Krintafel

Krintafel is a prescription medication used for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

Krintafel belongs to a group of antimalarial drugs called 8-aminoquinoline derivatives. The exact way this medication works to kill the parasite is not fully understood.

Krintafel is given as 2 tablets that you take together as a single dose. Take with food. Swallow Krintafel tablets whole. Do not break, crush, or chew the tablets.

Common side effects include nausea, vomiting and decreased red blood cells. Krintafel can also cause dizziness. Do not drive or operate heavy machinery until you know how Krintafel affects you.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Krintafel. See the “Krintafel Precautions” section.

Common side effects of Krintafel include the following:

• dizziness
• nausea
• vomiting
• decreased hemoglobin
• headache

This is not a complete list of Krintafel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Medications that bind to a specific transporter called the organic cation transporter-2 (OCT2) such as choline, norepinephrine, histamine, dopamine, dofetilide, cimetidine, prazosin, metformin, cisplatin, epinephrine, memantine, pramipexole, reserpine, oxaliplatin, agmatine, lamivudine, nafamostat, choline salicylate, tetraethylammonium, and ranitidine
• Medications that bind to a specific transporter called the multidrug and toxin extrusion (MATE) such as acyclovir, cimetidine, gancyclovir, metformin, procainamide, and topotecan

This is not a complete list of Krintafel drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Krintafel including the following:

• 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.

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

• 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 a dose of Krintafel. Tell your healthcare provider or get emergency help right away if you have any signs or symptoms of an allergic reaction including:

  • swelling of the face, lips, tongue or throat
  • itching
  • difficulty breathing or swallowing
  • fainting, dizziness, feeling lightheaded
  • rash
  • hives

• Other side effects of Krintafel 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.

Krintafel can cause dizziness. Do not drive or operate heavy machinery until you know how Krintafel affects you.

Do not take Krintafel if you:

• are allergic to Krintafel or to any of its ingredients
• have a medical condition known as G6PD deficiency or have unknown G6PD status
• breastfeeding when infant has G6PD deficiency or has unknown G6PD status

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Krintafel, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Krintafel, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Krintafel or to any of its ingredients
• have or have had mental health problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Krintafel is not recommended during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Krintafel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Krintafel is contraindicated in breastfeeding women when the infant has G6PD deficiency or the infant's G6PD status is unknown.

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

• Krintafel is given as 2 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 with food to make sure the right amount of medicine is absorbed into your body.

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

• If you vomit within 1 hour of taking Krintafel, call your healthcare provider as you may need to take a second dose of Krintafel.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Krintafel for the treatment of inactive liver-stage malaria is 300 mg (two 150 mg tablets taken together).

If you take too much Krintafel, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Keep this and all medicines out of the reach of children.