Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
What Is Krintafel?
Krintafel (tafenoquine) is an antimalarial indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.
What Are Side Effects of Krintafel?
Krintafel may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- dizziness,
- pale or yellowed skin,
- dark colored urine,
- darkening of your mouth, lips, or fingernails,
- fast heartbeats,
- shortness of breath,
- headache,
- lightheadedness,
- confusion,
- tiredness,
- anxiety,
- strange dreams, and
- trouble sleeping
Get medical help right away, if you have any of the symptoms listed above.
Common side effects of Krintafel include:
- dizziness,
- nausea,
- vomiting,
- headache, and
- decreased hemoglobin
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Krintafel
The recommended dose of Krintafel in patients aged 16 years and older is a single dose of 300 mg administered as two 150 -mg Krintafel tablets taken together with food. Coadminister Krintafel on the first or second day of the appropriate antimalarial therapy for the acute P. vivax malaria.
What Drugs, Substances, or Supplements Interact with Krintafel?
Krintafel may interact with dofetilide and metformin. Tell your doctor all medications and supplements you use.
Krintafel During Pregnancy and Breastfeeding
Krintafel is not recommended for use during pregnancy. The use of Krintafel during pregnancy may cause hemolytic anemia in a fetus who is G6PD deficient. Females of reproductive potential should have a pregnancy test prior to initiating treatment with Krintafel. It is unknown if Krintafel passes into breast milk. Women are advised not to breastfeed a G6PD-deficient infant or infant with unknown G6PD status for 3 months after the dose of Krintafel. Consult your doctor before breastfeeding.
Additional Information
Our Krintafel (tafenoquine) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
QUESTION
Bowel regularity means a bowel movement every day. See AnswerGet emergency medical help if you have signs of an allergic reaction: hives; dizziness, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- pale or yellowed skin, dark colored urine;
- darkening of your mouth, lips, or fingernails;
- fast heartbeats, shortness of breath;
- a headache, or light-headed feeling (like you might pass out);
- confusion, tiredness; or
- new or worsening mental health problems--anxiety, strange dreams, trouble sleeping.
Common side effects may include:
- nausea, vomiting;
- abnormal hemoglobin tests;
- dizziness; or
- headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SLIDESHOW
Fungal Skin Infections: Types, Symptoms, and Treatments See SlideshowSIDE EFFECTS
The following clinically significant adverse reactions have been observed with KRINTAFEL and are discussed in detail in the Warnings and Precautions section:
- Hemolytic anemia [see WARNINGS AND PRECAUTIONS]
- Methemoglobinemia [see WARNINGS AND PRECAUTIONS]
- Psychiatric effects [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety data described below reflect exposure to 4,129 subjects, of whom 810 received a 300-mg single dose of KRINTAFEL. KRINTAFEL was evaluated in patients with P. vivax malaria (n = 483) in 3 randomized, double-blind trials including a placebo-controlled trial comparing KRINTAFEL plus chloroquine (n = 260) with chloroquine alone (Trial 1), a placebo-controlled dose-ranging trial (Trial 2) (n = 57) [see Clinical Studies], and a hematologic safety trial (Trial 3, NCT02216123) (n = 166).
In Trial 1, in patients with P. vivax malaria, the most common adverse reactions reported in ≥5% of patients treated with KRINTAFEL are listed in Table 1. Patients included in the trial had a mean age of 35 (range: 16 to 79 years), were 75% male and from the following regions: 70% Latin America (Brazil and Peru), 19% Southeast (SE) Asia (Thailand, Cambodia, and the Philippines), and 11% Africa (Ethiopia).
Table 1: Selected Adverse Reactionsa Reported in ≥5% of Patients with P. vivax Malaria Receiving KRINTAFEL in a Randomized, Active-Controlled Trial (Trial 1)
| Adverse Reaction | Chloroquine (n = 133) % |
KRINTAFEL + Chloroquine (n = 260) % |
| Dizziness | 3 | 8 |
| Nausea | 7 | 6 |
| Vomiting | 5 | 6 |
| Decreased Hemoglobin | 2 | 5 |
| Headache | 7 | 5 |
| aAdverse reactions reported prior to Day 29 as subsequent adverse reactions can be confounded by recurrence of malaria or retreatment with another agent from the quinoline class. | ||
Other Adverse Reactions Reported With KRINTAFEL
Clinically significant adverse reactions with KRINTAFEL 300-mg single dose in clinical trials (n = 810) in ≤3% of subjects are listed below:
Psychiatric Disorders: Anxiety, insomnia, abnormal dreams.
Nervous System Disorders: Somnolence.
Laboratory Investigations: Increased blood creatinine, increased blood methemoglobin, increased alanine aminotransferase.
Immune System Disorders: Hypersensitivity reactions (e.g., angioedema, urticaria) [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Eye Disorders: Vortex keratopathy, photophobia.
DRUG INTERACTIONS
Effect Of KRINTAFEL On Organic Cation Transporter-2 (OCT2) And Multidrug And Toxin Extrusion
(MATE) Substrates The effect of coadministration of tafenoquine on the pharmacokinetics of OCT2 and MATE substrates in humans is unknown. However, in vitro observations suggest the potential for increased concentrations of these substrates [see CLINICAL PHARMACOLOGY] which may increase the risk of toxicity of these drugs.
Avoid coadministration of KRINTAFEL with OCT2 and MATE substrates (e.g., dofetilide, metformin). If coadministration cannot be avoided, monitor for drug-related toxicities and consider dosage reduction if needed based on approved product labeling of the coadministered drug.
Read the entire FDA prescribing information for Krintafel (Tafenoquine Tablets)
© Krintafel Patient Information is supplied by Cerner Multum, Inc. and Krintafel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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