Tafenoquine Succinate (2 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- ARAKODA
- KRINTAFEL
Indications and Usage
KRINTAFEL is indicated for the radical cure (prevention of relapse) of Plasmodium vivax malaria in patients aged 16 years and older who are receiving chloroquine therapy for acute P. vivax infection [see Dosage and Administration (2.2)]. Limitations of Use •KRINTAFEL is NOT indicated for the treatment of acute P. vivax malaria. •Concomitant use of KRINTAFEL with antimalarials other than chloroquine is not recommended because of the risk of recurrence of P. vivax malaria [see Warnings and Precautions (5.6)].
Contraindications
KRINTAFEL is contraindicated in: •Patients with G6PD deficiency or unknown G6PD status due to the risk of hemolytic anemia [see Warnings and Precautions (5.1)]. •Breastfeeding by a lactating woman when the infant is found to be G6PD deficient or if the G6PD status of the infant is unknown [see Use in Specific Populations (8.2)]. •Patients with known hypersensitivity to tafenoquine, other 8-aminoquinolines, or any component of KRINTAFEL [see Warnings and Precautions (5.5)].
Adverse Reactions
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 (5.1)] •Methemoglobinemia [see Warnings and Precautions (5.3)] •Psychiatric effects [see Warnings and Precautions (5.4)] •Hypersensitivity reactions [see Warnings and Precautions (5.5)]
Mechanism of Action
Tafenoquine is an 8-aminoquinoline antimalarial drug [see Microbiology (12.4)].
Overdosage
Hemoglobin decline and methemoglobinemia may be encountered in an overdose with KRINTAFEL. Treatment of overdosage consists of institution of appropriate symptomatic and/or supportive therapy.