Usual Adult Dose for Malaria

2.4 mg/kg IV at 0, 12, and 24 hours, then once a day until patient able to tolerate oral antimalarial therapy

Comments:

• Treatment of severe malaria with this drug should always be followed by a complete course of an appropriate oral antimalarial regimen.
• This drug should be administered with an antimalarial agent active against the hypnozoite liver stage forms of Plasmodium (such as an 8-aminoquinoline drug) to patients with severe malaria due to Plasmodium vivax or P ovale.

• Continuation of IV therapy (if needed): 2.4 mg/kg IV once a day for up to 6 more days

• Recommended for severe malaria, regardless of infecting species; drug susceptibility not relevant for acute treatment of severe malaria.
• If P vivax or P ovale infections, in addition to this acute treatment, antirelapse treatment required.
• Reassessment and follow-on therapy:
• Parasite density should be reassessed at least 4 hours after the third dose.
• If parasite density 1% or less and patient able to tolerate oral therapy, a complete follow-on oral regimen should be given.
• If parasite density 1% or less and patient unable to tolerate oral therapy, IV therapy should continue for up to 6 more days until patient able to take oral therapy.
• If parasite density exceeds 1%, IV therapy should continue for up to 6 more days until parasite density 1% or less; when parasite density 1% or less, a complete follow-on oral regimen should be given.
• Parasite density should be repeated every 12 to 24 hours until negative.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Malaria

2.4 mg/kg IV at 0, 12, and 24 hours, then once a day until patient able to tolerate oral antimalarial therapy

Comments:

• Treatment of severe malaria with this drug should always be followed by a complete course of an appropriate oral antimalarial regimen.
• This drug should be administered with an antimalarial agent active against the hypnozoite liver stage forms of Plasmodium (such as an 8-aminoquinoline drug) to patients with severe malaria due to P vivax or P ovale.

• Continuation of IV therapy (if needed): 2.4 mg/kg IV once a day for up to 6 more days

• Recommended for severe malaria, regardless of infecting species; drug susceptibility not relevant for acute treatment of severe malaria.
• If P vivax or P ovale infections, in addition to this acute treatment, antirelapse treatment required.
• Reassessment and follow-on therapy:
• Parasite density should be reassessed at least 4 hours after the third dose.
• If parasite density 1% or less and patient able to tolerate oral therapy, a complete follow-on oral regimen should be given.
• If parasite density 1% or less and patient unable to tolerate oral therapy, IV therapy should continue for up to 6 more days until patient able to take oral therapy.
• If parasite density exceeds 1%, IV therapy should continue for up to 6 more days until parasite density 1% or less; when parasite density 1% or less, a complete follow-on oral regimen should be given.
• Parasite density should be repeated every 12 to 24 hours until negative.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended.

Precautions

CONTRAINDICATIONS:
Known serious hypersensitivity to the active component (e.g., anaphylaxis)

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Administer constituted drug IV (through an established IV line or needle) as a slow bolus over 1 to 2 minutes; do not administer via continuous IV infusion.
• Administer this drug with an antimalarial agent active against the hypnozoite liver stage forms of Plasmodium (such as an 8-aminoquinoline drug) to patients with severe malaria due to P vivax or P ovale.
• Always follow this drug with a complete treatment course of an appropriate oral antimalarial regimen.

• Vials and sterile diluent: Store in the carton at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Do not freeze; avoid exposure to heat; protect from light. Do not use beyond the expiration date.
• Constituted solution: Administer within 1.5 hours of constitution with the supplied diluent.

• This drug must be constituted with the supplied diluent before administration.
• The manufacturer product information should be consulted.

• Limitations of Use: This drug does not treat the hypnozoite liver stage forms of Plasmodium; it will not prevent relapses of malaria due to P vivax or P ovale. Coadministration with an antimalarial agent such as an 8-aminoquinoline drug is required for treatment of severe malaria due to P vivax or P ovale.

• Hematologic: For evidence of hemolytic anemia (for 4 weeks after therapy); a direct antiglobulin test

• You must complete appropriate oral antimalarial therapy after treatment with this drug; you must take an additional antimalarial agent (e.g., an 8-aminoquinoline drug) during or after treatment with this drug for P vivax/P ovale malaria to prevent relapse.
• You need regular blood tests for 4 weeks after completing this drug to monitor for posttreatment delayed hemolysis.
• Seek immediate medical care if signs/symptoms of hypersensitivity reactions or anaphylaxis occur during or after administration of this drug.
• Inform healthcare provider of a known/suspected pregnancy; if exposed to this drug during pregnancy, report your pregnancy to the safety study that monitors pregnancy outcomes.