Artesunate injection

The recommended dosage of Artesunate for Injection is 2.4 mg/kg administered intravenously at 0 hours, 12 hours, and 24 hours, and thereafter administered once daily until the patient is able to tolerate oral antimalarial therapy.

The safety and effectiveness of Artesunate for Injection for the treatment of severe malaria have been established in pediatric patients. Use of Artesunate for Injection for this indication is supported by evidence from adequate and well-controlled studies in adults and pediatric patients with additional pharmacokinetic and safety data in pediatric patients aged 6 months and older. For pediatric patients younger than 6 months of age, a pharmacokinetic (PK) extrapolation approach using modeling and simulation indicated comparable or higher predicted P K steady-state AUC of DHA between this age group and older children or adults at the recommended 2.4 mg/kg dose regimen of Artesunate for Injection. No notable safety issues were identified in limited published safety and outcome data for Artesunate for Injection in pediatric patients younger than 6 months of age with severe malaria. No dose adjustment is necessary for pediatric patients regardless of age or bodyweight.

Artesunate for Injection 110 mg contains artesunate, a semi-synthetic artemisinin derivative, that is intended for intravenous administration. Artesunate is an antimalarial drug. The structural formula is:

Artesunate is a white or almost white powder with a molecular weight of 384.43. The chemical name is butanedioic acid, mono[(3R,5aS,6R,8aS,9R,10S,12R,12aR)-decahydro-3,6,9-trimethyl-3,12-epoxy-12Hpyrano[4,3-j]-1,2-benzodioxepin-10-yl] ester.

The empirical formula is C19H28O8.

Artesunate for Injection is supplied as white or almost white sterile powder for constitution. Each 20 mL glass single-dose vial contains 110 mg of artesunate for constitution with 11 mL of the supplied sterile diluent. The constituted solution should be a colorless solution.

Each single-dose vial of the supplied sterile diluent contains 12 mL of a sterile diluent. Each 11 mL of the sterile diluent that is used for constitution contains 24.1 mg sodium phosphate monobasic monohydrate and 443.6 mg sodium phosphate dibasic anhydrous in water for injection. Sodium hydroxide and phosphoric acid are used to adjust the pH to 7.9-8.1.

The pH specification for the constituted solution is 7.2-7.7 and the measured osmolality is 305-317 mOsm/kg.

The recommended dosage of Artesunate for Injection is 2.4 mg/kg administered intravenously at 0 hours, 12 hours, and 24 hours, and thereafter, administered once daily until the patient is able to tolerate oral antimalarial therapy.

Administer constituted Artesunate for Injection intravenously as a slow bolus over 1 minute to 2 minutes [see DOSAGE AND ADMINISTRATION]. Do NOT administer Artesunate for Injection via continuous intravenous infusion.

Administer Artesunate for Injection with an antimalarial agent that is 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.

Artesunate for Injection must be constituted with the supplied diluent prior to administration. A diluent consisting of 12 mL of sterile 0.3 M pH 8.0 sodium phosphate buffer is provided with Artesunate for Injection. To constitute Artesunate for Injection, withdraw 11 mL of this diluent with a needle and syringe and inject into the artesunate vial (when constituted the final concentration of artesunate is 10 mg/mL). Swirl gently (do not shake) for up to 5 to 6 minutes until the powder is fully dissolved and no visible particles remain.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Artesunate for Injection if particulate matter and/or discoloration is observed.

After constitution, inject the constituted solution intravenously (through an established intravenous line or needle) as a slow bolus over 1 to 2 minutes. Discard the vial and any unused portion of the drug product after use.

Administer the constituted solution within 1.5 hours of constitution with the supplied diluent.

For Injection: 110 mg of artesunate as a sterile white or almost white, fine crystalline powder in a clear glass single-dose vial for constitution.

Artesunate for Injection is supplied as follows:

Artesunate for Injection single-dose vial: NDC 73607-002-01
Sterile Diluent for Constitution single-dose vial: NDC 73607-003-02
Packages of 4 total vials (2 vials of Artesunate for Injection, 110 mg and 2 vials sterile diluent for Artesunate for Injection): NDC 73607-011-11

Store vials of Artesunate for Injection and sterile diluent in the carton at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Do not freeze. Avoid exposure to heat. Keep protected from light. Do not use beyond the expiration date.

Artesunate injection dosage & administration
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Artesunate (Intravenous Route)
https://www.mayoclinic.org/drugs-supplements/artesunate-intravenous-route/side-effects/drg-20489625?p=1#:~: