Artesunate for Injection is an antimalarial indicated for the initial treatment of severe malaria in adult and pediatric patients. Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
What are side effects of Artesunate?
Side effects of Artesunate include:
- acute kidney (renal) failure requiring dialysis,
- hemoglobin in urine (hemoglobinuria), and
- yellowing skin and eyes (jaundice)
DESCRIPTION
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.
INDICATIONS
Artesunate for Injection is indicated for the initial treatment of severe malaria in adult and pediatric patients.
Treatment of severe malaria with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen [see DOSAGE AND ADMINISTRATION].
Limitations Of Use
Artesunate for Injection does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to Plasmodiumvivax or Plasmodium ovale. Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary for the treatment of severe malaria due to
P. vivax or P. ovale [see DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATION
Recommended Dosage And Administration In Adult And Pediatric Patients
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 Preparation Of Artesunate For Injection For Intravenous 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.
Preparation Of Artesunate For Injection For Intravenous Administration
Constitution
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.
Storage Of The Constituted Solution
Administer the constituted solution within 1.5 hours of constitution with the supplied diluent