Artesunate for Injection is now available for the initial treatment of severe malaria in adult and pediatric patients.
Artesunate and its metabolite dihydroartemisinin (DHA) are both active against the blood-stage asexual parasites and gametocytes of Plasmodium species including the chloroquine resistant strains. Treatment with Artesunate for Injection should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Prior to FDA approval, access to investigational artesunate had been managed by the Centers for Disease Control and Prevention (CDC) through an expanded access investigational new drug program. “Amivas is excited to now manufacture, distribute, and commercialize Artesunate for Injection on an exclusive basis through a network of select distributors across the US,” said Amivas (US), LLC Chief Executive Officer, David Bradshaw. “This is an entirely new system designed to save lives by ensuring that patients who need Artesunate for Injection have rapid access to it at any time of day or night, every day of the year.”
Artesunate for Injection is supplied in single-dose vials containing 110mg of artesunate as a powder for reconstitution with the supplied sterile diluent. The product can be ordered via Cardinal Health 3PL Services (GMB-SPS-Amivas@cordlogistics.com);
Cardinal Health Specialty Pharmaceutical Distribution (1-866-677-4844); AmerisourceBergen Wholesale Distribution (1-844-222-2273); AmerisourceBergen Specialty Distribution (1-800-746-6273); McKesson Plasma & Biologics (1-877-625-2566); and McKesson Specialty Health (1-800 482-6700). Healthcare professionals who are unable to secure an emergency shipment within 24 hours from these distribution channels can also contact the CDC.
Artesunate for Injection is not active against the hypnozoite liver stage forms of P. vivax and P. ovale. Concomitant therapy with an antimalarial agent such as an 8-aminoquinoline drug is necessary to treat severe malaria due to P. vivax or P. ovale.
- Amivas (US), LLC announces U.S. launch of Artesunate for Injection for initial treatment of severe malaria. [press release]. Wilmington, DE: Amivas LLC; March 30, 2021.
2. Artesunate for Injection [prescribing information]. Wilmington, DE; Amivas LLC. 2020.
This article originally appeared on MPR