No.21. Artesunate -(ARTESUNATE )- (May 2020)

PATIENT COUNSELING INFORMATION-                                                                        Additional Antimalarial Treatment-                                                                                   Advise patients of the need to complete appropriate oral antimalarial therapy after treatment with Artesunate for Injection 

. Advise patients of the need to take an additional antimalarial agent such as an 8-aminoquinoline drug during or after treatment with Artesunate for Injection for P. vivax/P. ovale malaria to prevent relapse

 Post-treatment Hemolysis -                                                                                                   Advise patients of the need for regular blood tests for the 4-week period following completion of Artesunate for Injection to monitor for post-treatment delayed hemolysis

 Hypersensitivity Reactions and Anaphylaxis -                                                                   Inform patients that hypersensitivity reactions, including anaphylaxis, have occurred with administration of Artesunate for Injection.

Inform patients of the signs and symptoms of hypersensitivity reactions and anaphylaxis and instruct patients to seek immediate medical care if they experience such symptoms during or following administration of Artesunate for Injection

Embryo-Fetal Toxicity in Animals-                                                                                            Advise pregnant patients and patients who could be pregnant of the potential drug-related embryo-fetal toxicity based on animal studies and the serious risks to mother and fetus of delaying treatment for severe malaria.

Instruct patients to inform their healthcare provider of a known or suspected pregnancy

Advise women who are exposed to Artesunate for Injection during pregnancy that there is a pregnancy safety study that monitors pregnancy outcomes.

Encourage these patients to report their pregnancy to Amivas LLC at 1-855-526-4827 (1-855-5AMIVAS) or www.amivas.com/our-products

Manufactured for Amivas LLC 1209 Orange St Wilmington Delaware 19801 USA 20190530