Artesunate

Artesunate is used to treat severe malaria. Artesunate is not FDA approved nor commercially available in the U.S.; however, the Centers for Disease Control (CDC) has taken action to ensure intravenous (IV) artesunate is available through an expanded use investigational new drug (IND) protocol.

Dosage Forms and Strengths

Injection, Lyophilized Powder for Reconstitution

• 110mg/vial
• Not FDA approved nor commercially available in U.S.; however, Centers for Disease Control (CDC) has taken action to ensure intravenous (IV) artesunate is available through an expanded use investigational new drug (IND) protocol
• CDC malaria hotline (770-488-7788): Call to obtain IV artesunate; call 770-488-7100 evenings or weekends and ask for CDC malaria expert

Malaria

• CDC IND protocol: Indicated as first-line treatment for severe malaria
• Consider treating with oral antimalarials while waiting for IV artesunate; when IV artesunate arrives, discontinued oral antimalarials
• Adults: 2.4 mg/kg IV at 0 hour, 12 hours, 24 hours, and 48 hours
• Children 20 kg and over: 2.4 mg/kg IV at 0 hour, 12 hours, 24 hours, and 48 hours
• Children under 20 kg: 3 mg/kg IV at 0 hour, 12 hours, 24 hours, and 48 hours

Follow-on drug therapy

• Administer follow-on drug after IV artesunate regimen completed (e.g., artemether/lumefantrine, atovaquone/proguanil, doxycycline, mefloquine)
• Patients who still cannot tolerate oral medications after completing artesunate treatment may continue artesunate IV once daily (not to exceed total course of 7 days) or switch to IV doxycycline or clindamycin for 7 days

Common side effects of Artesunate include:

• Loss of appetite on days 1-2
• Dizziness on days 1-2
• Nausea on days 1-2
• Diarrhea on days 1-2

Additional Side Effects of Artesunate can include:

• Hives
• Rash
• Hemoglobinuria
• Seizures
• Neuropsychiatric reactions
• Reversible neurologic changes

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Artesunate has no listed severe interactions with other drugs.

Artesunate has no listed serious interactions with other drugs.

Artesunate has no listed moderate interactions with other drugs.

Artesunate has no listed mild interactions with other drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Warnings

This medication contains artesunate. Do not take artesunate if you are allergic to artesunate or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to artemisinins

Effects of Drug Abuse

• No information available.

Short-Term Effects

• See "What Are Side Effects Associated with Using Artesunate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Artesunate?"

Cautions

• Rare, delayed post-artemisinin hemolytic anemia reported; monitor for up to 4 weeks after treatment; patients with higher parasitemias may be more prone to hemolytic anemia

Pregnancy and Lactation

Artesunate may be administered to pregnant women in the second and third trimesters. Data are limited for use of artesunate during the first trimester of pregnancy; no harmful effects have been observed.

Animal studies: Artesunate causes fetal toxicity in rats and rabbits resulting in fetal resorption and abortion. There is a low incidence of cardiac malformations and skeletal defects also observed.