Artesunate
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment No specific PK studies have been carried out in patients with renal impairment. Most patients with severe malaria present with some degree of related renal impairment. No specific dosage adjustments are needed for patients with renal impairment.
Dosing in liver impairment
Hepatic Impairment No specific PK studies have been carried out in patients with hepatic impairment. Most patients with severe malaria present with some degree of related hepatic impairment. No specific dose adjustments are needed for patients with hepatic impairment.
Preparation and administration
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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 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 .
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
Drug interactions
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- Artesunate
Label text (3 paragraphs)
Nevirapine or ritonavir antiretrovirals If used concomitantly, monitor for possible reduced antimalarial efficacy. ( 7 , 12.3 ) Strong UGT inducers (e.g., rifampin, carbamazepine, phenytoin)
7.1 Effect of Other Drugs on Artesunate and Dihydroartemisinin (DHA) Ritonavir, Nevirapine or Strong UDP-Glucuronosyltransferase (UGT) Inducers : Published clinical reports or in vitro reports indicate that concomitant use of Artesunate for Injection with oral ritonavir, nevirapine, or UGT inducers may decrease dihydroartemisinin (DHA) AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may reduce the efficacy of Artesunate for Injection. If Artesunate for Injection is co-administered with ritonavir, nevirapine or strong UGT inducers (e.g., rifampin, carbamazepine, phenytoin), monitor for possible reduced antimalarial efficacy of Artesunate for Injection.
Strong UGT Inhibitors Published reports of in vitro data indicate that concomitant use of Artesunate for Injection with UGT inhibitors may increase DHA AUC and C max [see Clinical Pharmacology ( 12.3 )] , which may increase DHA associated adverse reactions. Monitor for adverse reactions when co-administering Artesunate for Injection with strong UGT inhibitors (e.g., axitinib, vandetanib, imatinib, diclofenac).
Contraindications
Serious hypersensitivity to artesunate, such as anaphylaxis. ( 4 )
4.1 Hypersensitivity Known serious hypersensitivity to artesunate, such as anaphylaxis [See Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] .
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Artesunate for injection is an antimalarial drug used as the initial treatment of severe malaria in both adults and children. Typically, infusions of artesunate are continued for 2 to 7 days until the patient can tolerate oral antimalarial therapy. Artesunate therapy is associated with mild-to-moderate serum aminotransferase elevations during therapy but has not been linked instances of clinically apparent liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are serious risks to the mother and fetus associated with untreated severe malaria during pregnancy; delaying treatment of severe malaria in pregnancy may result in serious morbidity and mortality to the mother and fetus (see Clinical Considerations ) . Pregnancy outcomes reported from a prospective surveillance study with intravenous artesunate are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or fetal death.
Experience with oral artesunate (not an approved route of administration) and other artemisinin class drugs (via various routes of administration) in pregnant women over several decades, based on published literature from randomized controlled trials and cohort studies, have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data ) . The bioavailability of oral artesunate is expected to be significantly lower than intravenous artesunate; therefore, the clinical relevance of studies involving oral exposure to artesunate and other artemisinin class drugs is uncertain.
Animal reproduction studies show that a single intravenous administration of artesunate to rats early in gestation results in embryolethality. Oral administration of artesunate during organogenesis in rats, rabbits, and monkeys induces a dose-dependent increase in embryolethality and fetal malformations (e.g., cardiovascular, brain, and/or skeletal) at 0.3- to 1.6-times the clinical dose based on body surface area (BSA) comparisons (see Data ) . Although animal reproduction studies in several species have demonstrated fetal harm from oral and intravenously administered artesunate and other artemisinin class drugs, the clinical relevance of the animal data is uncertain.
The estimated background risk of miscarriage and maternal and fetal death for the indicated population is higher than the general population. The estimated background risk of major birth defects for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. There is a pregnancy safety study for Artesunate for Injection.
If Artesunate for Injection is administered during pregnancy, healthcare providers should report Artesunate for Injection exposure by contacting Amivas, Inc at 1-855-526-4827 (1-855-5AMIVAS) or www.amivas.com/our-products .…
Breastfeeding (LactMed)
Limited information indicates that a maternal dose of 200 mg orally produced low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. Withholding breastfeeding for 6 hours after a dose should markedly reduce the dose the infant receives. In general, very small amounts of antimalarial drugs are excreted in the breast milk of lactating women. Because the quantity of antimalarial drugs transferred in breast milk is insufficient to provide adequate protection against malaria, infants who require chemoprophylaxis must receive the recommended dosages of antimalarial drugs.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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