Artesunate

Hypersensitivity to artesunate.

Patient with cardiac and gastrointestinal disease. Hepatic and renal impairment. Children. Pregnancy and lactation. Monitoring Parameters Monitor for signs and symptoms of hypersensitivity and cardiotoxicity (high doses); Hb, reticulocyte count, haptoglobin, lactate dehydrogenase and total bilirubin once weekly for up to 4 weeks after treatment initiation. Monitor for evidence of haemolytic anaemia for 4 weeks after therapy. Consider performing direct antiglobulin test to determine if therapy for immune-mediated haemolysis is needed.

Significant: Haemolysis, severe haemolytic anaemia, hypersensitivity (including anaphylaxis). Ear and labyrinth disorders: Tinnitus. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, taste alteration (metallic/bitter taste). General disorders and administration site conditions: Asthenia, pancreatitis, fever, fatigue, malaise, inj site pain. Hepatobiliary disorders: Jaundice. Musculoskeletal and connective tissue disorders: Muscle pain, arthralgia. Nervous system disorders: Ataxia, balance impairment, restlessness, tremor, dizziness, headache, paresis. Psychiatric disorders: Confusion. Renal and urinary disorders: Haemoglobinuria, acute renal failure. Respiratory, thoracic and mediastinal disorders: Cough, nasal symptoms. Skin and subcutaneous tissue disorders: Pruritus, rash.

May decrease dihydroartemisinin (DHA) plasma concentration thus reduce efficacy of artesunate with ritonavir, nevirapine or UDP-glucuronosyltransferase (UGT) inducers (e.g. rifampicin, carbamazepine, phenytoin). May increase DHA plasma concentration thereby increase the risk of side effects with UGT inhibitors (e.g. axitinib, vandetanib, imatinib, diclofenac).

Antimalarials

P01BE03 - artesunate ; Belongs to the class of artemisinin and derivative antimalarials.