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Artemisinin Derivative Antimalarial Pregnancy: Section 4.6: 'Pregnancy - There is limited clinical experience with the use of Artesunate Amivas in the first trimester of pregnancy. A risk to the fetus cannot be excluded. Animal studies have shown reproductive toxicity. The use of Artesunate Amivas in the first trimester is therefore not recommended unless the benefit to the mother outweighs the risk to the fetus. A moderate amount of clinical data on pregnant women (between 300-1000 pregnancy outcomes) indicate no malformative or feto/neonatal toxicity of artesunate when given IV in their second or third trimester. As a precautionary measure, it is preferable to avoid the use of Artesunate Amivas during the second or third trimester of pregnancy. Breast-feeding - DHA, a metabolite of artesunate, is present in human milk. There are no data on the effects of artesunate or DHA on the breastfed infant or on milk production. The benefits of breastfeeding to mother and infant should be weighed against potential risk from infant exposure to DHA through breast milk.'

Artesunate

Brand names: Artesun (IV), Falcimon (oral — not licensed UK)

Artesunate is a water-soluble artemisinin derivative and is the treatment of choice for severe malaria, given parenterally.

Adult dose

Dose: Initial treatment of severe malaria in adults: 2.4 mg/kg by intravenous (IV) injection at 0, 12 and 24 hours. After at least 24 hours (3 doses), patients unable to tolerate oral treatment may continue IV treatment with 2.4 mg/kg once every 24 hours (from 48 hours after start of treatment).
Route: Intravenous (slow bolus injection over 1-2 minutes)
Frequency: At 0, 12 and 24 hours; then once every 24 hours (from 48 hours after start) if oral treatment is not tolerated
Strength (SPC section 2): each vial contains 110 mg artesunate powder; after reconstitution with the supplied solvent the solution contains 10 mg artesunate per mL, i.e. 0.24 mL of reconstituted solution per kg body weight (dose in mg = patient's weight in kg x 2.4). ROUTES NOT COVERED: this SPC is for the IV product only (IV administration only); the page's rectal (pre-referral) route and the oral Falcimon brand are not covered by this source and no dose is written for them. Should be used to treat severe malaria only after consultation with a physician with appropriate experience in the management of malaria (section 4.2). Initial treatment of severe malaria with artesunate should always be followed by a complete treatment course with appropriate oral antimalarial therapy (stop IV treatment when oral treatment can be tolerated, then give a complete course of an appropriate oral combination antimalarial regimen) (section 4.2). Reconstituted solution must be used within 1.5 hours of preparation (unstable in aqueous solution); calculate the required dose and number of vials before reconstituting; for reconstitution see SPC section 6.6 (not retrieved in the bundle) (section 4.2). Not evaluated in severe malaria due to P. vivax, P. malariae or P. ovale; it does not treat the hypnozoite liver stage and will not prevent relapse of P. vivax or P. ovale - such patients should receive an agent active against hypnozoites (section 4.4). Elderly: no dose adjustment, but insufficient clinical data in patients aged 65 years and older (sections 4.2, 4.4). CHILDREN: the SPC prints this same 2.4 mg/kg regimen for 'adults and children (birth to less than 18 years)' with no dose adjustment based on age or weight (section 4.2), but insufficient clinical data exist for infants under 6 months, in whom DHA exposure is likely to be higher (section 4.4). No separate paediatric block is written here; use a children's formulary / specialist advice for anyone under 18.

Dose adjustments

Renal

SPC 4.2: no dose adjustment is required in renal impairment.

Hepatic

SPC 4.2: no dose adjustment is required in hepatic impairment.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via MHRA Products — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance, to any other artemisinin antimalarial agent or to any of the excipients (section 4.3)

Side effects

  • Anaemia - the most common adverse drug reaction in clinical trials; occurs very commonly in severe malaria as a result of the disease and effective treatment (section 4.8)
  • Post-artesunate delayed haemolysis (PADH) - reported very commonly after effective treatment of severe malaria with IV artesunate in travellers and in children; onset at least 7 days and sometimes several weeks after starting treatment; can require transfusion (sections 4.4, 4.8)
  • Reticulocytopenia (reduced reticulocyte count) - occurs commonly or very commonly; resolves after treatment (sections 4.4, 4.8)
  • Immune haemolytic anaemia (section 4.8)
  • Hypersensitivity: anaphylaxis, urticaria, rash, pruritus; Stevens-Johnson syndrome (sections 4.4, 4.8)
  • Also listed in section 4.8 Table 1 (frequency category per term not reliably readable in the extracted table): rhinitis, anorexia, dizziness, dysgeusia, headache, bradycardia, QT prolonged on ECG, hypotension, phlebitis, flushing, cough, abdominal pain, diarrhoea, vomiting, nausea, constipation, hyperbilirubinaemia, jaundice, haemoglobinuria, acute renal failure, pyrexia, fatigue, pain at injection site, ALT increased, AST increased

Interactions

  • Strong UGT inhibitors (e.g. axitinib, vandetanib, imatinib, diclofenac) - may increase plasma exposures to DHA; co-administration should be avoided if possible (section 4.5)
  • UGT inducers (e.g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) - may decrease DHA exposures, leading to reduced or lost efficacy; co-administration should be avoided (section 4.5)
  • Substrates of CYP3A4 or CYP1A2 with narrow therapeutic windows - caution (DHA induces CYP3A and inhibits CYP1A2) (section 4.5)
  • No clinical drug-drug interaction studies have been conducted with the product (section 4.5)

Monitoring

  • Monitor for evidence of haemolytic anaemia for 4 weeks after starting artesunate treatment (PADH); risk may be highest in hyperparasitaemia and in younger children (section 4.4)
  • Consider a direct antiglobulin test in delayed haemolysis to determine whether therapy, e.g. with corticosteroids, is necessary (section 4.4)
  • Reticulocyte count - reversible reticulocytopenia occurs at least commonly; recovers after cessation (section 4.4)
  • Hypersensitivity reactions including anaphylaxis (section 4.4)

Clinical monograph

How it works

Its active metabolite generates reactive species that damage parasite proteins and membranes, producing rapid killing of blood-stage Plasmodium parasites.

Prescribing in practice

  • Delayed post-treatment haemolytic anaemia can occur, so haemoglobin should be monitored for several weeks after treatment.
  • It is the preferred agent for severe malaria; oral artemisinin-based combination therapy should follow once the patient can tolerate it.
  • Treatment should be initiated promptly in suspected severe malaria without waiting for full confirmation.

Monitoring

Monitor parasitaemia, clinical recovery and haemoglobin during and for several weeks after treatment to detect delayed haemolysis.

Counselling the patient

  • Further blood tests are needed in the weeks after treatment to check for anaemia.
  • Report tiredness, breathlessness or dark urine after treatment.
  • You will usually switch to tablets to complete your malaria treatment.

Evidence & guidelines

Intravenous artesunate is recommended over quinine for severe malaria, supported by the SEAQUAMAT and AQUAMAT trials.

Reference: PHE/UKHSA Malaria Treatment Guidelines (2022); AQUAMAT trial (Lancet 2010); WHO Guidelines for Treatment of Malaria (3rd ed.); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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