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ARTESUNATE AMIVAS is a brand name for Artesunate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Artesunate Amivas is indicated for the initial treatment of severe malaria in adults and children (see sections 4.2 and 5.1). Consideration should be given to official guidance on the appropriate use of antimalarial agents.
Verbatim from this product's MHRA label. Tap a section to expand.
It is recommended that Artesunate Amivas should be used to treat patients with severe malaria only after consultation with a physician with appropriate experience in the management of malaria. Posology Initial treatment of severe malaria with artesunate should always be followed by a complete treatment course with appropriate oral antimalarial therapy.
2). 4 mg/kg once every 24 hours (from 48 hours after start of treatment). Treatment with Artesunate Amivas should be stopped when patients can tolerate oral treatment. After stopping Artesunate Amivas, all patients should receive a complete treatment course of an appropriate oral combination antimalarial regimen.
2). 2). 2). 2). Method of administration Artesunate Amivas is for IV administration only. The reconstituted solution should be administered as a slow bolus injection over 1-2 minutes. Artesunate Amivas must be reconstituted with the supplied solvent prior to administration.
5 hours of preparation. 4) and the number of vials of artesunate needed should be determined prior to reconstituting the artesunate powder. 6.
8. Reticulocytopenia The artemisinins have shown direct inhibitory effects on human erythroid precursors in vitro and inhibit bone marrow responses (especially red blood cell precursors) in animal models. 8). The reticulocyte count recovers after cessation of treatment.
Malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale Artesunate Amivas has not been evaluated in the treatment of severe malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale. 1). It does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to Plasmodium vivax or Plasmodium ovale.
Patients treated initially with artesunate for severe malaria due to P. vivax or P. ovale should receive an antimalarial agent that is active against the hypnozoite liver stage forms of Plasmodium. Infants aged less than 6 months There are insufficient clinical data to establish the safety and efficacy of Artesunate Amivas in infants below 6 months of age.
2). 2). 6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. 2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. 5 Interaction with other medicinal products and other forms of interaction No clinical drug-drug interactions studies have been conducted with Artesunate Amivas.
Effect of other medicinal products on artesunate and/or dihydroartemisinin (DHA) After intravenous administration, artesunate is converted to DHA by esterases and by CYP2A6. DHA is converted to inactive glucuronide conjugates primarily by UGT1A9.
g. axitinib, vandetanib, imatinib, diclofenac) may increase plasma exposures to DHA. Co-administration should be avoided if possible. g. nevirapine, ritonavir, rifampicin, carbamazepine, phenytoin) may decrease DHA exposures, leading to a reduction in, or loss of, efficacy.
Hypersensitivity Allergic reactions to intravenous artesunate, including anaphylaxis, have been reported. 8). Post-artesunate delayed haemolysis Post-artesunate delayed haemolysis (PADH) is characterised by decreased haemoglobin with laboratory evidence of haemolysis (such as decreased haptoglobin and increased lactate dehydrogenase) with onset at least 7 days and sometimes several weeks after initiating artesunate treatment.
PADH has been reported to occur very commonly after successful treatment of severe malaria that commenced with IV artesunate in returning travellers. The risk of PADH may be highest in patients with hyperparasitaemia and in younger children.
Patients should be monitored for evidence of haemolytic anaemia for 4 weeks after starting artesunate treatment. Spontaneous recovery from PADH usually occurs within a few weeks. However, cases of post- artesunate haemolytic anaemia severe enough to require transfusion have been reported.
g. with corticosteroids, is necessary. 8. Reticulocytopenia The artemisinins have shown direct inhibitory effects on human erythroid precursors in vitro and inhibit bone marrow responses (especially red blood cell precursors) in animal models.
8). The reticulocyte count recovers after cessation of treatment. Malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale Artesunate Amivas has not been evaluated in the treatment of severe malaria due to Plasmodium vivax, Plasmodium malariae or Plasmodium ovale.
1). It does not treat the hypnozoite liver stage forms of Plasmodium and will therefore not prevent relapses of malaria due to Plasmodium vivax or Plasmodium ovale. Patients treated initially with artesunate for severe malaria due to P.
vivax or P. ovale should receive an antimalarial agent that is active against the hypnozoite liver stage forms of Plasmodium. Infants aged less than 6 months There are insufficient clinical data to establish the safety and efficacy of Artesunate Amivas in infants below 6 months of age.
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Co-administration should be avoided. Effect of artesunate and/or DHA on other medicinal products Limited data from in-vitro studies and from clinical drug-drug interaction studies with oral artesunate and/or oral DHA have indicated that DHA induces CYP3A and inhibits CYP1A2.
Caution is advised when co-administering intravenous artesunate with substrates of CYP3A4 or CYP1A2 that have narrow therapeutic windows. 6 Fertility, pregnancy and lactation 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. 3). 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. Pregnancy registry A pregnancy registry has been set up to monitor all pregnancies and their outcomes following treatment with Artesunate Amivas.
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.
Fertility No fertility data are available in humans. 3). 7 Effects on ability to drive and use machines No studies on the effects on the ability to drive and use machines have been performed. Patients should be warned not to drive or use machines if they feel tired or dizzy.
8 Undesirable effects Summary of the safety profile The most common adverse drug reaction reported in clinical trials has been anaemia. While anaemia occurs very commonly in patients with severe malaria as a result of the disease and effective treatment, anaemia that was not dose-related was also reported in healthy subjects in clinical pharmacology studies with IV artesunate.
4). 4). Tabulated list of adverse reactions Adverse events considered at least possibly related to artesunate are listed below by body system, organ class and absolute frequency. Frequencies are […]
2). 2). 6 % of the WHO recommended maximum daily intake of 2 g sodium for an adult. 2 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.