Artesunate rectal capsules: a pre-referral intervention for children with severe malaria

Severe malaria, a life-threatening condition, may ensue rapidly if a bout of acute uncomplicated malaria is not promptly treated.  

Artesunate rectal capsules: a pre-referral intervention to gain time  

Artesunate rectal capsules (ARC) administered at the community level have been shown to save livesin particular those of critically ill young children unable to access parenteral treatment within 6 hours.  

This emergency intervention halts the progression of the diseasereducing parasite levels in the blood while the patient is transported to a health facility.  

Once admitted to a referral centre, patients should receive injectable artesunate, followed by a full treatment course of artemisinin-based combination therapy (ACT), as per WHO guidelines.  

Developing quality ARfor malaria-endemic countries 

The WHO Guidelines for the treatment of malaria have recommended ARC for over 10 years, but the lack of quality-assured ARC product on the market hampered its widespread availability and use, forcing malaria-endemic countries to choose from sources of drug supply that did not meet international quality standards. 

MMV collaborated with two pharmaceutical partners (Strides Pharma and Cipla) to develop and secure WHO prequalification of ARC as part of the Unitaid-funded project ‘Improving Severe Malaria Outcomes’ (ISMO).This work also supported the correct rollout and use of ARC as a pre-referral intervention. 

An essential medicine recognized by the World Health Organization 

In June 2017, after review of an application submitted by Cipla, the 100mg presentation of ARC was added to the WHO’s Model List of Essential Medicines (EML) and Model List of Essential Medicines for Children (EMLc). WHO’s Model EML identifies medicines that “satisfy the priority health care needs of the population.”  

In 2018, both the Cipla and Strides Pharma ARC products obtained WHO prequalification. It is estimated that over 95% of ARC procured by malaria-endemic countries for use in public health facilities is now WHO prequalified. Since 2017, 3.2 million ARC have been supplied  to malaria-endemic countries with the support of international donor funding. Currently the product is registered in 16 countries. 

ARC is an interim solution until proper treatment is secured 

As a pre-referral intervention, ARC is not intended to substitute for WHO-recommended parenteral treatments, preferably injectable artesunate. Neither is ARC intended to substitute for the treatment of acute uncomplicated malaria, for which WHO recommends the use of artemisinin-based combination therapies (ACTs). 

  • Past and current partners: 

    CHAI,Cipla, Strides Pharma, Fosun Pharma, Ipcahealth-E-net, Malaria Consortium, StridesPharma,Transaid,WHO-TDR, WellSense Consultancy, University of Malawi College of Medicine, Mentor Initiative, Unitaid.

    Updated November 2020