Artesunate Rectocaps

Cipla

Product category	Severe malaria pre-referral intervention (artesunate rectal capsules)
Therapeutic indication	Pre-referral emergency intervention for severe P. falciparum malaria in children aged 6 months* (5kg) to 6 years (20kg) and >6h from a treatment centre
Dosing	For ages 6 months to <3 years – 1 x 100mg, 3 to 6 years - 2 x 100mg Administration should be followed immediately by referral to health facility able to administer parenteral treatment
Efficacy	Halves death and disability in the target population Implementation program in Zambia supported by MMV resulted in >95% reduction in the severe malaria case fatality rate
Key features	WHO prequalified (in 2018) Two-year shelf life
Challenges	Requires close supervision and referral mechanisms to ensure correct use WHO recommends that artesunate rectal capsules should not remain in field longer than 4-6 months in areas exceeding 30°C
Status	100mg artesunate rectal capsules included in WHO Essential Medicines List (April 2017 revision) 3.8 million artesunate rectal capsules have been supplied since 2017** Product registered in 10 malaria-endemic countries
Next milestone	Ongoing country registrations and deliveries Generation of new stability data to support longer field use
Previously	WHO Special Programme for Research and Training in Tropical Diseases (TDR) completed Phase lll trials
MMV Project Director	Hans Rietveld

* Lower age limit specified as 2 months in WHO Public Assessment Report part 4 (November 2018) ** Combined data from Cipla and Strides up to and including 2020