Artesunate rectocaps

Cipla

Paediatric formulation

Pre-referral intervention (TPP-1)

Artesunate rectal capsules

Access

-

Approved

Therapeutic indication	Pre-referral emergency intervention for severe P. falciparum malaria in children aged 6 months* (5 kg) to 6 years (20 kg) and >6 h from a treatment centre
Dosing	For ages 6 months to <3 years – 1 x 100 mg, 3 to 6 years - 2 x 100 mg Administration should be followed immediately by referral to health facility able to administer parenteral treatment
Efficacy	Halves death and disability in the target population
Key features	WHO prequalified 2-year shelf life
Challenges	Requires close supervision and referral mechanisms to ensure correct use; risk of monotherapy if not followed up with injectable artesunate and ACT WHO recommends that artesunate rectal capsules should not remain in field longer than 6 months in areas exceeding 30^°C
Status	100 mg artesunate rectal capsules included in WHO Essential Medicines List (April 2017 revision) 7.6 million artesunate rectal capsules have been supplied since 2017** Product registered in 20 malaria-endemic countries
Next milestone	Updated guidance for countries following WHO Technical Consultation Generation of real-world stability data to support longer field use
Previously	WHO Special Programme for Research and Training in Tropical Diseases (TDR) completed phase lll trials
Project Director	Hans Rietveld

Footnotes:
* 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 2021