Artesunate rectal capsules

Artesunate rectal capsules

Access
-
Approved
Artesunate rectocaps
Cipla
Paediatric formulation
Pre-referral intervention (TPP-1)
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

  • Implementation programme in Zambia supported by MMV resulted in >95% reduction in the severe malaria case fatality rate
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 the 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)
  • 9.3 million artesunate rectal capsules have been supplied since 2017**
  • Product registered in 9 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