Artesunate Rectocaps

Cipla

Legend
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)
  • 3.2 million artesunate rectal capsules have been supplied since 2017**
  • Product registered in 9 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