Result of a three-year collaborative partnership, starting in 2008, between DNDi and the Pernambuco State Pharmaceutical Laboratory (Laboratório Farmacêutico do Estado de Pernambuco; LAFEPE) of Brazil. LAFEPE is the second largest public laboratory in Brazil and the only producer of benznidazole in the world.
An improved treatment option
- First paediatric drug
- Age-adapted, easy-to-use, affordable, and non-patented tablet, for the treatment of Chagas
- Disease in infants and young children under two years of age (20 kg body weight)
- Contributes to improved dosing accuracy, safety, and adherence to treatment
- Registered in Brazil in 2011
- On WHO Essential Medicines List (children)
- Collaboration with Mundo Sano Foundation to deliver a second source of treatment with Laboratorio ELEA, Argentina
- Granted registration by Brazil’s National Health Surveillance Agency (ANVISA), with further endemic countries targeted for obtaining registration
Main advantages of the Paediatric dosage form of Benznidazole
- A single tablet allows coverage of a wide age range, up to two years old or body weight 20 kg
- Child-adapted dose of 12.5 mg per tablet taken twice daily for 60 days
- Easily dispersible tablet to facilitate oral administration
- No need for tablet fractionation (except for low-birth weight babies <2.5 kg: half a tablet)
- Simple and reliable administration that does not require complex preparation and can therefore be administered at home, even during the long duration of treatment (twice daily for 60 days)
Population Pharmacokinetics of Benznidazole in Children with Chagas’ Disease
by Jaime Altcheh, Isabela Ribeiro, Fabiana Alves, Martin Caruso, Celia Monla, Oscar Ledesma Patiño, Facundo Garcia-Bournissen, Hospital de Niños Ricardo Gutiérrez, Buenos Aires, Argentina; Drugs for Neglected Diseases initiative, Rio de Janeiro, Brazil; Hospital de Niños de Jujuy, Jujuy, Argentina; Hospital Público Materno Infantil, Salta, Argentina; Programa Provincial de Chagas, Santiago del Estero, Argentina.
- Download Paediatric Benznidazole dossier – English (12/2011)
- Download Paediatric Benznidazole dossier – Español (12/2011)
UPDATE – In April 2018, Elea announced Argentina has approved the paediatric indication of benznidazole, which will now be available in 12.5mg pills, the dose required to treat children under the age of 2.