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Preliminary consultation on preferred product characteristics of benzathine penicillin G for secondary prophylaxis of rheumatic fever

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Abstract

Rheumatic fever is caused by an abnormal immune reaction to group A streptococcal infection. Secondary prophylaxis with antibiotics is recommended for people after their initial episode of rheumatic fever to prevent recurrent group A streptococcal infections, recurrences of rheumatic fever and progression to rheumatic heart disease. This secondary prophylaxis must be maintained for at least a decade after the last episode of rheumatic fever. Benzathine penicillin G is the first line antibiotic for secondary prophylaxis, delivered intramuscularly every 2 to 4 weeks. However, adherence to recommended secondary prophylaxis regimens is a global challenge. This paper outlines a consultation with global experts in rheumatic heart disease on the characteristics of benzathine penicillin G formulations which could be changed to improve adherence with secondary prophylaxis. Characteristics included dose interval, pain, administration mechanism, cold chain independence and cost. A sample target product profile for reformulated benzathine penicillin G is presented.

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Acknowledgments

Funding from the Telethon New Children’s Hospital Research Fund Supported this project. Formulation and drug development advice was kindly provided Medicines Development Limited and the Monash Institute of Pharmaceutical Sciences.

Author information

Authors and Affiliations

  1. Telethon Kids Institute, University of Western Australia, 100 Roberts Road, Subiaco, Western Australia, 6008, Australia

    Rosemary Wyber, Meru Sheel & Jonathan Carapetis

  2. Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University (Parkville Campus), Parkville, Australia

    Ben J Boyd

  3. Murdoch Childrens Research Institute, University of Melbourne, Parkville, Australia

    Samantha Colquhoun

  4. Menzies School of Health Research, Charles Darwin University, Darwin, Australia

    Bart J Currie

  5. Royal Darwin Hospital, Darwin, Australia

    Bart J Currie

  6. Department of Medicine, University of Cape Town, Cape Town, South Africa

    Mark Engel

  7. College of Medicine, Nursing and Health Sciences, Fiji National University, Suva, Fiji

    Joseph Kado

  8. Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India

    Ganesan Karthikeyan & Anita Saxena

  9. Medicines Development for Global Health, Melbourne, Australia

    Mark Sullivan

  10. Group A Streptococcal Research Group, Murdoch Children’s Research, University of Melbourne, Melbourne, Australia

    Andrew Steer

  11. Department of Paediatrics, King Faisal Hospital, Kigali, Rwanda

    Joseph Mucumbitsi

  12. Department of Paediatric Cardiology, University of Cape Town, Cape Town, South Africa

    Liesl Zühlke

  13. Princess Margaret Hospital for Children, Perth, Western Australia, Australia

    Jonathan Carapetis

Authors
  1. Rosemary Wyber
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  2. Ben J Boyd
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  3. Samantha Colquhoun
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  4. Bart J Currie
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  5. Mark Engel
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  6. Joseph Kado
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  7. Ganesan Karthikeyan
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  8. Mark Sullivan
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  9. Anita Saxena
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  10. Meru Sheel
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  11. Andrew Steer
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  13. Liesl Zühlke
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  14. Jonathan Carapetis
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Corresponding author

Correspondence to Rosemary Wyber.

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Conflict of interest

Benjamin Boyd, Mark Sullivan and Jonathan Carapetis have received funding from the Telethon New Children’s Hospital Research Fund to explore new formulations of benzathine penicillin G (Grant number: F55541) Jonathan Carapetis and Meru Sheel are investigators on a BPG projected funded by Novartis Institutes for BioMedical Research. Rosemary Wyber has provided technical advice to Pfizer on BPG but has not received funding.

Samantha Colquhoun, Bart Currie, Mark Engel, Joseph Kado, Ganesan Karthikeyan, Anita Saxena, Andrew Steer, Joseph Mucumbitsi and Liesl Zühlke declare that they have no conflict of interest.

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Wyber, R., Boyd, B., Colquhoun, S. et al. Preliminary consultation on preferred product characteristics of benzathine penicillin G for secondary prophylaxis of rheumatic fever. Drug Deliv. and Transl. Res. 6, 572–578 (2016). https://doi.org/10.1007/s13346-016-0313-z

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