FOI 21/169 - Freedom of Information Request - Caffeine RMP Request
Published 24 March 2021
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Thank you for your FOI request dated 9th February 2021, whereby you requested the following information;
‘a copy of the Risk Management Plan for Peyona / Nymusa 20mg/ml solution for infusion and oral solution (EU/1/09/528/002 and EU/1/09/528/001) which according to the CHMP and EPAR Assessment Reports (Copies attached) was submitted by Chiesi Farmaceutici SpA.’
We are unable to provide the RMP because we do not hold a copy of it but we are able to provide the approved list of safety concerns and the list of required risk materials.
(1) Approved list of safety concerns from the RMP for Peyona: Important identified risks
• Toxicity due to maternal caffeine ingestion • Increase in caffeine plasma levels in premature infants with cholestatic hepatitis • Increase in caffeine plasma levels in premature infants with clinically relevant renal insufficiency • Cardiac disorder in infants with pre-existing cardiac disease, including arrhythmias • Treatment-related convulsions/seizures.
Important potential risks
• Decrease in weight gain / failure to thrive • Caffeine withdrawal • Necrotising enterocolitis • Medication errors
Missing Information
• Rare ADRs • Drug interaction with the most commonly used drugs in the NICU • Long-term effects of caffeine therapy.
(2) Risk Materials required as part of the RMP for Peyona:
• Dear Healthcare Professional Communication (DHPC): Before product launch, the MAH for Peyona was required to issue a DHPC (available on the eMC website) to all relevant Healthcare Professionals (HCPs) to summarise the key information for the safe use of the product and what to do if adverse events occur. There is no expectation for the DHPC to be actively distributed but it should be made available electronically and hard copies provided on request. This is assuming that the strength, salt and formulation is the same as Peyona (20mg/ml caffeine citrate) as the DHPC relates to possible dosing errors if mixed up with other strengths of caffeine solution which are also available (10 mg/ml).
• Laminated card: A Laminated Card (available on the eMC website) is provided to staff of neonatal intensive care units (NICUs) to promote the safe administration of the product. The card highlights the appropriate dosing regimen, the approved therapeutic indications, the key warnings in the SmPC and the important steps to minimise risk following use of caffeine citrate in the approved indication. The effectiveness of the card is evaluated through routine pharmacovigilance activities.
We hope you find this information helpful.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team, Vigilance and Risk Management of Medicines Division