Epanutin 50mg Infatabs supply issue

Information from the Department of Health and Social Care (DHSC) regarding the Epanutin 50mg Infatabs supply issue:

Pfizer, the sole supplier of Epanutin (phenytoin base 50mg) Infatabs have experienced global delays in the manufacturing of this product.  As a result, they are anticipating an imminent gap in supply until early November 2019 when their next batch arrives. Pfizer has issued a Dear Healthcare Professional letter with detailed information on the issue and management plan see below.

The MHRA has classified phenytoin as a Category 1 antiepileptic drug. In the event that you need to prescribe a product from a different manufacturer then this must be carefully managed and increased monitoring of the patient may be required as clinically relevant differences between different manufacturers’ products might occur. Pfizer have been able to secure supplies of a Canadian phenytoin base Infatabs (brand name Dilantin 50mg Infatabs), which will be available when current supplies of Epanutin Infatabs are depleted. Further information on this is attached and below:

• Pfizer are confident they have sufficient supplies of Dilantin 50mg Infatabs to meet demand for Epanutin 50mg Infatabs to cover the full out of stock period. However, Dilantin will be considered an unlicensed medicine in the UK
• The active ingredient in Epanutin 50 mg Infatabs and Dilantin 50 mg Infatabs is the same, however in the absence of bioequivalence data from Pfizer, there may be clinically relevant differences between the two products. Further information on this can be found in the DHCP letter and documents below
• Switching to alternative presentations should be managed under medical supervision and monitoring of phenytoin serum levels are advised to ensure the correct dosage is being given.
• Epanutin 30 mg/5 ml Oral Suspension remains available, however, supplies are only available to meet normal market demand, as such patients should not be switched to Epanutin Oral Suspension as this may precipitate a shortage of this presentation
• General Practitioners should identify all patients currently prescribed Epanutin 50mg Infatabs. Early contact should be made with the patient or the patient’s parent/carer to determine if and when switches are likely to be required during this stock out period.
• Alternative formulations of phenytoin continue to remain available including tablets, capsules and injections

Details on prescribing and ordering

• If a clinician chooses to prescribe Dilantin 50mg Infatabs, they should be aware this is an unlicensed medicine in the UK.
• Any decision to prescribe an unlicensed medicine must take into account the relevant GMC guidance and NHS Trust governance procedures.
• Prescribers should ensure that they issue a prescription for the unlicensed product and clearly mark on the prescription that this is a special/unlicensed product. This is to ensure the pharmacy/contractor is reimbursed appropriately.
• Pharmacies/ contractors may be unable to dispense Dilantin 50mg Infatabs and/or be reimbursed if the prescription states Epanutin.
• Pharmacies/contractors wishing to order Dilantin should contact Pfizer Customer Contact Centre on 0845 608 8866 directly who will manage the order.

Further information

Dilantin PIL

Epanutin PIL

Dilantin Infatab DHCP letter

Epanutin and Dilantin Images