Prescribing Myalepta6

Dosing of Myalepta

Due to Myalepta being provided in the form of a powder for solution, there is potential for over- or under-dosing of the reconstituted Myalepta solution. To avoid this, Myalepta should be prescribed in both milligrams and the volume to inject in millilitres (unless a dose of less than 0.3 mls is prescribed in which case prescribe in units). A dosing calculator is available in the brochure Information for Healthcare Professionals to assist this. When prescribing Myalepta, the patient should also be given a Dose Information Card on which the dosage should be noted.

One vial of Myalepta and one vial/ampoule of water for injection must be prescribed per day and the patient instructed to dispose of any unused medicine and unused water for injection. The smallest appropriate size of water for injection (5 ml or less) should be prescribed to reduce the risk of re-use.

In addition to the Myalepta and water for injection, the patient needs to be provided with appropriate ancillary items (needles, syringes and alcohol wipes) to prepare and administer the product plus a sharps bin. Guidance on these items and the provision of reconstitution and administration kits is provided in the brochure Information for Healthcare Professionals.

Administration of Myalepta

The patient should be instructed that Myalepta is to be administered subcutaneously at approximately the same time every day. It can be administered any time of the day without regard to the timing of meals. If the patient misses a dose, Myalepta should be administered as soon as the omission is noticed and the normal dosing schedule resumed the next day.

Further information about prescribing Myalepta can be found in the brochure Information for Healthcare Professionals and the Summary of Product Characteristics.

Suspected adverse reactions and adverse events should be reported.

Reporting forms and information can be found on the MHRA Yellow Card reporting site or yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse reactions should also be reported to Aegerion by calling 00800 23437466 or e-mail: medinfo.emea@aegerion.com