Patient Instructions for Use

Training6

During the administration process, patients must dissolve Myalepta with water for injection and then draw up the correct dose and self-inject the solution. Each of these steps involves the risk of potential errors; therefore appropriate training is required. Patients should never self-inject unless they have received this training from a healthcare professional. Equally, no attempt to self-inject should be made if the patient has questions about the technique or does not feel confident.

Patients and/or carers should prepare and administer the first dose of Myalepta under the supervision of a qualified healthcare professional. A review of self-administration technique should be performed every six-months.

Instructions for Use for the patient

As part of the Risk Management Plan, educational materials have been developed to facilitate the self-injection process. Healthcare professionals should ensure that the patient is given access to the Patient Care Guide, the Instructions for Use from the Package Leaflet, the Dose Information Card on which a healthcare professional is able to mark the dose in milligrams and milliliters (or units), the correct syringe to be used and volume to be used, and the Patient Video which instructs patients on how to prepare and inject Myalepta correctly. Within these materials, patients are advised to contact their physician if they have any questions on self-administering Myalepta.

[Note to programmer and designer: Insert patient video]

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