Amid a shortage that may last a year, the TGA has given temporary approval for an alternative.
The Ryzodeg FlexTouch all-in-one insulin prefilled pen may be unavailable until June next year.
As a replacement, the TGA has temporarily approved cartridges that will need to be used with a separate injection device (NovoPen). The alternative can be prescribed by GPs or provided at the pharmacy.
“This means that pharmacists can give patients Ryzodeg 70/30 Penfill cartridges instead of Ryzodeg 70/30 FlexTouch prefilled pen under certain conditions. Both products contain the same medicine, at the same strength, have the same storage requirements, and are administered by subcutaneous injection, however the device to administer the medicine is different,” the TGA says.
The substitution requires that the patient be provided with a reusable NovoPen (free of charge) in which to load the insulin cartridges, and the appropriate instructions for its use. NovoPen 4, NovoPen Echo or NovoPen 6 are all suitable. All pharmacies can obtain NovoPens through a special program. Those who already have it are listed in an online directory via postcode.
The TGA advises that substitution “might not be appropriate for all patients … For example, a level of dexterity is required to load a cartridge into a reusable pen, and your patient may not be able to comfortably do this, either due to their age or medical conditions.
“Consider instructing patients on how to use the substitute medicine and devices at their next appointment. Patients presenting at the pharmacy may be given information and guidance on how to administer the substitute product by their pharmacist, or they may be asked to contact you for this information.”
According to the TGA, the shortage is due to “unprecedented global demand for other medicines using the FlexTouch delivery device”.
