Approved first generic for Apokyn injection cartridges requires separately packaged pen

The U.S. Food and Drug Administration has approved the first generic of Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomobility “off” episodes (“end-of-dose wearing off” and unpredictable “on/off” episodes) associated with advanced Parkinson’s disease.

Prescribers and pharmacists should be aware that patients starting treatment with generic apomorphine hydrochloride injection will need to separately obtain the Apokyn Pen. This approval is for Sage Chemical Inc.’s application of the drug cartridges only, which are compatible for use with the Apokyn Pen, the brand-name pen injector. The Apokyn Pen is supplied by the brand manufacturer, is distributed and packaged separately, and is generally only dispensed through specialty pharmacies.

Patients should first obtain the prescribed Apokyn Pen through a specialty pharmacy before being prescribed the generic apomorphine hydrochloride injection. Patients on established generic apomorphine hydrochloride injection who need a replacement Apokyn Pen may also only obtain an Apokyn Pen separately from the brand manufacturer.

Additionally, prescribers, pharmacists, and patient advocates should ensure that patients with Parkinson’s disease who are prescribed the brand-name Apokyn cartridges or the generic apomorphine hydrochloride cartridges understand generic substitution in their state and how it affects the patient’s apomorphine hydrochloride injection prescription.

The most common side effects associated with apomorphine hydrochloride injection are yawning, drowsiness/somnolence, dyskinesias (involuntary muscle movements), dizziness/postural hypotension, rhinorrhea (runny nose), nausea, vomiting, hallucination/confusion, and edema/swelling of extremities.