APOKYN- apomorphine hydrochloride injection
US WorldMeds, LLC
1 INDICATIONS AND USAGE
APOKYN (apomorphine hydrochloride injection) is indicated for the acute, intermittent treatment of hypomobility, �off" episodes (�end-of-dose wearing off" and unpredictable �on/off" episodes) in patients with advanced Parkinson�s disease. APOKYN has been studied as an adjunct to other medications [see Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
APOKYN is indicated for subcutaneous administration only [see Warnings and Precautions (5.1)] and only by a multiple-dose APOKYN Pen with supplied cartridges. The initial dose and dose titrations should be performed by a healthcare provider. Blood pressure and pulse should be measured in the supine and standing position before and after dosing.
A caregiver or patient may administer APOKYN if a healthcare provider determines that it is appropriate. Instruct patients to follow the directions provided in the Patients Instructions For Use. Because the APOKYN Pen has markings in milliliters (mL), the prescribed dose of APOKYN should be expressed in mL to avoid confusion.
Visually inspect the APOKYN drug product through the viewing window for particulate matter and discoloration prior to administration. The solution should not be used if discolored (it should be colorless), or cloudy, or if foreign particles are present. Rotate the injection site and use proper aseptic technique [see How Supplied/Storage and Handling (16) and Patient Counseling Information (17)].
2.2 Premedication and Concomitant Medication
? Because of the high incidence of nausea and vomiting with APOKYN treatment, an antiemetic, e.g., trimethobenzamide 300 mg three times a day, should be started 3 days prior to the initial dose of APOKYN [see Warnings and Precautions (5.2)]. Treatment with trimethobenzamide should only be continued as long as necessary to control nausea and vomiting, and generally no longer than two months after initiation of treatment with APOKYN, as trimethobenzamide increases the incidence of somnolence, dizziness and falls in patients treated with APOKYN [see Warnings and Precautions (5.2)].