PROFESSIONAL AREA

More Detailed Dosing Instructions

The dose of APOKYN^® (apomorphine hydrochloride injection) must be titrated on the basis of effectiveness and tolerance, starting at 0.2 mL and up to a maximum recommended dose of 0.6 mL as follows:

Patients in an off state should be given a 0.2-mL test dose in a setting where blood pressure can be closely monitored by medical personnel. Both supine and standing blood pressure should be checked predose and at 20, 40, and 60 minutes post-dose. Patients who develop clinically significant orthostatic hypotension in response to this test dose of apomorphine should not be considered candidates for treatment with APOKYN. If the patient tolerates the 0.2-mL dose, and responds, the starting dose should be 0.2 mL used on an as-needed basis to treat existing off episodes. If needed, the dose can be increased in 0.1-mL increments every few days on an outpatient basis.

Beyond this, the general principle guiding dosing (described in detail below) is to determine a dose (0.3 or 0.4 mL) that the patient will tolerate as a test dose under monitored conditions, and then begin an outpatient dosing trial (periodically assessing both efficacy and tolerability) using a dose 0.1 mL lower than the tolerated test dose.

For patients who tolerate the test dose of 0.2 mL but achieve no response, a dose of 0.4 mL may be administered at the next observed off period, but no sooner than 2 hours after the initial test dose of 0.2 mL. Both supine and standing blood pressure should be checked predose and at 20, 40, and 60 minutes post-dose. If the patient tolerates a test dose of 0.4 mL the starting dose should be 0.3 mL used on an as-needed basis to treat existing off episodes. If needed, the dose can be increased in 0.1-mL increments every few days on an outpatient basis. If a patient does not tolerate a test dose of 0.4 mL, a test dose of 0.3 mL may be administered during a separate off period, no sooner than 2 hours after the test dose of 0.4 mL. Both supine and standing blood pressure should be checked predose and at 20, 40, and 60 minutes post-dose. If the patient tolerates the 0.3-mL test dose, the starting dose should be 0.2 mL used on an as-needed basis to treat existing off episodes. If needed, and the 0.2-mL dose is tolerated, the dose can be increased to 0.3 mL after a few days. In such a patient, the dose should ordinarily not be increased to 0.4 mL on an outpatient basis.

Most patients studied in the apomorphine development program responded to 0.3 to 0.6 mL. There is no evidence from controlled trials that doses greater than 0.6 mL give an increased effect and these doses are not recommended. The average frequency of dosing was 3 times per day in the development program, and there is limited experience with single doses greater than 0.6 mL, dosing more than 5 times per day, and with total daily doses greater than 2.0 mL.

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