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Apokyn

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Apokyn

Apokyn

INDICATIONS

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) associated with advanced Parkinson's disease. APOKYN (apomorphine) has been studied as an adjunct to other medications (see CLINICAL PHARMACOLOGY: Clinical Studies).

DOSAGE AND ADMINISTRATION

The prescribed dose of APOKYN (apomorphine) should always be expressed in mL to avoid confusion and doses greater than 0.6 mL (6 mg) are not recommended. Patients and caregivers must receive detailed instructions in the preparation and injection of doses, with particular attention paid to the correct use of the dosing pen (see PATIENT INFORMATION).

APOKYN (apomorphine) is indicated for subcutaneous administration only. APOKYN (apomorphine) should not be initiated without use of a concomitant antiemetic (see WARNINGS: Nausea and Vomiting). Most antiemetic experience is with trimethobenzamide and this should generally be used. Trimethobenzamide (300 mg tid orally) should be started 3 days prior to the initial dose of apomorphine and continued at least during the first two months of therapy. Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with drugs of the 5HT3 antagonist class (including, for example, ondansetron, granisetron, dolasetron, palonosetron, and alosetron) is contraindicated (see CONTRAINDICATIONS).

The dose of APOKYN (apomorphine) must be titrated on the basis of effectiveness and tolerance, starting at 0.2 mL (2 mg) and up to a maximum recommended dose of 0.6 mL (6 mg) as follows:

Patients in an “off” state should be given a 0.2 mL (2 mg) 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 (apomorphine) . If the patient tolerates the 0.2 mL (2 mg) dose, and responds, the starting dose should be 0.2 mL (2 mg) used on an as needed basis to treat existing “off” episodes. If needed, the dose can be increased in 0.1 mL (1 mg) 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 mL 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 (1 mg) lower than the tolerated test dose.

For patients who tolerate the test dose of 0.2 mL (2 mg) but achieve no response, a dose of 0.4 mL (4 mg) may be administered at the next observed “off” period, but no sooner than 2 hours after the initial test dose of 0.2 mL (2 mg). 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 (4 mg) the starting dose should be 0.3 mL (3 mg) used on an as needed basis to treat existing “off” episodes. If needed, the dose can be increased in 0.1 mL (1 mg) increments every few days on an outpatient basis. If a patient does not tolerate a test dose of 0.4 mL (4 mg), a test dose of 0.3 mL (3 mg) may be administered during a separate “off” period, no sooner than 2 hours after the test dose of 0.4 mL (4 mg). 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 (3 mg) test dose, the starting dose should be 0.2 mL (2 mg) used on an as needed basis to treat existing “off” episodes. If needed, and the 0.2 mL (2 mg) dose is tolerated, the dose can be increased to 0.3 mL (3 mg) after a few days.

In such a patient, the dose should ordinarily not be increased to 0.4 mL (4 mg) on an out-patient basis.

Most patients studied in the apomorphine development program responded to 0.3 mL to 0.6 mL (3 mg to 6 mg). There is no evidence from controlled trials that doses greater than 0.6 mL (6 mg) 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 (6 mg), dosing more than 5 times per day and with total daily doses greater than 2.0 mL (20 mg).

If a single dose of apomorphine is ineffective for a particular “off” period, a second dose should not be given for that “off” episode. The efficacy of a second dose for a single “off” episode has not been systematically studied and the safety of redosing has not been characterized.

Patients who have a significant interruption in therapy (more than a week) should be restarted on a 0.2 mL (2 mg) dose and gradually titrated to effect.

When dosing patients with mild and moderate hepatic impairment, caution should be exercised due to the increased Cmax and AUC in these patients (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

For patients with mild and moderate renal impairment, the testing dose and subsequently the starting dose should be reduced to 0.1 mL (1 mg) (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

Patients should be instructed to administer apomorphine as described in the Patient Instruction Leaflets.

HOW SUPPLIED

APOKYN® (10 mg/mL) containing apomorphine hydrochloride (as apomorphine hydrochloride hemihydrate), USP is supplied as a clear, colorless, sterile, solution in 3 mL cartridges. The 3 mL glass cartridges are used with a manual reusable, multiple dose injector pen. The pen can deliver doses up to 1.0 mL in 0.02 mL increments. The pen is provided in a package with six needles and a carrying case.

The 3 mL glass cartridges are provided as follows:

NDC 15054-0211-5

Cartons of five 3 mL cartridges

Manufactured by: Vetter Pharma-Fertigung GmbH & Co. KG 88212 Ravensburg, Germany. Distributed by: Tercica, Inc. a subsidiary of the Ipsen Group, Brisbane, CA 94005. The injector pen is manufactured by: Becton, Dickinson and Company Franklin Lakes, NJ 07417 or Becton Dickinson Europe 11, Rue Aristide Berges B.P. 4, 38800 Le Pont–De-Claix, France. Store at 25°C (77°F) Excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. IPSEN, Distributed by: Tercica, Inc. a subsidiary of the Ipsen Group, Brisbane, CA 94005. Revised July 2010

Last reviewed on RxList: 9/23/2010
This monograph has been modified to include the generic and brand name in many instances.

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