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Apomorphine Dosage

Applies to the following strength(s): 10 mg/mL

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Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Parkinson's Disease

Test dose: 0.2 mL (2 mg) during "Off" period.

Initial: 0.2 mL (2 mg) subcutaneously during the 'Off" period, up to three times per day, if test dose tolerated and provided good response.

Maintenance: Titrate every few days in 0.1 mL (1 mg) increments upwards to a maximum of 0.6 mL (6 mg) per dose.

Maximum single dose is 0.6 mL (6 mg),.

Maximum: do not administer more than 5 times per day, and do not exceed 2 mL (20 mg) per day.

Renal Dose Adjustments

In patients with mild to moderate renal impairment, the starting dose should be reduced to 0.1 mL (1 mg).

No data available in patients with severe renal impairment.

Liver Dose Adjustments

In patients with mild and moderate hepatic impairment exercise caution due to increased Cmax and AUC in these patients.

No data available in patients with severe hepatic impairment.

Dose Adjustments

For patients who tolerated the initial test dose but achieved 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. If the test dose is tolerated, the starting dose should be 0.3 mL (3 mg) used on as needed basis. Dose may be increased in 0.1 mL (1 mg) increments every few days.

If the patient does not tolerate the 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. If the test dose is tolerated, the starting dose should be 0.2 mL (2 mg) used on as needed basis. In these patients dose should not be increased to 0.4 mL (4 mg) on an outpatient setting.

Patients who have an interruption in therapy of more than 1 week should be restarted on the lowest dose and gradually titrated to effect.

Precautions

Severe nausea and vomiting can be expected at the recommended doses of apomorphine.

Syncope has been reported in clinical studies.

Hallucinations have been reported during clinical development.

Rare cases of apomorphine abuse by patients with PD in other countries have been reported. These cases are characterized by increasingly frequent dosing leading to hallucinations, dyskinesia, and abnormal behavior. Psychosexual stimulation with increased libido is thought to underlie these cases. Prescribers should monitor for evidence that patients are abusing apomorphine, such as use out of proportion to motor signs.

Dyskinesia or worsening dyskinesia may be caused by apomorphine.

It is not conclusively known if nonergot derived dopamine agonists can cause fibrotic complications (retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, and cardiac valvulopathy) reported by some patients treated with ergot-derived dopaminergic agents.

If a single dose is ineffective for a particular "Off" period, a second dose should not be given for that "Off" episode.

Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).

Dialysis

No data available

Other Comments

The apomorphine dose should always be expressed in mL to avoid confusion.

Apomorphine should not be started without the use of a concomitant antiemetic. Most studies have been conducted using trimethobenzamide at doses of 300 mg three times daily orally. Trimethobenzamide should be started 3 days before the initial dose and continued for at least the first two months of apomorphine therapy.

An initial test dose of 0.2 mL (2 mg) is given to patients in an "Off" state. Supine and standing blood pressure should be checked predose, and 20, 40, and 60 minutes post dose. If patient develops clinically significant orthostatic hypotension in response to this test dose, then apomorphine should not be considered for treatment.

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