Medically reviewed by Drugs.com. Last updated on May 22, 2019.
Applies to the following strengths: 10 mg/mL
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Parkinson's Disease
Test doses and dose titrations should be administered under close medical supervision:
-Antiemetic premedication should be initiated prior to therapy
TEST DOSE: 2 mg (0.2 mL) subcutaneously in an OFF state
-Obtain supine and standing blood pressure and pulse pre-dose, 20, 40, and 60 minutes post-dose; if significant hypotension is present at 60 minutes post-dose, recheck after 60 minutes
-If a 2 mg test dose is tolerated, but response is inadequate, administer a 4 mg (0.4 mL) test dose subcutaneously at least 2 hours after the previous dose at the next observed OFF period
-If the 4 mg test dose is not tolerated, a 3 mg (0.3 mL) test dose may be administered during a separate OFF period at least 2 hours after the previous dose
-If the 2 mg test-dose is effective and tolerated: Initial dose: 2 mg (0.2 mL) subcutaneously
-If the 3 mg test-dose is effective and tolerated: Initial dose: 2 mg (0.2 mL) subcutaneously
-If the 4 mg test-dose is effective and tolerated: Initial dose: 3 mg (0.3 mL) subcutaneously
-Doses are repeated to treat recurring OFF episodes; a repeat dose should be administered no sooner than 2 hours after the previous dose
-If a single dose is ineffective for a particular OFF episode, a second dose should not be given for that episode
-Average dosing frequency in clinical trials was 3 times per day
DOSE TITRATIONS: Subsequent dose titrations should occur under close medical supervision; titrate in 1 mg increments every few days as needed based on tolerability and effectiveness
Maximum single dose: 6 mg (0.6 mL)
Maximum dosing frequency: 5 times per day
Maximum daily dose: 20 mg (2 mL) per day
-Antiemetic medication is recommended prior to initiating therapy because of the high incidence of nausea and vomiting, e.g., trimethobenzamide 300 mg 3 times a day starting 3 days prior to the initial dose.
-Concomitant use of ondansetron or other 5HT3 antagonist drugs are contraindicated due to reports of profound hypotension and loss of consciousness with concomitant use of ondansetron.
-Patients developing clinically significant orthostatic hypotension to the test dose are not good candidates for therapy with this drug
-The safety and efficacy of administering a second dose for a single OFF episode has not been systematically studied.
-This drug has been studied as an adjunct to other medications.
Use: For the acute, intermittent treatment of hypomobility known as OFF episodes (end-of-dosing wearing off and unpredictable on/off episodes) in patients with advanced Parkinson's disease.
Renal Dose Adjustments
Mild and moderate renal impairment: Reduce test dose and initial dose to 1 mg (0.1 mL)
Severe renal impairment: Data not available
Liver Dose Adjustments
Mild to moderate hepatic impairment: No adjustment recommended; use with close monitoring
Severe hepatic impairment: Data not available
-Patients having an interruption in therapy of more than 1 week should be restarted at the 2 mg dose and gradually titrated to effect and tolerability
-Concomitant use of 5HT3 antagonist drugs including antiemetics (e.g. ondansetron, granisetron, dolasetron, palonosetron) and alosetron; profound hypotension and loss of consciousness has been reported with ondansetron
-Hypersensitivity/allergic reaction to the active substance or any product excipients including a sulfite (i.e., sodium metabisulfite; angioedema or anaphylaxis may occur
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
No data available
-For subcutaneous administration only
-Administer subcutaneously in stomach area, upper arm, or upper leg; rotate injection sites
-Initial dose and dose titrations should be performed by a healthcare provider under close medical supervision
-Patient/caregiver may self-administer once healthcare provider determines it is appropriate
-Doses should be verified in mg and mL to avoid dosing errors; the dose displayed in the dosing window is mL; doses are generally expressed in mL
-Repeat doses should be administered no sooner than 2 hours after previous dose
-Dose is supplied via a multiple-dose pen and cartridge; pens are for single patient use only and should not be shared
-The solution is colorless; do not use if it is cloudy, green, or contains particles
-The dose is set by turning white dose knob until correct number of mL is shown in the window
-If too high a dose is showing, do not dial backwards, but continue to turn dial until it is fully turned; press the injection button fully and this will reset the dial to zero without pushing medicine out of the needle
-It is important to understand that it is possible to dial a dose even if the cartridge contains less than full dose of drug; in this case, a partial dose will be delivered, and the amount remaining to be injected will appear in the dosing window
-To avoid having insufficient drug to deliver a complete dose, patients/caregivers should be encouraged to keep records of how many doses have been delivered for each cartridge, so the cartridge can be replaced before this occurs
-Consult manufacturer product information for complete instructions with illustrations
-Patients who develop clinically significant orthostatic hypotension to the test dose are not good candidates for therapy with this drug.
-There is no evidence to suggest that single doses greater than 6 mg (0.6 mL) provide an increased benefit and therefore are not recommended.
-This drug causes severe nausea and vomiting and therefore 98% of patients in clinical trials were premedicated with trimethobenzamide for 3 days prior to study enrollment and encouraged to continue for at least 6 weeks.
-Studies in healthy individuals have shown concomitant use of ethanol both high (0.6 g/kg) or low dose (0.3 mg/kg) causes greater decreases in blood pressure compared to ethanol alone; patients should avoid alcohol while taking this drug.
-Test Dose: Measure blood pressure and pulse supine and standing before, and 20, 40, and 60 minutes post dose; if there is significant hypotension at 60 minutes, repeat after 60 minutes
-Monitor for signs and symptoms of orthostatic hypotension, especially during dose escalation
-Monitor blood pressure for orthostatic hypotension in patients taking concomitant antihypertensives or vasodilators
-Monitor for somnolence, worsening mental status or behavioral changes, impulse control, and signs and symptoms of coronary or cerebral ischemia
-Patients should be instructed to read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
-Patients should understand they may experience severe nausea and/or vomiting and antiemetics are generally prescribed to help with that.
-Patients should understand they may develop postural hypotension or worsening orthostatic hypotension with this drug; they should be instructed to avoid alcohol and rise slowly after sitting or lying down.
-Patients should be instructed to report hallucinations, changes in behaviors, especially if accompanied by psychosis or intense urges, palpitations, or syncope.
-Patients should be instructed to speak with their healthcare provider before discontinuing therapy.
-Male patients experiencing prolonged painful erections should seek immediate medical attention.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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