ONAPGO (apomorphine hydrochloride)

AbsorptionAfter subcutaneous administration, apomorphine appears to have bioavailability equal to that of intravenous administration. Steady-state concentrations are reached in approximately two hours after initiation of a continuous dose. If an extra dose is administered at the initiation of the continuous dose [see Dosage and Administration (2.3) ] , time to reach half (50%) of infusion steady-state concentrations can be shortened by 50-75%. If an extra dose is administered two hours or later...

Study 1(NCT02006121) was a multicenter, parallel-group, double-blind, randomized, placebo-controlled trial to evaluate the efficacy and safety of ONAPGO subcutaneous infusion in patients with Parkinson's disease who had motor fluctuations while receiving carbidopa/levodopa and other concomitant medications to treat PD. The study design included a double-blind, 12-week treatment period, inclusive of 1-4 weeks of dose titration and then continued treatment with study medication at an individualized, stable dosage. Patients then had the option to receive ONAPGO in a 52-week, open-label treatment...

The following clinically significant adverse reactions are described elsewhere in the labeling: Serious Adverse Reactions After Intravenous Administration [see Warnings and Precautions (5.1) ] Nausea and Vomiting [see Warnings and Precautions (5.2) ] Falling Asleep During Activities of Daily Living and Somnolence [see Warnings and Precautions (5.3) ] Syncope/Hypotension/Orthostatic Hypotension [see Warnings and Precautions (5.4) ] Falls [see Warnings and Precautions (5.5) ] Infusion Site Reactio...

ONAPGO is contraindicated in patients: Using concomitant 5HT 3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1) ] . There have been reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. With hypersensitivity/allergic reaction to apomorphine or any of the e...

Subcutaneous use only; thrombus formation and pulmonary embolism have followed intravenous administration of ONAPGO. ( 5.1 ) May cause nausea and vomiting. ( 2.2 , 5.2 ) Falling asleep during activities of daily living and daytime somnolence may occur. ( 5.3 ) May cause hypotension/orthostatic hypotension and syncope may occur. ( 5.4 ) May cause or increase the risk of falls. ( 5.5 ) May cause infusion site reactions and infections. Monitor and change infusion site every day. ( 2.4 , 5.6 ) May c...

7 DRUG INTERACTIONS Concomitant use of antihypertensive medications and vasodilators: increased risk for hypotension, falls, and injuries. ( 7.2 ) Dopamine antagonists such as neuroleptics or metoclopramide, may diminish the effectiveness of ONAPGO. ( 7.4 ) 7.1 5HT 3 Antagonists Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, t...