Apomorphine Hydrochloride (4 brand names, 3 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, SOLUTION, FILM.
Routes of administration: SUBCUTANEOUS, SUBLINGUAL.
Brand Names
- APOKYN
- APOMORPHINE HYDROCHLORIDE
- KYNMOBI
- ONAPGO
Indications and Usage
ONAPGO is indicated for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Contraindications
ONAPGO is contraindicated in patients: Using concomitant 5HT 3antagonists, 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 excipients of ONAPGO, including sulfite (i.e., sodium metabisulfite). Angioedema or anaphylaxis may occur [see Warnings and Precautions (5.13)].
Adverse Reactions
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 Reactions and Infections [see Warnings and Precautions (5.6)] Hallucinations/Psychotic-Like Behavior [see Warnings and Precautions (5.7)] Dyskinesia [see Warnings and Precautions (5.8)] Hemolytic Anemia [see Warnings and Precautions (5.9)] Impulse Control/Compulsive Behaviors [see Warnings and Precautions (5.10)] Cardiac Events [see Warnings and Precautions (5.11)] QTc Prolongation and Potential for Proarrhythmic Effects [see Warnings and Precautions (5.12)] Hypersensitivity [see Warnings and Precautions (5.13)] Fibrotic Complications [see Warnings and Precautions (5.14)] Priapism [see Warnings and Precautions (5.15)]
Mechanism of Action
ONAPGO is a non-ergoline dopamine agonist with high in vitro binding affinity for the dopamine D4 receptor, and moderate affinity for the dopamine D2, D3, and D5, and adrenergic α1D, α2B, α2C receptors. The precise mechanism of action of ONAPGO as a treatment for Parkinson’s disease is unknown, although it is believed to be due to stimulation of post-synaptic dopamine D2-type receptors within the caudate-putamen in the brain.