Apomorphine Hydrochloride
Generic Name: apomorphine hydrochloride
Brand Names:
Onapgo
11 DESCRIPTION ONAPGO (apomorphine hydrochloride) contains apomorphine hydrochloride hemihydrate, a non-ergoline dopamine agonist. It is chemically designated as 6aβ-aporphine-10,11-diol hydrochloride hemihydrate with a molecular formula of C 17 H 17 NO 2 ∙HCl∙½H 2 O. Its structural formula and molecular weight are: Apomorphine hydrochloride hemihydrate appears as minute, white or grayish-white glistening crystals or as white powder that is soluble in water at 80°C.
Overview
11 DESCRIPTION ONAPGO (apomorphine hydrochloride) contains apomorphine hydrochloride hemihydrate, a non-ergoline dopamine agonist. It is chemically designated as 6aβ-aporphine-10,11-diol hydrochloride hemihydrate with a molecular formula of C 17 H 17 NO 2 ∙HCl∙½H 2 O. Its structural formula and molecular weight are: Apomorphine hydrochloride hemihydrate appears as minute, white or grayish-white glistening crystals or as white powder that is soluble in water at 80°C.
Uses
1 INDICATIONS AND USAGE ONAPGO is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ONAPGO is a dopaminergic agonist indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION For subcutaneous use by infusion only. ( 2.1 ) Maximum recommended total daily dosage of ONAPGO, including the continuous dosage and any extra dose(s), is 98 mg generally administered over the waking day (e.g., 16 hours). ( 2.3 ) The recommended initial continuous dosage is 1 mg/hr with a maximum of 6 mg/hr for up to 16 hours per day. ( 2.3 ) The extra dose may be titrated in increments of 0.5 mg or 1 mg based on clinical response and tolerability. Subsequent extra doses are between 0.5 mg and 2 mg, with at least 3 hours between extra doses and a maximum of 3 extra doses per day.
Side Effects
6 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 W...
Interactions
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, the concomitant use of ONAPGO with 5HT 3 antagonists, including antiemetics (e.g., ondansetron, granisetron, palonosetron) and alosetron, is contraindicated [see Warnings and Precautions (5.4) ].
Warnings
5 WARNINGS AND PRECAUTIONS 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 cause hallucinations and psychotic-like behavior. ( 5.7 ) May cause dyskinesia or exacerbate pre-existing dyskinesia. ( 5.8 ) May cause hemolytic anemia. ( 5.9 ) May cause impulse control/ compulsive and impulsive behaviors. Consider dose reductions or stopping ONAPGO. 4 CONTRAINDICATIONS 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.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of ONAPGO in pregnant women. In animal reproduction studies, apomorphine had adverse developmental effects in rats (increased neonatal deaths) and rabbits (increased incidence of malformation) when administered during pregnancy at clinically relevant doses. These doses were also associated with maternal toxicity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Storage
16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
Frequently Asked Questions
What is Apomorphine Hydrochloride used for?▼
1 INDICATIONS AND USAGE ONAPGO is indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ONAPGO is a dopaminergic agonist indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease. ( 1 )
What are the side effects of Apomorphine Hydrochloride?▼
6 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 W...
Can I take Apomorphine Hydrochloride during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of ONAPGO in pregnant women. In animal reproduction studies, apomorphine had adverse developmental effects in rats (increased neonatal deaths) and rabbits (increased incidence of malformation) when administered during pregnancy at clinically relevant doses. These doses were also associated with maternal toxicity. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
What are the important warnings for Apomorphine Hydrochloride?▼
5 WARNINGS AND PRECAUTIONS 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 cause hallucinations and psychotic-like behavior. ( 5.7 ) May cause dyskinesia or exacerbate pre-existing dyskinesia. ( 5.8 ) May cause hemolytic anemia. ( 5.9 ) May cause impulse control/ compulsive and impulsive behaviors. Consider dose reductions or stopping ONAPGO. 4 CONTRAINDICATIONS 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.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.