ONAPGO
Generic: APOMORPHINE HYDROCHLORIDE
Basic Information
Manufacturer
MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
SUBCUTANEOUS
FDA Set ID
f3552b6e-5ae7-4993-aa1a-e399c4a7080a
Indications & Usage
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 )
ONAPGO is a dopaminergic agonist indicated for the treatment of motor fluctuations in adults with advanced Parkinson's disease.
( 1 )
Adverse Reactions
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 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) ] Most common adverse reactions (incidence ≥10% on ONAPGO and at least twice the rate of placebo) were infusion site nodule, nausea, somnolence, infusion site erythema, dyskinesia, headache, and insomnia.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
at toll-free number 1-833-366-2746 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 197 Parkinson's disease patients were exposed to ONAPGO in Study 1 and subsequent open-label studies.
In Study 1 [see Clinical Studies (14) ], the most common adverse reactions (incidence 10% or greater in patients treated with ONAPGO and at a rate at least twice the placebo rate) were infusion site nodule, nausea, somnolence, infusion site erythema, dyskinesia, headache, and insomnia.
Table 1 presents adverse reactions that occurred in ≥5% of patients treated with ONAPGO and that occurred more frequently than placebo in patients who were enrolled in Study 1.
Table 1: Adverse Reactions Reported by ≥5% of Patients Treated with ONAPGO and More Frequently than Placebo in Study 1 ONAPGO Variable doses [see Dosage and Administration (2.3)] N=54 % Placebo N=53 % Infusion site nodule 44 0 Nausea 22 9 Somnolence 22 4 Infusion site erythema 17 4 Dyskinesia 15 0 Headache 13 4 Insomnia 11 2 Dizziness 9 4 Hypotension 7 0 Asthenia 7 0 Fatigue 7 2 Constipation 7 6 Vomiting 7 4 Infusion Site Reactions In Study 1, infusion site reactions were most commonly reported as nodule formation (44% of patients treated with ONAPGO compared to no patients who received placebo) or erythema (17% of patients treated with ONAPGO compared to 4% of patients who received placebo).
Less Common Adverse Reactions Other adverse reactions, including hallucinations, psychotic disorder, impulse control disorder, prolonged QT interval, and infusion site infections [see Warnings and Precautions (5.6) ] , have been reported in patients treated with ONAPGO [see Warnings and Precautions (5.7 , 5.10 .
5.12) ].
Adverse Reactions Leading to Discontinuation of ONAPGO Treatment Six (11%) patients treated with ONAPGO reported one of the following adverse reactions as the reason for discontinuing from Study 1: nausea, orthostatic intolerance, visual hallucination, gait disturbance, infusion site nodule, and hypotension.
None of the patients who received placebo discontinued from Study 1 because of an adverse reaction.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of apomorphine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hematologic and Lymphatic Systems: hemolytic anemia [see Warnings and Precautions (5.9) ]
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
at toll-free number 1-833-366-2746 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
A total of 197 Parkinson's disease patients were exposed to ONAPGO in Study 1 and subsequent open-label studies.
In Study 1 [see Clinical Studies (14) ], the most common adverse reactions (incidence 10% or greater in patients treated with ONAPGO and at a rate at least twice the placebo rate) were infusion site nodule, nausea, somnolence, infusion site erythema, dyskinesia, headache, and insomnia.
Table 1 presents adverse reactions that occurred in ≥5% of patients treated with ONAPGO and that occurred more frequently than placebo in patients who were enrolled in Study 1.
Table 1: Adverse Reactions Reported by ≥5% of Patients Treated with ONAPGO and More Frequently than Placebo in Study 1 ONAPGO Variable doses [see Dosage and Administration (2.3)] N=54 % Placebo N=53 % Infusion site nodule 44 0 Nausea 22 9 Somnolence 22 4 Infusion site erythema 17 4 Dyskinesia 15 0 Headache 13 4 Insomnia 11 2 Dizziness 9 4 Hypotension 7 0 Asthenia 7 0 Fatigue 7 2 Constipation 7 6 Vomiting 7 4 Infusion Site Reactions In Study 1, infusion site reactions were most commonly reported as nodule formation (44% of patients treated with ONAPGO compared to no patients who received placebo) or erythema (17% of patients treated with ONAPGO compared to 4% of patients who received placebo).
Less Common Adverse Reactions Other adverse reactions, including hallucinations, psychotic disorder, impulse control disorder, prolonged QT interval, and infusion site infections [see Warnings and Precautions (5.6) ] , have been reported in patients treated with ONAPGO [see Warnings and Precautions (5.7 , 5.10 .
5.12) ].
Adverse Reactions Leading to Discontinuation of ONAPGO Treatment Six (11%) patients treated with ONAPGO reported one of the following adverse reactions as the reason for discontinuing from Study 1: nausea, orthostatic intolerance, visual hallucination, gait disturbance, infusion site nodule, and hypotension.
None of the patients who received placebo discontinued from Study 1 because of an adverse reaction.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of apomorphine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hematologic and Lymphatic Systems: hemolytic anemia [see Warnings and Precautions (5.9) ]