Apomorphine

Onapgo

98MG/20ML solutionVereinigte StaatenIm HandelZugelassen am 3. Feb. 2025

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Anwendungsgebiete

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 )

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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 excipients of ONAPGO, including sulfite (i.e., sodium metabisulfite).

Angioedema or anaphylaxis may occur [see Warnings and Precautions (5.13) ]. Concomitant use of ONAPGO with 5HT 3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron. ( 4 , 7.1 ) Hypersensitivity to apomorphine or the excipients of ONAPGO, including sulfite (i.e., sodium metabisulfite). ( 4 , 5.13 )

Warnhinweise und Vorsichtsmaßnahmen

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. ( 5.10 ) May cause cardiac events. ( 5.11 ) May prolong QTc and cause torsades de pointes or sudden death.

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Warnhinweise und Vorsichtsmaßnahmen

Wechselwirkungen

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) ].

7.2Antihypertensive Medications and Vasodilators

In clinical studies with intermittent subcutaneous administration of apomorphine, the following adverse reactions were experienced more commonly in patients receiving concomitant antihypertensive medications or vasodilators (n=94) than in patients not receiving these medications (n=456): hypotension (10% vs 4%), myocardial infarction (3% vs 1%), [see Warnings and Precautions (5.4 , 5.11) ]. In a study of healthy subjects, concomitant administration of 0.4 mg sublingual nitroglycerin with subcutaneous apomorphine caused greater decreases in blood pressure than with subcutaneous apomorphine alone [see Clinical Pharmacology (12.3) ].

Patients treated with ONAPGO should lie down before and after taking sublingual nitroglycerin to decrease the potential risks associated with hypotension .

7.3 Alcohol In a study of healthy subjects, concomitant administration of high dose (0.6 g/kg) or low dose (0.3 g/kg) ethanol with apomorphine caused greater decreases in blood pressure than with apomorphine alone [see Clinical Pharmacology (12.3) ] . Patients should be advised not to consume alcohol while treated with ONAPGO because it may cause greater decreases in blood pressure [see Warnings and Precautions (5.4) ] .

7.4Dopamine Antagonists Because

ONAPGO is a dopamine agonist, it is possible that concomitant use of dopamine antagonists, such as the neuroleptics (phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of ONAPGO. Antiemetics with anti-dopaminergic actions should be avoided [see Warnings and Precautions (5.2) ]. Patients with major psychotic disorders, treated with neuroleptics, should be treated with dopamine agonists only if the potential benefits outweigh the risks [see Warnings and Precautions (5.7) ].

7.5Drugs Prolonging the QT/QTc Interval

Caution should be exercised when prescribing ONAPGO concomitantly with drugs that prolong the QT/QTc interval [see Warnings and Precautions (5.12) and Clinical Pharmacology (12.2) ] .

Nebenwirkungen

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.

6.1Clinical 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.

6.2Postmarketing 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) ]

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Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

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Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

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5.1Serious Adverse Reactions After Intravenous Administration Do

5.2Nausea and Vomiting

5.3Falling Asleep During Activities of Daily Living and Somnolence

5.4Syncope/Hypotension/Orthostatic Hypotension

5.6Infusion Site Reactions and Infections

Wechselwirkungen

7.2Antihypertensive Medications and Vasodilators

7.4Dopamine Antagonists Because

7.5Drugs Prolonging the QT/QTc Interval

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

Nebenwirkungen

6.1Clinical Trials Experience

6.2Postmarketing Experience

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