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IMPORTANT SAFETY INFORMATION & USE

Do not take ONAPGO if you are:

• taking certain medicines to treat nausea (ondansetron, granisetron, dolasetron, palonosetron) and alosetron. People taking ondansetron with apomorphine had very low blood pressure and lost consciousness (blacked out).
• allergic to apomorphine or to any ingredients in ONAPGO including sulfite. Sulfites can cause severe, life-threatening allergic reactions, especially in people with asthma.

Call your healthcare provider or get emergency help right away if you have any of the following symptoms of severe life-threatening allergic reaction: 

• hives • itching • rash • swelling (eyes, tongue, lips, or mouth) • chest pain • throat tightness • trouble breathing or swallowing

Before you start using ONAPGO, tell your healthcare provider about all of your medical conditions, including: 

• difficulty staying awake during the daytime • dizziness, fainting spells, or low blood pressure • asthma • allergies to any medicines containing sulfites • heart problems • a history of stroke or other brain problems • kidney problems • liver problems • kidney problems • a mental problem called a major psychotic disorder • drinking alcohol • if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if ONAPGO will harm your unborn baby or pass into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription (over-the-counter) medicines, vitamins, and herbal supplements. ONAPGO and certain other medicines may affect each other and cause serious side effects.

• If you take nitroglycerin under your tongue (sublingual) while using ONAPGO, your blood pressure may decrease and cause dizziness. If possible, lie down before taking it and then try to continue lying down for at least 45 minutes after.

What should I avoid while using ONAPGO? 

• Do not drink alcohol. It can increase your chance of developing serious side effects.
• Do not take medicines that make you sleepy.
• Do not drive, operate machinery, or do other dangerous activities until you know how ONAPGO affects you.
• Do not change your position too fast, get up slowly from sitting or lying. ONAPGO can lower blood pressure and cause dizziness or fainting.

What are the possible side effects of ONAPGO?

ONAPGO may cause serious side effects, including: 

• blood clots. Infusing ONAPGO into a vein (intravenous) can cause blood clots. Do not infuse ONAPGO in your vein.
• nausea and vomiting are common. May be serious or severe. Your healthcare provider may prescribe medicine (trimethobenzamide) to help decrease nausea/vomiting. Follow your healthcare provider’s instructions on how to take/when to stop this medicine.
• sleepiness or falling asleep during the day is common and may be serious. Some people may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving.
• dizziness is common and may be serious. ONAPGO can lower your blood pressure and cause dizziness. Dizziness can happen when treatment is started or when the dose is increased. Do not get up too fast from sitting or lying down, especially if you have been sitting or lying down for a long time.
• falls. Changes that can happen with PD, and effects of some PD medicines, including ONAPGO, as well as trimethobenzamide, can increase your risk of falling.
• infusion site reaction is common and may be serious. Reactions and infections including infusion site nodules, redness, bruising, swelling, rash, and itching may happen.
• hallucinations or psychotic-like behavior. ONAPGO can cause/worsen psychotic-like behavior including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking.
• sudden uncontrolled movements (dyskinesia) are common and may be serious. Some people with PD may get sudden, uncontrolled movements after treatment with some PD medicines. ONAPGO can cause/make dyskinesia worse.
• low red blood cells (hemolytic anemia). Tell your healthcare provider if you have: become pale, fast heartbeat, feel more tired or weaker than usual, skin or eyes look yellow, chest pain, shortness of breath or trouble breathing, dark-colored urine, fever, dizziness, or confusion.
• strong (intense) urges. New or increased gambling urges, sexual urges, and other intense urges have been reported. 
• heart problems. If you have shortness of breath, fast heartbeat, or chest pain, call your healthcare provider or get emergency help right away.
• serious heart rhythm changes (QT prolongation). Tell your healthcare provider right away if you have a change in your heartbeat (a fast or irregular heartbeat), or faint. 
• allergic reaction. Tell your healthcare provider or get medical help right away if you get hives, itching, rash, swelling of the eyes and tongue, or trouble breathing. 
• tissue changes (fibrotic complications). Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called non-ergot derived dopamine agonists like ONAPGO.
• prolonged painful erections (priapism). May occur. If you have an erection that lasts more than 4 hours, call your healthcare provider or go to the nearest hospital emergency room right away.

Other common side effects of ONAPGO include headache and trouble falling asleep or staying asleep (insomnia). 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

USE
ONAPGO is a prescription medicine used to treat motor fluctuations (OFF episodes) in adults with advanced Parkinson’s disease (PD). It is not known if ONAPGO is safe and effective in children.

Patients and care partners must receive complete instructions on the proper use of ONAPGO. Please see Patient Information and Patient Instructions for Use and talk to your healthcare provider.