Who should not take ONAPGO?

Do not take ONAPGO if you are:

• taking certain medicines to treat nausea called 5HT3 antagonists including Anzemet® (dolasetron), Kytril® (granisetron), Zofran® (ondansetron), Lotronex® (alosetron), and Aloxi® (palonosetron). People taking Zofran® (ondansetron) together with apomorphine, the active ingredient in ONAPGO, have had very low blood pressure and lost consciousness or “blacked out.”
• allergic to ONAPGO or its ingredients and experience hives, itching, rash, or swelling (e.g., eyes, tongue, etc.). ONAPGO also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people, especially people with asthma.

What should I tell my healthcare provider before taking ONAPGO?

Before you start using ONAPGO, tell your healthcare provider if you:

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

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

• If you take nitroglycerin under your tongue while using ONAPGO, your blood pressure may decrease and cause dizziness. After taking nitroglycerin, lie down for at least 45 minutes.

What should I avoid while using ONAPGO?

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

What are the possible side effects of ONAPGO?

Tell your healthcare provider if you experience the following serious side effects:

• blood clots. Injecting ONAPGO into a vein (intravenous) can cause blood clots. Do not inject ONAPGO in your vein.
• nausea and vomiting. Severe nausea and vomiting can happen with ONAPGO. Your healthcare provider may prescribe medicine called an antiemetic, such as trimethobenzamide (Tigan® ), to help prevent it. If Tigan is prescribed, talk to your healthcare provider about how long you should remain on this medicine.
• sleepiness or falling asleep during the day. Some people treated with ONAPGO may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car.
• dizziness. ONAPGO can lower your blood pressure and cause dizziness. Dizziness can happen when ONAPGO 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 period of time.
• falls. The changes that can happen with PD, and the effects of some PD medicines, can increase the risk of falling. ONAPGO may also increase your risk of falling.
• hallucinations or psychotic-like behavior. ONAPGO can cause or 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 (dyskinesias). Some people with PD may get sudden, uncontrolled movements after treatment with some PD medicines. ONAPGO can cause or make dyskinesias worse.
• intense urges. Some people with PD have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking PD medicines, including ONAPGO.
• heart problems. If you have shortness of breath, fast heartbeat, or chest pain while taking ONAPGO, 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 if you faint.
• injection site problems. Bruising, swelling, and itching can happen at the injection site.
• prolonged painful erections (priaprism). ONAPGO may cause prolonged, painful erections in some people. If you have an erection that lasts more than 4 hours you should call your healthcare provider or go to the nearest hospital emergency room right away.

Other common side effects of APOKYN include:

• yawning • runny nose • confusion • swelling of ankles/legs

What is ONAPGO?

ONAPGO is a prescription medicine used to treat acute, intermittent episodes of poor mobility called “off” episodes (end-of-dose wearing “off” or unpredictable “on-off” episodes) in people with advanced Parkinson’s disease (PD). It is not known if ONAPGO is safe and effective in children.

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.

Patients and care partners must receive complete instructions on the proper use of ONAPGO. Please see full Prescribing Information and Instructions for Use/Patient Information.