WHAT IS ONAPGO^TM?

The first and only wearable apomorphine infusion device for people with Parkinson's disease (PD)

ONAPGO is for the continuous treatment of OFF episodes in people with Parkinson’s disease (PD) that are not adequately controlled with oral levodopa and one or more PD medications. Discover what’s possible with ONAPGO.

CONTINUOUS

Help smooth the ups and downs in your day

ONAPGO provides a constant delivery of apomorphine through a wearable infusion device that is generally worn all day.

Wearable device applied just under the skin (subcutaneous), similar to insulin devices

About the size and weight of an average smartphone

CONSISTENT

Help make your days with Parkinson's more predictable with less OFF time

In a clinical trial, patients experienced:

Less daily OFF time with ONAPGO

(primary endpoint)

2.6 HOURS/DAY

VS 0.9 HOURS/DAY
WITH PLACEBO

OFF time = when PD symptoms are not adequately controlled with oral levodopa and can disrupt your day-to-day life.

More GOOD ON time each day

(key secondary endpoint)

2.8 HOURS/DAY

VS 1.1 HOURS/DAY
WITH PLACEBO

GOOD ON time = when you are not experiencing motor symptoms or bothersome dyskinesia.

Study design: The main objective of the ONAPGO clinical study was to evaluate efficacy and safety in people with PD with unsatisfactory control of motor fluctuations despite treatment with oral levodopa and one or more other PD medications. 53 patients received ONAPGO and 54 patients received placebo for 12 weeks. Efficacy was assessed from the start of the study to the end at 12 weeks. The primary measure was the average change in total daily OFF time based on patient diaries. Key secondary efficacy measures included average change in total daily ON time without troublesome dyskinesia.

SAFETY INFORMATION

The most common side effects in the ONAPGO 12-week clinical trial were:

Infusion site bump
Nausea
Sleepiness
Infusion site redness
Dyskinesia
Headache
Insomnia

ONAPGO can cause serious side effects, including:

Allergic reaction
Blood clots
Nausea and vomiting
Sleepiness or falling asleep during the day
Dizziness
Falls
Hallucinations or psychotic-like behavior
Sudden uncontrolled movements (dyskinesia)
Low red blood cells (hemolytic anemia)
Strong (intense) urges
Heart problems
Serious heart rhythm changes (QT prolongation)
Fever and confusion
Tissue changes (fibrotic complications)

Circle of Care^TM Program

For the entire time you’re on ONAPGO, you and your care partner will receive ongoing comprehensive support.

Clinical Educators are licensed and experienced nurses who provide personalized help with starting ONAPGO, setting up and wearing the device, collaborating with your doctor, and more.

Circle of Care Coordinators can assist with insurance coverage, assistance programs, and answer any questions. They'll also work with your doctor's office and specialty pharmacy for medication delivery.

Call 1-833-3-ONAPGO or 1-833-366-2746 for more information

Stay in the know about ONAPGO

IMPORTANT SAFETY INFORMATION

Use & Important Safety Information Do not take ONAPGO if you are:

taking certain medicines to treat nausea (ondansetron, granisetron, dolasetron, palonosetron) and alosetron. People Read More

taking certain medicines to treat nausea (ondansetron, granisetron, dolasetron, palonosetron) and alosetron. People taking ondansetron with apomorphine had very low blood pressure Read More

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.

IMPORTANT SAFETY INFORMATION

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 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 body 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. OR adjust your ONAPGO dosing to manage symptoms. 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 the 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 (dyskinesias) 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 dyskinesias 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, 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-10881-800-FDA-1088.

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.