Onapgo

Pronunciation: on-AP-goh
Generic name: apomorphine hydrochloride 98 mg/20 mL [ 4.9 mg/mL ]
Drug class: Dopaminergic antiparkinsonism agents

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 13, 2025.

What is Onapgo?

Onapgo (apomorphine hydrochloride) is a wearable Infusion device used to help relieve motor fluctuations in adults with advanced Parkinson's disease. Onapgo delivers a continuous infusion of apomorphine under the skin for consistent control of intermittent episodes of poor mobility called " off " episodes of Parkinson's symptoms during the waking day. 

"Off" episodes in Parkinson’s disease (PD) refer to periods when the effects of medication wear off, leading to a return of motor and non-motor symptoms. 

Onapgo infusion works by acting on dopamine receptors in the brain, mimicking the effects of dopamine, a neurotransmitter that is deficient in individuals with Parkinson's disease. By continuously activating these receptors, ONAPGO helps alleviate motor symptoms such as tremors, rigidity, and bradykinesia (slowness of movement). ​

Onapgo mechanism of action is thought to be stimulating D2-type receptors (dopamine receptors) within the caudate-putamen in the brain. Onapgo is from the class of medicines called dopamine agonists.

Onapgo FDA approval and clinical trials

Onapgo FDA approval is to treat motor fluctuations in adults with advanced Parkinson's disease was received on February 4, 2025.  FDA approval is based on positive results from Study 1 (NCT02006121 - TOLEDO),  a  Phase 3, double-blind, placebo-controlled study.

The clinical trial demonstrated Onapgo patients had a:

• 2.6-hour reduction in OFF time per day compared to 0.9 hours with placebo (p=0.0114).
• 2.8-hour increase in ON time (good motor control) compared to 1.1 hours with placebo (p=0.0188).

Onapgo side effects

Common Onapgo side effects

The most common side effects of Onapgo are:

• Lumps at Infusion site  44%
• Nausea 22%
• Sleepiness  22%
• Infusion site redness17%
• Uncontrollable movements, dyskinesia 15%
• Headache 13%
• Insomnia 11%
• Dizziness 9%
• Low blood pressure 7%
• Weakness, lack of energy or strength - Asthenia 7%
• Tiredness, fatigue 7%
• Constipation 7%
• Vomiting 7%

These common side effects occurred in 5 % or more of Onapgo patients in the clinical trial Study 1.

Serious side effects

Onapgo infusion may cause serious side effects. Call your healthcare provider right away if you have any of the serious side effects, including:

• Allergic reaction. An allergic reaction with side effects of hives, itching, rash, swelling (e.g., eyes, tongue, etc.); trouble breathing and/or swallowing may occur after injecting apomorphine.
• Blood clots. Injecting apomorphine into a vein (intravenous) can cause blood clots. Do not inject it in your vein.
• Nausea and vomiting. Severe nausea and vomiting can happen with apomorphine injection. Your healthcare provider may prescribe a medicine called trimethobenzamide (Tigan) to help prevent nausea and vomiting. Some patients can stop taking Tigan after using this medication for several months. Some patients may need to keep taking Tigan to help prevent nausea and vomiting. Talk to your healthcare provider before you stop taking Tigan.
• Sleepiness or falling asleep during the day. Some people treated with apomorphine injection may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car.
• Dizziness. Apomorphine injection can lower your blood pressure and cause dizziness. Dizziness can happen when apomorphine injection treatment is started or when the dose is increased. Do not get up too fast from sitting or after lying down, especially if you have been sitting or lying down for a long period of time.
• Falls. The changes that can happen with Parkinson's disease, and the effects of some Parkinson's disease medicines, can increase the risk of falling. Apomoprhine injection may also increase your risk of falling.
• Hallucinations or psychotic-like behavior. Apomorphine injection 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 Parkinson's disease may get sudden, uncontrolled movements after treatment with some Parkinson's disease medicines. Apomorphine injection can cause or make dyskinesias worse.
• Intense urges. Some people with Parkinsion's disease have reported new or increased gambling urges, increased sexual urges, and other intense urges, while taking Parkinson's disease medicines, including apomorphine injection.
• Heart problems. If you have shortness of breath, fast heartbeat, or chest pain while taking apomorphine injection, 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 site where you inject apomorphine.
• Fever and confusion. This can happen in some people when their Parkinson's disease medicine is stopped or there is a fast decrease in the dose of their Parkinson's disease medicine.
• 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 apomorphine injection.
• Prolonged painful erections (priaprism). Apomorphine injection 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.
• Swelling of ankles/legs. Apomorphine injection may cause swelling, especially in the ankles or legs. Tell your healthcare provider if you notice any swelling.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of apomorphine. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Who should not use this medicine

Do not use this medicine if you:

• Have an allergy or hypersensitivity to the active ingredient apomorphine or the inactive ingredients, including sulfite (i.e., sodium metabisulfite). Call your healthcare provider or get emergency help right away if you get any symptoms of a severe life-threatening allergic reaction.
•  Are taking medicines called 5HT3 antagonists, this includes medicines to treat nausea (ondansetron, granisetron, dolasetron, palonosetron) and alosetron. People taking ondansetron together with apomorphine, the active ingredient in ONAPGO, have had very low blood pressure and lost consciousness (blacked out).

Before taking this medicine

Before you start using the Onapgo infusion, tell your healthcare provider if you have:

• Difficulty staying awake during the daytime
• Dizziness
• Fainting spells
• Low blood pressure
• Asthma
• Are allergic to any medicines containing sulfites
• Liver problems
• Kidney problems
• Heart problems
• Have had a stroke or other brain problems
• Have a mental problem called a major psychotic disorder
• Drink alcohol

Pregnancy

Tell your healthcare professional if you are pregnant or plan to become pregnant, as it is not known if Onapgo infusion will harm your unborn baby.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if Onapgo passes into your breast milk. You and your healthcare provider should decide if you will use Onapgo infusion or breastfeed.

How should I use Onapgo?

Onapgo directions

Keep the infusion site clean and use aseptic technique.

Administer Onapgo infusion under the skin in one of the following areas:

• Abdomen at least 2 inches away from the navel
• Top of thigh
• Lower back
• Upper back, only when the infusion site is being prepared by a caregiver or healthcare provider
• Change the infusion site every day

Do not select an infusion site that is bruised, has bumps or nodules, or is irritated.

A new single-dose cartridge and cartridge holder should be used each day. Discard the unused portion.

For full instructions with diagrams, see Onapgo Patient Instructions for Use.

General Onapgo instructions

• Use this infusion device exactly as your healthcare provider tells you to use it.
• Follow your healthcare provider’s instructions precisely when using Onapgo. They will teach you the correct way to use it.
• Your healthcare provider will prescribe your dose of Onapgo; your dose should only be changed by your healthcare provider.
• A healthcare provider or a nurse provided by the drug company will program your pump.
• Onapgo is supplied in single-dose prefilled glass cartridges designed for use with the Onapgo pump, as prescribed by your healthcare provider.
• Infuse Onapgo under your skin (subcutaneously) only. Do not inject this medicine into a vein.
• Keep the infusion site clean, and change the infusion site every day.
• Use a new infusion set with each infusion. Never reuse an infusion set.
• The solution is a clear and almost colorless liquid. Do not use it if it looks cloudy, discolored, or contains particles.
• Your healthcare provider may also prescribe trimethobenzamide, starting 3 days before the first dose to help reduce nausea and vomiting that may occur while using this medicine
• Read the Instructions for Use for specific information about the right way to use and to throw away (dispose of) this medicine.

Onapgo dosing information

Onapgo (apomorphine hydrochloride) is given as a subcutaneous infusion using the Onapgo pump. 

Daily Dosage

• The daily dosage is individualized based on patient titration.
• It consists of a continuous infusion and extra doses as needed.
• The maximum recommended total daily dosage, including both continuous and extra doses, is 98 mg per day, typically spread over 16 waking hours.

Continuous Dosage

• The recommended starting dose for continuous infusion is 1 mg/hr.
• The dose can be increased as needed in increments of 0.5 mg/hr to 1 mg/hr.
• Adjustments can be made daily or over longer intervals.
• In clinical studies, had a mean dose of 4 mg/hr.
• The maximum continuous infusion dose is 6 mg/hr, administered over 16 waking hours.

Extra Doses

Extra doses may be used:

• In the morning when starting the infusion.
• After a break of 1 hour or longer (ie, as a loading dose).
• To manage acute OFF symptoms not controlled by the continuous dosage.

Guidelines for Extra Doses:

• The dose can be adjusted based on patient response, increasing in 0.5 mg or 1 mg increments.
• Subsequent extra doses can range from 0.5 mg to 2 mg per dose.
• No more than 3 extra doses per day should be taken within a 16-hour period, with at least 3 hours between extra doses.
• If 3 extra doses are regularly needed each day, the continuous dosage may need further adjustment.
• For patients with mild or moderate renal impairment, the recommended initial extra dose is 0.5 mg to 1 mg and should not exceed 1 mg

Maximum dose

The maximum recommended total daily dosage, including both continuous infusion and extra doses, must not exceed 98 mg over the 16-hour waking period.

What to avoid while using this medicine

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

What other drugs will affect this medicine

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 can cause serious side effects.

If you take nitroglycerin under your tongue while using apomorphine, your blood pressure may decrease and cause dizziness. After taking nitroglycerin, you should lie down and try to continue lying down for at least 45 minutes. You should avoid standing for 45 minutes after taking nitroglycerin.

Know the medicines you take. Keep a list to show your healthcare provider or pharmacist when you get a new medicine.

Not all possible drug interactions are listed here.

Onapgo J code

Onapgo  J code is J0364.
J codes are used for medicines that are not taken orally and include injections, inhalations, and chemotherapies. J codes are important for accurate and consistent coding for billing and reimbursement purposes.

Your physician will need  Onapgo J code when filling out forms for your treatment.

Onapgo Package Insert 

HCPs and patients often use the Onapgo Package Insert (PI) for more detailed information about this medicine. The Package Insert (prescribing information) contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Onapgo Prescribing Information (PI) or FDA label.

Storage

Store at 20°C to 25°C (68°F to 77°F).

Ingredients

Active ingredient: apomorphine hydrochloride

Inactive ingredients: hydrochloric acid, sodium metabisulfite in water for injection.

Manufacturer

Onapgo Manufacturer MDD US Operations, LLC, 9715 Key West Ave., Rockville, MD 20850.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer