Kynmobi is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson's disease (PD).

It is not known if this medicine is safe and effective in children.

• Read the step-by-step Instructions for Use that comes with your prescription.
• Take Kynmobi exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much to take and teach you the right way to take it.
• Your healthcare provider may change your dose if needed.
• Do not change your dose or take it more often than prescribed unless your healthcare provider has told you to.
• Do not take more than 1 dose of Kynmobi to treat a “OFF” episode.
• Do not take another dose of Kynmobi sooner than 2 hours after the last dose.
• Do not take Kynmobi more than 5 times a day.
• Do not cut, chew or swallow the sublingual film.

Your healthcare provider may prescribe another medicine for nausea called an antiemetic to take while you are taking Kynmobi. Antiemetic medicines help to decrease the symptoms of nausea and vomiting that can happen during treatment.

Do not take Kynmobi if you are:

• taking certain medicines to treat nausea called 5HT3 antagonists including ondansetron, granisetron, dolasetron, palonosetron, and alosetron.
• People taking ondansetron together with apomorphine, the active ingredient in Kynmobi, have had very low blood pressure and lost consciousness or “blacked out.”
• allergic to apomorphine hydrochloride or to any of the other ingredients. See the end of the page for a complete list of ingredients.
• Kynmobi also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites.
  Call your healthcare provider or get emergency help right away if you get any of the following symptoms of a severe life-threatening allergic reaction:
  
  • hives
  • itching
  • rash
  • swelling of the lips, tongue, and mouth
  • redness of your face (flushing)
  • throat tightness
  • trouble breathing or swallowing

Before taking Kynmobi

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

• have difficulty staying awake during the daytime.
• have dizziness.
• have fainting spells.
• have low blood pressure.
• have asthma.
• are allergic to any medicines containing sulfites
• have liver problems.
• have kidney problems.
• have 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. It is not known if Kynmobi will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Kynmobi passes into your breast milk. You and your healthcare provider should decide if you will take Kynmobi or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription medicines and, over-the-counter medicines, vitamins, and herbal supplements.

Kynmobi may affect the way other medicines work, and other medicines can affect how Kynmobi works.

Taking Kynmobi with other medicines may cause serious side effects.

• If you take nitroglycerin under your tongue (sublingual) while using Kynmobi, your blood pressure may decrease and cause dizziness. You should lie down before and after taking sublingual nitroglycerin.

Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.

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

Kynmobi can cause serious side effects, including:

• nausea and vomiting. Nausea is a common side effect. Nausea and vomiting can happen with Kynmobi. Your healthcare provider may prescribe a medicine called an antiemetic, such as trimethobenzamide, to help prevent nausea and vomiting. Some patients can stop taking trimethobenzamide after using Kynmobi, when advised by your healthcare provider. Some patients may need to keep taking trimethobenzamide to help treat nausea and vomiting. Talk to your healthcare provider before you stop taking trimethobenzamide.
• sleepiness or falling asleep during the day. Sleepiness is a serious and common side effect. Some people treated with Kynmobi may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car. allergic reactions.
• dizziness. Dizziness is a serious, and common side effect. Kynmobi may 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 after lying down, especially if you have been sitting or lying down for a long period of time.
• mouth (oral) irritation. Mouth (oral) irritation is a common side effect. You should call your healthcare provider if you develop any of these signs or symptoms:
  • redness
  • swelling
  • mouth sores (ulceration)
  • pain
  • dryness of the mouth, lips or tongue pain with swallowing
    These signs and symptoms may go away if treatment is stopped.
• falls. The changes that can happen with PD, and the effects of some PD medicines, can increase the risk of falling. Kynmobi may also increase your risk of falling.
• hallucinations or psychotic-like behavior. Kynmobi may cause or make psychotic-like behavior worse 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.
  strong (intense) urges. Some people with PD have reported new or strong uncontrollable urges to gamble, increased sexual urges, increased urges to spend money (compulsive shopping), and other intense urges, while taking PD medicines, including Kynmobi. If you or your family members notice that you have strong urges, talk to your healthcare provider. The strong urges may go away if your Kynmobi dose is lowered or stopped.
• high fever and confusion. Kynmobi may cause a problem that can happen in people who suddenly lower their dose, stop using, or change their dose. Symptoms include:
  • very high fever
  • stiff muscles
  • confusion
  • changes in breathing and heartbeat
    Do not stop taking Kynmobi or change your dose unless you are told to do so by your healthcare provider.
• heart problems. If you have shortness of breath, fast heartbeat, chest pain, or feel like you are going to pass out (faint) while taking Kynmobi, call your healthcare provider or get emergency help right away.
• tissue changes (fibrotic complications). Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called nonergot derived dopamine agonists like Kynmobi.
• prolonged painful erections (priapism). Kynmobi may cause prolonged, painful erections in some people. If you have a prolonged and painful erection you should call your healthcare provider or go to the nearest hospital emergency room right away.

If you have any of these symptoms, stop treatment and call your healthcare provider right away before taking another dose.

The most common side effects include:

• nausea
• sleepiness
• dizziness
• mouth swelling, pain, or sores

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.