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Take on OFF episodes
with KYNMOBI

Lisa is a person living with
Parkinson's disease taking KYNMOBI.

In a clinical study, KYNMOBI improved motor symptoms when taken during an OFF episode

In the KYNMOBI clinical study, people with Parkinson's disease (PD) and taking carbidopa/levodopa were assigned to also take either KYNMOBI or a placebo to treat their OFF episodes.

RESULTS SHOWED:

Improved scores in motor symptoms reported in as soon as 15 minutes Improved scores in motor symptoms reported in as soon as 15 minutes

Improved scores in
motor symptoms
reported in as soon
as 15 minutes

3X greater improvements in OFF symptoms at 30 minutes compared with placebo 3X greater improvements in OFF symptoms at 30 minutes compared with placebo

3X greater improvement
in OFF symptoms
at 30 minutes
compared with placebo

Improved scores in motor symptoms last reported at 90 minutes Improved scores in motor symptoms last reported at 90 minutes

Improved scores in
motor symptoms
last reported
at 90 minutes

The main objective of the KYNMOBI clinical study was to improve motor symptoms at 30 minutes as defined by the Movement Disorder Society‐Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III. In the study, 54 patients received KYNMOBI and 55 patients received placebo.

Other goals of this study measured movement symptoms using the same scale at different times (eg, at 15 minutes and 90 minutes) after taking KYNMOBI during an OFF time. These results are observational and descriptive in nature.

KYNMOBI may help you get to your Full ON during an OFF episode

2x as many people on KYNMOBI reported achieving a Full
ON compared to placebo

as many people on KYNMOBI
reported achieving a Full ON
compared to placebo
(35% vs 16%)*

*The key secondary objective of the KYNMOBI clinical study was the percentage
of people who reported a Full ON response within 30 minutes.

In the KYNMOBI clinical study, Full ON was defined as a time when people experienced at least one of the following:

Improved mobility, reduced stiffness and slowness

Improved mobility,
reduced stiffness and slowness

The ability to perform normal daily activities

The ability to perform
normal daily activities

The same relief from symptoms as taking their
carbidopa/levodopa

The same relief from symptoms
as taking their carbidopa/levodopa

Patients assessed a Full ON using these 3 components, which were not individually recorded.

The most common side effects in the KYNMOBI 12-week clinical study were:

  • Nausea
  • Sleepiness
  • Dizziness
  • Mouth swelling, pain, or sores

KYNMOBI can cause serious side effects, including:

  • Nausea
  • Sleepiness or falling asleep during the day
  • Dizziness
  • Mouth (oral) irritation
  • Falls
  • Hallucinations or psychotic-like behavior
  • low red blood cells (hemolytic anemia)
  • Strong (intense) urges
  • High fever and confusion
  • Heart problems
  • Tissue changes (fibrotic complications)
  • Prolonged painful erections (priapism)
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IMPORTANT SAFETY INFORMATION AND INDICATION FOR KYNMOBI (apomorphine HCI) SUBLINGUAL FILM

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."

Do not use KYNMOBI if you are allergic to apomorphine hydrochloride or to any of the ingredients in KYNMOBI. 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 if you have hives, itching, rash, swelling of the lips, tongue and mouth, redness of your face (flushing), throat tightness, trouble breathing or swallowing.

Before starting KYNMOBI, tell your healthcare provider:

About all of your medical conditions, including if you:

  • have difficulty staying awake during the daytime
  • have liver problems
  • have dizziness
  • have kidney problems
  • have fainting spells
  • have heart problems
  • have low blood pressure
  • have had a stroke or other brain problems
  • have asthma
  • have a mental problem called a major psychotic disorder
  • are allergic to any medicines containing sulfites
  • 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
  • over-the-counter medicines
  • vitamins
  • 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.

KYNMOBI can cause serious side effects, including:

  • nausea and vomiting. Nausea is a common side effect of KYNMOBI. Nausea and vomiting can happen with KYNMOBI. Your healthcare provider may prescribe a medicine called trimethobenzamide, an antiemetic, to help decrease nausea and vomiting, either before starting or during treatment with KYNMOBI. Follow your healthcare provider’s instructions on how to take and when to stop taking trimethobenzamide.
  • sleepiness or falling asleep during the day. Sleepiness is a serious, and common side effect of KYNMOBI. 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.
  • dizziness. Dizziness is a serious, and common side effect of KYNMOBI. KYNMOBI may lower blood pressure and cause dizziness. Dizziness can happen when KYNMOBI treatment is started or when the KYNMOBI 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 of KYNMOBI. You should call your healthcare provider if you develop any of these signs or symptoms:
    • redness
    • mouth sores (ulceration)
    • dryness of the mouth, lips or tongue
    • swelling
    • pain
    • pain with swallowing
  • 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.
  • low red blood cells (hemolytic anemia). Tell your healthcare provider if you have any of the following signs or symptoms:
    • you become pale
    • skin or eyes look yellow
    • chest pain
    • dizziness
    • fever
    • dark-colored urine
    • fast heartbeat
    • feel more tired or weaker than usual
    • shortness of breath or trouble breathing
    • confusion
  • 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 of KYNMOBI. Symptoms include:
    • very high fever
    • confusion
    • stiff muscles
    • 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.

The most common side effects of KYNMOBI include:

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

INDICATION

KYNMOBI® (apomorphine HCl) sublingual film is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson’s disease (PD).

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.

For more information, please see the KYNMOBI Patient Information, full Prescribing Information, and Instructions for Use.