(BPT) - Living with Parkinson’s disease (PD) can be hard for the nearly 1 million Americans with the disease[i] and may present unexpected daily challenges. As the disease progresses, a person’s response to medications to treat their PD symptoms can change, leading to the re-emergence or worsening of PD symptoms between doses. These periods are known as OFF episodes and are experienced by an estimated 350,000 people in the U.S. living with PD.
The symptoms of OFF episodes may include motor symptoms like tremor, stiffness, slow movement, and difficulty communicating, as well as non-motor symptoms like anxiety and depression.[ii],[iii] During OFF episodes, someone with PD may have difficulties doing everyday tasks like walking unassisted or getting up out of a chair.
OFF episodes are more common than people might think
OFF episodes may occur in as many as 50% of people with PD after five years of levodopa treatment, and the percentage increases over time.[iv] 70% of patients beyond nine years of oral levodopa treatment will experience OFF episodes.[v] These episodes can take place in the morning upon waking or throughout the day.
Drew Falconer, M.D., a leading movement disorder specialist at the Inova Parkinson’s and Movement Disorders Center in Fairfax, Va., and Associate Professor of Neurology at the UVA School of Medicine, Inova Campus, has worked with people with PD and their families for over six years and recognizes that OFF episodes can be a challenge.
“The first signs of OFF episodes may be as subtle as realizing that PD medications do not last as long as they once did, having difficulty getting out of bed in the morning, or getting dressed for the day,” said Dr. Falconer. “As PD progresses, symptoms may get worse, and these episodes may become more frequent.”
The impact of OFF episodes
Living with OFF episodes may be challenging for some patients and their care partners. They may affect a person’s ability to perform daily activities, such as buttoning a shirt or eating meals. In addition, the often unpredictable nature of OFF episodes can make them difficult to identify and even discuss effectively with healthcare providers.
Talking to the doctor about difficult parts of PD like OFF episodes is important. Some people may accept these episodes as part of PD, without realizing that they are manageable. Other people may find it hard to choose which symptoms to share and find the right words to explain their experiences to their physician.
“As people notice OFF episodes becoming more frequent and disruptive, they can keep a journal to track symptoms and identify patterns of when they occur most often, and discuss a treatment plan with their physician,” says Dr. Falconer. “It’s important for people living with PD and their families to know that OFF episodes can be managed. Fortunately, there are medicines available that can safely and effectively treat OFF episodes as they occur.”
New options for patients
Most medicines focus on keeping people ON (when levodopa/carbidopa is working and symptoms are improved) rather than treating OFF episodes as they happen. Patients now have treatment options to treat OFF episodes on-demand, as they occur, wherever they occur.
The newest FDA-approved treatment for OFF episodes associated with PD is KYNMOBI™ (apomorphine HCl) sublingual film, which is now available by prescription in the U.S. KYNMOBI is the first and only sublingual (under the tongue) treatment for PD OFF episodes. It dissolves under the tongue and may help people improve motor symptoms when they need it.
Before starting any treatment, people should talk to their doctor to determine which treatment options may be right for them and to understand the potential benefits and risks.
For more information about OFF episodes and treatment with KYNMOBI, visit KYNMOBI.com. Please see below for Important Safety Information.
IMPORTANT SAFETY INFORMATION 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
- 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 an antiemetic, such as trimethobenzamide to help prevent nausea and vomiting. If trimethobenzamide is prescribed, talk to your healthcare provider about how long you should remain on this medicine.
- 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.
- mouth sores (ulceration)
- dryness of the mouth, lips or tongue
- 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.
- 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
- 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:
- mouth swelling, pain, or sores
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.
[i] Parkinson’s Disease Foundation Website: https://www.parkinson.org/about-us/Press-Room/Press-Releases/New-Study-Shows-Over-1-Million-People-in-the-United-States-Estimated-to-be-Living-with-Parkinsons-Disease-by-2030. Accessed December 2020.
[ii] The Michael J. Fox Foundation. “Ask the MD: The Language of Parkinson's, 'Off' Time.’” https://www.michaeljfox.org/news/ask-md-language-parkinsons-time. Accessed December 2020.
[iii] Racette BA, et al. “Clinical features and comorbidity of mood fluctuations in Parkinson's disease.” Journal of Neuropsychiatry and Clinical Neurosciences. 2002 Fall;14(4):438-42. https://doi.org/10.1176/jnp.14.4.438.
[iv] Thanvi BR, Lo TCN. Long term motor complications of levodopa: clinical features, mechanisms, and management strategies. Postgrad Med J. 2004;80:452-458.
[v] Ahlskog JE, Muenter MD. Frequency of levodopa-related dyskinesias and motor fluctuations as estimated from the cumulative literature. Mov Disord. 2001;16(3):448-458.