(BPT) - Parkinson’s affects about one million people in the U.S. and millions more globally. Medicines have existed to help with Parkinson’s symptoms for many years, but many people with Parkinson’s, about 40 percent in the U.S., still face a problem related to their symptoms: OFF periods. One of these people is Bob Harmon, 70, who experiences these disruptive OFF periods, which are also known as OFF episodes, daily. Here are four things to know:
1. What is Parkinson’s?
With approximately 60,000 Americans newly diagnosed each year, there is a chance Parkinson’s could impact someone in your own life. Parkinson’s is a neurological disorder caused by a progressive loss of neurons in the brain with symptoms including tremor or shaking, slowness and stiffness, among others.
While the exact cause of Parkinson’s is unknown, most experts agree that the condition is likely caused by a combination of genetic and environmental factors.
2. What causes OFF periods?
An OFF period occurs when Parkinson's disease symptoms return before it is time for the next dose of oral medication or when the usual dose of medicine does not work as expected.
Parkinson’s symptoms result from low levels of dopamine, a chemical in the brain, which helps with movement, and symptoms can become more challenging to control over time due to the loss of dopamine nerve cells.
Digestive problems, common in people with Parkinson’s, can affect the way the body absorbs oral medicine, which can also contribute to the development of OFF periods.
OFF periods can include a wide range of symptoms including tremor or shaking, slowness and stiffness, among others. The combination and severity of symptoms are unique for each person with Parkinson’s, and they may appear without warning.
3. Why are OFF periods so troublesome?
A 2014 survey of more than 3,000 people with Parkinson’s conducted by The Michael J. Fox Foundation found that about two-thirds of participants reported having more than two hours of OFF time per day. Because each person with Parkinson’s may experience OFF periods differently, they can be difficult to identify and articulate to loved ones and healthcare providers.
Bob, who was diagnosed with Parkinson’s in 2006 at the age of 57, describes his daily OFF periods as frequent and disruptive. He experiences issues with his stride, making it hard to walk, and has problems keeping his expression.
“My OFF periods were so bothersome that when my doctor let me know there was an investigational treatment for OFF periods, I was eager to participate in the clinical trial to see if it would help me,” Bob said.
People with Parkinson’s and healthcare providers face challenges in discussing OFF periods. These can include difficulty in correctly identifying symptoms and their connection to the “wearing off” of baseline medicines, the differing experiences between people with Parkinson’s and differences in terminology used to describe symptoms.
4. What can people experiencing OFF periods do?
FDA-approved treatment options are available, including an inhaled medicine for many patients who experience OFF periods. Bob participated in the clinical trial for this medicine, called INBRIJA™ (levodopa inhalation powder), which was developed over 20 years and in collaboration with the Parkinson’s community.
“During the trial, INBRIJA helped me manage my OFF periods,” Bob said. He added that he did experience a mild cough while taking the medicine.
Today, Bob takes INBRIJA, as prescribed by his doctor, Robert Hauser, MD, MBA, who is a movement disorder specialist and the director of the Parkinson's & Movement Disorder Center at the University of South Florida.
“If you have Parkinson’s and are experiencing OFF periods while taking carbidopa-levodopa, talk to your healthcare team about the benefits and risks of INBRIJA as a treatment option,” said Dr. Hauser.
Effective communication between physicians and patients about Parkinson’s symptoms could help identify OFF periods and treatment options for those with Parkinson's. For more information about INBRIJA as a treatment option, visit: MoreAboutINBRIJA.com.
INBRIJA™ (levodopa inhalation powder) is a prescription medicine used for the return of Parkinson’s symptoms (known as OFF episodes) in adults treated with carbidopa-levodopa medicines. INBRIJA does not replace regular carbidopa-levodopa medicines.
Important Safety Information
INBRIJA is not to be used if patients take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last 2 weeks.
Before using INBRIJA, patients should tell their healthcare provider about all their medical conditions, including:
- asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
- daytime sleepiness from a sleep disorder or if they get drowsy/sleepy without warning or take a medicine that increases sleepiness such as sleep medicines, antidepressants, or antipsychotics
- feel dizzy, nausea, sweaty, or faint when standing from sitting/lying down
- history of abnormal movement (dyskinesia)
- mental health problem such as hallucinations or psychosis
- uncontrollable urges (for example, gambling, increased sexual urges, intense urges to spend money, or binge eating)
- pregnancy or plans to become pregnant. It is not known if INBRIJA will harm an unborn baby.
- breastfeeding or plans to breastfeed. Levodopa (the medicine in INBRIJA) can pass into breastmilk and it is unknown if it can harm the baby.
Patients should tell their healthcare provider if they take:
- MAO-B inhibitors
- dopamine D2 receptor antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide), or isoniazid
- iron salts or multivitamins that contain iron salts
No more than 1 dose (2 capsules) should be taken for any OFF period. No more than 5 doses (10 capsules) of INBRIJA should be taken in a day.
INBRIJA is for oral inhalation only. INBRIJA capsules are not to be swallowed or opened.
Patients are not to drive, operate machinery, or do other activities until they know how INBRIJA affects them. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.
INBRIJA can cause serious side effects including the following. Patients should tell their healthcare provider if they experience them:
- falling asleep during normal daily activities (such as driving, doing physical tasks, using hazardous machinery, talking, or eating) which can be without warning. If patients become drowsy while using INBRIJA, they should not drive or do activities where they need to be alert. Chances of falling asleep during normal activities increases if patients take medicines that cause sleepiness.
- withdrawal-emergent hyperpyrexia and confusion (symptoms including fever, confusion, stiff muscles, and changes in breathing and heartbeat) in patients who suddenly lower or change their dose or stop using INBRIJA or carbidopa-levodopa medicines.
- low blood pressure with or without dizziness, fainting, nausea, and sweating. Patients should get up slowly after sitting or lying down.
- hallucinations and other psychosis – INBRIJA may cause or worsen psychotic symptoms including hallucinations (seeing/hearing things that are not real); confusion, disorientation, or disorganized thinking; trouble sleeping; dreaming a lot; being overly suspicious or feeling people want to harm them; believing things that are not real, acting aggressive, and feeling agitated/restless.
- unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicines like INBRIJA.
- uncontrolled, sudden body movements (dyskinesia) may be caused or worsened by INBRIJA. INBRIJA may need to be stopped or other Parkinson’s medicines may need to be changed.
- bronchospasm – people with asthma, COPD, or other lung diseases may wheeze or have difficulty breathing after inhaling INBRIJA. If patients have these symptoms, they should stop taking INBRIJA and call their healthcare provider or go to the nearest hospital emergency room right away.
- increased eye pressure in patients with glaucoma. Healthcare providers should monitor this.
- changes in certain lab values including liver tests
The most common side effects of INBRIJA include cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.
This article is sponsored by Acorda Therapeutics.