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Q. What is STALEVO?
A. STALEVO contains 3 active ingredients: carbidopa, levodopa, and entacapone and is intended for use by patients with Parkinson's disease (PD) who experience signs and symptoms of end-of-dose levodopa "wearing-off." Levodopa is the most widely used and one of the most effective drugs available for PD. Together, carbidopa and entacapone enhance the benefits of levodopa therapy by blocking the enzymes that break down levodopa before it reaches the brain. This allows for more levodopa to reach the brain in a more consistent and reliable fashion.
In fact, STALEVO does more than carbidopa/levodopa alone. STALEVO is the most recent advance in levodopa therapy. It contains:
- Carbidopa, which inhibits the action of dopa decarboxylase, an enzyme in the body that breaks down levodopa, making more dopamine available to receptors in the brain
- Levodopa, which is converted by the body into dopamine to replace, or supplement, the dopamine no longer produced by the brain, is the most widely prescribed treatment for Parkinson's disease
- Entacapone, which is added to inhibit the action of COMT, another enzyme in the body that breaks down levodopa, to further inhibit the breakdown of levodopa in the body before it reaches the brain
Since it contains carbidopa, levodopa, and entacapone, STALEVO provides a more persistent presence of levodopa in the body, leading to more consistent symptom control than carbidopa/levodopa alone.
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Q. What is STALEVO indicated for?
A. STALEVO (carbidopa, levodopa and entacapone) tablets are indicated for certain patients with PD who are experiencing symptom reemergence due to levodopa "wearing-off."
STALEVO is different from other therapies because one tablet contains levodopa, the cornerstone of PD therapy, plus carbidopa and entacapone, which together extend the benefits of efficacy of levodopa therapy.
Within 2 years, almost 50% of PD patients receiving levodopa therapy begin to notice that their levodopa lasts for shorter periods of time, a phenomenon known as "wearing-off." In about 15% to 20% of patients, "wearing-off" becomes extreme and disabling. Eventually, the effect of a levodopa dose may decrease from 8 hours when patients begin carbidopa/levodopa therapy to only 1 to 2 hours. STALEVO, which contains carbidopa, levodopa, and entacapone in one tablet, extends the duration of benefit of levodopa (an average of almost an hour and a half each day), lessening "wearing-off" and affording better symptom control throughout the day.
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Q. How does STALEVO help treat Parkinson's disease?
A. STALEVO contains levodopa plus carbidopa, the 2 drugs in Sinemet®, the most widely used agent for PD, and COMTAN® (entacapone) 200 mg tablets. Carbidopa and entacapone extend the benefits of levodopa, permitting patients with PD to have an improved ability to perform everyday tasks, and a reduction in symptoms associated with the disease.
| Sinemet is a registered trademark of Merck & Co., Inc. |
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Q. How does STALEVO work?
A. Most of the symptoms of PD are due to a loss of dopamine in the brain. The addition of entacapone to levodopa in STALEVO inhibits the breakdown of levodopa and extends the duration of effect of each dose of levodopa. STALEVO therefore provides more consistent levels of levodopa to the brain, where it can be converted to the much-needed dopamine.
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Q. What should I expect from STALEVO treatment?
A. STALEVO does more than carbidopa/levodopa alone. It has been clinically proven to deliver more active time during the day—an average of almost an hour and a half each day (1.4 hours). So you can enjoy more time with fewer symptoms.
People who take STALEVO may have more active time between doses, which may improve their daily activities.
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Q. What is the Important Safety Information for STALEVO?
A. STALEVO is a prescription medication for the treatment of idiopathic (unknown cause) Parkinson's disease (PD) if you are experiencing a return of symptoms before your next dose ("wearing-off") of carbidopa/levodopa (only if you are taking a total daily dose of levodopa of 600 mg or less and not experiencing uncontrolled movements called dyskinesias).
STALEVO is a tablet combining 3 medications known as carbidopa, levodopa, and entacapone, so it may be used to replace these medications if you are taking them in separate tablets.
You should not take STALEVO with an antidepressant medication class known as nonselective monoamine oxidase (MAO) inhibitors. STALEVO may be used with selective MAO type B inhibitors. Make sure you tell your health care professional (HCP) about all of the medications you take, including nonprescription medications and supplements.
Do not take STALEVO if you have a history of or currently have active skin cancer or abnormal skin growths or have an eye problem known as narrow-angle glaucoma. Patients with wide-angle glaucoma can take STALEVO but must be monitored for changes in eye pressure.
Tell your HCP about any health problems you might have or if you experience any side effects while taking STALEVO. Tell your HCP if you: have or develop uncontrolled sudden movements (called dyskinesias); have a history of or currently have mental problems, such as psychosis or depression with thoughts of suicide; have severe heart or lung disease, asthma, kidney, liver, or gall bladder disease; have endocrine disease (a hormone disorder); or have a history of heart attacks or stomach ulcers.
Some serious side effects that may occur with STALEVO include symptoms resembling neuroleptic malignant syndrome (a condition characterized by fever and muscle stiffness); an interaction with drugs such as isoproterenol and epinephrine that are broken down by the COMT enzyme (COMT breaks down levodopa), therefore, these drugs should be used with caution when taking STALEVO; low blood pressure upon rising rapidly after sitting or lying down with or without symptoms such as dizziness, nausea, fainting, and sweating; diarrhea, sometimes severe; colitis (inflammation of the large intestine), which may be caused by prolonged diarrhea; hallucinations; and increased dyskinesias (uncontrolled movements). Rare events may include serious muscle problems or muscle aches; high fever; confusion; a lung condition called fibrosis; and skin cancer. Your physician or dermatologist should examine your skin on a regular basis.
Do not drive or operate other complex machinery until you know how STALEVO affects you. While taking STALEVO you may notice that your saliva, urine, or sweat may be a dark brown or brownish-orange color. Although the color is harmless, it may cause staining. Tell your HCP if you develop unusual urges to gamble, increased sexual urges, or other urges.
The most common side effects of STALEVO include dyskinesias (uncontrolled movements), nausea, an increase in movement (called hyperkinesia), change in the color of your urine, diarrhea, and stomach pain.
Tell your HCP if you have side effects that bother you. He or she can make adjustments that may reduce those effects. You should not quickly lower your STALEVO dose or suddenly stop taking it altogether. Be sure to take your medicine as instructed.
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Q. Is STALEVO covered by my prescription plan?
A. STALEVO is available on most Medicare Part D plans. For comprehensive information on Medicare benefits:
STALEVO is also available through Patient Assistance NOW, an easy-to-use and comprehensive resource developed by Novartis Pharmaceuticals Corporation. Patient Assistance NOW offers access to programs that may help you pay for your Novartis treatments.
For further information:
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