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Q. What is STALEVO?
A. STALEVO contains three active ingredients: carbidopa, levodopa and entacapone and is intended for use by Parkinson's patients who experience signs and symptoms of end-of-dose "wearing off". Levodopa is the most widely used and one of the most effective drugs available for Parkinson's disease. Together, carbidopa and entacapone enhance the benefits of levodopa therapy by blocking the enzymes that break down levodopa in the periphery. 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 monoamine oxidase, another enzyme in the body that breaks down levodopa, to further inhibit the breakdown of levodopa in the body before it reaches the brain
As a result of having carbidopa, levodopa and entacapone, STALEVO provides a more persistent presence of levodopa in the body, leading to more consistent symptom control than carbidopa/levodopa.
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Q. What is STALEVO indicated for?
A. STALEVO (carbidopa/levodopa/entacapone) tablets are indicated for certain patients with Parkinson's disease (PD) and end-of-dose "wearing-off".
STALEVO is different from other therapies because in one tablet, it contains levodopa, the cornerstone of Parkinson therapy, plus carbidopa and entacapone, which together extend the benefits of efficacy and safety of levodopa therapy.
Within two years, almost 50 percent 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 percent of patients, "wearing off" becomes extreme and disabling. Eventually, the effect of a levodopa dose may decrease from eight hours when patients begin levodopa therapy to only one to two hours. STALEVO, which contains carbidopa, levodopa, and entacapone in one tablet, extends the duration of benefit of levodopa, 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 two drugs in Sinemet®, the most widely used agent for Parkinson's disease, and COMTAN® (entacapone) 200 mg tablets. Carbidopa and entacapone extend the benefits of levodopa, permitting Parkinson's disease patients to have an improved ability to perform everyday tasks, and a reduction in symptoms associated with the disease.
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Q. How does STALEVO Work?
A. Most of the symptoms of Parkinson's disease are due to a loss of dopamine in the brain. The addition of entacapone to levodopa in STALEVO prevents the breakdown of levodopa and extends the duration of effect of each dose of levodopa. STALEVO therefore provides more consistent and reliable 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-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.
STALEVO may improve activities of daily living. Activities of daily living include:
- Speech
- Walking
- Handwriting
- Dressing
- Hygiene
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Q. Does STALEVO have side effects?
A. The most common side effects of STALEVO are unwanted or uncontrollable movements (known as dyskinesia), nausea, diarrhea, excessive muscle movements (known as hyperkinesia), harmless discoloration of urine, sweat and/or saliva; diminished or slow movements (known as hypokinesia), abdominal pain, dizziness, constipation, fatigue, pain, and hallucinations. Some of the more serious side effects may include severe diarrhea, severe dyskinesia, hallucinations, other mental disturbances, orthostatic hypotension (low blood pressure), rhabdomyolysis (a muscle disease), and symptoms resembling neuroleptic malignant syndrome (a condition characterized by fever and muscle stiffness).
Be careful using STALEVO if you have severe heart or lung disease, asthma, renal, hepatic, or endocrine disease, or a history of heart attacks or ulcers. Do not take STALEVO if you have glaucoma, melanoma, or other related medical disorders.
In some people, STALEVO may cause urine or sweat to change color, becoming brownish orange. STALEVO may also cause saliva to darken. These are harmless side effects and are not cause for concern, although sweat may stain clothes.
Drugs broken down by the COMT enzyme (eg, isoproterenol, epinephrine) should be used with caution when taking STALEVO. If you take a nonselective monoamine oxidase (MAO) inhibitor, you should not take STALEVO. STALEVO should not be taken with selegiline at doses higher than 10 mg/day.
Before you take STALEVO, talk to your doctor about any health problems you might have. For more information about STALEVO, read the full prescribing information. The prescribing information will explain how STALEVO will act in your body, possible side effects, drug interactions, and precautions.
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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. Patient Assistance NOW offers access to programs that may help you pay for your Novartis treatments.
For further information:
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