- Stalevo®(as a combination product containing Carbidopa, Entacapone, Levodopa)
[Posted 08/20/2010]Issue: FDA notified healthcare professionals that it is evaluating clinical trial data that suggest patients taking Stalevo (a combination of carbidopa/levodopa and entacapone) may be at an increased risk for cardiovascular events (heart attack, stroke, and cardiovascular death) compared to those taking carbidopa/levodopa (sold as the combination product, Sinemet). FDA's decision to conduct a meta-analysis was based on findings from the Stalevo Reduction In Dyskinesia Evaluation - Parkinson's Disease or STRIDE-PD trial, which reported an imbalance in the number of myocardial infarctions in patients treated with Stalevo compared to those receiving only carbidopa/levodopa. Although myocardial infarction, cardiac irregularities, hypertension, and palpitations have been reported with levodopa, previous clinical trials with Stalevo did not show an imbalance in myocardial infarction, stroke, and cardiovascular death.
Background: Both Stalevo and Sinemet have been shown to be effective treatments for the symptoms of Parkinson's disease. The addition of entacapone to carbidopa/levodopa has been shown to lead to a greater degree of improvement in some of the symptoms of Parkinson's disease than treatment with carbidopa/levodopa alone. Entacapone is also available as a single ingredient product (sold under the brand name Comtan) to be always administered in association with carbidopa/levodopa (entacapone has no antiparkinsonian effect of its own). It is estimated that 154,000 patients were dispensed a prescription for Stalevo from its approval in June 2003 through October 2009.
Recommendations: At this time, FDA's review of the potential cardiovascular risk with Stalevo is ongoing. Healthcare professionals should regularly evaluate the cardiovascular status of patients who are taking Stalevo, especially if they have a history of cardiovascular disease. Patients should not stop taking Stalevo unless told to do so by their healthcare professional.
FDA is exploring additional ways to assess whether Stalevo increases the risk of cardiovascular events, and will update the public when this review is complete. For more information visit the FDA website at: Web Siteand Web Site.
[Posted 03/31/2010] FDA notified healthcare professionals and patients that it is evaluating data from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo (entacapone, levodopa, and carbidopa combination) may be at an increased risk for developing prostate cancer. Other controlled clinical trials evaluating Stalevo or entacapone (Comtan) did not find an increased risk of prostate cancer. FDA is still reviewing the available information and has not concluded that Stalevo increases the risk of developing prostate cancer. Healthcare professionals should be aware of this possible risk and follow current guidelines for prostate cancer screening. FDA recommends that healthcare professionals follow the recommendations in the drug label when prescribing Stalevo and entacapone. Patients should not stop taking their medication unless directed to do so by their healthcare professional. For more information visit the FDA website at: Web Siteand Web Site.
WHY is this medicine prescribed?
Entacapone is an inhibitor of catechol-O-methyltransferase (COMT). It is used in combination with levodopa and carbidopa (Sinemet) to treat the end-of-dose 'wearing-off' symptoms of Parkinson's disease. Entacapone helps the levodopa and carbidopa work better by allowing more of it to reach the brain, where it has its effects.
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
HOW should this medicine be used?
Entacapone comes as a tablet to take by mouth. It is taken with every dose of levodopa and carbidopa, up to 8 times a day. Entacapone may be taken with or without food. Read your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take entacapone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Entacapone helps control the symptoms of Parkinson's disease, but it does not cure it. Continue to take entacapone even if you feel well. Do not stop taking entacapone without talking to your doctor. Stopping entacapone suddenly may make your Parkinson's disease worse and could have other dangerous effects. Your doctor probably will decrease your dose gradually if necessary.
What SPECIAL PRECAUTIONS should I follow?
Before taking entacapone,
- tell your doctor and pharmacist if you are allergic to entacapone or any other drugs.
- tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially ampicillin, apomorphine (Zydis), bitolterol (Tornalate), chloramphenicol (AK-Chlor, Chloromycetin), cholestyramine (Cholybar, Questran, Questran Light, others), medications that cause drowsiness (including medications for anxiety and sleeping pills), dobutamine (Dobutrex), epinephrine (AsthmaHaler, EpiPen Auto-Injector, Primatene Mist, others), erythromycin (E-Base, E.E.S., E-Mycin, others), isoetharine (Arm-a-Med Isoetharine, Beta-2, Bronkometer, others), isoproterenol (Dispos-a-Med Isoproterenol, Isuprel, Medihaler-Iso, others), methyldopa (Aldomet), phenelzine (Nardil), probenecid (Benemid), rifampin (Rifadin, Rimactane), tranylcypromine (Parnate), and vitamins and herbal products.
- tell your doctor if you have or have ever had liver disease or a history of alcoholism.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking entacapone, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking entacapone.
- you should know that this medication may make you drowsy. Do not drive a car or operate heavy machinery until you know how entacapone affects you.
What should I do IF I FORGET to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed dose.
What SIDE EFFECTS can this medicine cause?
Entacapone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- upset stomach
- movements you cannot control
- stomach pain
If you experience any of the following symptoms, call your doctor immediately:
- difficulty breathing
- high fever
- muscle stiffness
- weakness with or without a fever
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. You may become dizzy when you get up after sitting or lying down, especially when you begin taking entacapone. To avoid this problem, make sure to get up slowly, especially if you have been sitting or lying down for a long time.
Entacapone may cause your urine to change to a brownish-orange color. This effect is common and is not harmful.
Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: September 1, 2010.