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The information in this medication sheet has been adapted from the FDA-approved prescribing information for dalfampridine.
Description
Dalfampridine blocks tiny pores, or potassium channels, on the surface of nerve fibers, which may improve the conduction of nerve signals in along nerve fibers whose insulating myelin coating has been damaged by MS. In two phase III clinical trials of the drug, a significantly greater proportion of people on therapy had a consistent improvement in walking speed compared to those in the placebo group. In the first tiral, involving 301 people with any type of MS, walking speed increased by 25% compared with placebo. Results from the second phase III study, involving 240 people with MS, confirmed the benefits seen in the first trial. Among those taking dalfampridine who improved in walking speed, there was also a statistically significant improvement in leg strength. Approval by the U.S. Food and Drug Administration (FDA)
Approval by the U.S. Food and Drug Administration (FDA)
Dalfampridine is approved to improve walking in patients with multiple sclerosis.
Proper Usage
- Keep this medication out of the reach of children.
- Take dalfampridine exactly as your doctor tells you to take it. Do not change your dose or take more than 2 dalfampridine tablets in a 24-hour period.
- This medication is released into your system slowly over time. Do not break, crush, chew or dissolve the dalfampridine tablet before swallowing it because that may cause the medication to be released too quickly, which may increase your risk of having a seizure. If you cannot swallow the tablet whole, tell your doctor.
- This medication can be taken with or without food.
- If you miss a dose of dalfampridine, do not make up the missed dose or take 2 doses at the same time. Take your next dose at your regular scheduled time.
- If you take too much dalfampridine, call your doctor or go to the nearest hospital emergency room right away.
Warnings and Precautions
- Do not take dalfampridine if you have ever had a seizure. Dalfampridine can cause seizures and the risk of a seizure increases with increasing doses of medication.
- People with certain types of kidney problems should not take dalfampridine because the level of medication in the body may become too high, leading to increased risk of seizures. Before taking this medication, let your physician know if you have a history of kidney problems.
- Do not take dalfampridine together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).
- Before taking dalfampridine, tell your doctor if you are pregnant or planning to become pregnant. The effect of dalfampridine on pregnancy or an unborn child is not known.
- Before taking dalfampridine, tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if fampridine passes into breast milk.
- It is not known whether dalfampridine is safe or effective in children less than 18 years of age.
Possible Side Effects
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Common side effects of dalfampridine include urinary tract infection, difficulty sleeping, dizziness*, headache, nausea, weakness*, back pain, problems with balance*, MS relapse, burning, tingling or itching of the skin*, irritation of the nose and throat, constipation*, indigestion, throat pain.
For information about Acorda's support program, call 888-881-1918.
News about Ampyra
Ampyra Post-Marketing Study Results Announced - Low dose does not improve walking: Approved dose misses primary endpoint but shows benefit in several secondary endpoints
Aug 14, 2012
A post-marketing study of Ampyra® (dalfampradine-ER, Acorda Therapeutics) did not meet its primary endpoint, showing that a low dose (one-half of the approved dose) did not improve walking speed. The dose approved by the U.S. Food and Drug Administration (FDA) to improve walking in MS did not meet this endpoint in this study either, but did improve walking speed and endurance based on several secondary measures.
FDA Updates Prescribing Info for Ampyra to Address Risk of Seizure in Those with Reduced Kidney Function
Jul 23, 2012
The FDA released a Drug Safety Communication to address the risk of seizures in people with MS who are starting Ampyra (dalfampridine, Acorda Therapeutics). Ampyra was approved in January 2010 to improve walking in people with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug.