AMPYRA® (am-PEER-ah) (Dalfampridine) Extended Release Tablets
Read this Medication Guide before you start taking AMPYRA and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.
What is the most important information I should know about AMPYRA?
AMPYRA can cause seizures.
– You could have a seizure even if you never had a seizure before.
– Your chance of having a seizure is higher if you take too much AMPYRA or if your kidneys have a mild decrease of function, which is common after age 50.
– Your doctor may do a blood test to check how well your kidneys are working, if that is not known before you start taking AMPYRA.
– Do not take AMPYRA if you have ever had a seizure.
– Before taking AMPYRA tell your doctor if you have kidney problems.
– Take AMPYRA exactly as prescribed by your doctor. See “How should I take AMPYRA?”
Stop taking AMPYRA and call your doctor right away if you have a seizure while taking AMPYRA.
What is AMPYRA?
AMPYRA is a prescription medicine used to help improve walking in people with multiple sclerosis (MS). This was shown by an increase in walking speed.
It is not known if AMPYRA is safe or effective in children less than 18 years of age.
Who should not take AMPYRA?
Do not take AMPYRA if you:
– have ever had a seizure
– have certain types of kidney problems
– are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA
What should I tell my doctor before taking AMPYRA?
Before you take AMPYRA, tell your doctor if you:
– have any other medical conditions
– are taking compounded 4-aminopyridine (fampridine, 4-AP)
– are pregnant or plan to become pregnant. It is not known if AMPYRA will harm your unborn baby. You and your doctor will decide if you should take AMPYRA while you are pregnant
– are breast-feeding or plan to breast-feed. It is not known if AMPYRA passes into your breast milk. You and your doctor should decide if you will take AMPYRA or breast-feed. You should not do both.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take AMPYRA?
– Take AMPYRA exactly as your doctor tells you to take it. Do not change your dose of AMPYRA.
– Take one tablet of AMPYRA 2 times each day about 12 hours apart. Do not take more than 2 tablets of AMPYRA in a 24-hour period.
– Take AMPYRA tablets whole. Do not break, crush, chew or dissolve AMPYRA tablets before swallowing. If you cannot swallow AMPYRA tablets whole, tell your doctor.
– AMPYRA is released slowly over time. If the tablet is broken, the medicine may be released too fast. This can raise your chance of having a seizure.
– AMPYRA can be taken with or without food.
– If you miss a dose of AMPYRA, do not make up the missed dose. Do not take 2 doses at the same time. Take your next dose at your regular scheduled time.
– If you take too much AMPYRA, call your doctor or go to the nearest hospital emergency room right away.
– Do not take AMPYRA together with other aminopyridine medications, including compounded 4-AP (sometimes called 4-aminopyridine, fampridine).
What are the possible side effects of AMPYRA?
AMPYRA may cause serious side effects, including:
– serious allergic reactions. Stop taking AMPYRA and call your doctor right away or get emergency medical help if you have:
* shortness of breath or trouble breathing.
* swelling of your throat or tongue o hives.
– kidney or bladder infections
See “What is the most important information I should know about AMPYRA?”
The most common side effects of AMPYRA include:
– urinary tract infection.
– trouble sleeping (insomnia).
– back pain.
– problems with balance.
– multiple sclerosis relapse.
– burning, tingling or itching of your skin.
– irritation in your nose and throat.
– pain in your throat.
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of AMPYRA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
How should I store AMPYRA?
– Store AMPYRA at 59ºF to 86ºF (15ºC to 30ºC).
– Safely throw away AMPYRA that is out of date or no longer needed.
Keep AMPYRA and all medicines out of the reach of children.
General Information about the safe and effective use of AMPYRA
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use AMPYRA for a condition for which it was not prescribed. Do not give AMPYRA to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about AMPYRA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about AMPYRA that is written for health professionals.
For more information, go to www.AMPYRA.com or call 1-800-367-5109.
What are the ingredients in AMPYRA?
Active ingredient: dalfampridine (previously called fampridine)
Inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.
Distributed by: Acorda Therapeutics, Inc.
Ardsley, NY 10502
This Medication Guide has been approved by the U.S. Food and Drug Administration.
AMPYRA® is a registered trademark of Acorda Therapeutics, Inc.
Manufactured for Acorda under license from Alkermes Pharma Ireland Limited (APIL),
Athlone, Ireland, utilizing APIL’s MatriX Drug Absorption System (MXDAS®) technology.
MXDAS® is a registered trademark of Alkermes Pharma Ireland Limited (APIL).
U.S. Patent Nos.: US 5,540,938; US 8,007,826; US 8,354,437; US 8,440,703; and US 8,663,685 © 2016 Acorda Therapeutics, Inc. All rights reserved.