Dalfampridine

What is Dalfampridine?

• Dalfampridine (AMPYRA) is a potassium channel blocker used to improve walking in adult patients with multiple sclerosis (MS).

What are the uses of this medicine?

• AMPYRA is a prescription medicine used to help improve walking in adults with multiple sclerosis (MS). This was shown by an increase in walking speed.

How does this medicine work?

• Dalfampridine (dal fam' pri deen) is a pyrimidine analogue (4-aminopyridine) and potassium channel blocker that is used to improve mobility and walking speed in patients with multiple sclerosis.
• Dalfampridine appears to act by prolonging neuronal action potentials and thus improving conduction in demyelinated nerve fibers.
• Multiple clinical studies have demonstrated that dalfampridine (previously known as 4-aminopyridine) has a rapid onset of action increasing motor strength and mobility in 25% to 40% of patients with multiple sclerosis as well as other neuromuscular conditions.
• In clinical trials, the effect of dalfampridine has been sustained with long term use.
• It has no effect on the course of underlying disease in preventing relapses or slowing progression of disability.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have ever had a seizure
• have certain types of kidney problems
• are allergic to dalfampridine (4-aminopyridine), the active ingredient in AMPYRA

What drug interactions can this medicine cause?

• Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine. Elevated levels of dalfampridine increase the risk of seizures.
• No interaction was identified between dalfampridine and baclofen.

Is this medicine FDA approved?

• Dalfampridine was approved for use in the United States in 2010 and current indications are for symptomatic treatment of motor weakness in relapsing multiple sclerosis.
• Dalfampridine is available in tablets of 10 mg under the brand name Ampyra.

How should this medicine be used?

Recommended dosage:

• The maximum recommended dosage of AMPYRA is one 10 mg tablet twice daily and should not be exceeded. Take doses approximately 12 hours apart.
• There is no evidence of additional benefit at doses greater than 10 mg twice daily.

Administration:

• 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 10 mg tablets

This medicine is available in fallowing brand namesː

• AMPYRA

What side effects can this medication cause?

The most common side effects of this medicine include:

• urinary tract infection
• trouble sleeping (insomnia)
• dizziness
• headache
• nausea
• weakness
• back pain
• problems with balance
• multiple sclerosis relapse
• burning, tingling or itching of your skin
• irritation in your nose and throat
• constipation
• indigestion
• pain in your throat

AMPYRA may cause serious side effects, including:

• serious allergic reactions
• seizures

What special precautions should I follow?

• AMPYRA may cause dizziness or vertigo. If you have these symptoms, do not drive, operate machinery, or do other dangerous activities.
• AMPYRA can cause seizures; the risk of seizures increases with increasing AMPYRA doses; discontinue AMPYRA and do not restart if a seizure occurs.
• Avoid concomitant use with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same.
• AMPYRA can cause anaphylaxis and severe allergic reactions. Signs and symptoms have included respiratory compromise, urticaria, and angioedema of the throat and or tongue. AMPYRA is contraindicated in patients with a history of hypersensitivity to AMPYRA or 4-aminopyridine.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• altered mental state
• partial seizure
• confusion
• tremulousness
• diaphoresis
• amnesia
• status epilepticus

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with use of AMPYRA in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in patients younger than 18 years of age have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: dalfampridine (previously called fampridine)
• Inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.

Who manufactures and distributes this medicine?

Distributed by: Acorda Therapeutics, Inc. Ardsley, NY

What should I know about storage and disposal of this medication?

• Store AMPYRA at 59ºF to 86ºF (15ºC to 30ºC).
• Safely throw away AMPYRA that is out of date or no longer needed.

Multiple sclerosis drugs

Disease modifying agents

• Alemtuzumab
• Dimethyl Fumarate
• Fingolimod
• Glatiramer Acetate
• Interferon Beta
• Interferon Beta-1a
• Interferon Beta-1b
• Peginterferon Beta-1a
• Mitoxantrone
• Natalizumab
• Ocrelizumab
• Teriflunomide

Symptomatic Therapies

• Dalfampridine

• Dailymed label info on Dalfampridine
• FDA Dalfampridine

Dalfampridine Resources
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