Amifampridine

What is Amifampridine?

Amifampridine (FIRDAPSE) is a potassium channel blocker used to treat Lambert-Eaton myasthenic syndrome (LEMS).

What are the uses of this medicine?

• This medicine is used to treat Lambert-Eaton myasthenic syndrome (LEMS) in adults.

How does this medicine work?

• The mechanism by which amifampridine exerts its therapeutic effect in LEMS patients has not been fully elucidated.
• Amifampridine is a broad spectrum potassium channel blocker.

Who Should Not Use this medicine ?

This medcine cannot be used in patients with:

• A history of seizures
• Hypersensitivity to amifampridine phosphate or another aminopyridine

What drug interactions can this medicine cause?

• The concomitant use of FIRDAPSE and drugs that lower seizure threshold may lead to an increased risk of seizures.
• The concomitant use of FIRDAPSE and drugs with cholinergic effects (e.g., direct or indirect cholinesterase inhibitors) may increase the cholinergic effects of FIRDAPSE.

Is this medicine FDA approved?

• It was approved for use in the United States in 2018.

How should this medicine be used?

Recommended Dosageː

• The recommended starting dosage of FIRDAPSE is 15 mg to 30 mg daily, taken orally in divided doses (3 to 4 times daily).
• The dosage can be increased by 5 mg daily every 3 or 4 days.
• The maximum recommended total daily dosage is 80 mg.
• The maximum single dose is 20 mg.

Patients with Renal Impairment:

• The recommended starting dosage of FIRDAPSE in patients with renal impairment (creatinine clearance 15 to 90 mL/min) is 15 mg daily, taken orally in 3 divided doses.
• No dosage recommendation for FIRDAPSE can be made for patients with end-stage renal disease.

Patients with Hepatic Impairment:

• The recommended starting dosage of FIRDAPSE in patients with any degree of hepatic impairment is 15 mg daily, taken orally in 3 divided doses.

Administration

• Take FIRDAPSE exactly as your doctor tells you to take it. Do not change your dose of FIRDAPSE.
• Do not take more than 2 tablets of FIRDAPSE at one time or more than 8 tablets in a 24-hour period.
• FIRDAPSE can be taken with or without food.
• If you miss a dose of FIRDAPSE, skip that dose and take your next dose at your next scheduled dose time. Do not double your dose to make up the missed dose.
• Do not take FIRDAPSE together with other medicines known to increase the risk of seizures.
• If you take too much FIRDAPSE, call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 10 mg, functionally scored

This medicine is available in fallowing brand namesː

• FIRDAPSE

What side effects can this medication cause?

The most common side effects of this medicine include:

• tingling around the mouth, tongue, face, fingers, toes, and other body parts
• upper respiratory infection
• stomach pain
• nausea
• diarrhea
• headache
• increased liver enzymes
• back pain
• high blood pressure
• muscle spasms

FIRDAPSE may cause serious side effects, including:

• Seizures
• Serious allergic reactions, such as anaphylaxis

What special precautions should I follow?

• FIRDAPSE can cause seizures. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment.
• In clinical trials, hypersensitivity reactions and anaphylaxis associated with FIRDAPSE administration have not been reported. If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated.

What to do in case of emergency/overdose?

• Overdose with FIRDAPSE was not reported during clinical studies.

Management for overdosage:

• Patients with suspected overdose with FIRDAPSE should be monitored for signs or symptoms of exaggerated FIRDAPSE adverse reactions or effects, and appropriate symptomatic treatment instituted immediately.

Can this medicine be used in pregnancy?

• There are no data on the developmental risk associated with the use of FIRDAPSE in pregnant women.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FIRDAPSE during pregnancy. Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the registry by calling 855-212-5856 (toll-free), using the Fax number 877-867-1874 (toll-free), by contacting the Pregnancy Coordinating Center at firdapsepregnancyregistry@ubc.com

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: amifampridine
• Inactive ingredients: calcium stearate, colloidal silicon dioxide, and microcrystalline cellulose.

Distributed by Catalyst Pharmaceuticals, Inc., Coral Gables

Who manufactures and distributes this medicine?

• Packager: Catalyst Pharmaceuticals, Inc.

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

• Store FIRDAPSE at 68°F to 77°F (20°C to 25°C).
• Safely throw away FIRDAPSE that is out of date or no longer needed.
• Keep FIRDAPSE and all medicines out of the reach of children.

• Dailymed label info on Amifampridine
• FDA Amifampridine

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