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Taking Firdapse

FIRDAPSE Blister Pack and Pill Bottle

How FIRDAPSE is supplied

FIRDAPSE is an oral medication that comes in 10-mg scored tablets. These tablets are supplied in bottles as well as blister packs, so you and your doctor can choose the right option for you.

How to take FIRDAPSE

FIRDAPSE is typically taken 3 to 4 times per day and can be taken with or without food. It’s important to take FIRDAPSE exactly as directed by your doctor.

10-mg tablets
taken 3 to 4 times daily*
With or without food
Every day
In clinical trials, the average total daily dose of FIRDAPSE was 60 mg*

*Each patient’s dose is based on individual needs. Your doctor will work with you to find the right dose for you. Use a pill cutter when necessary to take the prescribed dose. Dosage should not exceed a maximum daily dose of 80 mg.

Sticking to the schedule

It is important to follow your prescription carefully. Take your FIRDAPSE dose on time and according to schedule.

If you miss a dose, skip it altogether and take your next dose at the scheduled time.

  • Do not take 2 doses to make up for a missed dose!
  • Do not take more than 8 tablets in a 24-hour period

What to expect

Some people may experience a rapid improvement in their symptoms when treated with FIRDAPSE. For others, it may take longer to reach the optimal dose.

Your dose of FIRDAPSE will be customized by your doctor based on how well your treatment manages your symptoms and how well you tolerate the treatment. Once you start FIRDAPSE, your doctor may steadily increase your dose according to a regular schedule. This process is called titration. It is important to provide regular feedback to your physician during this process so that he or she can identify the dosage that offers you the most symptom relief with the fewest side effects.

Mary Ann Talking

MARY ANN, A LEMS PATIENT TAKING FIRDAPSE, DISCUSSES HOW TITRATION HELPED HER REACH HER OPTIMAL DOSE.

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What is FIRDAPSE®?

FIRDAPSE is a prescription medicine used to treat adults 17 years of age or older with Lambert-Eaton myasthenic syndrome (LEMS). The safety and efficacy of FIRDAPSE in patients under the age of 17 has not been established.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about FIRDAPSE?

  • FIRDAPSE can cause seizures.
    • You could have a seizure even if you never had a seizure before.
    • Do not take FIRDAPSE if you have ever had a seizure.

Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.

Do not take FIRDAPSE if you:

  • have ever had a seizure.
  • are allergic to amifampridine phosphate, or another aminopyridine.

Before you take FIRDAPSE, tell your doctor about all of your medical conditions, including if you:

  • are taking another aminopyridine, such as compounded 3,4-diaminopyridine (3,4-DAP)
  • have had a seizure
  • have kidney problems
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if FIRDAPSE will harm your unborn baby. You and your doctor will decide if you should take FIRDAPSE while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if FIRDAPSE passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking FIRDAPSE.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take FIRDAPSE?

  • 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 of FIRDAPSE 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 possible side effects of FIRDAPSE?

FIRDAPSE may cause serious side effects, including:

  • Seizures. See "What is the most important information I should know about FIRDAPSE?"
  • Serious allergic reactions, such as anaphylaxis. FIRDAPSE can cause serious allergic reactions. Stop taking FIRDAPSE 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
    • ­hives
  • The most common side effects of FIRDAPSE 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

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 FIRDAPSE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FIRDAPSE?

  • Store FIRDAPSE at 68ºF to 77ºF (20ºC to 25ºC).
  • Safely throw away FIRDAPSE that is out of date or no longer needed.

Keep FIRDAPSE and all medicines out of the reach of children.

If you would like more information, ask your doctor or pharmacist for additional information about FIRDAPSE.

The active ingredient in FIRDAPSE is amifampridine phosphate. Inactive ingredients are calcium stearate, colloidal silicon dioxide, and microcrystalline cellulose.

Please see full Prescribing Information for additional Important Safety Information.

What is FIRDAPSE®?

FIRDAPSE is a prescription medicine used to treat adults 17 years of age or older with Lambert-Eaton myasthenic syndrome (LEMS). The safety and efficacy of FIRDAPSE in patients under the age of 17 has not been established.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about FIRDAPSE?

  • FIRDAPSE can cause seizures.
    • You could have a seizure even if you never had a seizure before.
    • Do not take FIRDAPSE if you have ever had a seizure.

Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.

Do not take FIRDAPSE if you:

  • have ever had a seizure.
  • are allergic to amifampridine phosphate, or another aminopyridine.

Before you take FIRDAPSE, tell your doctor about all of your medical conditions, including if you:

  • are taking another aminopyridine, such as compounded 3,4-diaminopyridine (3,4-DAP)
  • have had a seizure
  • have kidney problems
  • have liver problems
  • are pregnant or plan to become pregnant. It is not known if FIRDAPSE will harm your unborn baby. You and your doctor will decide if you should take FIRDAPSE while you are pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if FIRDAPSE passes into your breast milk. Talk to your doctor about the best way to feed your baby while taking FIRDAPSE.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take FIRDAPSE?

  • 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 of FIRDAPSE 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 possible side effects of FIRDAPSE?

FIRDAPSE may cause serious side effects, including:

  • Seizures. See "What is the most important information I should know about FIRDAPSE?"
  • Serious allergic reactions, such as anaphylaxis. FIRDAPSE can cause serious allergic reactions. Stop taking FIRDAPSE 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
    • ­hives
  • The most common side effects of FIRDAPSE 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

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 FIRDAPSE.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FIRDAPSE?

  • Store FIRDAPSE at 68ºF to 77ºF (20ºC to 25ºC).
  • Safely throw away FIRDAPSE that is out of date or no longer needed.

Keep FIRDAPSE and all medicines out of the reach of children.

If you would like more information, ask your doctor or pharmacist for additional information about FIRDAPSE.

The active ingredient in FIRDAPSE is amifampridine phosphate. Inactive ingredients are calcium stearate, colloidal silicon dioxide, and microcrystalline cellulose.

Please see full Prescribing Information for additional Important Safety Information.

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