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.
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
With or without food
Every day*10-mg tablets represents adult dosing; please see full Prescribing Information for pediatric dosing information. 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.
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.
Some people may experience a rapid improvement in their symptoms when treated with FIRDAPSE. For others, it may take longer to reach the optimal therapeutic dose the dose that provides the most symptom relief with the fewest side effects .
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 an established schedule. This process is called titration.
Help us track the safety of FIRDAPSE use during pregnancy. Contact the FIRDAPSE Pregnancy Registry by calling (855) 212-5856 or visiting www.firdapsepregnancystudy.com.
It is important to provide regular feedback to your physician during this process so he or she can identify your optimal therapeutic dose.
* For dosing pediatric patients (age 6 and older) who weigh less than 45 kg, please refer to the full Prescribing Information.
†The lowest starting initial daily dosage is recommended for adult and pediatric patients with kidney or liver impairment, or patients who slowly metabolize FIRDAPSE.
‡For patients age 6 years and older weighing 45 kg or more, the maximum single dose for FIRDAPSE is 20 mg.
Catalyst has created a voluntary patient registry designed to provide personalized metabolism information for FIRDAPSE. Patients who choose to enroll in the registry will be asked to provide a cheek swab sample for genetic testing of the NAT2 gene, which produces an enzyme that determines how fast or how slowly some medications, including FIRDAPSE, are metabolized by the body. The sample will be analyzed and the results sent back to the patient and to the patient’s doctor. The registry will also collect the patient’s dosing history and any reported side effects (if applicable) for a minimum of 6 months after the patient volunteered to participate in the registry. The patient’s doctor can use the patient’s metabolic rate, dosing history, and any reported side effects to further personalize treatment. All information collected will be kept anonymous, and patients can withdraw from the registry at any time.
Ask your doctor for more information about the registry and how you may participate.
FIRDAPSE is a prescription medicine used to treat Lambert-Eaton myasthenic syndrome (LEMS) in people 6 years of age or older. It is not known if FIRDAPSE is safe or effective in children less than 6 years of age.
What is the most important information I should know about FIRDAPSE?
Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.
Do not take FIRDAPSE if you:
Before you take FIRDAPSE, tell your doctor about all of your medical conditions, including if you:
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?
What are the possible side effects of FIRDAPSE?
FIRDAPSE may cause serious side effects, including:
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?
Keep FIRDAPSE and all medicines out of the reach of children.
General Information about the safe and effective use of FIRDAPSE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FIRDAPSE for a condition for which it was not prescribed. Do not give FIRDAPSE to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about FIRDAPSE that is written for health professionals.
What are the ingredients in FIRDAPSE?
Please see full Prescribing Information for additional Important Safety Information.
FIRDAPSE is a prescription medicine used to treat Lambert-Eaton myasthenic syndrome (LEMS) in people 6 years of age or older. It is not known if FIRDAPSE is safe or effective in children less than 6 years of age.
What is the most important information I should know about FIRDAPSE?
Stop taking FIRDAPSE and call your doctor right away if you have a seizure while taking FIRDAPSE.
Do not take FIRDAPSE if you:
Before you take FIRDAPSE, tell your doctor about all of your medical conditions, including if you:
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?
What are the possible side effects of FIRDAPSE?
FIRDAPSE may cause serious side effects, including:
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?
Keep FIRDAPSE and all medicines out of the reach of children.
General Information about the safe and effective use of FIRDAPSE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FIRDAPSE for a condition for which it was not prescribed. Do not give FIRDAPSE to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about FIRDAPSE that is written for health professionals.
What are the ingredients in FIRDAPSE?
Please see full Prescribing Information for additional Important Safety Information.
