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DOSING AND TITRATION WITH 10-MG FIRDAPSE TABLETS


FOR PATIENTS ≥6 YEARS OF AGE AND WEIGHING ≥45 KG2*






*Review FIRDAPSE dosing information for patients 6 years of age and older on the
pediatric dosing page.

†In patients with renal or hepatic impairment and individuals known to be poor
metabolizers of N-acetyltransferase 2 (NAT2), the starting dosage of FIRDAPSE
should be the lowest recommended dose taken orally in divided doses. This dose
should continue to be titrated to clinical effect and tolerability.2 ‡For
patients age 6 years and older weighing 45 kg or more, the maximum single dose
for FIRDAPSE is 20 mg.2


HELP YOUR PATIENTS REACH THEIR OPTIMAL THERAPEUTIC DOSE

Titration is an important step for new patients who are just getting started on
FIRDAPSE and have not taken amifampridine before. By guiding your patients
through the titration process, you can help:

 * Determine their optimal therapeutic dose of FIRDAPSE
 * Maximize neuromuscular benefit
 * Minimize issues with tolerability, including paresthesia


ADDITIONAL DOSING INFORMATION

 * FIRDAPSE tablets can be taken with or without food2
 * Scored tablets can be split with a pill splitter as needed2
   * NOTE: If you have dosing adjustments <5 mg or have patients who have
     trouble swallowing a tablet, a suspension can be prepared. Refer to the
     Medication Guide for instructions on suspension preparation.2
 * If a dose is missed, patients should not take double or extra doses2
 * Patients newly treated with amifampridine should be advised that based on
   clinical trial observations, they may experience transient paresthesia, but
   this side effect is expected to diminish with continued treatment2,28
 * In patients with renal or hepatic impairment and individuals known to be poor
   metabolizers of N-acetyltransferase 2 (NAT2), the recommended starting dose
   of FIRDAPSE is the lowest recommended initial daily dosage taken orally in
   divided doses. This dose should continue to be titrated to clinical effect
   and tolerability.2§

*For dosing pediatric patients (age 6 and older) who weigh less than 45 kg,
please refer to the full Prescribing Information.2 §No dosage recommendation for
FIRDAPSE can be made for patients with end-stage renal disease.2



HOW FIRDAPSE IS SUPPLIED

FIRDAPSE is dispensed in both bottles and child-resistant blister packs, making
it easy for you and your patients to choose the best option for them.

Bottles2

 * Containing 60 or 240 tablets

Blister packs2

 * Individual pack containing 10 tablets
 * Carton containing 12 packs (120 tablets total)



Do you have a patient taking FIRDAPSE who is pregnant?

The FIRDAPSE Pregnancy Registry: In conjunction with the FDA, Catalyst
Pharmaceuticals has created a registry to collect information about the safety
of FIRDAPSE use during pregnancy. Enroll patients with LEMS—even those not
taking FIRDAPSE—as soon as you learn of their pregnancy by calling
1-855-212-5856 or visiting www.firdapsepregnancystudy.com.

NEXT: Pediatric Dosing


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Learn more about LEMS diagnosis and treatment by visiting our LEMS Video
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INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE:

FIRDAPSE is a potassium channel blocker indicated for the treatment of
Lambert-Eaton myasthenic syndrome (LEMS) in adults and pediatric patients 6
years of age and older.

CONTRAINDICATIONS

FIRDAPSE is contraindicated in patients with:

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

WARNINGS AND PRECAUTIONS

Seizures: FIRDAPSE can cause seizures. Consider discontinuation or
dose-reduction of FIRDAPSE in patients who have a seizure while on treatment.

Hypersensitivity: If a hypersensitivity reaction such as anaphylaxis occurs,
FIRDAPSE should be discontinued and appropriate therapy initiated.

ADVERSE REACTIONS

The most common (> 10%) adverse reactions are: paresthesia, upper respiratory
tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver
enzymes, back pain, hypertension, and muscle spasms.

Please see full Prescribing Information for additional Important Safety
Information.
To report SUSPECTED ADVERSE REACTIONS, contact Catalyst Pharmaceuticals at
1-844-347-3277 (1-844-FIRDAPSE) or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
References:
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     of Lambert-Eaton myasthenic syndrome: a new take on an old drug. Ann
     Pharmacother. 2020;54(1):56-63.
 2.  Full Prescribing Information for FIRDAPSE (amifampridine). Catalyst Pharma;
     2023.
 3.  Oh SJ, Scherbakova N, Kostera-Pruszczyk A, et al; LEMS Study Group.
     Amifampridine phosphate (FIRDAPSE®) is effective and safe in a phase 3
     clinical trial in LEMS. Muscle Nerve. 2016;53(5):717-725.
 4.  Shieh P, Sharma K, Kohrman B, Oh SJ. Amifampridine phosphate (FIRDAPSE) is
     effective in a confirmatory phase 3 clinical trial in LEMS. J Clin
     Neuromuscul Dis. 2019;20(3):111-119.
 5.  Harms L, Sieb J-P, Williams AE, et al. Long-term disease history, clinical
     symptoms, health status, and healthcare utilization in patients suffering
     from Lambert Eaton myasthenic syndrome: results of a patient interview
     survey in Germany. J Med Econ. 2012;15(3):521-530.
 6.  National Organization for Rare Disorders (NORD) website. Rare disease
     database: Lambert-Eaton myasthenic syndrome. Accessed August 18, 2022.
     https://rarediseases.org/rare-diseases/lambert-eaton-myasthenic-syndrome/.
 7.  Orange Book: Approved drug products with therapeutic equivalence
     evaluations. US Food and Drug Administration. 42nd ed. 42. 2022:47,1260.
 8.  Muppidi S, Wolfe GI, Barohn RJ. Diseases of the neuromuscular junction. In:
     Swaiman K, Ashwal S, Ferriero D, Schor N, eds. Pediatric Neurology:
     Principles and Practice. 5th ed. Philadelphia, PA: Elsevier;
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 9.  Senanayake N, Roman GC. Disorders of neuromuscular transmission due to
     natural environmental toxins. J Neurol Sci. 1992;107:1-13.
 10. National Organization for Rare Disorders (NORD) website. Rare disease
     database: Myasthenia gravis. Accessed December 9, 2022.
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 11. Sanders DB. Lambert-Eaton myasthenic syndrome: diagnosis and treatment. Ann
     NY Acad Sci. 2003;998:500-508.
 12. Titulaer MJ, Lang B, Verschuuren JJ. Lambert-Eaton myasthenic syndrome:
     from clinical characteristics to therapeutic strategies. Lancet Neurol.
     2011;10(12):1098-1107.
 13. Gandhi L, Johnson BE. Paraneoplastic syndromes associated with small cell
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     cancer: a follow-up study of patients with Lambert-Eaton myasthenic
     syndrome. J Clin Oncol. 2008;26(26):4276-4281.
 15. Wirtz PW, Wintzen AR, Verschuuren JJ. Lambert-Eaton myasthenic syndrome has
     a more progressive course in patients with lung cancer. Muscle Nerve.
     2005;32(2):226-229.
 16. Wirtz PW, Smallegange TM, Wintzen AR, Verschuuren JJ. Differences in
     clinical features between the Lambert-Eaton myasthenic syndrome with and
     without cancer: an analysis of 227 published cases. Clin Neurol Neurosurg.
     2002;104(4):359-363.
 17. Tarr TB, Wipf P, Meriney SD. Synaptic pathophysiology and treatment of
     Lambert-Eaton myasthenic syndrome. Mol Neurolbiol. 2015;52(1):456-463.
 18. Maddison P, Lang B, Mill K, Newsom-Davis J. Long term outcome in
     Lambert-Eaton myasthenic syndrome without lung cancer. J Neurol Neurosurg
     Psychiatry. 2001;70(2):212-217.
 19. Merino-Ramírez MÁ, Bolton CF. Review of the diagnostic challenges of
     Lambert-Eaton syndrome revealed through three case reports. Can J Neurol
     Sci. 2016;43(5):635-647.
 20. Gilhus NE. Lambert-Eaton myasthenic syndrome; pathogenesis, diagnosis, and
     therapy. Autoimmune Dis. 2011;2011:973808.
 21. Kesner VG, Oh SJ, Dimachkie MM, Barohn RJ. Lambert-Eaton myasthenic
     syndrome. Neurol Clin. 2018;36(2):379-394.
 22. Lipka AF, Boldingh MI, van Zwet EW, et al. Long-term follow-up, quality of
     life, and survival of patients with Lambert-Eaton myasthenic syndrome.
     Neurology. 2020;94(5):e511-e520.
 23. Quartel A, Turbeville S, Lounsbury D. Current therapy for Lambert-Eaton
     myasthenic syndrome: development of 3,4-diaminopyridine phosphate salt as
     first-line symptomatic treatment. Curr Med Res Opin. 2010;26(6):1363-1375.
 24. Wirtz PW, Verschuuren JJ, van Dijk JG, et al. Efficacy of
     3,4-diaminopyridine and pyridostigmine in the treatment of Lambert-Eaton
     myasthenic syndrome: a randomized, double-blind, placebo-controlled,
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 26. Bain PG, Motomura M, Newsom-Davis J, et al. Effects of intravenous
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 28. Oh SJ, Sieb JP. Update on amifampridine as a drug of choice in
     Lambert-Eaton myasthenic syndrome. US J Neurol. 2014;10(2):83-89.
 29. Strupp M, Teufel J, Zwergal A, et al. Aminopyridines for the treatment of
     neurologic disorders. Neurol Clin Pract. 2017;7(1):65-76.
 30. Lindquist S, Stangel M. Update on treatment options for Lambert-Eaton
     myasthenic syndrome: focus on use of amifampridine. Neuropsychiatr Dis
     Treat. 2011;7:341-349.
 31. Data on file, Catalyst Pharmaceuticals.
 32. Verschuuren J, Strijbos E, Vincent A. Neuromuscular junction disorders.
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 33. Kirsch GE, Narahashi T. 3,4-diaminopyridine. A potent new potassium channel
     blocker. Biophys J. 1978;22(3):507-512.
 34. Dodson PD, Forsythe ID. Presynaptic K+ channels: electrifying regulators of
     synaptic terminal excitability. TINS. 2004;27(4):210-217.
 35. Sudhof TC. Calcium control of neurotransmitter release. Cold Spring Harb
     Perspect Biol. 2012;4(1):1-15.
 36. Ojala KS, Ginebaugh SP, Wu M, et al. A high-infinity, partial antagonist
     effect of 3,4-diaminopyridine mediates action potential broadening and
     enhancement of transmitter release at NMJs. J Biol Chem. 2021;296:100302.
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