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FIRDAPSE ACCESS AND FINANCIAL SUPPORT

FIRDAPSE is available and affordable to virtually every patient with LEMS

Catalyst Pathways® programs have helped patients gain access to treatment and minimized their out-of-pocket (OOP) costs for FIRDAPSE7

95% of patients pay nothing for FIRDAPSE prescription
of patients pay nothing for their FIRDAPSE prescription7
<$2/month
Average monthly copay for patients enrolled in Catalyst Pathways7*
Includes those who are covered by Medicare and accessing Foundation Assistance. Individual costs may vary. Average copay cost represents the latest 2021 data on file and excludes patients who did not elect to pursue Foundation Assistance.

Catalyst Pathways offers your patients a world of personalized support

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Catalyst Pathways provides intuitive programs and expert personnel to support adults with Lambert-Eaton myasthenic syndrome (LEMS) throughout their treatment journey.

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Keeping FIRDAPSE accessible

My FIRDAPSE Therapeutic Dose Program

Dosing and Titration Support

Available through Catalyst Pathways, the My FIRDAPSE Therapeutic Dose Program is designed to help your new patients achieve prompt and proper treatment of their LEMS symptoms.

By providing useful tools and materials, the program helps physicians:

Establish the proper starting dose of FIRDAPSE
Guide effective titration to achieve the optimal therapeutic dose for each patient

You and your patients will also receive one-on-one dosing support and monitoring from a Patient Access Liaison (PAL) throughout the titration process.

My FIRDAPSE Therapeutic Dose Program
ENROLL YOUR PATIENTS NOW IN CATALYST PATHWAYS!
There are 2 easy ways to secure all the benefits of Catalyst Pathways, including the My FIRDAPSE Therapeutic Dose Program:
Download and complete the Enrollment Form
Call 1-833-4-CATALYST (1-833-422-8259) to talk with a representative who can help you complete the Enrollment Form.
FIRDAPSE Delivery Assurance Program logo

Delivery Assurance Program

Catalyst Pharmaceuticals understands that FIRDAPSE can only help your patients if they can get their medication. Through the Catalyst Delivery Assurance Program, they will. Our Delivery Assurance team members are constantly monitoring and anticipating all potential obstacles to delivery and are formulating alternate plans to ensure that your patients can always get their tablets. Whatever the threat—hurricane, tornado, earthquake, transit strike, or major sporting event—Catalyst will have a plan in place to assure FIRDAPSE delivery.

FIRDAPSE Delivery Assurance Program logo

Keeping FIRDAPSE affordable

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Catalyst Bridge Medicine Program

While your patients’ insurance coverage is being reviewed, Catalyst Pathways will provide qualifying patients with “Bridge” medicine (free medicine to span the gap between insurance investigation and confirmation of coverage).

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Financial Assistance

An array of options, including a copay support program to reduce your patients’ out-of-pocket costs.

Dedicated team of experts helps optimize your patients’ FIRDAPSE treatment experience

Care Coordinator

To provide a warm welcome into the Catalyst Pathways program and introduce patients to their dedicated team.

Patient Access Liaison

Your patients’ go-to, local resource for one-on-one disease education, as well as treatment and insurance support.

Insurance Navigator

Personalized guidance to help your patients handle any complicated insurance and reimbursement issues that may arise.

2 easy ways to enroll patients in Catalyst Pathways

Catalyst Pathways Enrollment Form
1

Complete the Enrollment Form at YourCatalystPathways.com

2

Contact a FIRDAPSE Representative at 1-833-4-CATALYST (1-833-422-8259)

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Catalyst Pathways

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Discover everything Catalyst Pathways has to offer you and your patients by visiting our dedicated website.
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Request to be contacted by a FIRDAPSE Representative.
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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:
  1. Yoon CH, Owusu-Guha J, Smith A, Buschur P. Amifampridine for the management 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; 2022.
  3. Shieh P, Sharma K, Korhman 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.
  4. 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.
  5. Lennon VA, Kryzer TJ, Griesmann GE, et al. Calcium-channel antibodies in the Lambert-Eaton syndrome and other paraneoplastic syndromes. N Engl J Med. 1995;332(22):1467-1474.
  6. Skeie GO, Apostolski S, Evoli A, et al. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010;17(7):893-902.
  7. Data on file, Catalyst Pharmaceuticals.
  8. Orange Book: Approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed June 10, 2020.
  9. 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; 2011:1549-1569.
  10. Sanders DB. Lambert-Eaton myasthenic syndrome: diagnosis and treatment. Ann NY Acad Sci. 2003;998:500-508.
  11. Harms L, Sieb JP, 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.
  12. 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.
  13. Titulaer MJ, Lang B, Verschuuren JJ. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strategies. Lancet Neurol. 2011;10(12):1098-1107.
  14. Titulaer MJ, Wirtz PW, Willems LNA, et al. Screening for small-cell lung cancer: a follow-up study of patients with Lambert-Eaton myasthenic syndrome. J Clin Oncol. 2008;26(26):4276-4281.
  15. 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.
  16. 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.
  17. 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.
  18. Zalewski NL, Lennon VA, Lachance DH, et al. P/Q- and N-type calcium-channel antibodies: oncological, neurological, and serological accompaniments. Muscle Nerve. 2016;54(2):220-227.
  19. Lennon VA. Serologic profile of myasthenia gravis and distinction from the Lambert-Eaton myasthenic syndrome. Neurology. 1997;48(suppl 5):S23-S27.
  20. Gilhus NE. Lambert-Eaton myasthenic syndrome; pathogenesis, diagnosis, and therapy. Autoimmune Dis. 2011;2011:973808.
  21. 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.
  22. Chalk CH, Murray NM, Newsom-Davis J, O'Neill JH, Spiro SG. Response of the Lambert-Eaton myasthenic syndrome to treatment of associated small-cell lung carcinoma. Neurology. 1990;40(10):1552-1556.
  23. Hyun JW, Kim SH, Jeong IH, Kim HT, Kim HJ. Successful treatment of Lambert-Eaton myasthenic syndrome in a small cell lung cancer patient using 3,4-diaminopyridine: a case report. Onc Ltrs. 2016;11:1933-1935.
  24. Bain PG, Motomura M, Newsom-Davis J, et al. Effects of intravenous immunoglobulin on muscle weakness and calcium-channel autoantibodies in the Lambert-Eaton myasthenic syndrome. Neurology. 1996;47(3):678-683.
  25. Ivanovski T, Miralles F. Lambert-Eaton myasthenic syndrome: early diagnosis is key. Degener Neurol Neuromuscul Dis. 2019;9:27-37.
  26. 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, crossover study. Clin Pharmacol Ther. 2009;86(1):44-48.
  27. 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.
  28. Strupp M, Teufel J, Zwergal A, et al. Aminopyridines for the treatment of neurologic disorders. Neurol Clin Pract. 2017;7(1):65-76.
  29. 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.
  30. Jacob S, Muppidi S, Guidon A, et al; International MG/COVID-19 Working Group. Guidance for the management of myasthenia gravis (MG) and Lambert-Eaton myasthenic syndrome (LEMS) during the COVID-19 pandemic. J Neurol Sci. 2020;412:116803.

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:
  1. Yoon CH, Owusu-Guha J, Smith A, Buschur P. Amifampridine for the management 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; 2022.
  3. Shieh P, Sharma K, Korhman 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.
  4. 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.
  5. Lennon VA, Kryzer TJ, Griesmann GE, et al. Calcium-channel antibodies in the Lambert-Eaton syndrome and other paraneoplastic syndromes. N Engl J Med. 1995;332(22):1467-1474.
  6. Skeie GO, Apostolski S, Evoli A, et al. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010;17(7):893-902.
  7. Data on file, Catalyst Pharmaceuticals.
  8. Orange Book: Approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration website. https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm. Accessed June 10, 2020.
  9. 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; 2011:1549-1569.
  10. Sanders DB. Lambert-Eaton myasthenic syndrome: diagnosis and treatment. Ann NY Acad Sci. 2003;998:500-508.
  11. Harms L, Sieb JP, 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.
  12. 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.
  13. Titulaer MJ, Lang B, Verschuuren JJ. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strategies. Lancet Neurol. 2011;10(12):1098-1107.
  14. Titulaer MJ, Wirtz PW, Willems LNA, et al. Screening for small-cell lung cancer: a follow-up study of patients with Lambert-Eaton myasthenic syndrome. J Clin Oncol. 2008;26(26):4276-4281.
  15. 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.
  16. 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.
  17. 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.
  18. Zalewski NL, Lennon VA, Lachance DH, et al. P/Q- and N-type calcium-channel antibodies: oncological, neurological, and serological accompaniments. Muscle Nerve. 2016;54(2):220-227.
  19. Lennon VA. Serologic profile of myasthenia gravis and distinction from the Lambert-Eaton myasthenic syndrome. Neurology. 1997;48(suppl 5):S23-S27.
  20. Gilhus NE. Lambert-Eaton myasthenic syndrome; pathogenesis, diagnosis, and therapy. Autoimmune Dis. 2011;2011:973808.
  21. 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.
  22. Chalk CH, Murray NM, Newsom-Davis J, O'Neill JH, Spiro SG. Response of the Lambert-Eaton myasthenic syndrome to treatment of associated small-cell lung carcinoma. Neurology. 1990;40(10):1552-1556.
  23. Hyun JW, Kim SH, Jeong IH, Kim HT, Kim HJ. Successful treatment of Lambert-Eaton myasthenic syndrome in a small cell lung cancer patient using 3,4-diaminopyridine: a case report. Onc Ltrs. 2016;11:1933-1935.
  24. Bain PG, Motomura M, Newsom-Davis J, et al. Effects of intravenous immunoglobulin on muscle weakness and calcium-channel autoantibodies in the Lambert-Eaton myasthenic syndrome. Neurology. 1996;47(3):678-683.
  25. Ivanovski T, Miralles F. Lambert-Eaton myasthenic syndrome: early diagnosis is key. Degener Neurol Neuromuscul Dis. 2019;9:27-37.
  26. 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, crossover study. Clin Pharmacol Ther. 2009;86(1):44-48.
  27. 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.
  28. Strupp M, Teufel J, Zwergal A, et al. Aminopyridines for the treatment of neurologic disorders. Neurol Clin Pract. 2017;7(1):65-76.
  29. 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.
  30. Jacob S, Muppidi S, Guidon A, et al; International MG/COVID-19 Working Group. Guidance for the management of myasthenia gravis (MG) and Lambert-Eaton myasthenic syndrome (LEMS) during the COVID-19 pandemic. J Neurol Sci. 2020;412:116803.
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