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Indication & Important Safety Information

indications and usage:

FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

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. FIRDAPSE is contraindicated in patients with a history of seizures.

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.

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. 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;332:1467-1474.
  2. Skeie GO, Apostoloski S, Evoli A, et al. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010;17(7):893-902.
  3. Data on file, Catalyst Pharmaceuticals.
  4. Sanders DB. Lambert-Eaton myasthenic syndrome: diagnosis and treatment. Ann NY Acad Sci. 2003;998:500-508.
  5. Titulaer MJ, Lang B, Verschuuren JJ. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strategies. Lancet Neurol. 2011;10(12):1098-1107.
  6. 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.
  7. Mantegazza R, Meisel A, Sieb JP, et al. The European LEMS Registry: baseline demographics and treatment approaches. Neurol Ther. 2015;4(2):105-124.
  8. 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.
  9. Motomura M, Lang B, Johnston I, Palace J, Vincent A, Newsom-Davis J. Incidence of serum anti-P/Q-type and anti-N-type calcium channel autoantibodies in the Lambert-Eaton myasthenic syndrome. J Neuro Sci. 1997;147:35-42.
  10. 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.
  11. Strupp M, Teufel J, Zwergal A, et al. Aminopyridines for the treatment of neurologic disorders. Neurol Clin Pract. 2017;7(1):65-76.
  12. 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.
  13. Full Prescribing Information for FIRDAPSE (amifampridine). Catalyst Pharma.; 2018.
  14. Oh SJ, Shcherbakova 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.

Indication & Important Safety Information

indications and usage:

FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.

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. FIRDAPSE is contraindicated in patients with a history of seizures.

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.

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. 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;332:1467-1474.
  2. Skeie GO, Apostoloski S, Evoli A, et al. Guidelines for treatment of autoimmune neuromuscular transmission disorders. Eur J Neurol. 2010;17(7):893-902.
  3. Data on file, Catalyst Pharmaceuticals.
  4. Sanders DB. Lambert-Eaton myasthenic syndrome: diagnosis and treatment. Ann NY Acad Sci. 2003;998:500-508.
  5. Titulaer MJ, Lang B, Verschuuren JJ. Lambert-Eaton myasthenic syndrome: from clinical characteristics to therapeutic strategies. Lancet Neurol. 2011;10(12):1098-1107.
  6. 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.
  7. Mantegazza R, Meisel A, Sieb JP, et al. The European LEMS Registry: baseline demographics and treatment approaches. Neurol Ther. 2015;4(2):105-124.
  8. 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.
  9. Motomura M, Lang B, Johnston I, Palace J, Vincent A, Newsom-Davis J. Incidence of serum anti-P/Q-type and anti-N-type calcium channel autoantibodies in the Lambert-Eaton myasthenic syndrome. J Neuro Sci. 1997;147:35-42.
  10. 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.
  11. Strupp M, Teufel J, Zwergal A, et al. Aminopyridines for the treatment of neurologic disorders. Neurol Clin Pract. 2017;7(1):65-76.
  12. 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.
  13. Full Prescribing Information for FIRDAPSE (amifampridine). Catalyst Pharma.; 2018.
  14. Oh SJ, Shcherbakova 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.