RECOGNIZING THE SYMPTOMS

Early recognition of LEMS symptoms can lead to a quicker diagnosis and initiation of effective treatment5

1

PROXIMAL MUSCLE WEAKNESS

Can present as weakness in the upper leg, difficulty walking or rising from a seated position, and falling down.5,6

2

AUTONOMIC SYMPTOMS

Can present as dry mouth, impotence, constipation, and orthostatic hypotension.4,5

3

REDUCED TENDON REFLEXES

Patients with LEMS can present with decreased or absent tendon reflexes (areflexia). Areflexia may improve temporarily after a period of exercise.5

DIAGNOSING LEMS

If you suspect your patient may have LEMS, there are three clinical diagnostic methods you can utilize to get them on the right treatment path.5

PHYSICAL SYMPTOMS

A diagnosis of LEMS can often be made based on clinical symptomatology and physical signs, including proximal weakness, autonomic dysfunction, and areflexia.5

Diagnosis of LEMS may be further confirmed by use of the following tests individually or in combination.

Anti-VGCC Antibody Testing

Testing for the presence of anti-VGCC (voltage-gated calcium channel) antibodies can confirm diagnosis. Consider testing patients with symptoms of myasthenia gravis (MG) for the presence of anti-VGCC antibodies.5

Electrodiagnostic Testing

Increment on high-frequency repetitive nerve stimulation or post-exercise potentiation can also confirm diagnosis. Consider testing patients with symptoms of myasthenia gravis, especially with low CMAP amplitudes on regular nerve conduction studies.5

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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.