DOSING AND TITRATION WITH 10-MG FIRDAPSE TABLETS

For patients ≥6 years of age and weighing ≥45 kg2*

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*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 (15 mg daily in adults and in pediatric patients weighing 45 kg or more; 5 mg daily for pediatric patients weighing less than 45 kg). This dose should continue to be titrated to clinical effect and tolerability.2 No dosage recommendation for FIRDAPSE can be made for patients with end-stage renal disease.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

FIRDAPSE IS NOW APPROVED FOR MAXIMUM DOSING UP TO 100MG/DAY31

The US Food and Drug Administration has approved an increase in the maximum daily dose for FIRDAPSE from 80 mg to 100 mg daily.31 This expanded ceiling ensures patients taking higher doses of FIRDAPSE can still benefit from dose titration, when their symptoms progress or worsen, and warrant a dosing increase to achieve or maintain an optimal therapeutic effect.

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)
FIRDAPSE pill bottle and blister pack

Do you have a patient taking FIRDAPSE who is pregnant?

Pregnant Warning

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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