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Amifampridine Phosphate

Also known as: Firdapse

Route: Oral

Check Amifampridine Phosphate Interactions →

3 interactions on record

Amifampridine Phosphate has 3 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Direct Renin Inhibitors, Drugs That Lower Seizure Threshold, Mao Inhibitors. Patients taking Amifampridine Phosphate should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 3
Moderate: 3

Moderate (3)

Amifampridine Phosphate + Direct Renin Inhibitors— Concomitant use may increase cholinergic effects and increase risk of adverse reactions.
Amifampridine Phosphate + Drugs That Lower Seizure Threshold— Concomitant use may lead to an increased risk of seizures. Decision to use together should be carefully considered based…
Amifampridine Phosphate + Mao Inhibitors— Concomitant use may increase cholinergic effects and increase risk of adverse reactions.

Amifampridine Phosphate + Direct Renin Inhibitors🟡Moderate

Concomitant use may increase cholinergic effects and increase risk of adverse reactions.

Amifampridine Phosphate + Drugs That Lower Seizure Threshold🟡Moderate

Concomitant use may lead to an increased risk of seizures. Decision to use together should be carefully considered based on severity of risks.

Amifampridine Phosphate + Mao Inhibitors🟡Moderate

Concomitant use may increase cholinergic effects and increase risk of adverse reactions.

Contraindications

4 CONTRAINDICATIONS FIRDAPSE is contraindicated in patients with: A history of seizures [see Warnings and Precautions ( 5.1 )] Hypersensitivity to amifampridine phosphate or another aminopyridine [see Warnings and Precautions ( 5.2 )] FIRDAPSE is contraindicated in patients with: A history of seizures ( 4 ) Hypersensitivity to amifampridine or another aminopyridine ( 4 )

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FIRDAPSE during pregnancy. Physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the registry by calling 855- 212-5856 (toll-free), using the Fax number 877-867-1874 (toll-free), by contacting the Pregnancy Coordinating Center at firdapsepregnancyregistry@ubc.com, or by visiting the study website www.firdapsepregnancystudy.com. Risk Summary There are no data on the developmental risk associated with the use of FIRDAPSE in pregnant women. In animal studies, administration of amifampridine phosphate to rats during pregnancy and lactation resulted in developmental toxicity (increase in stillbirths and pup deaths, reduced pup weight, and delayed sexual development) at doses associated with maternal plasma drug levels lower than therapeutic drug levels (see Animal Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of amifampridine phosphate (0, 7.5, 22.5, or 75 mg/kg/day) to female rats prior to and during mating and continuing throughout organogenesis produced no adverse effects on embryofetal development. The highest dose tested is approximately 4 times the maximum recommended human dose (MRHD) of amifampridine (100 mg/day) on a body surface area (mg/m 2 ) basis. Oral administration of amifampridine phosphate (0, 9, 30, or 57 mg/kg/day) to pregnant rabbits throughout organogenesis produced no adverse effects on embryofetal development. The highest dose tested is approximately 6 times the MRHD of amifampridine on a body surface area (mg/m 2 ) basis. Oral administration of amifampridine phosphate (0, 7.5, 22.5, or 75 mg/kg/day) to fe

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.