Amifampridine

REMS

Lambert-Eaton myasthenic syndrome (LEMS).

Contraindicated in:

Hypersensitivity to amifampridine or another aminopyridine
History of seizures
Severe renal impairment (CCr 15 mL/min) (↑ risk of seizures).

Use Cautiously in:

Mild-to-moderate renal impairment (CCr 16–80 mL/min) (initiate with lowest dose and monitor closely)
Hepatic impairment (initiate with lowest dose and monitor closely)
NAT2 poor metabolizers (initiate with lowest dose and monitor closely)
OB: Safety not established in pregnancy
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
Pedi: Safety and effectiveness not established in children
Geri: Consider age-related ↓ in renal function.

CV: hypertension, peripheral edema.

Derm: erythema.

EENT: cataracts.

GI: abdominal pain, diarrhea, ↑liver enzymes, nausea, constipation, dyspepsia.

GU: urinary tract infection.

Metab: hypercholesterolemia.

MS: back pain, extremity pain, muscle spasms, muscle weakness, ↑ creatine kinase.

Neuro: dizziness, headache, paresthesia, depression, insomnia, SEIZURES, weakness.

Resp: dyspnea.

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS).

Drug-Drug:

Drugs that lower seizure threshold may ↑ risk of seizures.
Cholinesterase inhibitors (direct or indirect) may ↑ cholinergic effects.

PO (Adults): 15 to 30 mg/day in 3 to 4 divided doses; may ↑ by 5 mg/day every 3–4 days (not to exceed 20 mg/dose or 80 mg/day). NAT2 poor metabolizers — 5 mg 3 times daily; may adjust dose or discontinue use based on response and tolerability.

Renal Impairment

PO (Adults): CCr 15–90 mL/min — 5 mg 3 times daily; may adjust dose or discontinue use based on response and tolerability.

Hepatic Impairment

(Adults): 5 mg 3 times daily; may adjust dose or discontinue use based on response and tolerability.

Increases acetylcholine release in nerve terminals via potassium channel blockade.

Therapeutic Effects:

Decreased progression of muscle weakness.

Therapeutic Classification: cholinergic muscle stimulants

Pharmacologic Classification:

Absorption: Rapidly and well absorbed.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Extensively metabolized by N-acetyltransferase 2 (NAT2) to an inactive metabolite. Primarily eliminated in urine (as either unchanged drug or metabolite).

Half-life: 1.8–2.5 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	0.3–1 hr	unknown

Instruct patient to take medication as directed and follow dose escalation schedule. Advise patient to omit missed doses. Do not double doses; may increase risk of seizures. Do not change dose or stop medication without consulting health care professional.
Advise patient to notify health care professionals if seizures or signs and symptoms of hypersensitivity reaction (shortness of breath, trouble breathing, swelling of throat or tongue, hives) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Firdapse during pregnancy. Clinicians 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 .

NDC Code^*

49938- Jacobus Pharmaceutical Company,Inc
49938-110- Ruzurgi 49938-110-01- 1 BOTTLE, PLASTIC in 1 CARTON (49938-110-01) > 100 TABLET in 1 BOTTLE, PLASTIC

69616- Catalyst Pharmaceuticals, Inc.
69616-211- Firdapse 69616-211-03- 240 TABLET in 1 BOTTLE, PLASTIC (69616-211-03)

69616- Catalyst Pharmaceuticals, Inc.
69616-211- Firdapse 69616-211-06- 12 BLISTER PACK in 1 CARTON (69616-211-06) > 10 TABLET in 1 BLISTER PACK (69616-211-04)

69616- Catalyst Pharmaceuticals, Inc.
69616-211- Firdapse 69616-211-08- 60 TABLET in 1 BOTTLE, PLASTIC (69616-211-08)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆