Dalfampridine
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From MedlinePlus, U.S. National Library of Medicine
Potassium Channel Blocker
Dosing in kidney impairment
Renal Monitoring Prior to and During Treatment Estimated creatinine clearance (CrCl) should be known before initiating treatment with AMPYRA, and monitored at least annually during treatment with AMPYRA. CrCl can be estimated using the following equation (multiply by 0.85 for women): crcl-eqn-102716.jpg
Dosage in Patients with Renal Impairment In patients with mild renal impairment (CrCl 51–80 mL/min), AMPYRA plasma levels may approach those seen at a dose of 15 mg twice daily, a dose that is 1.5 times the maximum recommended dose and may be associated with an increased risk of seizures. As mild renal impairment is common after age 50, estimating CrCl is particularly important in these patients.
The potential benefits of AMPYRA should be carefully considered against the risk of seizures in these patients [ see Warnings and Precautions and Clinical Pharmacology ]. AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrCl≤50 mL/min).
Preparation and administration
Administration Instructions AMPYRA can be taken with or without food. Administer tablets whole; do not divide, crush, chew, or dissolve AMPYRA tablets. If a dose is missed, patients should not take double or extra doses.
Drug interactions
Check dalfampridine against a medication listLabel text (3 paragraphs)
7 DRUG INTERACTIONS OCT2 Inhibitors: Concomitant use may cause an increased exposure and potential risk of seizures ( 7.1 )
7.1 OCT2 Inhibitors Concurrent treatment with OCT2 inhibitors, such as cimetidine, may cause increased exposure to dalfampridine [ see Clinical Pharmacology (12.3) ]. Elevated levels of dalfampridine increase the risk of seizures [ see Warnings and Precautions (5.1 , 5.2) ]. The potential benefits of taking OCT2 inhibitors concurrently with AMPYRA should be considered against the risk of seizures in these patients.
7.2 Baclofen No interaction was identified between dalfampridine and baclofen [see Clinical Pharmacology (12.3) ].
Contraindications
The use of AMPYRA is contraindicated in the following conditions: History of seizure [ see Warnings and Precautions (5.1) ] Moderate or severe renal impairment (CrCl≤50 mL/min) [see Warnings and Precautions (5.2) ] History of hypersensitivity to AMPYRA or 4-aminopyridine; reactions have included anaphylaxis [see Warnings and Precautions (5.4) ] History of seizure ( 4 ) Moderate or severe renal impairment (CrCl≤50 mL/min) ( 4 ) History of hypersensitivity to AMPYRA or 4-aminopyridine ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Dalfampridine is a pyrimidine analogue used in the treatment of relapsing multiple sclerosis. Dalfampridine has had limited clinical use, but has not been linked to serum enzyme elevations during treatment nor to instances of clinically apparent liver injury with jaundice.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with use of AMPYRA in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see Data ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. The highest doses tested (10 mg/kg/day in rats, 5 mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the MRHD on a body surface area (mg/m 2 ) basis. Oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses.
The no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the MRHD on a mg/m 2 basis.
Breastfeeding (LactMed)
Because no information is available on the use of dalfampridine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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