dalfampridine (Rx)

Brand and Other Names:Ampyra
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, extended-release

  • 10mg
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Multiple Sclerosis

Indicated to improve walking in patients with multiple sclerosis by increasing walking speed

10 mg PO bid with or without food; take doses 12 hr apart

Extended-release tablet; swallow tablet whole and do not chew, crush, divide, or dissolve tablets

Renal & Hepatic Impairment

Renal impairment

  • Moderate-to-severe (CrCl ≤50 mL/min): Contraindicated due to increased risk of seizures
  • Mild (CrCl 51-80 mL/min): Risk of seizure unknown, but plasma levels may be similar to levels of 15 mg PO bid, a dose that is possibly associated with increased seizure risk

Hepatic impairment

  • Not studied, but not expected to change dosing recommendations (primarily renal excretion)

<18 years: Safety and efficacy not established

Multiple Sclerosis

It is important to know the estimated CrCl in the elderly prior to initiating therapy because the elderly are more likely to have decreased renal function

10 mg PO bid with or without food in normal renal function; take doses 12 hr apart

Extended-release tablet; swallow tablet whole and do not chew, crush, divide, or dissolve tablets

Renal & Hepatic Impairment

Mild renal impairment (CrCl 51-80 mL/min), Risk of seizure unknown, but plasma levels may be similar to levels of 15 mg PO bid, a dose that is possibly associated with increased seizure risk

Moderate or severe renal impairment (CrCl ≤50 mL/min): Contraindicated due to increased risk of seizures

Hepatic impairment: Not studied but not expected to change dosing recommendations (primarily renal excretion)

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Adverse Effects

>10%

Urinary tract infection (12%)

1-10%

Insomnia

Dizziness

Headache

Nausea

Asthenia

Back pain

Balance disorder

Multiple sclerosis relapse

Paresthesia

Nasopharyngitis

Constipation

Dyspepsia

Pharyngolaryngeal pain

Dose-related increased risk of seizures

Postmarketing Reports

Seizures; 4.6 per 1000 patient-years of use, which is comparable to the rate of seizures seen in the overall MS population

Vomiting

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Warnings

Contraindications

Hypersensitivity

Moderate or severe renal impairment (CrCl ≤50 mL/min)

History of seizure

Cautions

Discontinue if seizure occurs and do not restart; majority of seizures happened within days to weeks after starting the recommended dose and occurred in patients having no history of seizures

Age-related decreases in renal function, and mild renal impairment is common after age 50 yr, even when serum creatinine is normal; renal function should be assessed by estimating creatinine clearance

Do not take with other forms of 4-aminopyridine (4-AP, fampridine) to avoid adverse reaction due to the same active ingredient

Estimate CrCl before initiating (see Contraindications and Renal Impairment)

Do not double dose or take extra if dose missed

Anaphylaxis and severe allergic reactions; signs and symptoms have included respiratory compromise, urticaria, and angioedema of the throat and or tongue; discontinue immediately and do not restart (see Contraindications)

UTIs reported more frequently in clinical trials vs. placebo

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: Unknown if excreted in breast milk; discontinue drug or breast feeding

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Mechanism not completely understood, but in animal studies shown to block potassium channels, to delay repolarization and to increase duration of action potentials in demyelinated axons

Does not prolong QTc interval

Pharmacokinetics

Half-life elimination: 5-7 hr (prolonged up to 3 times longer in severe renal impairment)

Absorption: rapid and completely absorbed from GI tract; 96% relative bioavailability to aqueous oral solution; extended-release tablet

Vd: 2.6 L/kg

Peak Plasma Time: 3-4 hr  

Peak Plasma Concentration: 17.3 ng/mL-21.6 ng/mL (slight increase with food, 12-17%)

Protein Bound: 1-3%  

Metabolism: Minimal, 90.3% eliminated unchanged; 2 inactive metabolites (3-hydroxy-4-aminopyridine and 3-hydroxy-4-aminopyridine sulfate)

Excretion: feces (0.5%), urine (95.9%)  

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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