dalfampridine (Rx)

Brand and Other Names:Ampyra
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet, extended-release

  • 10mg

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)

Transverse Myelitis (Orphan)

Orphan designation for treatment of transverse myelitis

Sponsor

  • Magnum Therapeutics; 10 Park Ave; New York, New York

<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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Interactions

Interaction Checker

and dalfampridine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • trilaciclib

                trilaciclib will increase the level or effect of dalfampridine by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with dalfampridine. Consider potential benefits of trilaciclib against risk of seizures with increased dalfampridine blood levels.

              Monitor Closely (2)

              • dolutegravir

                dolutegravir will increase the level or effect of dalfampridine by Other (see comment). Modify Therapy/Monitor Closely. dolutegravir inhibits OCT2 and multidrug and toxin extrusion transporter 1

              • metformin

                metformin, dalfampridine. Either increases levels of the other by Other (see comment). Use Caution/Monitor. Comment: Metformin and dalfampridine are organic cation transporter 2 (OCT2) substrates; both drugs may compete for renal tubular uptake and could potentially increase systemic exposure of either drug when administered concomitantly.

              Minor (0)

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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, vertigo

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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

                There are no adequate data on developmental risk associated with use in pregnant women

                Animal data

                • Administration to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses

                Lactation

                There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition

                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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                dalfampridine oral
                -
                10 mg tablet
                dalfampridine oral
                -
                10 mg tablet
                dalfampridine oral
                -
                10 mg tablet
                dalfampridine oral
                -
                10 mg tablet
                Ampyra oral
                -
                10 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

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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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.