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

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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

            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

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            Formulary

            FormularyPatient Discounts

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            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.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the 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.