dalfampridine

(redirected from Ampyra)

dalfampridine

(dal-fam-pri-deen) ,

Ampyra

(trade name),

Fampyra

(trade name)

Classification

Therapeutic: anti multiple sclerosis agents
Pharmacologic: potassium channel blockers
Pregnancy Category: C

Indications

Treatment of mutiple sclerosis, to improve walking speed.

Action

Acts as a potassium channel blocker, which may increase conduction of action potentials.

Therapeutic effects

Increased walking speed in patients with multiple sclerosis.

Pharmacokinetics

Absorption: Rapidly and completely absorbed (96%).
Distribution: Unknown.
Metabolism and Excretion: 96% eliminated in urine, 0.5% in feces.
Half-life: 5.2–6.5 hr.

Time/action profile (improvement in walking speed)

ROUTEONSETPEAKDURATION
POunk3–4 hr24 hr

Contraindications/Precautions

Contraindicated in: HypersensitivityHistory of seizures;Moderate/severe renal impairment (CCr ≤50 mL/min)(↑ risk of seizures); Lactation: Avoid use.
Use Cautiously in: Mild renal impairment (CCr 51–80 mL/min) (↑ risk of seizures) Geriatric: Consider age-related ↓ in renal function; Obstetric: Use only if potential benefit justifies potential risk to fetus; Pediatric: Safety and effectiveness not established.

Adverse Reactions/Side Effects

Central nervous system

  • seizures (life-threatening)
  • dizziness
  • headache
  • insomnia
  • weakness

Ear, Eye, Nose, Throat

  • nasopharyngitis
  • pharyngolaryngeal pain

Gastrointestinal

  • constipation
  • dyspepsia
  • nausea

Genitourinary

  • urinary tract infection

Musculoskeletal

  • back pain

Neurologic

  • balance disorder
  • multiple sclerosis relapse
  • paresthesia

Miscellaneous

  • anaphylaxis (life-threatening)

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Oral (Adults) 10 mg twice daily.

Availability

Extended-release tablets: 10 mg

Nursing implications

Nursing assessment

  • Assess walking speed in patients with multiple sclerosis prior to and periodically during therapy.
  • Monitor for seizures during therapy, risk increases with increased dose. If seizure occurs, discontinue therapy.
  • Monitor for signs and symptoms of anaphylaxis (dyspnea, wheezing, urticaria, angioedema of the throat or tongue) during therapy.
  • Lab Test Considerations: Monitor creatinine clearance prior to and at least yearly during therapy; renal impairment may require dose reduction or discontinuation.

Potential Nursing Diagnoses

Impaired walking (Indications)

Implementation

  • Administer tablets twice daily approximately 12 hr apart without regard to food. Administer tablets whole; do not break, crush, chew, or dissolve.

Patient/Family Teaching

  • Instruct patient to take dalfampridine as directed, with approximately 12 hrs between tablets. If a dose is missed, omit and take next scheduled dose on time; do not double doses. May increase risk of seizures. Advise patient to read Medication Guide prior to beginning therapy and with each Rx refill; new information may be available.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • If a seizure or signs or symptoms of anaphylaxis occur, advise patient to notify health care professional immediately, to discontinue dalfampridine, and to report the event to Acorda (manufacturer) at 1-800-367-5109.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Improved walking and increased walking speed in patients with multiple sclerosis.
References in periodicals archive ?
AMPYRA (dalfampridine) Extended Release Tablets, 10 mg - For the quarter ended December 31, 2017, the Company reported AMPYRA net revenue of $167.
Visit Multiple Sclerosis Treatment Market by Drug Class (Immunomodulators - Ampyra, Avonex/Plegridy, Betaseron/Extavia, Copaxone, Gilneya, Rebif, Tecifidera, Tysabri; and Immunosuppressants - Aubagio, Lemtrada, Ocrelizumab, Zinbryta) and Forecast 2017-2021 at https://www.
Acorda markets three FDA-approved therapies, including Ampyra (dalfampridine) Extended Release Tablets, 10 mg.
s multiple sclerosis drug Ampyra," Engellenner told InsideCounsel.
Regarding Acorda specifically, the Bass fund has apparently decided to 'double down' on its bet, filing another petition against each of the previously challenged Acorda patents on September 2nd as well as new petitions against two other Acorda patents covering the Ampyra drug on September 3rd.
United States-based Acorda Therapeutics has received an additional US patent for ampyra covering a range of dosage strengths, it was reported yesterday.
AMPYRA is marketed outside the United States as FAMPYRA([R]) (prolonged-release fampridine tablets) by Biogen Idec under a licensing agreement from Acorda.
For example, in July 2012, the FDA issued a DSC regarding the risk of seizures in patients receiving Ampyra, a drug for multiple sclerosis.
The sustained-release formulation of the potassium channel blocker dalfampridine, marketed as Ampyra by Acorda Therapeutics, was approved in January 2010 to improve walking in people with multiple sclerosis, at a dosage of 10 mg twice a day.
Newly approved drugs such as the multiple sclerosis medication Ampyra supplement rather than replace existing treatments.
FDA approved the marketing of Ampyra [TM] (dalfampridine, formerly known as fampridine SR; Acorda Therapeutics) for its ability to improve walking in people with any type of MS.
received an Establishment Inspection Report (EIR) from the FDA stating that the company has passed pre-approval inspection (PAI) for the manufacture of 4-Aminopyridine, the active ingredient in Ampyra.