dalfampridine

(redirected from Fampyra)

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 ?
The Company's principal products include therapies designed to assist in the treatment of multiple sclerosis, including TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA.
Fampyra has been proven to help with mobility for those living with the disease and drastically increase their quality of life, but often for an extortionate cost of up to [euro]500 a month.
AMPYRA and FAMPYRA are manufactured under license from Alkermes Pharma Ireland Limited.
In this role, Wasman will be responsible to administer the company's association with Biogen Idec on the development and global commercialization of FAMPYRA.
Gerard Murphy, 49, yesterday admitted he is still sceptical about the Government coughing up to provide potentially life-changing drug Fampyra to people with crippling MS.
Gerard Murphy had to give up "miracle" drug Fampyra in January after five years receiving it for free because he couldn't afford it.
Fampyra is not on the list of medications approved under the HSE's drug payment scheme.
FAMPYRA([R]) (prolonged-release fampridine tablets) royalties - For the quarter ended December 31, 2012, the Company reported FAMPYRA royalties from sales outside of the U.
Jerry Buttimer and Regina Doherty said patients are benefitting from a trial of Fampyra.
Acorda's President and CEO, commented, "We are pleased that the Opposition Division has recognized the validity of our patent claims for FAMPYRA.
third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including Diazepam Nasal Spray ("DZNS") or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market DZNS or other products under development; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approval of or to successfully market Fampyra outside of the U.
The HSE has confirmed Fampyra is not covered under any of its community drugs schemes.