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Indication

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.

Important Safety Information

AMPYRA is contraindicated in patients with history of seizures, moderate or severe renal impairment (CrCl ≤ 50 mL/min), or history of hypersensitivity to AMPYRA or 4-aminopyridine.

Indication

AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg is indicated as a treatment to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed.

Important Safety Information

  • AMPYRA is contraindicated in patients with history of seizures, moderate or severe renal impairment (CrCl ≤ 50 mL/min), or history of hypersensitivity to AMPYRA or 4-aminopyridine.
  • AMPYRA can cause seizures. The risk of seizures increases with increasing doses. Discontinue AMPYRA and do not restart if seizure occurs. In the post-marketing period seizures have been reported. The majority of seizures occurred at the recommended dose, in patients without a history of seizures, and generally within days to weeks of starting therapy.
  • AMPYRA has not been evaluated in patients with history of seizures or with epileptiform activity on an EEG, as these patients were excluded from clinical trials. The risk of seizures in patients with epileptiform activity on an EEG is unknown, and could be substantially higher than that observed in clinical studies.
  • AMPYRA should not be taken with other forms of 4-aminopyridine (4-AP, fampridine), since the active ingredient is the same. Patients should discontinue use of any product containing 4-aminopyridine prior to initiating AMPYRA to reduce the potential for dose-related adverse reactions.
  • AMPYRA can cause anaphylaxis and severe allergic reaction. Signs and symptoms included respiratory compromise, urticaria, and angioedema of the throat or tongue. If an anaphylactic or other serious allergic reaction occurs, discontinue AMPYRA and do not restart.
  • AMPYRA is cleared predominantly by the kidneys. The risk of seizures in patients with mild renal impairment (CrCl 51–80 mL/min) is unknown, but AMPYRA plasma levels in these patients may approach those seen at a dose of 15 mg twice daily, a dose that may be associated with an increased risk of seizures; estimated CrCl should be known before initiating AMPYRA and monitored at least annually during treatment.
  • Urinary tract infections (UTIs) were reported more frequently in controlled studies in patients receiving AMPYRA (12%) as compared to placebo (8%). UTIs in AMPYRA-treated patients should be evaluated and treated as clinically indicated.
  • The most common adverse events (incidence ≥ 2% and at a rate greater than the placebo rate) for AMPYRA in MS patients were urinary tract infection, insomnia, dizziness, headache, nausea, asthenia, back pain, balance disorder, multiple sclerosis relapse, paresthesia, nasopharyngitis, constipation, dyspepsia, and pharyngolaryngeal pain.
  • The risk of adverse events, including seizures, increases with increasing AMPYRA doses. No additional benefit was demonstrated at doses greater than 10 mg twice daily.
  • There are no adequate and well-controlled studies of AMPYRA in pregnant women. AMPYRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • It is not known if AMPYRA passes into breast milk. Discontinue AMPYRA or nursing, taking into consideration the importance of AMPYRA to the mother.
  • Safety and effectiveness of AMPYRA in patients younger than 18 years have not been established.
  • Clinical studies of AMPYRA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Because elderly patients are more likely to have decreased renal function, it is important to know the estimated CrCl before initiating AMPYRA.

Please review the Full Prescribing Information.