AMPYRA- dalfampridine tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)

Available from:

Acorda Therapeutics, Inc.

INN (International Name):

DALFAMPRIDINE

Composition:

DALFAMPRIDINE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AMPYRA is indicated as a treatment to improve walking in adult patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed [see Clinical Studies (14)]. The use of AMPYRA is contraindicated in the following conditions: - History of seizure [ see Warnings and Precautions (5.1)] - Moderate or severe renal impairment (CrCl≤50 mL/min) [see Warnings and Precautions (5.2) ] - History of hypersensitivity to AMPYRA or 4-aminopyridine; reactions have included anaphylaxis [see Warnings and Precautions (5.4) ] Risk Summary There are no adequate data on the developmental risk associated with use of AMPYRA in pregnant women. Administration of dalfampridine to animals during pregnancy and lactation resulted in decreased offspring viability and growth at clinically relevant doses [see Data ]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data Oral administration of dalfampridine to pregnant rats and rabbits throughout organogenesis resulted in no evidence of developmental toxicity in either species. The highest doses tested (10 mg/kg/day in rats, 5 mg/kg/day in rabbits), which were associated with maternal toxicity, are approximately 5 times the MRHD on a body surface area (mg/m 2 ) basis. Oral administration of dalfampridine (0, 1, 3, and 9 to 6 mg/kg/day; high dose reduced during the second week of dosing) to female rats throughout pregnancy and lactation resulted in decreased offspring viability at the highest dose tested and decreased body weight in offspring at the mid and high doses. The no-effect dose for pre- and postnatal developmental toxicity in rats (1 mg/kg/day) is less than the MRHD on a mg/m 2 basis. Risk Summary There are no data on the presence of dalfampridine in human milk, the effects of dalfampridine on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AMPYRA and any potential adverse effects on the breastfed infant from AMPYRA or from the underlying maternal condition. Safety and effectiveness in patients younger than 18 years of age 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 than younger subjects. A population PK analysis showed that dalfampridine clearance modestly decreased with increasing age, but not sufficiently to necessitate a modification of dose with age. Other reported clinical experience has identified no differences in responses between the elderly and younger patients. AMPYRA is known to be substantially excreted by the kidneys and the risk of adverse reactions, including seizures, is greater with increasing exposure of dalfampridine. Because elderly patients are more likely to have decreased renal function, it is particularly important to know the estimated creatinine clearance (CrCl) in these patients [see Warnings and Precautions (5.2)]. Clearance of dalfampridine is decreased in patients with renal impairment and is significantly correlated with creatinine clearance (CrCl) [see Clinical Pharmacology (12.3)] . AMPYRA is contraindicated in patients with moderate or severe renal impairment (CrCl ≤50 mL/min) [see Contraindications (4)]. The risk of seizures in patients with mild renal impairment (CrCl 51–80 mL/min) is unknown, but dalfampridine 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. If unknown, estimated creatinine clearance should be calculated prior to initiating treatment with AMPYRA [see Dosage and Administration (2.3) and Warnings and Precautions (5.2)] .

Product summary:

AMPYRA (dalfampridine) extended release tablets, 10 mg are film-coated, white to off-white, biconvex, oval shaped, non-scored tablets with flat edge. The tablets are identified by a debossed code "A10" on one side and are available in bottles of 60. Store at 25°C (77°F). Excursions permitted 15°C to 30°C (59°F to 86°F).

Authorization status:

New Drug Application

Patient Information leaflet

AMPYRA- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Acorda Therapeutics, Inc.
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MEDICATION GUIDE
AMPYRA® (am-PEER-ah)
(dalfampridine)
Extended Release Tablets
Read this Medication Guide before you start taking AMPYRA and each
time you get a refill. There may
be new information. This information does not take the place of
talking with your doctor about your
medical condition or your treatment.
What is the most important information I should know about AMPYRA?
AMPYRA can cause seizures.
•
You could have a seizure even if you never had a seizure before.
•
Your chance of having a seizure is higher if you take too much AMPYRA
or if your kidneys have
a mild decrease of function, which is common after age 50.
•
Your doctor may do a blood test to check how well your kidneys are
working, if that is not known
before you start taking AMPYRA.
•
Do not take AMPYRA if you have ever had a seizure.
•
Before taking AMPYRA tell your doctor if you have kidney problems.
•
Take AMPYRA exactly as prescribed by your doctor. See "How should I
take AMPYRA?"
Stop taking AMPYRA and call your doctor right away if you have a
seizure while taking AMPYRA.
What is AMPYRA?
AMPYRA is a prescription medicine used to help improve walking in
adults with multiple sclerosis
(MS). This was shown by an increase in walking speed.
It is not known if AMPYRA is safe or effective in children less than
18 years of age.
Who should not take AMPYRA?
Do not take AMPYRA if you:
•
have ever had a seizure
•
have certain types of kidney problems
•
are allergic to dalfampridine (4-aminopyridine), the active ingredient
in AMPYRA
What should I tell my doctor before taking AMPYRA?
Before you take AMPYRA, tell your doctor if you:
•
have any other medical conditions
•
are taking compounded 4-aminopyridine (fampridine, 4-AP)
•
are taking any other medicines, including over-the-counter medicines
such as cimetidine
•
are pregnant or plan to become pregnant. It is not known if AMPYRA
will harm your unborn baby
•
are breast-feeding

Summary of Product characteristics

AMPYRA- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
ACORDA THERAPEUTICS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMPYRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMPYRA.
AMPYRA (DALFAMPRIDINE) EXTENDED RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
AMPYRA
(dalfampridine) is a potassium channel blocker indicated to improve
walking in adult patients
with multiple sclerosis (MS). This was demonstrated by an increase in
walking speed ( 1, 14).
DOSAGE AND ADMINISTRATION
The maximum recommended dosage is 10 mg twice daily (approximately 12
hours apart). There is no
evidence of additional benefit with doses greater than 10 mg twice
daily. Adverse reactions, including
seizures, were more frequent at higher doses. ( 2.1)
Take with or without food. Administer tablets whole; do not divide,
crush, chew, or dissolve. ( 2.2)
Patients should not take double or extra doses if they miss a dose. (
2.2)
Estimated creatinine clearance (CrCl) should be known before
initiating treatment with AMPYRA. In
patients with mild renal impairment (CrCl 51–80 mL/min), AMPYRA may
reach plasma levels associated
with a greater risk of seizures, and the potential benefits of AMPYRA
should be carefully considered
against the risk of seizures in these patients ( 2.3, 5.2, 8.6)
DOSAGE FORMS AND STRENGTHS
10 mg tablets ( 3)
CONTRAINDICATIONS
History of seizure ( 4)
Moderate or severe renal impairment (CrCl≤50 mL/min) ( 4)
History of hypersensitivity to AMPYRA or 4-aminopyridine ( 4)
WARNINGS AND PRECAUTIONS
AMPYRA can cause seizures; the risk of seizures increases with
increasing AMPYRA doses; discontinue
AMPYRA and do not restart if a seizure occurs ( 5.1)
Avoid concomitant use with other forms of 4-aminopyridine (4-AP,
fampridine), since the active
ingredient is the same ( 5.3)
AMPYRA can cause anaphylaxis. Discontinue and do not restart AMPYRA if
this occurs ( 5.4)
ADVERSE REACTIONS
The most common adverse e