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:

Accord Healthcare Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dalfampridine Extended-Release Tablets are 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 Dalfampridine Extended-Release Tablets are 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 dalfampridine 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 Dalfampridine Extended-Release Tablets 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 dalfampridine and any potential adverse effects on the breastfed infant from dalfampridine or from the underlying maternal condition. Safety and effectiveness in patients younger than 18 years of age have not been established. Clinical studies of Dalfampridine Extended-Release Tablets 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. Dalfampridine 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)] . Dalfampridine Extended-Release Tablets are 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 to 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 Dalfampridine Extended-Release Tablets [see Dosage and Administration (2.3)and Warnings and Precautions (5.2)] .

Product summary:

Dalfampridine Extended-Release Tablets, 10 mg are white to off white, oval shaped,biconvex, film coated tablets, debossed with “FH6” on one side and plain on other side. The tablets are identified by a debossed code "FH6" on one side and are available as follows: Store at 25°C (77°F). Excursions permitted 15°C to 30°C (59°F to 86°F).

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
Accord Healthcare Inc.
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MEDICATION GUIDE
Dalfampridine Extended-Release Tablets
(dal-FAM-pri-deen)
Read this Medication Guide before you start taking Dalfampridine
Extended-Release Tablets 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
Dalfampridine Extended-Release Tablets?
Dalfampridine Extended-Release Tablets 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
Dalfampridine Extended-Release
Tablets 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 Dalfampridine Extended-Release Tablets.
•
Do not take Dalfampridine Extended-Release Tablets if you have ever
had a seizure.
•
Before taking Dalfampridine Extended-Release Tablets tell your doctor
if you have kidney
problems.
•
Take Dalfampridine Extended-Release Tablets exactly as prescribed by
your doctor. See “How
should I take Dalfampridine Extended-Release Tablets?”
Stop taking Dalfampridine Extended-Release Tablets and call your
doctor right away if you have a
seizure while taking Dalfampridine Extended-Release Tablets.
What are Dalfampridine Extended-Release Tablets?
Dalfampridine Extended-Release Tablets are 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 Dalfampridine Extended-Release Tablets are safe or
effective in children less than 18
years of age.
Who should not take Dalfampridine Extended-Release Tablets?
Do not take Dalfampridine Extended-Release Tablets if you:
•
have ever had a seizure
•
have certain type

Summary of Product characteristics

DALFAMPRIDINE- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE
ACCORD HEALTHCARE INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DALFAMPRIDINE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DALFAMPRIDINE EXTENDED-RELEASE TABLETS.
DALFAMPRIDINE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
INDICATIONS AND USAGE
Dalfampridine Extended-Release Tablets are 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 Dalfampridine
Extended-Release Tablets. In patients with mild renal impairment (CrCl
51 to 80 mL/min), Dalfampridine
Extended-Release Tablets may reach plasma levels associated with a
greater risk of seizures, and the
potential benefits of Dalfampridine Extended-Release Tablets 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 dalfampridine or 4-aminopyridine ( 4)
WARNINGS AND PRECAUTIONS
Dalfampridine can cause seizures; the risk of seizures increases with
increasing Dalfampridine
Extended-Release Tablets doses; discontinue Dalfampridine
Extended-Release Tablets and do not
restart if a seizure occurs ( 5.1)
Avoid co