Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
DALFAMPRIDINE (UNII: BH3B64OKL9) (DALFAMPRIDINE - UNII:BH3B64OKL9)
Acorda Therapeutics, Inc.
DALFAMPRIDINE
DALFAMPRIDINE 10 mg
ORAL
PRESCRIPTION DRUG
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)] .
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).
New Drug Application
AMPYRA- DALFAMPRIDINE TABLET, FILM COATED, EXTENDED RELEASE Acorda Therapeutics, Inc. ---------- 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 Preberite celoten dokument
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 Preberite celoten dokument