FINGOLIMOD- fingolimod capsule

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

Fingolimod Hydrochloride (UNII: G926EC510T) (FINGOLIMOD - UNII:3QN8BYN5QF)

から入手可能:

Biocon Pharma Inc.

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 18 years of age and older. Pediatric use information is approved for Novartis Pharmaceuticals Corporation’s GILENYA (fingolimod) capsules. However, due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. Fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization or Class III/IV heart failure - a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker [see Warning and Precautions (5.1)] - a baseline QTc interval ≥500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with Cla

製品概要:

Fingolimod capsules 0.5 mg are hard gelatine capsules with a white opaque body and bright yellow cap imprinted with Biocon Logo on the cap and “F 0.5” on the body with black ink. Fingolimod capsules are supplied in blister packs. Carton of 28 capsules containing 1 blister card (1 X 28 capsules) - NDC 70377-019-21 Fingolimod capsules should be stored at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Protect from moisture.

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

FINGOLIMOD - FINGOLIMOD CAPSULE
Biocon Pharma Inc.
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MEDICATION GUIDE FINGOLIMOD (fin gol' i mod) Capsules
Read this Medication Guide before you start taking fingolimod capsules
and each time you get a refill. There
may be new information. If you are the parent of a child who is being
treated with fingolimod capsules, the
following information applies to your child. This information does not
take the place of talking to your
doctor about your medical condition or your treatment.
What is the most important information I should know about fingolimod
capsules?
Fingolimod capsules may cause serious side effects, including:
1. Slow heart rate (bradycardia or bradyarrhythmia) when you start
taking fingolimod capsules.
Fingolimod capsules can cause your heart rate to slow down, especially
after you take your first dose.You
will have a test, called an electrocardiogram (ECG), to check the
electrical activity of your heart before you
take your first dose of fingolimod capsules.
All adults will be observed by a healthcare professional for at least
6 hours after taking their first dose of
Fingolimod capsules.
After you take your first dose of fingolimod capsules:
• Your pulse and blood pressure should be checked every hour.
• You should be observed by a healthcare professional to see if you
have any serious side effects. If your
heart rate slows down too much, you may have symptoms such as:
o dizziness
o tiredness
o feeling like your heart is beating slowly or skipping beats
o chest pain
• If you have any of the symptoms of slow heart rate, they will
usually happen during the first 6 hours after
your first dose of fingolimod capsules. Symptoms can happen up to 24
hours after you take your first
fingolimod capsules dose.
• 6 hours after you take your first dose of fingolimod capsules you
will have another ECG. If your ECG
shows any heart problems or if your heart rate is still too low or
continues to decrease, you will continue to
be observed.
• If you have any serious side effects after your first dose of

製品の特徴

FINGOLIMOD - FINGOLIMOD CAPSULE
BIOCON PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FINGOLIMOD CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FINGOLIMOD CAPSULES.
FINGOLIMOD CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2010
RECENT MAJOR CHANGES
Indication and Usage (1) 8/2019
Dosage and Administration (2.1) 8/2019
Contraindications (4) 1/2019
Warnings and Precautions (5.1) 8/2019
Warnings and Precautions (5.9) 10/2018
Warnings and Precautions (5.11) 1/2019
INDICATIONS AND USAGE
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated
for the treatment of relapsing forms
of multiple sclerosis (MS), to include clinically isolated syndrome,
relapsing-remitting disease, and active secondary
progressive disease, in patients 18 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Assessments are required prior to initiating Fingolimod capsules (2.1)
Recommended dosage for adults: 0.5 mg orally once-daily, with or
without food (2.2, 2.3)
First-Dose Monitoring (including re-initiation after discontinuation
greater than 14 days and dose increases):
• Observe all patients for bradycardia for at least 6 hours; monitor
pulse and blood pressure hourly. Electrocardiograms
(ECGs) prior to dosing and at end of observation period required.
(2.4)
• Monitor until resolution if heart rate < 45 beats per minute (bpm)
in adults, atrioventricular (AV) block, or if lowest
postdose heart rate is at the end of the observation period. (2.4)
• Monitor symptomatic bradycardia with ECG until resolved. Continue
overnight if intervention is required; repeat first-
dose monitoring for second dose. (2.4)
• Observe patients overnight if at higher risk of symptomatic
bradycardia, heart block, prolonged QTc interval, or if
taking drugs with known risk of torsades de pointes. (2.4, 7.1)
DOSAGE FORMS AND STRENGTHS
0.5 mg hard capsules. (3)
CONTRAINDICATIONS
Recent myocardial infarction, unstable angina, stroke, transient
ische