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:

Sun Pharmaceutical Industries, 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 10 years of age and older. Fingolimod is contraindicated in patients who have: - in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (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 Warnings and Precautions (5.1)] - a baseline QTc interval ≥ 500 msec - cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs - had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. Observed reactions include rash, urticaria and angioedema upon treatment initiation [see Warni

製品概要:

0.5 mg fingolimod capsules are supplied as follows: Hard gelatin capsule, size '4' yellow cap and white body, axially imprinted with '064' on cap and on body in black ink, filled with white to off-white powder. Bottles of 30 with child resistant cap……………………………………...NDC 62756-064-83 Bottles of 90 with child resistant cap……………………………………...NDC 62756-064-81 Carton of 28 capsules containing 2 blister cards of 14 capsules per blister card NDC 62756-064-96 Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 62756-064-59 Fingolimod capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°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

Sun Pharmaceutical Industries, Inc.
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MEDICATION GUIDE
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
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 and children 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:
•
dizziness
•
tiredness
•
feeling like your heart is beating slowly or skipping beats
•
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 d

製品の特徴

FINGOLIMOD - FINGOLIMOD CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, 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
Warning and Precautions (5.3, 5.9) 8/2023
INDICATIONS AND USAGE
(1)
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 10 years of age and
older. (1) (1)
(1)
DOSAGE AND ADMINISTRATION
Assessments are required prior to initiating fingolimod capsules.
(2.1)
Recommended dosage for adults and pediatric patients (10 years of age
and older) weighing more than
40 kg: 0.5 mg orally once-daily, with or without food. (2.2, 2.3)
First-Dose Monitoring (including reinitiation 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, < 55 bpm in patients
aged 12 years and above, or < 60 bpm in pediatric patients aged 10 to
below 12 years,
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) (3)
CONTRAINDICATIONS
Recent myocardial infarction, unstable angina