FINGOLIMOD- fingolimod hydrochloride capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

FINGOLIMOD HYDROCHLORIDE (UNII: G926EC510T) (FINGOLIMOD - UNII:3QN8BYN5QF)

Tilgængelig fra:

Ascend Laboratories, LLC

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 capsules are 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 Warnings and Precautions (5.1)] - a baseline QTc interval ≥500 msec - cardiac arrhythmias requiring anti-arrhythmic treatm

Produkt oversigt:

Fingolimod capsules 0.5 mg are supplied as follows: hard gelatin capsules with a white opaque body with two radial band imprinted with yellow ink and bright yellow cap imprinted with “FIG 0.5 mg” with black ink. Container pack of 28 capsules                                                      NDC 67877-476-56 Container pack of 30 capsules                                                      NDC 67877-476-30 Carton of 10 capsules containing 1 blister pack of 10 capsules   NDC 67877-476-33 Carton of 7 capsules containing 1 blister card of 7 capsules       NDC 67877-476-32 Carton of 28 capsules two fold blister card of 14 capsules          NDC 67877-476-58 Fingolimod capsules should be stored at 20ºC to 25ºC (68ºF to 77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from moisture.

Autorisation status:

Abbreviated New Drug Application

Indlægsseddel

FINGOLIMOD - FINGOLIMOD HYDROCHLORIDE CAPSULE
Ascend Laboratories, LLC
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MEDICATION GUIDE
Fingolimod (fin gol' i mod)
Capsules
Read this Medication Guide before you start taking fingolimod 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, 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?
Fingolimod may cause serious side effects, including:
1. Slow heart rate (bradycardia or bradyarrhythmia) when you start
taking fingolimod.
Fingolimod can cause your heart rate to slow down, especially after
you take your first dose. You will have a
test, to check the electrical activity of your heart called an
electrocardiogram (ECG), before you take your
first dose of fingolimod.
All adults will be observed by a healthcare professional for at least
6 hours after taking their first dose of
fingolimod.
After you take your first dose of fingolimod:
•
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. Symptoms can happen up to 24
hours after you take your first
fingolimod dose.
•
6 hours after you take your first dose of fingolimod 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
fingolimod, especially those that require
treatment with other medicines, you

Produktets egenskaber

FINGOLIMOD - FINGOLIMOD HYDROCHLORIDE CAPSULE
ASCEND LABORATORIES, LLC
----------
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
INDICATIONS AND USAGE
Fingolimod capsules are 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 reinitiation after discontinuation
greater than 14 days and dose
increases):
o 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)
o 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)
o Monitor symptomatic bradycardia with ECG until resolved. Continue
overnight if intervention is required;
repeat first-dose monitoring for second dose. (2.4)
o 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
ischemic attack, decompensated heart
failure with hospitalization, or Class III/IV heart failure. (4)
History of Mobitz Type II 2
degree or 3 degree AV block or sick sinus syndrome, unless patient has
a
pacemaker.