FINGOLIMOD capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 capsules are contraindicated in patients who have: Risk Summary Based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. Data from prospective reports to the Fingolimod Pregnancy Registry are currently not sufficient to allow for an adequate assessment of the drug-associated risk for birth defects and miscarriage in humans. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. In rats, the highest no-effect dose was less than the recommended human dose of 0.5 mg/day on a body surface area (mg/m2 ) basis. The most common fetal visceral malformations in rats were pe

Product summary:

Fingolimod capsules 0.5 mg are size 3 hard gelatin capsules with a light yellow to yellow opaque cap and off-white to white opaque body, imprinted with a Glenmark Logo 'G' on the cap and '559' on the capsule body in black ink containing white to off-white powder. Fingolimod capsules are supplied as follows: Bottle of 30 with child-resistant closure, NDC 68462-166-30 Carton of 28 capsules containing 2 cartons of 14 capsules per blister card NDC 68462-166-15 Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 68462-166-07 Fingolimod capsules should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FINGOLIMOD- FINGOLIMOD CAPSULE
Glenmark Pharmaceuticals Inc., USA
----------
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. Children should also be observed by
a healthcare professional for at
least 6 hours after taking their first dose of 0.5 mg of fingolimod
capsules when switching from the 0.25
mg dose.
After you take your first dose of fingolimod capsules, and after a
child takes their first dose of 0.5 mg of
fingolimod when switching from the 0.25 mg dose:
• 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 fing

Summary of Product characteristics

FINGOLIMOD- FINGOLIMOD CAPSULE
GLENMARK PHARMACEUTICALS INC., USA
----------
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
Warnings and Precautions (5.3, 5.9) 8/2023
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 10
years of age and older. (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
0.5 mg hard capsules (3)
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS
•
•
•
•
•
•
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 d