FINGOLIMOD- fingolimod hcl capsule

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Rising Pharma Holdings, Inc.

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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 Warnings and Precautions (5.14)] . 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 (GPR) 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/m 2 ) basis. The most common fetal visceral malformations in rats were persistent truncus arteriosus and ventricular septal defect. The receptor affected by fingolimod (sphingosine 1-phosphate receptor) is known to be involved in vascular formation during embryogenesis (see Data). Advise pregnant women of the potential risk to a fetus. In the US 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. Clinical Considerations In females planning to become pregnant, fingolimod should be stopped 2 months before planned conception. The possibility of severe increase in disability should be considered in women who discontinue or are considering discontinuation of fingolimod because of pregnancy or planned pregnancy. In many of the cases in which increase in disability was reported after stopping fingolimod, patients had stopped fingolimod because of pregnancy or planned pregnancy [see Warnings and Precautions (5.9)] . Data Animal Data When fingolimod was orally administered to pregnant rats during the period of organogenesis (0, 0.03, 0.1, and 0.3 mg/kg/day or 0, 1, 3, and 10 mg/kg/day), increased incidences of fetal malformations and embryofetal deaths were observed at all but the lowest dose tested (0.03 mg/kg/day), which is less than the recommended human dose (RHD) on a mg/m 2 basis. Oral administration to pregnant rabbits during organogenesis (0, 0.5, 1.5, and 5 mg/kg/day) resulted in increased incidences of embryofetal mortality and fetal growth retardation at the mid and high doses. The no-effect dose for these effects in rabbits (0.5 mg/kg/day) is approximately 20 times the RHD on a mg/m 2 basis. When fingolimod was orally administered to female rats during pregnancy and lactation (0, 0.05, 0.15, and 0.5 mg/kg/day), pup survival was decreased at all doses and a neurobehavioral (learning) deficit was seen in offspring at the high dose. The low-effect dose of 0.05 mg/kg/day is similar to the RHD on a mg/m 2 basis. Risk Summary There are no data on the presence of fingolimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Fingolimod is excreted in the milk of treated rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fingolimod and any potential adverse effects on the breastfed infant from fingolimod or from the underlying maternal condition. Pregnancy Testing The pregnancy status of females of reproductive potential should be verified prior to starting treatment with fingolimod [see Use in Specific Populations (8.1)] . Contraception Before initiation of fingolimod treatment, females of reproductive potential should be counseled on the potential for a serious risk to the fetus and the need for effective contraception during treatment with fingolimod [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1)] . Since it takes approximately 2 months to eliminate the compound from the body after stopping treatment, the potential risk to the fetus may persist and women should use effective contraception during this period [see Warnings and Precautions (5.8, 5.13)] . Safety and effectiveness of fingolimod for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (fingolimod n = 107; intramuscular interferon (IFN) beta-1a n = 108) [see Clinical Studies (14.2)] . In the controlled pediatric study, the safety profile in pediatric patients (10 to less than 18 years of age) receiving fingolimod 0.25 mg or 0.5 mg daily was similar to that seen in adult patients. In the pediatric study, cases of seizures were reported in 5.6% of fingolimod-treated patients and 0.9% of interferon beta-1a-treated patients. It is recommended that pediatric patients, if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating fingolimod therapy. Safety and effectiveness of fingolimod in pediatric patients below the age of 10 years have not been established. Juvenile Animal Toxicity Data In a study in which fingolimod (0.3, 1.5, or 7.5 mg/kg/day) was orally administered to young rats from weaning through sexual maturity, changes in bone mineral density and persistent neurobehavioral impairment (altered auditory startle) were observed at all doses. Delayed sexual maturation was noted in females at the highest dose tested and in males at all doses. The bone changes observed in fingolimod-treated juvenile rats are consistent with a reported role of S1P in the regulation of bone mineral homeostasis. When fingolimod (0.5 or 5 mg/kg/day) was orally administered to rats from the neonatal period through sexual maturity, a marked decrease in T-cell dependent antibody response was observed at both doses. This effect had not fully recovered by 6-8 weeks after the end of treatment. Overall, a no-effect dose for adverse developmental effects in juvenile animals was not identified. Clinical MS studies of fingolimod did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Fingolimod should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy. Because fingolimod, but not fingolimod-phosphate, exposure is doubled in patients with severe hepatic impairment, patients with severe hepatic impairment should be closely monitored, as the risk of adverse reactions may be greater [see Warnings and Precautions (5.5), Clinical Pharmacology (12.3)] . No dose adjustment is needed in patients with mild or moderate hepatic impairment. The blood level of some fingolimod metabolites is increased (up to 13-fold) in patients with severe renal impairment [see Clinical Pharmacology (12.3)] . The toxicity of these metabolites has not been fully explored. The blood level of these metabolites has not been assessed in patients with mild or moderate renal impairment.

Produktu pārskats:

0.5 mg fingolimod capsules are hard gelatin capsules with a white or off-white opaque body and cap imprinted with “S2” on the cap with black ink. Fingolimod capsules are supplied as follows: Bottle of 30 capsules NDC 64980-449-03 Carton of 28 capsules containing 4 blister cards of 7 capsules per blister card NDC 64980-449-28 Carton of 7 capsules containing 1 blister card of 7 capsules per blister card NDC 64980-449-07 Fingolimod capsules should be stored at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature]. Protect from moisture.

Autorizācija statuss:

Abbreviated New Drug Application

Lietošanas instrukcija

Rising Pharma Holdings, Inc.
----------
This Medication Guide has been
approved by the U.S. Food and Drug
Administration.
Revised: 01/2024
MEDICATION GUIDE
Fingolimod (fin-GOE-li-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 capsules 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:
•
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 fingol

Produkta apraksts

FINGOLIMOD- FINGOLIMOD HCL CAPSULE
RISING PHARMA HOLDINGS, INC.
----------
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 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)
DOSAGE AND ADMINISTRATION
Assessments are required prior to initiating fingolimod. ( 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)
Recommended dosage for pediatric patients (10 years of age and above)
weighing less than or equal to
40 kg: 0.25 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