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Fingolimod Hcl (Gilenya)

Trade Name : Gilenya

Novartis Pharmaceuticals Corporation

CAPSULE

Strength 0.5 mg/1

FINGOLIMOD HYDROCHLORIDE Sphingosine 1-Phosphate Receptor Modulators [MoA],Sphingosine 1-phosphate Receptor Modulator [EPC]

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Fingolimod Hcl (Gilenya) which is also known as Gilenya and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 0.5 mg/1 per ml. Read more

Fingolimod Hcl (Gilenya) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • GILENYA is 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.
  • GILENYA 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. ()
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  • Assessments are required prior to initiating GILENYA. ()
  • 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. (, )
  • 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. (, )
  • First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): n
  • GILENYA is available as:
  • 0.25 mg hard capsules ()
  • 0.5 mg hard capsules ()
  • GILENYA is contraindicated in patients who have:
  • Recent myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure. ()
  • History of Mobitz Type II 2 degree or 3 degree AV block or sick sinus syndrome, unless patient has a pacemaker. ()
  • Baseline QTc interval u2265 500 msec. ()
  • Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs. ()
  • Hypersensitivity to fingolimod or its excipients. ()
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  • Infections:
  • Progressive Multifocal Leukoencephalopathy (PML):
  • Macular Edema:
  • Liver Injury:
  • Posterior Reversible Encephalopathy Syndrome (PRES):
  • Respiratory Effects:
  • Fetal Risk:
  • Severe Increase in Disability After Stopping GILENYA:
  • Tumefactive MS:
  • Increased Blood Pressure (BP):
  • Malignancies:
  • The following serious adverse reactions are described elsewhere in labeling:
  • Most common adverse reactions (incidence u2265 10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. ()
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  • Systemic Ketoconazole:
  • Vaccines:
  • No data
  • GILENYA can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within 1 hour of the first dose and is maximal within 6 hours in most patients . In case of GILENYA overdosage, observe patients overnight with continuous ECG monitoring in a medical facility, and obtain regular measurements of blood pressure .
  • Neither dialysis nor plasma exchange results in removal of fingolimod from the body.
  • Fingolimod is a sphingosine 1-phosphate receptor modulator.
  • Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below:
  • Fingolimod hydrochloride is a white to practically white powder that is freely soluble in water and alcohol and soluble in propylene glycol. It has a molecular weight of 343.93 g/mol.
  • GILENYA is provided as 0.25 mg and 0.5 mg hard gelatin capsules for oral use.
  • Each 0.25 mg capsule contains 0.28 mg of fingolimod hydrochloride, equivalent to 0.25 mg fingolimod.
  • Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod.
  • Each GILENYA 0.25 mg capsule contains the following inactive ingredients: gelatin, hydroxypropylbetadex, hydroxypropylcellulose, magnesium stearate, mannitol, titanium dioxide, and yellow iron oxide.
  • Each GILENYA 0.5 mg capsule contains the following inactive ingredients: gelatin, magnesium stearate, mannitol, titanium dioxide, and yellow iron oxide.
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  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Tell patients not to discontinue GILENYA without first discussing this with the prescribing physician. Advise patients to contact their physician if they accidently take more GILENYA than prescribed.
  • Cardiac Effects
  • Advise patients that initiation of GILENYA treatment results in a transient decrease in heart rate. Inform patients that they will need to be observed in the doctor's office or other facility for at least 6 hours after the first dose, after reinitiation if treatment is interrupted or discontinued for certain periods, and after the dosage is increased .
  • Risk of Infections
  • Inform patients that they may have an increased risk of infections, some of which could be life-threatening, when taking GILENYA, and that they should contact their physician if they develop symptoms of infection. Advise patients that the use of some vaccines should be avoided during treatment with GILENYA and for 2 months after discontinuation. Recommend to patients that they delay treatment with GILENYA until after VZV vaccination if they have not had chickenpox or a previous VZV vaccination. Inform patients that prior or concomitant use of drugs that suppress the immune system may increase the risk of infection .
  • Progressive Multifocal Leukoencephalopathy
  • Inform patients that cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients who received GILENYA. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes .
  • Macular Edema
  • Advise patients that GILENYA may cause macular edema, and that they should contact their physician if they experience any changes in their vision. Inform patients with diabetes mellitus or a history of uveitis that their risk of macular edema is increased .
  • Hepatic Effects
  • Inform patients that GILENYA may cause liver injury. Advise patients that they should contact their physician if they have any unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine .
  • Posterior Reversible Encephalopathy Syndrome
  • Advise patients to immediately report to their healthcare provider any symptoms involving sudden onset of severe headache, altered mental status, visual disturbances, or seizure. Inform patients that delayed treatment could lead to permanent neurological sequelae .
  • Respiratory Effects
  • Advise patients that they should contact their physician if they experience new onset or worsening of dyspnea .
  • Fetal Risk
  • Severe Increase in Disability After Stopping GILENYA
  • Inform patients that severe increase in disability has been reported after discontinuation of GILENYA. Advise patients to contact their physician if they develop worsening symptoms of MS following discontinuation of GILENYA .
  • Malignancies
  • Advise patients that basal cell carcinoma and melanoma are associated with use of GILENYA. Advise patients that any suspicious skin lesions should be promptly evaluated. Advise patients to limit exposure to sunlight and ultraviolet light by wearing protective clothing and using a sunscreen with a high protection factor. Inform patients that lymphoma has also occurred in patients receiving GILENYA .
  • Persistence of GILENYA Effects After Drug Discontinuation
  • Advise patients that GILENYA remains in the blood and continues to have effects, including decreased blood lymphocyte counts, for up to 2 months following the last dose .
  • Hypersensitivity Reactions
  • Advise patients that GILENYA may cause hypersensitivity reactions, including rash, urticaria, and angioedema. Advise patients to contact their physician if they have any symptoms associated with hypersensitivity .
  • Pregnancy and Pregnancy Registry
  • Instruct patients that if they are pregnant or plan to become pregnant while taking GILENYA they should inform their physician. Encourage patients to enroll in the GILENYA Pregnancy Registry if they become pregnant while taking GILENYA .
  • T2019-143ntttttt
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  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0607-15ntttttttu00a0u00a0u00a0u00a0u00a0nntttttttu00a0u00a0u00a0u00a0u00a0ntttttttRx only
  • GILENYAn
  • (fingolimod)
  • capsules
  • 0.5 mg
  • Equivalent to 0.56 mgfingolimod hydrochloride
  • 30 Capsules
  • Dispense with enclosed Medication Guide.
  • NOVARTIS
  • PRINCIPAL DISPLAY PANEL
  • NDC 0078-0965-89
  • GILENYAn
  • (fingolimod)
  • capsules
  • 0.25 mg
  • Equivalent to 0.28 mgfingolimod hydrochloride
  • 7 Capsules
  • Rx only
  • This package includes a 1-week supply of capsules.
  • Dispense with enclosed Medication Guide.
  • NOVARTIS

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