Gilenya go program

Monitor patients for development of severe increase in disability following discontinuation of GILENYA and begin appropriate treatment as needed. Most reported cases occurred within the first 9 months after initiation, but may occur at any point during treatment. Tumefactive MS should be considered when a severe MS relapse occurs during treatment, especially during initiation, or after discontinuation, prompting imaging evaluation and initiation of appropriate treatment.

An average increase of 3 mm Hg in systolic and 2 mm Hg in diastolic BP was observed in clinical trials versus placebo. Monitor and evaluate suspicious skin lesions. Cutaneous T-cell lymphoma including mycosis fungoides has also been reported in the postmarketing setting. Immune System Effects Following Discontinuation: Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose.

Lymphocyte counts generally return to normal range within 1 to 2 months of stopping therapy. Initiating other drugs during this period warrants the same considerations needed for concomitant administration. Drug Interactions: Closely monitor patients receiving systemic ketoconazole. Seizure: Cases of seizures, including status epilepticus, have been reported with the use of GILENYA in clinical trials and in the postmarketing setting in adults.

In adult clinical trials, the rate of seizures was 0. Cases of seizures were reported in 5. Click here for full Prescribing Information. Telehealth Etiquette Series. Patient is responsible for any costs once limit is reached in a calendar year.

Program not valid i under Medicare, Medicaid, TRICARE, VA, DoD, or any other federal or state health care program, ii where patient is not using insurance coverage at all, iii where the patient's insurance plan reimburses for the entire cost of the drug, or iv where product is not covered by patient's insurance. The value of this program is exclusively for the benefit of patients and is intended to be credited towards patient out-of-pocket obligations and maximums, including applicable co-payments, coinsurance, and deductibles.

Program is not valid where prohibited by law. Patient may not seek reimbursement for the value received from this program from other parties, including any health insurance program or plan, flexible spending account, or health care savings account. Patient is responsible for complying with any applicable limitations and requirements of their health plan related to the use of the Program.

Valid only in the United States and Puerto Rico. This Program is not health insurance. Program may not be combined with any third-party rebate, coupon, or offer.

Proof of purchase may be required. Novartis reserves the right to rescind, revoke, or amend the Program and discontinue support at any time without notice.

Novartis Pharmaceuticals Corporation does not endorse any particular plan. Check with your individual health plans. This offer is not valid for prescriptions and medical assessments for which payment may be made in whole or in part under federal or state health programs, including but not limited to Medicare or Medicaid, or for residents of RI. Valid only for those with commercial insurance.

This program is subject to termination or modification at any time. You should not take GILENYA if in the last 6 months you experienced heart attack, unstable angina, stroke or mini-stroke transient ischemic attack or TIA , or certain types of heart failure.

GILENYA is a prescription medicine used to treat relapsing forms of multiple sclerosis MS , to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older. Slow heart rate, especially after first dose. Adults and children will be monitored by a health care professional for at least 6 hours after the first dose or after a child takes the first dose of 0.

Call your doctor, or seek immediate medical attention if you have any symptoms of slow heart rate, such as dizziness, tiredness, feeling like your heart is beating slowly or skipping beats, or chest pain. Symptoms can happen up to 24 hours after the first dose. During pregnancy. Consult your doctor before getting pregnant. You should avoid becoming pregnant while taking GILENYA or in the 2 months after you stop taking it because of the risk of harm to the baby.

Increased risk of serious infections, some of which could be life threatening and cause death. These may be symptoms of meningitis. Progressive multifocal leukoencephalopathy PML. PML is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems but has happened in people who do not have weakened immune systems. Call your doctor right away if you have any new or worsening symptoms of PML that have lasted several days, including changes in your thinking or memory, changes in your vision, decreased strength, problems with balance, weakness on 1 side of your body, loss of coordination in your arms and legs, confusion, or changes in your personality.

Macular edema, a vision problem that can cause some of the same vision symptoms as an MS attack optic neuritis , or no symptoms. Vision problems may continue after macular edema has gone away. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye uveitis. Call your doctor right away if you have blurriness, shadows, or a blind spot in the center of your vision; sensitivity to light; or unusually colored vision.

Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae.

Obtain spirometry and DLCO when clinically indicated. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. The possibility of severe increase in disability should be considered in patients who discontinue GILENYA, including those who are pregnant or planning for pregnancy.

Monitor patients for development of severe increase in disability following discontinuation of GILENYA and begin appropriate treatment as needed. Most reported cases occurred within the first 9 months after initiation, but may occur at any point during treatment. Tumefactive MS should be considered when a severe MS relapse occurs during treatment, especially during initiation, or after discontinuation, prompting imaging evaluation and initiation of appropriate treatment.

An average increase of 3 mm Hg in systolic and 2 mm Hg in diastolic BP was observed in clinical trials versus placebo. Monitor and evaluate suspicious skin lesions. Cutaneous T-cell lymphoma including mycosis fungoides has also been reported in the postmarketing setting. Immune System Effects Following Discontinuation: Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose.

Lymphocyte counts generally return to normal range within 1 to 2 months of stopping therapy. Initiating other drugs during this period warrants the same considerations needed for concomitant administration.

Drug Interactions: Closely monitor patients receiving systemic ketoconazole. Seizure: Cases of seizures, including status epilepticus, have been reported with the use of GILENYA in clinical trials and in the postmarketing setting in adults. In adult clinical trials, the rate of seizures was 0. Cases of seizures were reported in 5.