EAST HANOVER, N.J., Oct. 7 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced the availability of patient support programs for Gilenya™ (fingolimod) 0.5 mg daily, a first-line oral treatment for relapsing forms of multiple sclerosis. Gilenya was approved by the US Food and Drug Administration (FDA) on September 21, 2010.
For people with MS and healthcare professionals seeking information about Gilenya, Novartis offers free programs to learn about educational resources, the availability of free starter product, and the details of our prescription and medical co-pay support program for eligible patients. People can visit www.Gilenya.com or call 877-408-4974 for information about:
- The Gilenya Support Program, which offers treatment information, educational resources, assistance scheduling medical assessments and prescription benefits investigation.
- The option of free starter product once a prescription has been written to help ensure immediate access to treatment during the benefits investigation process. Free samples are also being provided to physician's offices and are available through the Gilenya Support Program.
- The Gilenya Prescription Co-Pay Support Program, which will cover a significant portion of prescription out-of-pocket costs for eligible patients with commercial health insurance.*
- The Gilenya Medical Co-Pay Support Program, which will reduce the out-of-pocket costs associated with Gilenya initiation for eligible patients who require certain tests before starting treatment.**
- The Novartis Patient Assistance Program (PAP), which provides access to Gilenya at no cost for eligible patients who have no third-party coverage. This program is open to all US residents without pharmacy coverage whose income is less than 500% of the Federal Poverty Level. In 2009, the Novartis PAP provided free product valued at over $232 million to over 105,000 patients.
"We are deeply committed to helping provide comprehensive support services to people with MS," said Andy Wyss, Head of Pharma North America and President, Novartis Pharmaceuticals Corporation. "As part of this commitment, Novartis is providing the MS community with education and resources to help them make informed treatment decisions and to help ensure access to Gilenya when it is deemed an appropriate treatment option."
Other Novartis educational activities range from office-based education to a national satellite broadcast for healthcare professionals taking place in more than 75 cities nationwide. To help foster responsible communications between healthcare providers and people with MS, Novartis will commence these healthcare provider educational activities immediately.
Gilenya is a prescription medicine used to treat relapsing forms of MS in adults. Gilenya can decrease the number of MS flare-ups (relapses). Gilenya does not cure MS, but it can help slow the build up of physical problems that MS causes.
Gilenya Important Safety Information
Gilenya may cause serious side effects such as slow heart rate (bradycardia or bradyarrhythmia), infections, macular edema, breathing and liver problems.
Gilenya can cause a patient's heart rate to slow down, especially after the first dose. The heart rate will usually slow down the most about six hours after a patient takes their first dose of Gilenya. Patients might feel dizzy or tired or be aware of a slow or irregular heartbeat if their heart rate slows down. A doctor will watch patients for the first six hours after they take the first dose to see if they have any serious side effects. A patient's slow heart rate will usually return to normal within about one month after they start taking Gilenya. Patients should call their doctor if at any time they have dizziness, tiredness or a slow or irregular heartbeat.
Gilenya can increase a patient's risk of serious infections. Gilenya lowers the number of white blood cells (lymphocytes) in the blood. This will usually go back to normal within two months of stopping treatment. A patient's doctor may perform a blood test before they start taking Gilenya. Patients should call their doctor right away if they have fever, tiredness, body aches, chills, nausea or vomiting.
Macular edema can cause some of the same vision symptoms as an MS attack (optic neuritis). Patients may not notice any symptoms with macular edema. Macular edema usually starts in the first three to four months after taking Gilenya. A doctor should test a patient's vision before they start taking Gilenya and three to four months after they start taking Gilenya, or any time they notice vision changes during treatment. Risk of macular edema may be higher if a patient has diabetes or has had an inflammation of the eye called uveitis. Patients should call their doctor right away if they have blurriness, shadows or a blind spot in the center of their vision, sensitivity to light or unusually colored vision.
Some patients who take Gilenya have shortness of breath. Patients should call their doctor right away if they have trouble breathing.
Gilenya may cause liver problems. A doctor should do blood tests to check a patient's liver before they start taking Gilenya. Patients should call their doctor right away if they have nausea, vomiting, stomach pain, loss of appetite, tiredness, dark urine, or their skin or the whites of their eyes turn yellow.
Gilenya may harm an unborn baby. Women should talk to their doctor if they are pregnant or planning to become pregnant. Women who can become pregnant should use effective birth control while on Gilenya and for at least two months after stopping. If a patient becomes pregnant while taking Gilenya or if they become pregnant within two months after stopping Gilenya, they should tell their doctor right away. Women who take Gilenya should not breastfeed, as it is not known if Gilenya passes into breast milk.
Patients should tell their doctor about all their medical conditions, including if they have had or now have an irregular or abnormal heartbeat, a heart rate of less than 55 beats a minute, a fever, infection or if they are unable to fight infections, eye problems, diabetes, breathing or liver problems, or high blood pressure. Patients should especially tell their doctor if they have had chicken pox or have recently received the vaccine for chicken pox. A doctor may do a test for chicken pox virus and patients may need to get the vaccine for chicken pox and wait one month before starting Gilenya.
Patients should tell their doctor about all the medicines they take, including medicines for heart problems or high blood pressure, vaccines, other medicines to control their immune system or treat cancer, or ketoconazole (an antifungal) by mouth.
The most common side effects with Gilenya were headache, flu, diarrhea, back pain, abnormal liver tests and cough.
For full Prescribing Information, including the Medication Guide please visit www.pharma.us.novartis.com.
About Multiple Sclerosis
While there is still much to be understood about multiple sclerosis, it is thought to be an autoimmune disease of the central nervous system that is chronic, progressive and often disabling. It affects over 400,000 Americans and more than 2.1 million people worldwide. The most common forms of the disease, relapsing forms of MS, are characterized by exacerbations or flare-ups interspersed with periods of disease remission. Typically, MS strikes in early adulthood between the ages of 20 and 50 and affects women twice as frequently as men.
The foregoing release contains forward-looking statements that can be identified by terminology such as “committed,” “launching,” “will,” “commitment,” “can,” or similar expressions, or by express or implied discussions regarding potential future revenues from Gilenya. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Gilenya will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding Gilenya could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected adverse event reports; competition in general; government, industry and general public pricing pressures; the company’s ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.
Novartis Pharmaceuticals Corporation
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets innovative prescription drugs used to treat a number of diseases and conditions, including cardiovascular, dermatological, central nervous system, bone disease, cancer, organ transplantation, psychiatry, infectious disease and respiratory. The company's mission is to improve people's lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG, which provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 102,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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*Government program beneficiaries and residents of Massachusetts are excluded.
**Government program beneficiaries and residents of Massachusetts, Michigan, Rhode Island and Minnesota are excluded by law and are not eligible.
SOURCE Novartis Pharmaceuticals Corporation