Gilenya patient information














Gilenya patient information

I certify that the above therapy is medically necessary and that this information is accurate to the best of my knowledge. 2, 7. com, or by going to www. The SRF serves as both the prescription for Gilenya and request for GAN services. Gilenya Nurse Where Spokane, WA What you'll be doing The gilenya nurse is responsible for coordinating and delivering resources and information to optimize the MS patient and physician experience with gilenya, with the ultimate goal of improving patient outcomes. 2 Important Administration Instructions 2. The exact mechanism is unknown, but Gilenya is thought to work by reducing the immune system's attack If you received this document by mistake, please know that sharing, copying, distributing or using information in this document is against the law. 25-mg and 5-mg doses were tested in the Gilenya Phase II and Phase III trials. Based on animal studies, Gilenya may harm the fetus. e.

3 Recommended Dosage Fingolimod (Gilenya) Patient Information USED FOR Relapsing forms of multiple sclerosis (MS) Fingolimod will not cure MS. You will be observed for at least 6 hours following your first dose. For more information, contact the GILENYA Pregnancy Registry by calling Quintiles at 1-877-598-7237, by e-mailing gpr@quintiles. Recommendations and precautions to be followed by healthcare professionals a nd patients for the safe CONSUMER INFORMATION PrGILENYA® Fingolimod (as fingolimod hydrochloride) This leaflet is part III of a three-part "Product Monograph" published when GILENYA® was approved for sale in Canada and is designed specifically for Consumers. Patient Name. This prior authorization does not have an expiration date. In a study of 698 patients with available 24-hour Holter monitoring data after their first dose (N=351 on GILENYA 0. GILENYA (fingolimod) capsules, for oral use Initial U. I certify that I am the physician who has prescribed GILENYA to the previously identified patient and that I provided the patient with a description of the GILENYA Go Program.

At the time, temporary recommendations were given, advising doctors to perform ECG monitoring for six hours after taking the first dose, and to consider the Novartis AG has updated the prescribing information for Gilenya® (fingolimod) their oral capsule disease modifying therapy for relapsing remitting multiple sclerosis. Worth keeping an eye on this story, for sure. . For a complete rundown of Gilenya side effect and other important safety information, be sure to read the complete Medication Guide. Patient Name: Prescriber Name: This telecopy transmission contains confidential information belonging to the sender that is legally privileged. Gilenya can cause a patient’s heart rate to slow down, especially after the first dose. The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information. Read this Medication Guide before you start taking GILENYA and each time you get a refill. 25 mg capsule* Dose Requested: Precertification Requirements.

Novartis has agreed with the FDA to update the U. Your patient will be contacted by a pharmacy in the TECFIDERA Pharmacy Network to arrange for delivery of the prescription. The new warning is in regards to Cryptococcal fungal infections to the present list of possible infections that patients taking Gilenya Oral capsule drug summary. I hope this puts your mind at ease a bit, Lulu Gilenya Brain Infection Problems Lead To FDA Warning Label Update The FDA is urging doctors to stop Gilenya treatment immediately if a patient shows any symptoms of PML and to perform a treatment with Gilenya. Important Safety Information (continued) Infections: GILENYA may increase the risk of infections. You can help by reporting any side effects you may get. GILENYA PRIOR APPROVAL REQUEST The information provided on this form will be used to determine the provision of healthcare benefits under a U. I certify that I am the physician who has prescribed GILENYA to the previously identified patient and that I provided the patient with a description of the GILENYA . If you are the parent of a child who is being treated with GILENYA, the following information applies to your child.

UPMC Health Plan GILENYA Prior Authorization Form If this is an urgent request, please call UPMC Health Plan Pharmacy Services. A European patient with multiple sclerosis developed progressive multifocal leukoencephalopathy after taking the drug. An oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Take Gilenya by mouth with or without food. o Of 2951 patients completing FDO under Gilenya@Home, 1067 (36%) returned a completed survey. PHYSICIAN INFORMATION PATIENT INFORMATION Gilenya (fingolimod) is a disease modifying drug (DMD) for relapsing remitting MS. Our online pharmacy allows you to purchase medication 24 hours a day and 7 days a week to serve your health needs. I just wanted to encourage those of you who are starting Gilenya to be patient with it. Compare prices, print coupons and get savings tips for Gilenya (Fingolimod) and other Multiple Sclerosis drugs at CVS, Walgreens, and other pharmacies.

However, we can't guarantee the accuracy or completeness of the information. You will be required to be at the FDO facility for at least six (6) hours, which is the length PDR Drug Summaries are concise point-of-care prescribing, dosing and administering information to help phsyicans more efficiently and accurately prescribe in their practice PDR's drug summaries are available free of charge and serve as a great resource for US based MDs, DOs, NPs and PAs in patient practice Medscape - Multiple sclerosis dosing Gilenya (fingolimod) , frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. However, Gilenya’s safety was called into question last summer after a patient taking the drug developed progressive multifocal leukoencephalopathy, a rare and fatal brain infection. Have your patient read and sign the Patient Authorization and Marketing Consent pages and complete Section 1 of the Service Request Form. com. information is received. Fax signed forms to CVS/Caremark at 1-855-633-7673. Learn about its efficacy, find events near you, and see full ISI. 5 mg, but in no patient on placebo.

Gilenya is also known as Fingolimod. Gilenya® (fingolimod) for Multiple Sclerosis (MS) Gilenya (fingolimod) is a prescription medication taken by mouth for the treatment of multiple sclerosis (MS). The authorized recipient of this information is prohibited from disclosing this information to any other party. Gilenya is a sphingosine 1-phosphate receptor modulator. If you are not the intended recipient, please notify the sender immediately. not to replace the relationship between patient and physician/doctor and went from copaxone to gilenya a couple years ago as I was having disability progression faster than expected and I go tired of the shots. . Take one (500 microgram) capsule every day. 25mg achieved a relative ARR reduction of 14.

For the purposes of transmitting these See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Gilenya is an oral disease modifying treatment for relapsing-remitting MS and the first in a new class of medications known as sphingosine 1-phosphate receptor (S1PR) modulators. 1 Assessment Prior to Initiating GILENYA 2. Prescriptions are only valid when received via fax. 2 Crohn’s Disease (CD) 2 DOSAGE AND ADMINISTRATION 2. I have been on gilenya for 3 weeks and have gained, just started going to the Y the day after starting the drug, work out at the Y and walk a mile on the treadmill, and I should be losing not gaining, I am so depressed about this, but this drug is working for me, just so sad Novartis AG, manufacturer of the drug, Gilenya (fingolimod), confirmed this week that a 59 year old patient suffering from multiple sclerosis passed away after beginning treatment with the drug, the first of its kind to be approved by the FDA to treat the neurological disease. How do I take Gilenya? • Take Gilenya by mouth once per day. GILENYA ® (je-LEN-yah) (fingolimod) capsules, for oral use. Drugs.

page 2 Click here for full Prescribing Information , including Patient Medication Guide. Your first dose of Gilenya will be given in a doctor's office, hospital, or clinic. To speak with your local account manager to discuss a customized specialty pharmacy program to meet your unique needs, please complete the below form or email pharmacist@pantherspecialty. Reply. 8. A recent CBC should be available before initiating GILENYA. See full prescribing information for GILENYA. A pregnancy registry is available for women who become pregnant during GILENYA treatment. Over the past decade, Novartis Pharmaceuticals Canada has introduced 20 new medicines that have had an important impact on patients suffering from a wide variety of major illnesses including cancer, cardiovascular diseases, Alzheimer's disease, age-related macular degeneration, organ transplantation and osteoporosis.

Consider suspending treatment with GILENYA if a patient develops a serious infection, and reassess the benefits and risks prior to reinitiation of therapy. Gilenya can cause a patient's heart rate to slow down, especially after the first dose. Novartis executives have confirmed a multiple sclerosis (MS) patient has developed a rare brain infection after taking their drug Gilenya for more than four years. stopping GILENYA treatment. com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. interferon beta-1a, designed specifically for children and adolescents with RMS[4]. gilenyapregnancyregistry. Fingolimod (INN, trade name Gilenya, Novartis) is an immunomodulating drug, mostly used for treating multiple sclerosis (MS). Please take it with you to the First Dose Observation.

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. 04/2018 FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY 1 INDICATIONS AND USAGE 1. I was fearful and very hesitant to start, but it has done wonders for me with few side effects and I had few options left. Read it again each time you get Gilenya refilled. As your Neurologist begins the process of starting you on Gilenya, they initiate a Service Request Form (SRF) through the Gilenya Go patient services hub. Your Consultant Neurologist, Speciality Doctor or MS Specialist Nurse will be able to answer any further questions you may have. City, State, ZIP Home Phone. 6. Complete/review information, sign and date.

Patients should tell their doctor right away if they become pregnant while taking Gilenya or within two months after stopping the drug. Multiple sclerosis (MS) is a cell-mediated autoimmune condition characterised by repeated episodes of inflammation of the nervous tissue in the brain and spinal cord, causing loss of the insulating myelin sheath. No Is the patient on any Class Ia or Class III anti-arrhythmic drugs? • Inform patient that he will need to be observed for 6 hours after first dose. Review the information to see if you qualify. Missing information makes it difficult to approve requests and creates a longer processing time. com for more details. 1% of patients receiving GILENYA 0. This Medication Guide summarizes the most important information about GILENYA. GILENYA is pregnancy Category C.

Doctors were advised not to prescribe Gilenya to For additional important safety information, please see full Prescribing Information and Patient Information. 5mg as the superior efficacious dose for this patient population. Do not give GILENYA to other people, even if they have the same symptoms that you have. A European patient with multiple sclerosis developed progressive multifocal 3 Give your patient the Instructions for Patients and Patient Consent Information pages. Do not breast feed while taking Gilenya. Gilenya ® Prior Authorization Request Form . It may reduce flare-ups and slow the disease progression. If you are eligible, the programs below can help you afford Gilenya. The pack will also include information on the registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card with key safety information.

Fax complete signed and dated forms to CVS Caremark at 1-888-836-0730. Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with fingolimod and each time you refill your prescription. Talk to your doctor before you discontinue taking Gilenya. PATIENT INFORMATION. There may be new information. Monitor for signs and symptoms of infection during treatment and up to 2 months after discontinuation. information in this document is against the law. Indication. Find user ratings and reviews for Gilenya oral on WebMD including side effects and drug interactions, medication effectiveness, ease of use and satisfaction NeedyMeds is the best source of information on patient assistance programs.

We previously communicated safety information about Gilenya in August 2015 and August 2013 (rare brain infection), May 2012 (revised cardiovascular monitoring recommendations), and December 2011 Fingolimod is a treatment for relapsing-remitting multiple sclerosis (MS) in adults. It may harm them. 5 mg per day? The approved dose of Gilenya is 0. The FDA decided to conduct the safety review after receiving an adverse event report in November of 2011, regarding a 59 year-old patient died within 24 hours of taking Gilenya for the first time. DO NOT COPY FOR FUTURE USE. Learn about side effects and other safety issues. In order to assess patient response to the first dose of fingolimod, observe all patients for 6 hours for signs and symptoms of bradycardia with hourly pulse and blood pressure measurement. • Advise patient to avoid live attenuated vaccines during treatment and for 2 months post treatment because of risk of infection. may use the information you provide to contact you to remind you that your co-pay assistance is about to expire and to confirm your eligibility to continue participating in co-pay assistance.

I've been taking Gilenya for nearly 3 years through the Gilenya clinical trial. This leaflet is a summary and will not tell you everything about GILENYA®. • For all aspects of Gilenya@Home evaluated, at least 89% of patients rated Contact Us. Gilenya has slowed down the disability issue while stopping the exacerbtations or at least, my suspicion is it's making them less obvious. See the end of section 4 for how to report side effects. You have fewer relapses than you might have had with no treatment and any relapses you do have should be less severe. For GILENYA - also complete the following: Product Information . In the US, approximately 73,000 patients have been exposed to Gilenya. The Patient Service Center can also provide advocacy with insurance claims as well as financial assistance to those who qualify.

Complete the following questions if patient is NOT currently receiving Gilenya. Then, you will fill out the remaining sections of the form and sign where indicated. MS is a neurological condition where the immune system attacks the • Before initiating treatment with GILENYA, a recent CBC (i. This information is for informational purposes only and is not meant to be a substitute for professional medical advice, diagnosis or treatment. Talk to your doctor about the best way to feed your baby if you take GILENYA. It is written for patients and gives information about taking or using a medicine. Neither RxAssist nor RxVantage is offering advice, recommending or endorsing any specific prescription drug, pharmacy or other information on the site. No changes to patient management or routine monitoring with Gilenya treatment are recommended beyond the guidance in the Gilenya Product Monograph at this time. Go Program And test patient 0 0 0 0 1 for gilenya is open study.

Alternate Phone DOB. within 6 months, or after discontinuation of prior therapy) should be available. S. Click here for more information. All scheduling is done via the Gilenya Go Program (GGP). It has reduced the rate of relapses in relapsing-remitting multiple sclerosis by approximately one-half over a two-year period. Second degree AV blocks following the first dose were also identified in 0. Find patient medical information for Gilenya Oral on WebMD including its uses, side effects and safety, interactions, pictures, warnings and user ratings. If you’ve already stopped taking the drug and experience new or worsened symptoms of MS, seek medical attention immediately.

MEDICATION GUIDE GILENYA® (je-LEN-yah) (fingolimod) capsules Read this Medication Guide before you start taking GILENYA and each time you get a refill. Office use only: Gilenya_Jan_2018 . Gilenya® is a new class of medication called a sphingosine 1-phosphate receptor modulator, which is thought to act by retaining certain white blood cells (lymphocytes) in the lymph nodes, thereby preventing those cells from crossing the blood-brain barrier into the central nervous system (CNS). This information is intended only for the use of the individual or entity named above. federal government program, and any falsification of records may subject the provider to MEDICAL INFORMATION (Section must be completed to process prescription) (Attach separate sheet if needed) Please complete the following or send patient demographic sheet. Last Four of SS# Gender. ALERT: Stopping Gilenya May Worsen MS Symptoms! In November 2018, the FDA warned that patients who stopped treatment with Gilenya could experience severe worsening of MS Gilenya 0. This slows or blocks Patient Phone Patient DOB G. Gilenya Oral capsule 0.

The Switzerland-based Does the patient have a diagnosis of multiple sclerosis? Yes No Will Gilenya be used as monotherapy? Yes No Has your patient had failure, contraindication, or intolerance to Avonex, Copaxone, or Rebif? Consumer Medicine Information (CMI) about Gilenya (Fingolimod hydrochloride) intended for persons living in Australia. Does the patient have a baseline QTc interval ≥500 ms (as measured on most recent ECG)? Yes. Office use only: Gilenya_CMS_2019May-W . Please contact Aetna Better Health of Michigan at 1-866-316-3784 with questions regarding the Prior Authorization process. annual gross household income Annual gross household income is a total of one's earnings for a specific year. Ed Tobias says: November 28, 2018 at 8:53 AM Hi Gilbert, Thanks very much for sharing that information. Don’t forget—your Gilenya comes with an extra patient information sheet called a Medication Guide. Please take Gilenya as directed by your doctor. • Take Gilenya at the same time each day.

Member Information (required) Provider Information Before initiating treatment with GILENYA, a recent CBC (i. Gilenya ® Prior Authorization Request Form (Page 1 of 2) Member Information (required) Regarding safety, the profile of both Gilenya doses in the trial was consistent with the established safety characteristics. " In a statement to CNN, the company says the cause of death remains unknown. Individuals may also call Gilenya’s Patient Service Center at (877) 408-4974 for more information. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. Instructions for health care providers To prescribe GILENYA®, please follow these steps: 1. No . Side effects, drug interactions, warnings and precautions, and pregnancy information should be reviewed prior to taking any medication. 5 mg and N=347 on You may experience slowed heartbeat when you start taking fingolimod again, so you will need to restart the medication in your doctor's office.

Used to reduce the frequency of flare-ups (clinical I certify that the prescribed therapy is medically necessary and that this information is accurate to the best of my knowledge. This eMedTV Web article describes other possible drug interactions with Gilenya, as well as the possible complications these reactions can cause. This medication will not cure MS, it will only decrease the frequency of HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use sinus syndrome, unless patient has a pacemakeGILENYA® safely and effectively. Gilenya This fax machine is located in a secure location as required by HIPAA regulations. The first dose of GILENYA should be administered in a setting in which resources to appropriately manage symptomatic bradycardia are available. Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. It’s very useful. Novartis, the maker of Gilenya (fingolimod), said it has been informed of a third case of progressive multifocal leukoencephalopathy (PLM) in a patient with relapsing multiple sclerosis (MS Information describing these two cases has been added to the Warnings and Precautions and Patient Counseling Information sections of the drug label, as well as to the patient Medication Guide, the The Gilenya medication listed above is manufactured by Novartis. • Consider suspending treatment with GILENYA if a patient develops a serious infection, and reassess the benefits and risks prior to reinitiation of therapy.

A dedicated portal for patients registered in the GILENYA ® Go program™, with tools to help manage medication and appointment reminders. your home or you will have to pick up your initial supply of Gilenya at CNMRI; call your physician’s patient care coordinator to find out if it has arrived in advance of your FDO date. Please contact CVS/Caremark at 1-855-344-0930 with questions regarding the prior authorization process. 2 Crohn’s Disease (CD) cardiovascular safety of Gilenya, following receipt of information relating to an unexplained and sudden death of a patient within 24 hours of taking Gilenya for the first time. * GILENYA Patient Services Liaisons cannot provide direct patient care, respond to off-label questions or questions about competitive drugs, or share patient information beyond the scope of their responsibilities. Fax signed forms to Aetna Better Health of Michigan at 1-855-799-2551. 25 mg hard capsules Gilenya® 0. Before this drug is covered, the patient must meet all of the following requirements: 1. The other checks to be sure of monitoring side effects are Cardiologist - to check heart before beginning Gilenya Opthamologist -to check for macular edema which can develp with Gilenya Pulmonologist - to check lung functions And a check of liver enzymes.

The US Food and Drug Administration (FDA) is reporting a case of progressive multifocal leukoencephalopathy (PML) in a patient with multiple sclerosis (MS) taking fingolimod (Gilenya, Novartis Vaccines, immunosuppressants, and beta blockers are some of the products that can react with Gilenya. 3) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Does the patient continue to respond to therapy by experiencing a decreased number of relapses or no relapses? Yes No No further questions . You can purchase these and other quality medications from MapleLeafMeds. Processed and FDA updates label for Novartis' MS pill Gilenya after reports of brain infection linked to Gilenya because the patient had already been treated with other drugs that can weaken the immune Mellen Center Approaches: Use of fingolimod in MS (Gilenya, FTY720), continued Can the dose of Gilenya be increased beyond 0. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Fingolimod (Gilenya) is a drug prescribed for reducing the frequency of relapses and delaying the physical disability in individuals with relapsing forms of MS (multiple sclerosis). It involves only one patient so far, and that patient is still alive. Gilenya is the most prescribed oral once-daily DMT.

Always check with the individual program if you have questions. Read it carefully. The checklist includes information on the tests and monitoring in patients before and after starting or when restarting treatment with Gilenya. The changes in thalamic volume over the same time period in HC will be used as a reference. Gilenya® Prior Authorization Request Form . Novartis has updated the prescribing information for Gilenya (fingolimod), a once daily oral therapy indicated to reduce the number of relapses and slow disability progression in patients with A pregnancy registry is available for women who become pregnant during GILENYA treatment. Package leaflet: Information for the user Gilenya® 0. Otherwise, please return completed form to: Gilenya is indicated for the treatment of relapsing forms of multiple sclerosis (MS) in patients 10 years of age and older. Despite ahving not used tysabri, they had used an interferon just before Gilenya, and steroids both before and during the Gilenya treatme t.

See Important Safety Information for details. Quintiles, a leading research provider for patient registries, will manage the registry on behalf of Novartis Pharmaceuticals Corporation and collect information related to GILENYA exposure and maternal, fetal and infant outcomes. This is not intended to replace discussions with your doctor. The Does the patient have history or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome? Yes. On April 20, 2012, Novartis announced changes to the prescribing information for Gilenya® (fingolimod) in the treatment of relapsing forms of multiple sclerosis (MS). The agency also reviewed clinical trials and post-marketing safety information. doc . Multiple areas of scar tissue (sclerosis) form along the neurons. 1 Multiple Sclerosis (MS) 2.

patients receiving GILENYA 0. HOW IT WORKS Fingolimod worksbykeeping theimmunesystem'swhitebloodcellsin lymph Fingolimod (marketed as Gilenya) Information. If you received this document by mistake, please know that sharing, copying, distributing or using information in this document is against the law. Must be 10 years of age or older 2. 6% but did not reach statistical significance, thereby suggesting Gilenya 0. Please contact CVS Caremark at 1-855-240-0536 with questions regarding the prior authorization process. The patient also 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. The Swiss pharmaceutical company Novartis says last November it was "notified of the first reported case of a patient death that occurred within 24 hours after receiving the first dose of Gilenya. There are no adequate and well-controlled studies in pregnant women.

I understand that the Health Plan, insurer, Medical Group or its designees may perform a routine audit and request the medical information necessary to verify the accuracy of the information reported on this form. Fingolimod (Gilenya) is an oral drug used to treat symptoms of relapsing-remitting multiple sclerosis. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Prices start at $8,136. Welcome to My-GILENYA. fingolimod (GILENYA) This request is: Expedited* (Urgent) Standard (Non-Urgent) *Expedited means the standard review time may seriously jeopardize the life or health of the patient or the patient’s ability to regain maximum function. For more information on MS and its treatments, please call MSAA’s Helpline at (800) 532-7667. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged. information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information.

See what others have said about Gilenya, including the effectiveness, ease of use and side effects. Discover Tecfidera® (dimethyl fumarate), a twice-daily pill for relapsing MS. Secondary Outcome Measures In May 2012, the FDA added new Gilenya warnings about the risk of heart problems after a patient died within 24 hours after taking the drug. , within 6 months) should be available. 5 mg hard capsules fingolimod This medicine is subject to additional monitoring. Gilenya Gilenya® (fingolimod) Drug identification number (DIN): 02365480 Novartis Pharmaceutical Canada Inc. For the first time, results are being presented at the 2019 American Academy of Neurology Annual Meeting (AAN) in Philadelphia, Pennsylvania, USA[1]. [Back Multiple Sclerosis patients are again seeing headlines about a disease modifying drug causing Progressive Multifocal Leukoencephalopathy, or PML, in a patient – this time that drug is Gilenya (fingolimod), the oral pill from Novartis. 2 Gilenya To assess the effect of the Gilenya over 6, 12 and 24 months on the evolution of thalamic atrophy in patients with relapsing MS, as measured by change in thalamic volume loss.

2) DMD; in clinical trials people taking Gilenya had about 50% fewer relapses than people taking placebo. 1. ca. Gilenya is an important treatment option for appropriate patients. All our information is free and updated regularly. These higher doses were less well tolerated without increased efficacy PATIENT DIAGNOSIS & ICD-10 CODE Relapsing form of multiple sclerosis Primary progressive multiple sclerosis (PPMS) First clinical episode of multiple sclerosis Other _____ ICD-10: _____ DRUG SPECIFIC QUESTIONS - Please note that more than one section may need to be completed. Gilenya is the brand name of the drug fingolimod, which is used to treat symptoms of relapsing forms of multiple sclerosis (MS). Worldwide, Gilenya has been used to treat approximately 217,000 patients in both clinical trials and the post-marketing setting, with approximately 480,000 years of patient experience (GLOBE NEWSWIRE via COMTEX) -- Novartis International AG / New Novartis data presented at ECTRIMS show benefit of Gilenya(R) on patient disability progression at 10 years . • Advise patient who hasn't had chickenpox or VZV vaccination to consider vaccination before treatment begins.

Then, fax the Start Form to 1-855-474-3067. The FDA has added this new warning to the prescribing information section of the Gilenya drug label and the patient medication guide. A side effect can therefore be any unfavorable and unintended sign, symptom, or disease associated with the use of the product. The findings of this registry will be used to give health care providers important information for treating and counseling patients who are pregnant or may become pregnant and are treated, or plan to be treated, with GILENYA. The decision to start this form of treatment can be difficult. Important Safety Information Patient Information & Prescribing Information for Fingolimod (Gilenya) obtained through the TRICARE Mail Order Pharmacy or from a TRICARE retail network pharmacy. Patient satisfaction with the Gilenya@Home program • Responses to satisfaction surveys were collected from October 2014 to May 2016. What other drugs will affect fingolimod (Gilenya)? Where can I get more information (Gilenya)? What is fingolimod (Gilenya)? Fingolimod is an immunosuppressant that is used to treat relapsing multiple sclerosis (MS) in adults and children who are at least 10 years old. The checklist includes information on the tests and monitoring in patients before and during treatment with Gilenya.

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. Address Address 2. Gilenya® is a sphingosine 1-phosphate receptor modulator indicated for treatment of patients with relapsing forms of multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and delay the increase in physical disability. Revised: 1/2019 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2. You can ask your doctor or pharmacist for information about GILENYA that is written for health Some, but not all, immunizations have been evaluated for safety and efficacy in people with MS: A study by the Vaccines in Multiple Sclerosis Study Group published in 2001 in the New England Journal of Medicine found that vaccination for tetanus, hepatitis B or influenza did not appear to increase the short-term risk of relapses (also called attacks or exacerbations) in people with MS. ATTESTATION: I attest the information provided is true and accurate to the best of my knowledge. Extavia, Gilenya, Glatiramer, Glatopa, Lemtrada, Ocrevus, Plegridy, Rebif, Tecfidera Notice: Please be sure to complete this form in its entirety. It is not known if Gilenya passes into breast milk, so women should not take Gilenya while breastfeeding. The GILENYA ® Go Program ® is dedicated to helping eligible individuals learn more about starting GILENYA and offers services to assist them with GILENYA treatment, such as: Verifying insurance benefits and providing coverage information; Assisting with prior authorization and appeals, if required Gilenya Education for First Dose This document contains information and/or instructional materials developed by Michigan Medicine for the typical patient with A pregnancy registry is available for women who become pregnant during GILENYA treatment.

Gilenya received an overall rating of 6 out of 10 stars from 2 reviews. A patient taking Novartis AG (NOVN)’s Gilenya multiple sclerosis pill contracted a potentially deadly brain infection, adding to concern that the medicine may lose ground to a competing product. The figure represents everything earned that year prior to deductions, tax credits, etc. Gilenya is a more effective (category 1. Reporting side effects What is a side effect? A side effect is any unwanted medical occurrence in a patient who has been given a pharmaceutical product that may or may not have been caused by treatment with the product. Please note: All information below is required to process this request. Drug product: Gilenya 0. Consider suspending GILENYA if a patient develops a serious infection. Tecfidera ® (dimethyl fumarate) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.

Learn about the reported side effects, related class drugs, and how these medications will affect your daily lifestyle. The typical scheduling of PATIENT INFORMATION. Gilenya Prescription Assistance Programs Gilenya: Apply for prescription assistance below. This will allow quick identification of new safety information. — Lena Freund. Does the patient have a pacemaker? Yes . The approval of Gilenya for the younger patient population was supported by PARADIGMS, a double-blind, randomized, multi-center Phase III safety and efficacy study of Gilenya vs. 1 Multiple Sclerosis (MS) 1. In general, there were more discontinuations due to adverse events and MULTIPLE SCLEROSIS (FA-PA) This fax machine is located in a secure location as required by HIPAA regulations.

(5. Read about a study identifying multiple sclerosis patients who are most at risk of their disease surging after they discontinue treatment with Gilenya. Side-effects include a slow heart rate at first, an increased risk of infection, and eye problems. Prior Authorization Criteria for Fingolimod (Gilenya) • Patient has a documented diagnosis for a relapsing form of multiple sclerosis. Office use only: Gilenya_UHCE&I_2016May-W. prescribing information for Gilenya to include updated patient selection parameters based on certain cardiovascular considerations to aid in the identification of patients for Gilenya. Therefore, this leaflet gives you some information about Gilenya. NeedyMeds, a registered 501(c)(3) national nonprofit (#46-3091990), makes every effort to ensure the accuracy of the information on the website. Approval: 2010 Talk to your doctor about the best way to feed your baby if you take GILENYA.

If you would like more information, talk with your doctor. CLINICAL INFORMATION (continued) – Required clinical information must be completed in its entirety for all precertification requests. 5 mg per day. The applications are available in Adobe PDF format and should be mailed directly to the provider of the patient assistance program. The FDA has issued a safety warning that patients who stopped taking Gilenya experienced worsening of multiple sclerosis, compared with before treatment started or during treatment, in rare cases. 5mg Drug Medication Dosage information. This new prescribing information is applicable only to individuals who have not been given a first dose of Gilenya or for those who have stopped and will be restarting the drug. 94 Novartis Gilenya Patient Diagnosed With Rare Infection By Phil Serafino - Jul 30, 2013 11:50 AM ET. The updated prescribing Novartis Drug Gilenya (Fingolimod) Has More Than 20,000 Patient-Years Of Exposure And Shows Up To 71% Reduction In Annualized Relapse Rates In MS Patients With Highly Active Disease patient is established on this drug with previous approval by another health plan patient is established on this drug with regular use for more than 1 year patient was previously established on this drug, and is restarting after a break in therapy Please provide the dates your patient has received Women taking Gilenya should not get pregnant.

For additional information or support with treatment of Gilenya please contact Gilenya® Go Program: 1-855-PILL-4MS (1-855-745-5467). The SRF serves as both the prescription for Gilenya and request for the support services available through the GAN. A Navigator within the Gilenya Go hub will then work closely with the patient to schedule the services you requested at the time and location that best meet your patient’s needs. 7. Learn more about Gilenya, a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing-remitting MS. Did the patient fail or is intolerant to Copaxone (glatiramer acetate)? Yes No . Our products are Patient Policies. Financial Aid Application; Patient Handbook Patient Handbook (Spanish) Patient Form Completion Policy Patient Co-Payment Policy; Authorization for Release of Records Request Amendment to Health Record Request Restrictions on Use of Health Information CNMRI Payment Policy CNMRI Payment Policy (Spanish) Patient Information "The patient had been treated with interferon beta-1a and azathioprine for one month before initiating Gilenya treatment; those medications were stopped when Gilenya was started. I have had no side effects I know of and my lab results are normal The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Prescriber’s Name Gor up / Hospital Address Gilenya (Medicare Prior Authorization) This fax machine is located in a secure location as required by HIPAA regulations. New request Continuation request . Visit cvs. 5 mg capsule Start date (or date of next dose): Gilenya 0. FORMS ARE UPDATED FREQUENTLY AND MAY BE BARCODED. gilenya patient information

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