Do you know which fingolimod product your patients are actually receiving?
There are currently 12 generic fingolimod products listed on DailyMed,1 which pharmacies can switch your Gilenya® (fingolimod) capsules patients to without your consent. They can then be switched among the generics as pharmacies see fit. This could lead to inconsistencies in what your patients are actually receiving and can cause significant increases in co-pay costs.
This wouldn't happen with TASCENSO ODT ® (fingolimod) because it is not substitutable at the pharmacy level.2
Product
TASCENSO ODT is the same proven fingolimod you are familiar with, but it comes in a unique orally disintegrating tablet formulation.3
- Unique orally disintegrating tablet for MS treatment
- Same proven fingolimod
- Same efficacy & safety as Gilenya®**
- A similar lowering of lymphocyte counts and effect on heart rate as Gilenya®4
- Not a generic2
- Not substitutable at the pharmacy level2
- Each and every batch tested
- Dissolves on the tongue in seconds
- Taken once daily, with or without food and with or without water
- Available as 0.25 mg and 0.5 mg orally disintegrating tablets
Support
We know that life-changing treatments need a support system which is tailored to the unique challenges your patients face. That’s why we created Cycle Vita, our dedicated hub support program, which delivers individualized product support* at every step. Including:
- $0 Co-pay Assistance Program: Commercially insured eligible patients may pay as little as $0
- Bridge Program: For patients taking another fingolimod treatment, a free supply of TASCENSO ODT is available to ensure the continuation of therapy while Cycle Vita secures appropriate benefit verification and prior authorization, if necessary
- TASCENSO Time Program: Access to in-home first dose observation and baseline assessments as necessary
- Hub Support: Including financial, logistics and medication adherence support
“There is no additional safety or efficacy data required to bring… [generics] onto the marketplace and there can be differences… [which] can cause therapeutic gaps or mishaps for patients.”
Dr Scagnelli, MD, Raleigh Neurology
Download an enrollment form to enroll a patient in TASCENSO ODT. Complete all the required fields either digitally or by printing it. You can then either fax the form to Cycle Vita at + 1 (888) 385-8482 or email it to hello@cyclevita.life.
References
1. National Library of Medicine (2023) Daily Med search results for fingolimod. Accessed August 22nd 2023. Available: https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=fingolimod&audience=professi
2. FDA., 2023. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Accessed August 22nd 2023. Available: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
3. TASCENSO ODT (fingolimod). Prescribing Information. Cycle Pharmaceuticals Ltd.
4. Data on File: REF-00075
* Some areas of support may not be accessible to all patients. Eligibility criteria may apply to ensure compliance with all applicable federal and state requirements, and benefits may be limited to commercially insured patients only. For more detailed information about eligibility, terms and conditions, please contact the Cycle Vita team at +1 (888) 360-8482.
** Gilenya® is a registered trademark of Novartis AG.
TASCENSO ODT 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.
- Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure with hospitalization, or Class III/IV heart failure.
- Patients with a history or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker.
- Patients with a baseline QTc interval ≥ 500 msec.
- Patients with cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs.
- Patients who had a hypersensitivity to fingolimod or any excipients in TASCENSO ODT.
- Concomitant use with other products containing fingolimod.
Warnings and Precautions:
Due to a risk for bradyarrhythmia and AV blocks patients should be monitored during TASCENSO ODT treatment initiation. TASCENSO ODT may increase blood pressure, risk of infections and may cause fetal harm. Cases of Progressive Multifocal Leukoencephalopathy and of clinically significant liver injury have occurred in patients treated with fingolimod in the postmarketing setting. TASCENSO ODT increases risk of macular edema. Rare cases of Posterior Reversible Encephalopathy Syndrome in adults have been reported with fingolimod. Fingolimod can have respiratory effects. Severe increase in disability accompanied by multiple new lesions on MRI has been reported following discontinuation of fingolimod. MS relapses with tumefactive demyelinating lesions on imaging have been observed during fingolimod therapy and after discontinuation. The risk of basal cell carcinoma and melanoma is increased in patients treated with fingolimod. Cases of lymphoma have been reported in patients receiving fingolimod. The reporting rate of non-Hodgkin lymphoma with fingolimod is greater than that expected in the general population. Fingolimod remains in the blood and has pharmacodynamic effects, including decreased lymphocyte counts for up to 2 months following the last dose. Hypersensitivity reactions including rash, urticaria, and angioedema have been reported with fingolimod. Cases of seizures, including status epilepticus, have been reported with the use of fingolimod.
Adverse Reactions:
In clinical trials, the most common adverse reactions (incidence ≥ 10% and >placebo) are headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.
Drug Interactions:
Patients on QT prolonging drugs with a known risk of torsades de pointes should be monitored during initiation of treatment with TASCENSO ODT. Monitor patients during use of systemic ketoconazole. Use of live attenuated vaccines during, and for 2 months after stopping TASCENSO ODT, should be avoided.
For more detailed information, please refer to the full Prescribing Information at www.tascenso.com/PI.
To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals Ltd at 1-888-533-1625 or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.
©2023 Cycle Pharmaceuticals Limited. All rights reserved.
TASCENSO ODT® is a registered trademark of Handa Neuroscience, LLC.
Cycle Vita is a trademark of Cycle Pharmaceuticals Limited in the United States.
