Frequently asked questions (FAQs)

Under the FDA’s 505(b)(2) pathway, TASCENSO ODT was shown to have the same pharmacokinetics (PK) as Gilenya® (fingolimod) capsules, meaning the rate and extent of exposure of the drug is the same for both formulations. Therefore, the two products are considered bioequivalent.³

TASCENSO ODT demonstrated a similar lowering of lymphocyte counts and effect on heart rate as Gilenya^®.³

TASCENSO ODT is not a generic.⁴

It has the same safety, efficacy and side effects as Gilenya® (fingolimod) capsules and other generic fingolimod products, but it comes in a unique orally disintegrating tablet formulation.¹

TASCENSO ODT is not substitutable (AB rated) to any other product, because it has a unique formulation, which could better suit your patients’ needs.³ Generic fingolimod products are not substitutable (AB rated) to TASCENSO ODT either.³

It is also accompanied by Cycle Vita™, our support platform.*

Fingolimod blocks lymphocytes from leaving the lymph node, reducing the number of lymphocytes in the blood.¹

It is thought this may reduce lymphocyte migration into the central nervous system.¹

During a study of TASCENSO ODT:

• 89% of participants agreed they had an overall favorable opinion of TASCENSO ODT.⁴
• All participants felt TASCENSO ODT left a pleasant taste.⁴
• 82% of participants agreed TASCENSO ODT had no bitter after-taste.⁴

You can print and send an enrollment form to Cycle Vita at hello@cyclevita.com or fax it to them at + 1 (888) 385-8482.

With TASCENSO ODT, no special storage conditions are required, the product should be stored at room temperature (68°F to 77°F) and protected from moisture.¹

Patients should take the TASCENSO ODT immediately after opening the blister pack and should not store it outside the blister pack for future use.

TASCENSO ODT may harm an unborn baby.¹ Patients should avoid getting pregnant whilst taking TASCENSO ODT and for two months after stopping TASCENSO ODT treatment.¹

TASCENSO ODT is different to other tablets to allow for quick dissolving. It is lightly adhered to the blister pack wall and a very small amount of product residue may remain inside the pack which can cause a slightly feathered edge. This is nothing to worry about and your patients will still receive the correct dose.

Patients should use dry hands when opening the blister pack and peel back the foil covering of 1 blister pack. They should gently remove the orally disintegrating tablet (ODT) and make sure not to push the ODT through the foil.

As soon as the blister pack is opened, the ODT should be removed and placed on the tongue, allowing it to dissolve. TASCENSO ODT should not be stored outside the blister pack for future use.

Cycle Pharmaceuticals manufactures TASCENSO ODT in the UK, with each and every batch tested and verified.

Eligible* patients who are switching to TASCENSO ODT from another fingolimod treatment will have access to our Bridge Program while Cycle Vita secures appropriate benefit verification and prior authorization.

It is available to patients with an urgent medical need for TASCENSO ODT, including:

• For new patients who are switching to TASCENSO ODT from another fingolimod treatment while Cycle Vita secures appropriate benefit verification and prior authorization, providing they have not had a lapse of two weeks or more in their medication.
• For existing patients who are experiencing a temporary disruption in TASCENSO ODT therapy due to changes in their insurance coverage.

If your patient’s insurance situation changes, the patient must notify Cycle Vita immediately at 1-+1 (888) 360-8482.

Commercially insured eligible patients who have been prescribed TASCENSO ODT may pay as little as $0 in co-pay.*

To find out more about eligibility criteria please contact Cycle Vita on +1 (888) 360-8482.

Baseline assessments may include:

• Blood work
• An ECG
• An eye exam
• Liver enzymes
• Vaccinations if needed

Yes, eligible* patients will have access to additional first dose observations required due to a lapse in therapy via the TASCENSO Time Program.

Eligible* patients who are switching to TASCENSO ODT from another fingolimod treatment will have access to our Bridge Program while Cycle Vita secures appropriate benefit verification and authorization.

Patients who are switching from another fingolimod treatment to TASCENSO ODT should not take both treatments at the same time. Once your patient starts TASCENSO ODT they should stop taking any other fingolimod treatment.

Our priority is to ensure patients experience a smooth transition from their current disease modifying therapy (DMT) to TASCENSO ODT.

For patients currently taking the same dose (0.25 mg or 0.5 mg) of another fingolimod treatment a FDO will not be required, providing the patient has not had a lapse in treatment for 14 days or more.¹

Patients who are currently not on another fingolimod treatment or are increasing their fingolimod dose (from 0.25 mg to 0.5 mg) will need to have baseline assessments (BA) and a FDO to initiate therapy. ¹

Yes, our registered clinicians, who have decades of experience supporting patients with MS, can provide disease state and medication training to facilitate adherence.

As soon as Cycle Vita receives a completed enrollment form, we can provide individualized support to eligible* patients, such as access to treatment, financial and pharmacy support, as well as clinical education and medication administration support. We will reach out to you and your patient in order to take the next steps.