FingolimodFingolimod Hydrochloride

About Fingolimod

Fingolimod, a sphingosine 1-phosphate receptor modulator, holds certain white blood cells in the lymph nodes so fewer reach the brain and spinal cord. The label approves it for relapsing forms of multiple sclerosis in adults and children 10 and older. The dose is 0.5 mg once a day, or 0.25 mg for children who weigh 40 kg or less. Before starting, the prescriber checks a blood count, liver tests, an ECG, the eyes, the skin and immunity to chickenpox.

There is no boxed warning. Heart rate drops after the first dose, so it is given under observation for six hours with pulse, blood pressure and ECG checks; some people need overnight monitoring. It must not be used within six months of a heart attack, unstable angina, stroke, mini-stroke (TIA) or heart failure that needed a hospital stay, by people with severe (Class III or IV) heart failure, with certain heart blocks or sick sinus syndrome unless a pacemaker is present, with a QTc of 500 msec or more, with heart rhythm problems that need Class Ia or Class III antiarrhythmic drugs, or with an allergy to fingolimod. Other warnings cover serious infections (including PML, a rare brain infection), macular edema, liver injury, high blood pressure, skin cancer and lymphoma. Common side effects include headache, raised liver enzymes, diarrhea, cough, flu, sinusitis and back pain.

What is distinctive is the restart rule: after a gap of more than 14 days, or shorter gaps in the first month, the first-dose observation is repeated. Its effects last up to two months after the last dose, and severe worsening of disability has been reported after stopping. The label asks for effective birth control during treatment and for two months after. Tascenso ODT, an orally disintegrating tablet, is a separate brand and a different dosage form. Fingolimod is not a controlled substance.

Taking Fingolimod

How to take it

Take it once a day at about the same time, with or without food. For Tascenso ODT, peel back the blister foil with dry hands just before the dose (do not push the tablet through the foil) and let the tablet dissolve on the tongue.

If you miss a dose

Call the prescriber as soon as you realize a dose was missed. Depending on how long the gap is, the next dose may need to be taken under observation in a medical setting.

Storage

Store at room temperature, 20 to 25 degrees C (68 to 77 degrees F), protected from moisture and out of reach of children. Keep orally disintegrating tablets sealed in the blister until the dose is taken.

Interactions to know about

Beta blockers, diltiazem, verapamil and digoxin raise the risk of a dangerously slow heart rate. Ketoconazole raises fingolimod levels, and live vaccines are avoided during treatment and for two months after stopping. Tell the pharmacist about every medicine and supplement, including St. John’s wort.

This summarizes the official prescribing information. Your prescriber’s and pharmacist’s instructions, and the leaflet that comes with your medicine, take priority.

Why the cash price for Fingolimod differs from pharmacy to pharmacy

Most quotes are for the generic 0.5 mg capsule, which many makers supply, so quotes differ with the maker, whether the pharmacy stocks it or orders it in, and its own cash pricing. A prescription for Gilenya with substitution blocked is priced as a brand. The 0.25 mg capsule is brand only, and Tascenso ODT is a separate brand product, so a quote for either is priced as a brand and not every pharmacy stocks them.

The 0.5 mg capsule comes in bottles of 30, so compare quotes for the same capsule count.

Ways to pay less for Fingolimod without insurance

• Ask the prescriber to write the generic name, fingolimod 0.5 mg capsules, and allow substitution, since AB rated generics can be dispensed in place of Gilenya.
• Once treatment is established, ask the prescriber whether a ninety-day supply is appropriate, and refill early, since a gap can mean repeating the first-dose observation.
• Compare quotes from more than one pharmacy.
• For Gilenya 0.25 mg or Tascenso ODT, ask the maker whether its savings or patient assistance program applies to someone paying cash; many require commercial insurance.
• Upload the prescription to Script Unlock so licensed pharmacies can quote their cash price. You pay the pharmacy directly.

Questions to ask your pharmacist about Fingolimod

1. 1.Is my capsule a generic rated as equivalent to Gilenya, and will it look different between refills?
2. 2.If I miss a dose of my fingolimod, when do I need to call my doctor about being observed again?
3. 3.Do any of my heart, blood pressure or other medicines slow my heart rate with fingolimod?
4. 4.Which vaccines should I avoid while I take this and for how long after I stop?

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