Adult Dosing
Relapsing forms of multiple sclerosis
- 0.5 mg PO qd with or without food
Note:
- Monitor for signs and symptoms of bradycardia for a period of 6 hrs after the first dose
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Therapy may cause decreased heart rate; monitor for signs and symptoms of bradycardia for a period of 6 hrs after the first dose. If symptoms of bradycardia occur, initiate appropriate management and continue monitoring until the symptoms resolve
- Use cautiously in patients receiving concurrent therapy with Class IA or Class III antiarrhythmics, beta blockers, those with a history of syncope, and in patients with second degree or higher AV block, sick sinus syndrome, ischemic heart disease or CHF
- To identify underlying risk factors for bradycardia and AV block, obtain an ECG if a recent (within 6 months) ECG is not available in patients on antiarrhythmics including beta-blockers and calcium channel blockers, those with cardiac risk factors, and those who have a slow or irregular heart beat prior to starting fingolimod
- Incidence of transient AV conduction delays has been reported after therapy initiation; these abnormalities were transient and asymptomatic, and resolved within the first 24 hours on treatment, but they occasionally required treatment with atropine or isoproterenol
- Caution should be exercised during re-initiation of therapy following discontinuation for more than 2 wks as the effects on heart rate and AV conduction may recur; apply same precautions as for initial dosing
- Prior to initiating treatment, a recent CBC (within 6 months) should be available. Consider discontinuation of therapy if a patient develops a serious infection, and reassess the risks and benefits prior to re-initiation of therapy
- Fingolimod should not be used in patients with active acute or chronic infections until the infection is resolved
- Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies may increase the risk of immunosuppression
- Prior to initiation of therapy, patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV) should be tested for VZV antibodies
- Consider VZV vaccination of antibody-negative patients prior to initiating treatment with fingolimod; postpone treatment for 1 month to allow full effect of vaccination to occur
- Perform adequate ophthalmologic evaluation at baseline and 3-4 months after initiation of treatment. Additional ophthalmologic evaluation must be undertaken if patients report visual disturbances at any time during treatment
- Therapy may cause macular edema; this is generally resolved with or without treatment after discontinuation of the drug. Residual visual acuity loss has been reported even after resolution of macular edema. Therefore, a decision should be made whether or not to discontinue therapy based on assessment of the potential benefits and risks for the individual patient
- Patients with diabetes mellitus or a history of uveitis should have ophthalmologic evaluation prior to initiating therapy and regular follow-up evaluations during therapy because they are at an increased risk of developing macular edema
- Dose-dependent reductions in forced expiratory volume at 1 second (FEV1) and diffusion lung capacity for carbon monoxide (DLCO) have occurred as early as 1 month after treatment initiation; on discontinuation of treatment, the changes in FEVI appeared to be reversible
- Perform spirometric evaluation of respiratory function and evaluation of DLCO during therapy if clinically required
- Prior to initiation of therapy, recent (within last 6 months) transaminase and bilirubin levels should be available
- Discontinue the therapy if transaminase levels increased 5-fold the ULN. After discontinuation of therapy, serum transaminase levels returned to normal within 2 months. Monitor liver enzyme in patients who develop symptoms suggestive of hepatic dysfunction
- Women of childbearing potential should use effective contraception to avoid pregnancy during and for 2 months after stopping fingolimod treatment
- Elevations in blood pressure may occur approximately 2 months after therapy initiation and persist with continued treatment; monitor blood pressure regularly during treatment
- Fingolimod remains in the blood and has pharmacodynamic effects such as reduced lymphocyte counts for up to 2 months following its last dose; however, lymphocyte counts come to normal within 1-2 months of treatment cessation. Due to its continued pharmacodynamic effects, initiating other drugs during this period warrants the same considerations needed for concomitant administration (risk of additive immunosuppressant effects)
Cautions: Use cautiously in
- Severe hepatic impairment
- Liver disease
Supplemental Patient Information
- Inform patients about the increased risk of infections while on treatment
- Advise patients that fingolimod may cause macular edema, and that they should contact their physician in case any vision changes develop
- Advise patients not to receive live attenuated vaccines during and for 2 months after treatment due to increased risk of infections
Pregnancy Category:C
Breastfeeding: As there is no information regarding the use of fingolimod during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 18 May 2011). As per manufacturer's data, it is not known whether this drug is excreted in breastmilk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Gilenya 0.5 MG CAPS [Disp Pack] (NOVARTIS)
28 mg = $4099.07
84 mg = $12093.32
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
