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General Medication Fact Sheet for Fingolimod
| Field | Information |
|---|---|
| Generic Name | Fingolimod |
| Brand Name Versions | Gilenya |
| Boxed/Label Warning | May increase the risk of serious infections. Evaluate patients for active and chronic infections before initiating treatment. Monitor patients for signs and symptoms of infection during and after treatment. Bradycardia can occur upon initiation, observe patients for at least 6 hours after the first dose. |
| Purpose | Disease-modifying therapy for relapsing forms of multiple sclerosis (MS) |
| Mechanism of Action | Sphingosine 1-phosphate (S1P) receptor modulator; prevents lymphocytes from leaving lymph nodes, reducing lymphocyte migration into the central nervous system |
| Dosage Forms | Oral capsules |
| Available Strengths | 0.5 mg |
| Dosage Frequency | Once daily |
| Common Side Effects | Headache, fatigue, cough, diarrhea, back pain, elevated liver enzymes |
| Serious Side Effects | Bradycardia (slow heart rate), infections, macular edema, liver injury, posterior reversible encephalopathy syndrome (PRES) |
| Drug Interactions | CYP450 inducers and inhibitors, certain vaccines, other immunosuppressants, beta-blockers, calcium channel blockers, antiarrhythmics |
| Important Notes | First dose should be monitored for bradycardia. Avoid live vaccines during treatment and for two months after stopping. Women of childbearing potential should use effective contraception. |
| Storage | Store at room temperature away from moisture and light |
| Missed Dose | Take as soon as you remember unless it’s almost time for your next dose. Do not double the dose. Contact your doctor if you miss more than one dose in a row. |
| Alternatives | Interferon beta-1a (Avonex, Rebif), Glatiramer acetate (Copaxone), Dimethyl fumarate (Tecfidera), Natalizumab (Tysabri) |
Fingolimod Alternatives
| Medication | Mechanism of Action | Notes |
|---|---|---|
| Interferon beta-1a (Avonex, Rebif) | Immunomodulator | Reduces inflammation and prevents damage to the nervous system. |
| Glatiramer acetate (Copaxone) | Synthetic polypeptide | May block myelin-damaging immune cell attacks. |
| Dimethyl fumarate (Tecfidera) | Nrf2 activator | Reduces oxidative stress and inflammation. |
| Natalizumab (Tysabri) | Alpha-4 integrin antagonist | Prevents immune cells from entering the brain and spinal cord. Higher risk of PML. |
Fingolimod Side Effects
| Common Side Effects | Serious Side Effects |
|---|---|
| Headache | Bradycardia (slow heart rate) |
| Fatigue | Infections (including PML) |
| Cough | Macular edema |
| Diarrhea | Liver injury |
| Back pain | Posterior reversible encephalopathy syndrome (PRES) |
| Elevated liver enzymes | Increased risk of certain cancers |
Fingolimod Dosage Guide
| Condition | Starting Dose | Maintenance Dose | Administration Notes |
|---|---|---|---|
| Relapsing-Remitting MS (Adults) | 0.5 mg | 0.5 mg once daily | First dose should be administered under the supervision of a physician with appropriate medical support to manage bradycardia. |
| Relapsing-Remitting MS (Children & Adolescents 10+ years, >40 kg) | 0.5 mg | 0.5 mg once daily | First dose should be administered under the supervision of a physician with appropriate medical support to manage bradycardia. |
| Relapsing-Remitting MS (Children & Adolescents 10+ years, <=40 kg) | 0.25 mg | 0.25 mg once daily | First dose should be administered under the supervision of a physician with appropriate medical support to manage bradycardia. |
Fingolimod Price With And Without Insurance
| Purchase Context | Estimated Price |
|---|---|
| With Insurance | $25 |
| Without Insurance (U.S.) | $1200 |
| From Canada | $800 |
