Medically reviewed by Drugs.com. Last updated on Aug 10, 2020.
Applies to the following strengths: 0.23 mg-0.46 mg; 0.92 mg; 0.23 mg-0.46 mg-0.92 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Multiple Sclerosis
DOSE TITRATION REGIMEN:
-Days 1 through 4: 0.23 mg orally once a day
-Days 5 through 7: 0.46 mg orally once daily
-Day 8 and thereafter: 0.92 mg orally once a day
MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8
Use: For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
Renal Dose Adjustments
No adjustment recommended.
Liver Dose Adjustments
REINITIATION OF THERAPY AFTER INTERRUPTION:
-If a dose is missed during the first 2 weeks of therapy, reinitiate therapy using the titration regimen.
-If a dose is missed after the first 2 weeks of therapy, continue with the dosing as planned.
-Patients, who in the last 6 months, have experienced a myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure
-Patients who have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sinoatrial block, unless the patient has a functioning pacemaker
-Patients who have severe untreated sleep apnea
-Patients who are taking a monoamine oxidase (MAO) inhibitor
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Swallow capsules whole; do not divide, chew, or crush.
-This drug may be administered with or without food.
-Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F).
Before initiation of therapy, assess the following:
-Delay therapy in patients with an active infection until the infection is resolved.
-Complete blood count (CBC)
-Obtain a recent (i.e., within the last 6 months or after discontinuation of prior MS therapy) CBC, including lymphocyte.
-Obtain an electrocardiogram (ECG) to determine whether preexisting conduction abnormalities are present.
-In patients with preexisting conditions, advice from a cardiologist should be sought.
-Obtain recent (i.e., within the last 6 months) transaminase and bilirubin levels.
-In patients with a history of uveitis or macular edema, obtain an evaluation of the fundus, including the macula.
-If patients are taking antineoplastic, immunosuppressive, or immune-modulating therapies, or if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects before initiating therapy with this drug.
-Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction.
-Test patients for antibodies to varicella zoster virus (VZV) before initiating this drug; VZV vaccination of antibody-negative patients is recommended prior to commencing therapy with this drug.
-If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of this drug.
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