Octec 0.5 Dosage/Direction for Use

Before initiating Fingolimod therapy: Review medications for current drugs that could slow heart rate or atrioventricular (AV) conduction. Perform a cardiac evaluation in patients with certain preexisting conditions. Perform an ECG before the first dose and at the end of the first-dose observation period.
Review results of a recent CBC.
Within 6 months before initiating Fingolimod treatment, obtain serum transaminases (ALT and AST) and total bilirubin levels.
Review current or past use of antineoplastic, immunosuppressive, or immune-modulating therapies that may have unintended additive immunosuppressive effects.
Test for antibodies to varicella zoster virus. Varicella zoster virus vaccination is recommended for antibody-negative patients before initiating treatment.
Adults: The recommended dose of Fingolimod is one 0.5 mg capsule taken orally once daily. Perform an ECG before the first dose and observe for 6 hours after the first dose and repeat ECG at the end of the first-dose observation period.
Pediatric patients (below the age of 18): The safety and efficacy of Fingolimod in pediatric patients below the age of 18 have not been studied. Fingolimod is not approved in pediatric patients.
Reinitiation of treatment: The same first dose monitoring as for treatment initiation is recommended when treatment is interrupted for: 1 day or more during the first 2 weeks of treatment; more than 7 days during weeks 3 and 4 of treatment; more than 2 weeks after one month of treatment.
If the treatment interruption is of shorter duration than the previously mentioned, the treatment should be continued with the next dose as planned.
Special populations: Renal impairment: Fingolimod was not studied in patients with renal impairment in the multiple sclerosis pivotal studies. Based on clinical pharmacology studies, no dose adjustments are needed in patients with mild to severe renal impairment.
Hepatic impairment: Mild or moderate hepatic impairment (Child-Pugh Class A-B): No dose adjustments are needed, Severe hepatic impairment (Child-Pugh Class C): No dosage adjustment, use with caution and closely monitor.
Administration: Fingolimod can be taken with or without food.
The capsules should always be swallowed intact, without opening them.
Discontinuation: Consider gradual discontinuation, such as a tiered reduction in dosage or alternate-day administration, due to an increased risk for disease exacerbation, especially in patients with lower peripheral total lymphocyte count (TLC) at the time of discontinuation and a higher ratio of TLCs in a short period.