Octec 0.5

Disease modifying therapy for patients w/ relapsing multiple sclerosis to reduce the frequency of relapses & delay progression of disability.

Adult 1 cap once daily.

May be taken with or without food: Swallow whole, do not open.

Hypersensitivity. Class III or IV heart failure, MI, stroke, transient ischaemic attack, or unstable angina w/in the last 6 mth; cardiac arrhythmias requiring anti-arrhythmic treatment w/ class Ia or III antiarrhythmics; decompensated heart failure requiring hospitalization w/in the last 6 mth; history or current Mobitz type II 2nd- or 3rd-degree AV block or sick-sinus syndrome, unless patient has functional pacemaker; QTc interval at baseline ≥500 msec.

Hypersensitivity reactions including rash, urticaria & angioedema upon treatment initiation. Not to initiate in patients w/ active acute or chronic infection. Discontinue treatment immediately if posterior reversible encephalopathy syndrome is suspected. Discontinue treatment & perform diagnostic evaluation if progressive multifocal encephalopathy occurs. Interrupt treatment & monitor patients w/ immunosuppression during & persisting for 2 mth after therapy. Suspend treatment if serious infection develops. Monitor & consider discontinuation in cases of liver enzyme elevations, clinically significant liver injury & active liver failure requiring liver transplant, & macular edema. AV conduction delays including transient asystole & fatalities, HTN, bradycardia; basal cell carcinoma, Merkel cell carcinoma, melanoma, cutaneous T-cell lymphoma including mycosis fungoides; decreased lymphocyte count persisting for 2 mth following discontinuation; disseminated varicella zoster & herpes simplex infections including encephalitis & multiorgan failure; cryptococcal infections (eg, cryptococcal meningitis, disseminated cryptococcal infections) including fatal cases of cryptococcal meningitis; HPV infections including papilloma, dysplasia, warts, & HPV-related cancer; lymphoma including T-cell & B-cell types & CNS lymphoma; serious, life-threatening, & fatal opportunistic infections; Kaposi's sarcoma; multiple sclerosis relapses w/ turnefactive demyelinating lesions on imaging during & after therapy; posterior reversible encephalopathy syndrome progressing to ischemic stroke or cerebral hemorrhage; dose-dependent decrease in resp function including reduced FEV1 & diffusion lung capacity for carbon monoxide. Increased risk of macular edema in patients w/ pre-existing uveitis or DM. Overnight monitoring in a medical facility required in patients w/ pre-existing CV conditions, cerebrovascular disease, baseline QT-interval prolongation, or risk factors for QT prolongation. Switch from immune-modulating or immunosuppressive medication. Severe increase in disability accompanied by multiple new lesions on MRI following drug discontinuation. Perform cardiac evaluation in patients w/ pre-existing conditions; ECG before 1st dose & at the end of 1st dose observation period. Obtain ALT, AST & total bilirubin levels w/in 6 mth before initiating treatment. Review results of recent CBC; current or past use of antineoplastic, immunosuppressive, or immune-modulating therapies w/ additive immunosuppressive effects. Test for presence of varicella zoster virus (VZV) Abs prior to initiation in patients w/ -ve history for chickenpox or w/o VZV vaccination. Recommend vaccination for Ab -ve patients 1 mth prior to initiation of therapy. Limit sun & UV light exposure. Discontinue treatment gradually. Avoid use of live attenuated vaccines during & 2 mth after treatment. Concomitant use w/ agents that slow heart rate or AV conduction eg, diltiazem, verapamil, digoxin, β-blockers. Additive effects w/ immunosuppressants. Severe hepatic impairment (Child-Pugh class C). Women of childbearing potential must use effective contraception during & 2 mth after treatment. Discontinue use 2 mth prior to conception. Pregnancy & lactation. Not approved in ped patients <18 yr.

Abdominal pain, diarrhea; increased liver enzymes, liver injury; flu; back ache, pain in extremity; headache; cough, sinusitis.

Increased risk bradycardia or heart block w/ bretylium. Increased risk of QT interval prolongation w/ mesoridazine, ziprasidone, saquinavir, sparfloxacin, bepridil, piperaquine, terfenadine, thioridazine, pimozide, dronedarone, cisapride & other QT prolonging drugs; QT interval prolongation & Torsades de Pointes w/ levomethadyl; QT interval prolongation, bradycadia or heartblock w/ dofetilide, amiodarone, ibutilide, disopyramide, quinidine, procainamide, sotalol. May increase levels/effects of class Ia & III antiarrhythmic agents, bradycardia-causing agents, ceretinib, higher risk QTc prolonging agents, ivabradine, lacosamide, leflunomide, moderate risk QTc-prolonging agents, natalizumab, tofacitinib, live vaccines, zoster vaccine. Increased effects w/ β-blockers, bretylium, denosumab, diltiazem, esmolol, immunosuppressants, systemic ketoconazole, mifepristone, pimecrolimus, roflumilast, topical tacrolimus, trastuzumab, verapamil. May decrease levels/effects of intravesical BCG, Coccidioides immitis skin test, nivolumab, sipuleucel-T, inactivated & live vaccines, zoster vaccine. Decreased levels/effects by carbamazepine, echinacea.

Immunosuppressants

L04AE01 - fingolimod ; Belongs to the class of sphingosine-1-phosphate (S1P) receptor modulators. Used as immunosuppressants.

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