Octec 0.5 Special Precautions

Cardiovascular: Atrioventricular conduction delays, including transient asystole and fatalities, have been reported; monitoring of therapy initiation in a medical facility is required and medical management may be warranted.
Blood pressure increases and hypertension have been reported; monitoring recommended.
Bradycardia has been reported; some preexisting conditions may cause decreased bradycardia tolerance or serious rhythm disturbance after the first dose; monitoring of therapy initiation in a medical facility is required and medical management may be warranted.
Patients with preexisting cardiovascular conditions, cerebrovascular disease, baseline QT-interval prolongation, or risk factors for QT prolongation require overnight monitoring of therapy initiation in a medical facility because bradycardia or rhythm disturbances may occur.
Avoid use of live attenuated vaccines during and for 2 months after treatment.
Concomitant use with agents that slow heart rate or atrioventricular conduction (eg, diltiazem, verapamil, digoxin, beta blockers) requires overnight ECG monitoring following the first dose of Fingolimod in a medical facility as severe bradycardia or heart block may occur.
Dermatologic: Basal cell carcinoma, Merkel cell carcinoma, and melanoma have been reported. Limit exposure to sunlight and ultraviolet light; monitoring recommended and prompt evaluation required.
Cutaneous T-cell lymphoma, including mycosis fungoides, has been reported.
Hematologic: Lymphocyte count decreases have been reported and may persist for 2 months following discontinuation of therapy; additive immunosuppressant effects may be expected when other immunosuppressant agents are given during this period; monitoring recommended and suspension of treatment should be considered if serious infection develops.
Hepatic: Liver enzyme elevations have been reported; monitoring recommended and discontinuation may be required.
Severe hepatic impairment increases risk of adverse events; monitoring recommended.
Clinically significant liver injury and cases of active liver failure requiring liver transplant have been reported; monitoring recommended and discontinuation may be required.
Immunologic: Do not initiate treatment in patients with active acute or chronic infection.
Disseminated varicella zoster and herpes simplex infections, including cases of encephalitis and multiorgan failure, have been reported.
Cryptococcal infections (eg, cryptococcal meningitis, disseminated cryptococcal infections) including fatal cases of cryptococcal meningitis have occurred; if suspected, prompt diagnostic evaluation and management required.
Immunosuppression, during therapy and persisting for 2 months after discontinuation, increases risk of serious infection; additive immunosuppressant effects may be expected when other immunosuppressant agents are given during this period; monitoring recommended and treatment interruption may be warranted.
Switching from immune-modulating or immunosuppressive medication to Fingolimod; consider the duration of action to avoid risk of additive immunosuppressive effects.
Test for presence of varicella zoster virus (VZV) antibodies prior to initiation in patients with a negative history for chickenpox or without VZV vaccination; vaccination is recommended for antibody-negative patients 1 month prior to Fingolimod initiation.
Human papilloma virus (HPV) infections, including papilloma, dysplasia, warts, and HPV-related cancer, have been reported; consider vaccination prior to therapy and follow standard of care for cancer screening.
Hypersensitivity reactions including rash, urticaria, and angioedema upon treatment initiation have been reported.
Lymphoma, including T-cell and B-cell types and CNS lymphoma, has been reported.
Infections: Serious, life-threatening, and fatal infections with opportunistic pathogens including viruses, herpes, fungi, and bacteria have been reported; if suspected, prompt diagnostic evaluation and management required.
Musculoskeletal: Kaposi's sarcoma has been reported; if suspected, prompt diagnostic evaluation and management required.
Neurologic: Multiple sclerosis relapses with tumefactive demyelinating lesions on imaging have been observed during and after therapy discontinuation; most cases have occurred within the first 9 months of therapy and has also been reported during the first 4 months following discontinuation.
Progressive multifocal leukoencephalopathy has been reported, including cases in patients who were not immunocompromised and had no prior exposure to immunosuppressant drugs, including natalizumab. MRI findings and JCV DNA detection in cerebrospinal fluid may be apparent before clinical signs or symptoms; discontinue use and perform diagnostic evaluation if suspected.
Severe increase in disability accompanied by multiple new lesions on MRI has been reported following drug discontinuation and generally occurs within 12 weeks of discontinuation, but may occur for up to 24 weeks following discontinuation. Patients may not regain function status attained prior to drug discontinuation; monitoring is recommended and treatment may be necessary.
Posterior reversible encephalopathy syndrome has been reported and may progress to ischemic stroke or cerebral hemorrhage; delayed diagnosis and treatment may result in permanent neurologic damage, discontinue use immediately if suspected.
Ophthalmic: Macular edema has been reported, the risk is dose-dependent and increased in patients with preexisting uveitis or diabetes mellitus; monitoring recommended; discontinuation may be required.
Reproductive: Drug may cause fetal harm; use of effective contraception during and for 2 months after treatment is recommended. For women planning to become pregnant, discontinue use 2 months prior to conception.
Respiratory: Dose-dependent decreases in respiratory function have been reported, including a reduction in FEVl and diffusion lung capacity for carbon monoxide (DLCO); monitoring may be warranted.