Hypersensitivity & infusion-related reactions may occur. Immediately discontinue use & initiate appropriate treatment if patient develops signs of anaphylaxis or other serious hypersensitivity. Contains polysorbate 20; may cause allergic reactions. Stop treatment & consider appropriate medical therapy (eg, systemic anti-histamines &/or corticosteroids) if patient develops mild or moderate infusion-related reaction. May increase risk of infections. Consider potential risks & expected clinical benefits of treatment prior to prescribing in patients w/ chronic infection or history of recurrent infection. Not to be initiated in patients w/ any clinically important active infection until infection resolves or is adequately treated. Evaluate patients for TB infection prior to treatment initiation. Not to be administered to patients w/ active TB infection. Consider anti-TB therapy prior to treatment initiation in patients w/ latent or history of TB in whom adequate treatment course cannot be confirmed; monitor signs & symptoms of active TB after treatment. At least 4 wk interval between live vaccinations & Spevigo initiation. Use w/ other immunosuppressants is not recommended. Do not administer live vaccines for at least 16 wk after Spevigo treatment. Potential peripheral neuropathy. Contains Na <1 mmol/900 mg dose. Renal &/or hepatic impairment. Avoid use during pregnancy. Lactation. Childn <18 yr. Elderly ≥65 yr.