Eyeworld Daily News

JULY 23, 2021 | EYEWORLD DAILY NEWS | 13 Mallinckrodt Spread (ad) 13 INDICATION Acthar ® Gel is indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation. IMPORTANT SAFETY INFORMATION Contraindications Acthar is contraindicated: • For intravenous administration • In infants under 2 years of age who have suspected congenital infections • With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar • In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin Warnings and Precautions • The adverse effects of Acthar are related primarily to its steroidogenic effects • Acthar may increase susceptibility to new infection or reactivation of latent infections • Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids. Monitor patients for effects of HPA axis suppression after stopping treatment • Cushing's syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms • Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels • Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy • Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding • Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated • Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis • Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms • Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity • There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver • Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients • Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy • Pregnancy Class C: Acthar has been shown to have an embryocidal effect and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus Adverse Reactions • Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased • The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks these seizures, which may become visible once the clinical spasms from IS resolve Other adverse events reported are included in the full Prescribing Information. Please see Brief Summary of full Prescribing Information on the adjacent page. All educational content of the ASCRS Annual Meeting is planned by its program committee, and ASCRS does not endorse, promote, approve, or recommend the use of any products, devices, or services. This promotional event is only intended for appropriate US healthcare professionals (HCPs). No guests or relatives of HCPs are permitted, unless they are also appropriate HCP attendees. Mallinckrodt, the "M" brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. Other brands are trademarks of a Mallinckrodt company or their respective owners. © 2021 Mallinckrodt. US-2100490 06/21 OR VISIT BOOTH 2223 FOR MORE INFORMATION ATTEND AT THE TAP ROOM JULY 25 th 12:10 PM to 12:50 PM HEAR FROM A KEY THOUGHT LEADER DR MELISSA TOYOS, MD

• Cover