For patients 5 years of age and older with Duchenne muscular dystrophy (DMD), We’re working together to deliver more than medicine We support providers, patients, and caregivers with the Upsher‑Smith Promise of Support® Program. For patients 5 years of age and older with Duchenne muscular dystrophy (DMD), We’re working together to deliver more than medicine We support providers, patients, and caregivers with the Upsher‑Smith Promise of Support® Program. Clarity. Choice. Support. Coverage and access have been challenging. That can change with KYMBEE™. The Upsher‑Smith Promise of Support® Program for KYMBEE is designed to improve access and affordability. Providers and families do have choices, and we: Provide guidance for benefits investigation Minimize out-of-pocket costs for eligible patients* Create pathways to access therapy, even when insurance challenges arise How to prescribe KYMBEE *Limitations apply. The Promise of Support® Program offers: Expert guidance for benefits investigation and coverage navigation Prior authorization and appeal assistance $0 copay* for eligible commercially insured patients Bridge Supply available for therapy continuity and Quick Start available as needed Our Promise of Support® Program *Limitations apply. When support programs aren’t included, other generic options may not always offer better value. Because support programs come from the company, not the pharmacy, switching deflazacort products could mean losing copay assistance or access to patient support. Through the Upsher-Smith Promise of Support® Program, we strive to make access to deflazacort more reliable for patients prescribed KYMBEE. KYMBEE Prescription Form KYMBEE (deflazacort) Tablets is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older. SELECTED IMPORTANT SAFETY INFORMATION: Contraindications: KYMBEE is contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients. Manufactured in the USA.† Upsher-Smith, a trusted U.S.-based pharmaceutical company, delivers consistent supply and industry-leading support. Patient Counseling InformationWarn patients and/or caregivers to not stop taking KYMBEE abruptly or without first checking with their healthcare providers as there may be a need for gradual dose reduction to decrease the risk of adrenal insufficiency. †Sourced using components from Italy. IMPORTANT SAFETY INFORMATION & INDICATION FOR KYMBEE™ (deflazacort) Tablets IMPORTANT SAFETY INFORMATION Contraindications: KYMBEE is contraindicated in patients with a hypersensitivity to deflazacort or any of the inactive ingredients. Warnings & Precautions Alterations in Endocrine Function: Corticosteroids, such as KYMBEE, can cause serious and life-threatening alterations in endocrine function, especially with chronic use. Monitor patients receiving KYMBEE for Cushing’s syndrome, hyperglycemia, and adrenal insufficiency after KYMBEE withdrawal. In addition, patients with hypopituitarism, primary adrenal insufficiency or congenital adrenal hyperplasia, altered thyroid function, or pheochromocytoma may be at increased risk for adverse endocrine events. Acute adrenal insufficiency or “withdrawal syndrome” can occur if corticosteroids are withdrawn abruptly and can be fatal. The risk is reduced by gradually tapering the corticosteroid dose when withdrawing treatment. During times of stress, corticosteroid dosage may need to be increased. Immunosuppression and Increased Risk of Infection: Increased risk of new, exacerbation, dissemination, or reactivation of latent infections, which can be severe and at times fatal; signs and symptoms of infection may be masked. Monitor for the development of infection and consider KYMBEE withdrawal or dosage reduction as needed. Tell patients and/or caregivers to inform their healthcare provider if the patient has had recent or ongoing infections or if they have recently received a vaccine. Warn patients who are on corticosteroids who have not had chickenpox or measles to avoid exposure to chickenpox or measles and to alert their healthcare provider immediately if they are exposed. Alterations in Cardiovascular/Renal Function: Monitor for elevated blood pressure. Dietary salt restriction and potassium supplementation may be necessary. KYMBEE should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Gastrointestinal Perforation: Increased risk of gastrointestinal perforation during corticosteroid use in patients with certain gastrointestinal disorders such as active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and non-specific ulcerative colitis. Signs and symptoms may be masked. Behavioral and Mood Disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Symptoms typically emerge within a few days or weeks of starting treatment and may be dose-related. Inform patients or caregivers of the potential for behavioral and mood changes and encourage them to seek medical attention if psychiatric symptoms develop, especially if depressed mood or suicidal ideation is suspected. Effects on Bones: The risk of osteoporosis increases with prolonged use of KYMBEE, which can predispose patients to vertebral and long bone fractures. Monitor for decreases in bone density with chronic use of KYMBEE. Ophthalmic Effects: May include cataract formation, ocular infections, and glaucoma. If treatment with corticosteroids, including KYMBEE, are continued for more than 6 weeks, monitor intraocular pressure. Vaccination: Do not administer live or live attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting KYMBEE. Serious Skin Rashes: Toxic epidermal necrolysis has been reported with the use of deflazacort. Discontinue at the first sign of rash, unless the rash is clearly not drug related. Effects on Growth and Development: Long-term use of corticosteroids, including KYMBEE, can have negative effects on growth and development in children. Thromboembolic Events: Observational studies have shown an increased risk of thromboembolism. Use KYMBEE with caution in patients who have or may be predisposed to thromboembolic disorders. Adverse Reactions: The most common adverse reactions (incidence 10% and greater than placebo) are Cushingoid appearance, weight increased, increased appetite, upper respiratory tract infection, cough, pollakiuria, hirsutism, central obesity, and nasopharyngitis. Drug Interactions: Give one third of the recommended dose of KYMBEE when KYMBEE is administered with strong or moderate CYP3A4 inhibitors. Avoid use of strong or moderate CYP3A4 inducers with KYMBEE, as they may reduce efficacy. This safety information is not comprehensive. Please see the full Prescribing Information for KYMBEE. You can also visit www.upshersmith.com or call 1-888-650-3789. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-888-650-9180 or to the FDA by visiting www.fda.gov/medwatch. INDICATION KYMBEE (deflazacort) Tablets are indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older.