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 Acute adrenal insufficiency or “withdrawal syndrome” can occur if corticosteroids are withdrawn abruptly and can be fatal.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.