Naturally occurring corticosteroids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs, such as prednisone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

RAYOS is a corticosteroid indicated

• as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic,
• gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic,
• specific infectious diseases or conditions and organ transplantation
• for the treatment of certain endocrine conditions
• for palliation of certain neoplastic conditions

Individualize dosing based on disease severity and patient response. The timing of administration should take into account the delayed-release pharmacokinetics and the disease or condition being treated:

• Initial dose: RAYOS 5 mg administered once per day. Patients currently on immediate-release prednisone, prednisolone, or methylprednisolone should be switched to RAYOS at an equivalent dose based on relative potency. (2.1, 2.4)
• Maintenance dose: Use lowest dosage that will maintain an adequate clinical response. (2.1)
• Discontinuation: Withdraw gradually if discontinuing long-term or high-dose therapy. (2.1)
• RAYOS should be taken daily with food. (2.3, 12.3)
• RAYOS should be swallowed whole and not broken, divided, or chewed. (2.3)

Common adverse reactions for corticosteroids include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Known hypersensitivity to prednisone or any excipients in the formulation

• Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and hyperglycemia: Monitor patients for these conditions with chronic use. Taper doses gradually for withdrawal after chronic use. (5.1)
• Immunosuppression and Increased Risk of Infection: Increased susceptibility to new infection and increased risk of exacerbation, dissemination, or reactivation of latent infection. Signs and symptoms of infection may be masked. (5.2)
• Elevated blood pressure, salt and water retention, and hypokalemia: Monitor blood pressure and sodium, potassium serum levels. (5.3)
• GI perforation: increased risk in patients with certain GI disorders. Signs and symptoms may be masked. (5.4)
• Behavioral and mood disturbances: May include euphoria, insomnia, mood swings, personality changes, severe depression, and psychosis. Existing conditions may be aggravated. (5.5)
• Decreases in bone density: Monitor bone density in patients receiving long-term corticosteroid therapy. (5.6) Ophthalmic effects: May include cataracts, infections, and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more than 6 weeks. (5.7)
• Live or live attenuated vaccines: Do not administer to patients receiving immunosuppressive doses of corticosteroids. (5.8)
• Negative effects on growth and development: Monitor pediatric patients on long-term corticosteroid therapy. (5.9)
• Embryo-Fetal Toxicity: Can cause fetal harm with first trimester use. Advise patients of potential harm to the fetus. (5.10)