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RAYOS® (prednisone) Delayed-Release Tablets

The First and Only Delayed-Release Prednisone

RAYOS® (prednisone) delayed release tablets* 1 mg, 2 mg and 5 mg are a proprietary delayed-release formulation of low-dose prednisone that is approved for a broad range of diseases. The pharmacokinetic profile of RAYOS is different from that of immediate-release prednisone formulations with an approximately four-hour lag time. In clinical trials studying the use of RAYOS in rheumatoid arthritis (RA), patients were administered RAYOS at 10 p.m. with food. Given the delayed-release profile of RAYOS, this helps to achieve therapeutic prednisone blood levels during the middle of the night when cytokine levels start rising. When taken at night (10 p.m. in clinical trials), the delayed release of prednisone in RAYOS helped improve RA symptoms and reduce morning stiffness. While the pharmacokinetic profile of RAYOS differs from immediate-release prednisone in terms of lag time, its absorption, distribution and elimination processes are comparable.

Indications and Usage

RAYOS, a corticosteroid, is an anti-inflammatory or immunosuppressive agent used in the treatment of many different conditions, such as certain allergic, skin, stomach and intestinal, blood, eye, nerve, kidney, breathing, rheumatologic, and specific infectious diseases or conditions, and organ transplantation. Key rheumatologic indications include RA, polymyalgia rheumatica, psoriatic arthritis and ankylosing spondylitis. RAYOS is used in the treatment of certain endocrine conditions and to ease the symptoms, including pain, of certain cancer conditions.

Important Safety Information

Do not use RAYOS if you are allergic to prednisone.

Long-term use of RAYOS can affect your hormones and one of the ways your body responds to stress. Symptoms, among others, can include weight gain, changes in body appearance (particularly the face), severe fatigue, weak muscles, and high blood sugar. Tell your doctor if you develop any of these symptoms after taking RAYOS.

RAYOS can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Signs and symptoms of infection may be hidden. Tell your doctor if you have had a recent or ongoing infection or if you have been exposed to chickenpox or measles.

RAYOS can cause high blood pressure, salt and water retention, and low blood potassium. Your doctor should monitor these levels.

There is an increased risk of developing perforations in the stomach or intestines if you have certain stomach and intestinal disorders. Signs and symptoms may be hidden.

Behavior and mood changes can occur, including intense excitement or happiness, sleeplessness, mood swings, personality changes, severe depression, and psychosis. Existing conditions may become worse.

Long-term use of RAYOS can cause decreases in bone density. You should talk with your doctor about this risk before you initiate therapy, particularly if you are postmenopausal. Your doctor should monitor bone density with long-term therapy.

RAYOS can cause cataracts, eye infections, and glaucoma. Your doctor should monitor eye pressure if you use RAYOS for more than 6 weeks.

Do not receive a “live” vaccine while taking RAYOS. The vaccine may not work as well during this time, and may not fully protect you from disease. Tell your doctor if you have recently received a vaccine.

Taking RAYOS during the first trimester of pregnancy can harm an unborn baby.

Long-term use of RAYOS can slow growth and development in children. Children on long-term therapy should be monitored for this.

The most common side effects with RAYOS are water retention, high blood sugar, high blood pressure, unusual behavior and mood changes, increased appetite, and weight gain.

Talk to your doctor before you stop taking RAYOS. You may need to gradually reduce the amount of RAYOS you are taking. Stopping RAYOS suddenly may cause unwanted side effects.

For more information on RAYOS, please see the Full Prescribing Information.

*Outside the United States, RAYOS is approved under the brand name LODOTRA in 16 European countries, Australia and Israel for the treatment of moderate-to-severe active RA when accompanied by morning stiffness. Horizon has granted commercialization rights for LODOTRA in Europe, Asia and Latin America to its distribution partner Mundipharma International Corporation Limited.

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