Rayos: (Prednisone) Delayed-release Tablets

Full Prescribing Information For HCPs

The first and only delayed-release prednisone
for the treatment of rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR)

Understanding polymyalgia
rheumatica (PMR)

PMR is an inflammatory disorder that has many similarities to rheumatoid arthritis (RA). If left untreated, PMR can have more serious effects.

Risk factors for PMR

Some of the risk factors for PMR are similar to RA:

  • Women are twice as likely to have PMR than men
  • PMR usually affects people 50 years of age or older
  • The risk for PMR is highest between the ages of 70 and 80 years

Diagnosis of PMR

Morning stiffness that lasts 45 minutes to more than 1 hour is a key symptom of PMR.

PMR is difficult to diagnose since there aren’t any tests that can identify the disease. However, one blood test can help. It’s called the erythrocyte sedimentation rate (ESR) and measures the level of certain kinds of inflammation in the body. People with PMR tend to have higher ESR.

Understanding polymyalgia rheumatica (PMR)

Learn more about
the symptoms of PMR.

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.

Approved uses of RAYOS
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. RAYOS is used in the treatment of certain endocrine conditions and to ease the symptoms, including pain, of certain cancer conditions.

For a complete list of indications for RAYOS, please see full Prescribing Information.

*For eligible patients. Terms and Conditions apply. Please click here for more information.

All rights reserved © 2014 Horizon Pharma USA, Inc.
RAYOS is a registered trademark of Horizon Pharma.
May 2014. 0108RAY01
www.horizonpharma.com