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)

RAYOS® (prednisone) delayed-release tablets are indicated in the treatment of the following diseases or conditions:

1.1 Allergic Conditions

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adults and pediatric populations with:

  • Atopic dermatitis
  • Drug hypersensitivity reactions
  • Seasonal or perennial allergic rhinitis
  • Serum sickness

1.2 Dermatologic Diseases

  • Bullous dermatitis herpetiformis
  • Contact dermatitis
  • Exfoliative erythroderma
  • Mycosis fungoides
  • Pemphigus
  • Severe erythema multiforme (Stevens-Johnson syndrome)

1.3 Endocrine Conditions

  • Congenital adrenal hyperplasia
  • Hypercalcemia of malignancy
  • Nonsuppurative thyroiditis
  • Primary or secondary adrenocortical insufficiency: hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable

1.4 Gastrointestinal Diseases

During acute episodes in:

  • Crohn's Disease
  • Ulcerative colitis

1.5 Hematologic Diseases

  • Acquired (autoimmune) hemolytic anemia
  • Diamond-Blackfan anemia
  • Idiopathic thrombocytopenic purport in adults
  • Pure red cell aplasia
  • Secondary thrombocytopenia in adults

1.6 Neoplastic Conditions

For the treatment of:

  • Acute leukemia
  • Aggressive lymphomas

1.7 Nervous System Conditions

  • Acute exacerbations of multiple sclerosis
  • Cerebral edema associated with primary or metastatic brain tumor, craniotomy or head injury

1.8 Ophthalmic Conditions

  • Sympathetic ophthalmia
  • Uveitis and ocular inflammatory conditions unresponsive to topical steroids

1.9 Conditions Related to Organ Transplantation

  • Acute or chronic solid organ rejection

1.10 Pulmonary Diseases

  • Acute exacerbations of chronic obstructive pulmonary disease (COPD)
  • Allergic bronchopulmonary aspergillosis
  • Aspiration pneumonitis
  • Asthma
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy
  • Hypersensitivity pneumonitis
  • Idiopathic bronchiolitis obliterates with organizing pneumonia
  • Idiopathic eosinophilic pneumonias
  • Idiopathic pulmonary fibrosis
  • Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV(+) individual who is also under treatment with appropriate anti-PCP antibiotics.
  • Symptomatic sarcoidosis

1.11 Renal Conditions

  • To induce a diuresis or remission of proteinuria in nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus

1.12 Rheumatologic Conditions

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

  • Acute gouty arthritis

During an exacerbation or as maintenance therapy in selected
cases of:

  • Ankylosing spondylitis
  • Dermatomyositis/polymyositis
  • Polymyalgia rheumatica
  • Psoriatic arthritis
  • Relapsing polychondritis
  • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy)
  • Sjogren's syndrome
  • Systemic lupus erythematosus
  • Vasculitis

1.13 Specific Infectious Diseases

  • Trichinosis with neurologic or myocardial involvement.
  • Tuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy.

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