Rayos: (Prednisone) Delayed-release Tablets

Full Prescribing Information For Patients

The first and only delayed-release prednisone
for the treatment of RA and PMR

CAPRA-2: The RAYOS® (prednisone) delayed-release tablets pivotal trial

The efficacy of RAYOS was studied in a multicenter, double-blind, placebo-controlled, randomized, 12-week study1

  • 350 adult patients with active rheumatoid arthritis (RA) receiving DMARD therapy1
  • Randomly assigned in a 2:1 ratio to treatment with RAYOS + DMARD therapy (n=231) or DMARD therapy alone (n=119)2
  • Primary endpoint

  • ACR20: percentage of patients achieving 20% improvement in RA signs and symptoms according to American College of Rheumatology criteria1
  • Selected prespecified secondary endpoints1

  • ACR50
  • ACR70
  • Duration of morning stiffness
  • Other secondary endpoints

    Dosing Protocol

  • A 5-mg dose of RAYOS was given at ~10 PM with food1
  • RAYOS was taken with a light meal or snack if more than 2 to 3 hours had passed since the evening meal3
  • DMARD=disease-modifying antirheumatic drug.
    CAPRA-2=Circadian Administration of Prednisone in Rheumatoid Arthritis-2.

    References:
    1. RAYOS (prednisone) delayed-release tablets [package insert]. Deerfield, IL: Horizon Pharma Inc; July 2012.
    2. Buttgereit F, Mehta D, Kirwan J, et al. Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2) [published online ahead of print May 5, 2012]. Ann Rheum Dis. doi:10.1136/annrheumdis-2011-201067.
    3. Clinical study protocol: A randomized multi-center, double-blind, placebo-controlled study of a new modified-release tablet formulation of prednisone (Lodotra®) in patients with rheumatoid arthritis: Circadian Administration of Prednisone in RA; The CAPRA-2 Study. http://ard.bmj.com/content/suppl/2012/05/04/annrheumdis-2011-201067.DC1/ annrheumdis-2011-201067_ds3.pdf. Accessed September 4, 2012.

    CONTRAINDICATIONS

  • Known hypersensitivity to prednisone or any excipients in the formulation
  • WARNINGS AND PRECAUTIONS

  • Corticosteroids can cause 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
  • RAYOS may increase susceptibility to new infection and increase risk of exacerbation, dissemination or reactivation of latent infection. RAYOS may mask signs and symptoms of infection. The rate of infectious complications increases with increasing doses of corticosteroids
  • Corticosteroids can cause elevated blood pressure, salt and water retention and hypokalemia. Monitor blood pressure and sodium, potassium serum levels. RAYOS should be used with caution in patients with a history of recent myocardial infarction, congestive heart failure, hypertension or renal insufficiency
  • There is an increased risk of gastrointestinal (GI) perforation in patients with certain GI disorders. RAYOS may mask signs and symptoms of GI perforation
  • Corticosteroid use may be associated with behavioral and mood disturbances, including euphoria, insomnia, mood swings, personality changes, severe depression and psychosis. Existing conditions may be aggravated
  • Corticosteroid use may lead to inhibition of bone growth in children and adolescents and the development of osteoporosis at any age. Give special consideration to patients at increased risk of osteoporosis (eg, postmenopausal women) before initiating corticosteroid therapy, and bone density should be monitored in patients on long-term corticosteroid therapy
  • Prolonged use of corticosteroids may result in cataracts, infections and glaucoma. Monitor intraocular pressure if corticosteroid therapy is continued for more
    than 6 weeks
  • Do not administer live or attenuated vaccines to patients receiving immunosuppressive doses of corticosteroids
  • Long‐term use of corticosteroids can have negative effects on growth and development in children. Monitor pediatric patients on long‐term corticosteroid therapy
  • Fetal harm can occur with first trimester use of corticosteroids. Apprise women of potential harm to the fetus
  • ADVERSE REACTIONS

  • 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
  • INDICATIONS AND USAGE

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

    For further information on RAYOS, please see full Prescribing Information at www.RAYOSrx.com/PI.

    *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. 0109RAY01
    www.horizonpharma.com