Rayos: (Prednisone) Delayed-release Tablets

Full Prescribing Information For Patients

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

Prednisone—a key component in the treatment of inflammatory conditions

Low-dose prednisone enhances
DMARD therapy1-3

In the CAMERA-II* trial of patients with early-stage rheumatoid arthritis (RA) treated with methotrexate (MTX), the addition of 10 mg/day of immediate-release (IR) prednisone showed:

  • Benefit in reduced progression of erosive joint damage, disease activity and physical disability during a 2-year period4
  • Earlier achievement of remission—6 months for the MTX + prednisone group vs 11 months for the MTX + placebo group (P<0.001)4
  • The safety profile of MTX + prednisone was similar to that of
    MTX alone4
  • Patients in the CAMERA-II trial received IR prednisone, not RAYOS.

    RAYOS does not have a specific indication for delay of
    joint destruction.

    Adverse effects of prednisone are directly related to the exposure

    Risk of First Serious Adverse Event (Odds Ratio) After 5 Years5

    Timing considerations for dosing of IR prednisone

  • Corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity, between 2 AM and 8 AM6
  • Although symptom control is improved with 2 AM dosing, it may be inconvenient for patients to wake up to take IR prednisone
    at that hour7
  • IR prednisone dosing before bedtime (~10PM) does not coincide with the early morning rise of cytokine release8
  • DMARD=disease-modifying antirheumatic drug.
    CAMERA-II=Computer Assisted Management in Early Rheumatoid Arthritis-II.

    References:
    1. Kirwan JR. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. N Engl J Med. 1995;333:142-146.
    2. Wassenberg S, Rau R, Steinfeld P, Zeidler H; for the Low-Dose Prednisolone Therapy Study Group. Very low-dose prednisolone in early rheumatoid arthritis retards radiographic progression over two years. Arthritis Rheum. 2005;52:3371-3380.
    3. van Everdingen AA, Jacobs JWG, van Reesema DRS, Bijlsma JWJ. Low-dose prednisone therapy for patients with early active rheumatoid arthritis: clinical efficacy, disease-modifying properties, and side effects. Ann Intern Med. 2002;136:1-12.
    4. Bakker MF, Jacobs JWG, Welsing PMJ, et al; for the Utrecht Rheumatoid Arthritis Cohort Study Group. Low-dose prednisone inclusion in a methotrexate-based, tight control strategy for early rheumatoid arthritis. Ann Intern Med. 2012;156:329-339.
    5. Saag KG, Koehnke R, Caldwell JR, et al. Low dose long-term corticosteroid therapy in rheumatoid arthritis: an analysis of serious adverse events. Am J Med. 1994;96:115-123.
    6. RAYOS (prednisone) delayed-release tablets [package insert]. Deerfield, IL: Horizon Pharma Inc; July 2012.
    7. Arvidson NG, Gudbjörnsson B, Larsson A, Hällgren R. The timing of glucocorticoid administration in rheumatoid arthritis. Ann Rheum Dis.
    1997;56:27-31.
    8. Cutolo M, Seriolo B, Craviotto C, Pizzorni C, Sulli A. Circadian rhythms in RA. Ann Rheum Dis. 2003;62:593-596.
    9. Caplan L, Wolfe F, Russell AS, Michaud K. Corticosteroid use in rheumatoid arthritis: prevalence, predictors, correlates, and outcomes. J Rheumatol. 2007;34:696-705.

    Many patients with RA use corticosteroids9

    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