Rayos: (Prednisone) Delayed-release Tablets

Full Prescribing Information For Patients

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

Polymyalgia rheumatica (PMR)—an inflammatory condition that can cause significant disability

Recognizing and diagnosing PMR

  • Symptoms include severe stiffness and pain in the neck, shoulders and upper arms, hips and thighs, and morning stiffness1,2
  • Symptoms of systemic inflammation are also present2
  • Markers of inflammation, including C-reactive protein and erythrocyte sedimentation rate, are elevated3,4
  • Prednisone is standard treatment for PMR2,8

  • Therapy is typically started at 15 to 20 mg/day9
  • Symptoms usually improve within days2
    • If the initial response is not rapid and dramatic, alternative diagnoses should be considered 9,10
  • After initial response to treatment, dose is slowly tapered to the lowest possible dose ( <10 mg/day) depending on
    symptom activity9
  • Treatment duration is often 1 to 2 years3
  • References:
    1. Salvarani C, Cantini F, Boiardi L, Hunder GG. Polymyalgia rheumatica and giant-cell arteritis. N Engl J Med. 2002;347:261-271.
    2. Unwin B, Williams CM, Gilliland W. Polymyalgia rheumatica and giant cell arteritis. Am Fam Physician. 2006;74:1547-1554,1557-1558.
    3. Mayo Clinic staff. Polymyalgia rheumatica. Mayo Clinic Web site. http://www.mayoclinic.com/health/polymyalgia-rheumatica/DS00441. Accessed August 14, 2012.
    4. Weyand CM, Fulbright JW, Evans JM, Hunder GG, Goronzy JJ. Corticosteroid requirements in polymyalgia rheumatica. Arch Intern Med. 1999;159:577-584.
    5. Dasgupta B, Cimmino MA, Kremers HM, et al. 2012 provisional classification criteria for polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. Arthritis Rheum. 2012;64:943-954.
    6. Spies CM, Cutolo M, Straub RH, Burmester G-R, Buttgereit F. More night than day—circadian rhythms in polymyalgia rheumatica and ankylosing spondylitis. J Rheumatol. 2010;37:894-899.
    7. Salvarani C, Popitone N, Versari A, Hunder GG. Clinical features of polymyalgia rheumatica and giant cell arteritis [published online ahead of print July 24, 2012]. Nat Rev Rheumatol. doi:10.1038/nrrheum.2012.97.
    8. Frearson R, Cassidy T, Newton J. Polymyalgia rheumatica and temporal arteritis: evidence and guidelines for diagnosis and management in older people. Age Ageing. 2003;32:370-374.
    9. Michet CJ, Matteson EL. Polymyalgia rheumatica. BMJ. 2008;336:765-769.
    10. Dasgupta B, Matteson EL, Maradit-Kremers H. Management guidelines and outcome measures in polymyalgia rheumatica (PMR). Clin Exp Rheumatol. 2007;25(suppl 47):S130-S136.

    A core symptom

    Learn about the circadian rhythm of inflammation.

    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