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)

Bibliography

1987 criteria for the classification of acute arthritis of rheumatoid arthritis. American College of Rheumatology Web site. http://www.rheumatology.org/practice/clinical/classification/ra/ra.asp. Accessed June 12, 2012.

Aletaha D, Neogi T, Silman AJ, et al. 2010 rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62:2569-2581.

American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis: 2002 update. Arthritis Rheum. 2002;46:328-346.

Arvidson NG, Gudbjörnsson B, Elfman L, Rydén A-C, Tötterman TH, Hällgren R. Circadian rhythm of serum interleukin-6 in rheumatoid arthritis. Ann Rheum Dis. 1994;53:521-524.

Arvidson NG, Gudbjörnsson B, Larsson A, Hällgren R. The timing of glucocorticoid administration in rheumatoid arthritis. Ann Rheum Dis.1997;56:27-31.

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.

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.

Caplan L, Wolfe F, Russell AS, Michaud K. Corticosteroid use in rheumatoid arthritis: prevalence, predictors, correlates, and outcomes. J Rheumatol. 2007;34:696-705.

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.

Crofford LJ, Kalogeras KT, Mastorakos G, et al. Circadian relationships between interleukin (IL)-6 and hypothalamic-pituitary-adrenal axis hormones: failure of IL-6 to cause sustained hypercortisolism in patients with early untreated rheumatoid arthritis. J Clin Endocrinol Metab.1997;82:1279-1283.

Cutolo M, Seriolo B, Craviotto C, Pizzorni C, Sulli A. Circadian rhythms in RA. Ann Rheum Dis. 2003;62:593-596.

da Silva JAP, Phillips S, Buttgereit F. Impact of impaired morning function on the lives and well-being of patients with rheumatoid arthritis. Scand J Rheumatol. 2011;40(suppl 125):6-11.

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.

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.

Data on file. Horizon Pharma.

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.

Gudbjörnsson B, Skogseid B, Oberg K, Wide L, Hällgren R. Intact adrenocorticotropic hormone secretion but impaired cortisol response in patients with active rheumatoid arthritis: effect of glucocorticoids. J Rheumatol. 1996;23:596-602.

Harkness JAL, Richter MB, Panayi GS, et al. Circadian variation in disease activity in rheumatoid arthritis. Br Med J. 1982;284:551-554.

Helmick CG, Felson DT, Lawrence RC, et al; for the National Arthritis Data Workgroup. Estimates of the prevalence of arthritis and other rheumatic conditions in the United States: part I. Arthritis Rheum. 2008;58:15-25.

Kirwan JR. The effect of glucocorticoids on joint destruction in rheumatoid arthritis. N Engl J Med. 1995;333:142-146.

Kowanko IC, Knapp MS, Pownall R, Swannell AJ. Domiciliary self-measurement in rheumatoid arthritis and the demonstration of circadian rhythmicity. Ann Rheum Dis. 1982;41:453-455.

Labrecque G, Bureau J-P, Reinberg AE. Biological rhythms in the inflammatory response and in the effects of non-steroidal anti-inflammatory drugs. Pharmacol Ther. 1995;66:285-300.

Mayo Clinic staff. Polymyalgia rheumatica. Mayo Clinic Web site. http://www.mayoclinic.com/health/polymyalgia-rheumatica/DS00441. Accessed August 14, 2012.

Michet CJ, Matteson EL. Polymyalgia rheumatica. BMJ. 2008;336:765-769.

Myasoedova E, Crowson CS, Kremers HM, Therneau TM, Gabriel SE. Is the incidence of rheumatoid arthritis rising? Results from Olmsted County, Minnesota,1955-2007. Arthritis Rheum. 2010;62:1576-1582.

Perry MG, Kirwan JR, Jessop DS, Hunt LP. Overnight variations in cortisol, interleukin 6, tumour necrosis factor α and other cytokines in people with rheumatoid arthritis. Ann Rheum Dis. 2009;68:63-68.

RAYOS (prednisone) delayed-release tablets [package insert]. Deerfield, IL: Horizon Pharma Inc; July 2012.

Rheumatoid arthritis. Mayo Clinic Web site. http://www.mayoclinic.com/health/rheumatoid-arthritis/DS00020. Accessed August 27, 2012.

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.

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.

Salvarani C, Cantini F, Boiardi L, Hunder GG. Polymyalgia rheumatica and giant-cell arteritis. N Engl J Med. 2002;347:261-271.

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.

Straub RH, Glück T, Cutolo M, et al. The adrenal steroid status in relation to inflammatory cytokines (interleukin-6 and tumour necrosis factor) in polymyalgia rheumatica. Rheumatology. 2000;39:624-631.

Unwin B, Williams CM, Gilliland W. Polymyalgia rheumatica and giant cell arteritis. Am Fam Physician. 2006;74:1547-1554,1557-1558.

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.

Weyand CM, Fulbright JW, Evans JM, Hunder GG, Goronzy JJ. Corticosteroid requirements in polymyalgia rheumatica. Arch Intern Med. 1999;159:577-584.

Yazici Y, Pincus T, Kautiainen H, Sokka T. Morning stiffness in patients with early rheumatoid arthritis is associated more strongly with functional disability than with joint swelling and erythrocyte sedimentation rate. J Rheumatol. 2004;31:1723-1726.

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.

 

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.

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RAYOS is a registered trademark of Horizon Pharma.
May 2014. 0108RAY01
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