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Cimzia® (certolizumab pegol)

Cimzia® (certolizumab pegol) COVERAGE CRITERIA

DRUG CLASS: GI Drugs, Miscellaneous – AHFS 56:92
BRAND NAME: Cimzia®
GENERIC NAME: certolizumab pegol
POLICY #: 0261
CATEGORY:
Commercial
FDA INDICATIONS:
Crohn’s Disease (CD) – for reducing signs and symptoms of Crohn’s
disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. • Rheumatoid Arthritis (RA) – for the treatment of adults with moderately to
CODE NAME
CODE NUMBER

BENEFIT DESIGN:
Coverage is provided immediately without initiating a coverage review in the
presence of prescription claims history for at least six consecutive months within
the past year for any DMARD as outlined in the COVERAGE CRITERIA.
In situations where none of the DMARDs listed below exist in history or where
the above does not apply, coverage for Cimzia® is determined through the prior
authorization process.
COVERAGE CRITERIA:
Coverage is provided if one of the following bullets applies:
Crohn’s Disease
Patients must be at least 18 years of age and have a diagnosis of CD Patients must have had an inadequate response to conventional therapy1 within the past year. • Rheumatoid Arthritis
Patients must be at least 18 years of age and have a diagnosis of RA Patients must have had an inadequate response to at least one (1) DMARD2 for at least six consecutive months in the past year. * If prior authorization is approved, coverage may be given for up to 12 months. Proprietary Information of Blue Cross and Blue Shield of Alabama QUANTITY LIMIT:
Disease State
Monthly Maximum
Cimzia® 200mg vials* (lyophilized powder for * Cimzia® 200mg vials for reconstitution require administration by a healthcare
professional and are not covered under the pharmacy benefit.
CONVENTIONAL THERAPY FOR CROHN’S DISEASE1
Generic Name:

Brand Name:
Azathioprine Azasan®, Imuran® Budesonide Entocort® Cyclosporine Neoral®, Sandimmune® Infliximab Remicade® Mercaptopurine (6-MP) Mesalamine Asacol®, Pentasa®
Methotrexate Rheumatrex®
Prednisone Sterapred®, Sterapred DS®
Sulfasalazine Azulfidine®, Azulfidine EN-Tabs®
NON-BIOLOGIC DMARDs2
Generic Name:
Brand Name:
Azathioprine Azasan®, Imuran® Cyclosporine Neoral® Gold sodium thiomalate Leflunomide Arava®
Methotrexate Rheumatrex®
Penicillamine Cuprimine®, Depen Titratable®
Sulfasalazine Azulfidine®, Azulfidine EN-Tabs®
BIOLOGIC DMARDs2
Tumor Necrosis Factor (TNF) Blocking Agents
Generic Name:

Brand Name:
Proprietary Information of Blue Cross and Blue Shield of Alabama Interkeukin-1 (IL-1) Blocking Agents
Generic Name:
Brand Name:
Other Biologic DMARDs
Generic Name:
Brand Name:

BLACK BOX WARNINGS:
Risk of Serious Infections

• Patients treated with Cimzia® are at increased risk for developing serious
infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. • Cimzia® should be discontinued if a patient develops a serious infection or − Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Cimzia® use and during therapy. Treatment for latent infection should be initiated prior to Cimzia® use. − Invasive fungal infections, including histoplasmosis, coccidiomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. − Bacterial, viral, and other infections due to opportunistic pathogens. • The risks and benefits of treatment with Cimzia® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. • Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cimzia®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.
RATIONALE:
• To ensure use for proper diagnosis.
• For RA, systemic DMARDs may be considered as initial therapy for patients unless a patient has a contraindication to or is not able to receive DMARD therapy. • For CD, DMARDs may be considered if patients had an inadequate response Proprietary Information of Blue Cross and Blue Shield of Alabama
DOSAGE AND ADMINISTRATION:
Crohn’s Disease:
• The recommended initial adult dose is 400mg (given as two subcutaneous
injections of 200mg) initially, and at weeks 2 and 4. In patients who obtain a clinical response, the recommended maintenance regimen is 400mg every 4 weeks.
Rheumatoid Arthritis:
• The recommended dose for adult patients is 400mg (given as two
subcutaneous injections of 200mg) initially, and at weeks 2 and 4, followed by 200mg every other week. For maintenance dosing, Cimzia® 400mg every 4 weeks can be considered.
RISK FACTORS/CONTRAINDICATIONS:
Warnings/Precautions:
Risk of Serious Infections – do not start Cimzia® during an active infection.
If an infection develops, monitor carefully, and stop Cimzia® if infection becomes serious. • Malignancies – in the controlled portions of clinical trials of some of the TNF-
blocking agents, more cases of lymphoma have been observed among patients receiving the TNF-blocker compared to control patients. • Heart Failure – cases of worsening or new onset congestive heart failure
have been reported with TNF-blocking agents, including Cimzia®. • Hepatitis B Virus (HBV) Reactivation – monitor HBV carriers during and
several months after therapy. If reactivation occurs, stop Cimzia® and begin antiviral therapy. • Neurologic Reactions – use of TNF blocking agents has been associated
with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of demyelinating disease. • Hematologic Reactions – rare reports of pancytopenia including aplastic
anemia have been reported with TNF blocking agents. • Immunizations – do not administer live vaccines or attenuated vaccines
Autoimmunity – treatment with Cimzia® may result in the formation of
antibodies and rarely, in the development of a lupus-like syndrome. Specific Populations:
• Pregnancy
• Pediatric Use – safety and effectiveness in pediatric patients have not been
DRUG INTERACTIONS:
Major:
• Abatacept – increased risk of infections. Concomitant use is not
Proprietary Information of Blue Cross and Blue Shield of Alabama • Anakinra – an increased risk of serious infections and neutropenia. • Live Vaccines – an increased risk of secondary transmission of infection by • Natalizumab – suspect an increased risk of serious infections (based on data with anakinra and abatacept). Concomitant use is not recommended. • Rituximab – suspect an increased risk of serious infections (based on data with anakinra and abatacept). Concomitant use is not recommended.
REFERENCES:
1. Cimzia [package insert]. Smyrna, GA: UCB, Inc.; 2009.
2. McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of
Health-System Pharmacists; 2009:3079-3081. 3. Micromedex Healthcare Series Web site. Available at: http://www.thomsonhc.com/hcs/librarian. Accessed June 1, 2009. 4. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis 2002 update. Arthritis Rheum 2002;46:328-46. 5. Saag KA, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum 2008;59(6):762-784. 6. Furst DE, Breedveld FC, Kalden JR, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases, 2006. Ann Rheum Dis 2006;65:2-15. 7. Pucino F, Harbus PT, Goldbach-Mansky R. Use of biologics in rheumatoid arthritis: where are we going? Am J Health-Syst Pharm 2006;63(Suppl 4):S19-S41. 8. Hanauer SB, Sandborn W, and the Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines: management of Crohn’s disease in adults. Am J Gastroenterol 2001;96(3):635-643. 9. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn’s disease. N Engl J Med 2007;357:228-38. 10. Schreiber S, Khaliq-Kareemi M, Lawrence IC, et al. Maintenance therapy with certolizumab pegol for Crohn’s disease. N Engl J Med 2007;357:239-50. 11. Rutgeerts P, Schreiber S, Feagan B, et al. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFα, improves health-related quality of life in patients with moderate to severe Crohn’s disease. Int J Colorectal Dis 2008;23:289-96. 12. Smolen J, Landewe RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study. A randomized controlled trial. Ann Rheum Dis 2009;68:797-804. 13. Fleischmann R, Vencovsky J, van Vollenhoven RF, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis 2009;68:805-811.
POLICY HISTORY:
• Pharmacy Review Date: June 1, 2009
• Original Effective Date: June 1, 2009 Proprietary Information of Blue Cross and Blue Shield of Alabama • Date of Pharmacy & Therapeutics Committee Approval: August 5, 2009 • Next Review Date: August 2010 This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment. The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients. Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment. Proprietary Information of Blue Cross and Blue Shield of Alabama

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Hydroxyurea Associated Leg Ulcer Succesfully Treated with Hyperbaric Oxygen in a Diabetic Patient B. Akinci 1 , S. Yesil 1 , A. Atabey 2 , S. Ilgezdi 3 Affi liations 1 Dokuz Eylul University, Endocrinology and Metabolism, Izmir, Turkey 2 Dokuz Eylul University, Plastic and Reconstructive Surgery, Izmir, Turkey 3 Yesilyurt Ataturk Education and Research Hospital, Undersea and

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