SIMPONI® and Medicare

SIMPONI® and Medicare

Overview of Medicare

Medicare is a federal program that provides health insurance coverage to the following types of people:

  • Individuals over age 65 with a work history
  • Individuals with certain disabilities who have been disabled for at least 2 years
  • Individuals diagnosed with end-stage renal disease (ESRD)

While Medicare covers many healthcare needs, it may not cover all of the patient's healthcare costs. The patient may have to pay a monthly premium for Medicare and then pay co-insurance and a deductible for many services.

The 4 Parts of Medicare

Medicare is divided into 4 parts: A, B, C, and D. Part A covers facility care such as hospitals, and Part B covers physician and other outpatient services. Part C, which is known as the Medicare Advantage program, allows private managed care plans to administer a patient's Medicare benefits.

Medicare Part D offers prescription drug coverage to anyone enrolled in Medicare Parts A or B. Table 1 provides additional detail regarding the 4 parts of the Medicare program.

 

Table 1. The 4 Parts of Medicare

Part A

Typically known as the hospital benefit, Part A provides coverage for services such as hospitalizations, hospice care, skilled nursing facility stays, and home health services.

Part B

Part B benefits provide reimbursement for physician services, clinical laboratory services, hospital outpatient services, prescription drugs administered "incident to" a physician's services, durable medical equipment, and some home health services.

Part C

Also known as Medicare Advantage, this benefit provides Medicare Part A, B and often Part D coverage through managed care plans.

Part D

Prescription drug coverage for medicines that are usually self-administered or taken orally.

To learn more about the different parts of Medicare, you can call the Medicare program at 1-800-MEDICARE (1-800-633-4227) or visit Medicare.gov

Our Medicare Resource Guide provides important information for your patients to consider as they are selecting their insurance coverage.

Medicare Part D

Third-party reimbursement is affected by many factors. The content provided is for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment, or charge. Similarly, all CPT®* and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations, and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document, the information may not be as current or comprehensive when you view it. We strongly recommend that you consult with your payer organization(s) for local or actual coverage and reimbursement policies and with your internal reimbursement specialist for any reimbursement or billing questions.

*CPT® copyright 2016 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association.

Janssen CarePath does not endorse and is not responsible for the content on any of the Web sites listed below, or the services provided by these organizations. Clicking on any of the links below will take you to a Web site to which our privacy policy does not apply. We encourage you to read the privacy policy of every Web site you visit.

Alabama

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Alaska

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Arizona

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Arkansas

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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California

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Anthem Blue Cross of California Yes 5 Yes For more information
Kaiser Permanente   5    

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Colorado

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Connecticut

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Delaware

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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District of Columbia DC

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Florida

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Humana Yes 5 Yes For more information
SantaFe HealthCare, Inc./AvMed Health Plans Yes 5 Dosage dependent For more information

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Georgia

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Hawaii

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Idaho

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Illinois

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Blue Cross and Blue Shield of Illinois Yes See payer for details.    

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Indiana

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Iowa

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Kansas

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Kentucky

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Louisiana

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Maine

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Maryland

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Massachusetts

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Michigan

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Minnesota

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Mississippi

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Missouri

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Montana

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Nebraska

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Nevada

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


New Hampshire

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


New Jersey

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


New Mexico

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


New York

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Empire BlueCross BlueShield Yes 5 Yes For more information
Excellus BlueCross BlueShield Yes 3, 5 Yes  

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North Carolina

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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North Dakota

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Ohio

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Anthem Blue Cross Blue Shield of Ohio Yes 5 Yes For more information
Humana Yes 5 Yes For more information

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Oklahoma

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Oregon

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Pennsylvania

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Highmark Blue Cross Blue Shield Yes 5 Yes For more information
Independence Blue Cross Yes 4, 5   For more information

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Rhode Island

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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South Carolina

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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South Dakota

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Tennessee

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Texas

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  
Scott & White Health Plan Yes 5    

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Utah

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Vermont

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Virginia

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Washington

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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West Virginia

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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Wisconsin

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

Back to Top


Wyoming

Please refer to the full Prescribing Information for SIMPONI® (golimumab). For additional information call 877-CarePath.
Medicare Part D
Payer Prior
Authorization
Tier Quantity
Limits
Exception & Appeals Process (EAP) Information
Aetna Yes Plan dependent Dosage dependent  

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R9

The information provided presents no statement, promise, or guarantee by Janssen Biotech, Inc., concerning levels of reimbursement, payment, or charge. Please consult your payer organizations with regard to local or actual coverage and reimbursement policies and determination processes.

What is SIMPONI® (golimumab)?

SIMPONI® is a tumor necrosis factor (TNF) blocker indicated for the treatment of adult patients with:

  • Moderately to severely active rheumatoid arthritis (RA) in combination with methotrexate
  • Active psoriatic arthritis (PsA) alone, or in combination with methotrexate
  • Active ankylosing spondylitis (AS)
  • Moderately to severely active ulcerative colitis (UC) for inducing and maintaining clinical response, improving endoscopic appearance of the mucosa during induction, inducing clinical remission, and achieving and sustaining clinical remission in induction responders who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6‑mercaptopurine
Important Safety Information For SIMPONI®

SERIOUS INFECTIONS

Patients treated with SIMPONI® (golimumab) 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. Discontinue SIMPONI® if a patient develops a serious infection.

Reported infections with TNF blockers, of which SIMPONI® is a member, include:

  • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent TB before SIMPONI® use and during therapy. Treatment for latent infection should be initiated prior to SIMPONI® use.

  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness.

  • Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with SIMPONI® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI® in patients with clinically important active infections, including localized infections. Closely monitor patients for the development of signs and symptoms of infection during and after treatment with SIMPONI®, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy, who are on treatment for latent TB, or who were previously treated for TB infection.

Risk of infection may be higher in patients greater than 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressant therapy. Other serious infections observed in patients treated with SIMPONI® included sepsis, pneumonia, cellulitis, abscess and hepatitis B infection.

MALIGNANCIES

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers of which SIMPONI® is a member. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies usually associated with immunosuppression and malignancies not usually observed in children or adolescents. Malignancies occurred after a median of 30 months after the first dose of therapy. Most of the patients were receiving concomitant immunosuppressants.

In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI®, more cases of lymphoma have been observed among patients receiving TNF-blocking treatment compared with control patients. In the Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ankylosing Spondylitis (AS) clinical trials, the incidence of lymphoma per 100 patient-years of follow-up was 0.21 (95% CI: 0.03, 0.77) in the combined SIMPONI® group compared with an incidence of 0 (95% CI: 0, 0.96) in the placebo group. In clinical trials, the incidence of malignancies other than lymphoma was not increased with exposure to SIMPONI® and was similar to what would be expected in the general population. In controlled and uncontrolled portions of the Phase 2/3 studies in ulcerative colitis (UC) with a mean follow-up of approximately 1 year, there were no cases of lymphoma with SIMPONI®. Short follow-up periods, such as those of 1 year or less in the studies above, may not adequately reflect the true incidence of malignancies. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI®. The risks and benefits of TNF-blocker therapy should be considered prior to initiating therapy in patients with a known malignancy or who develop a malignancy.

Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers. These cases have had a very aggressive disease course and have been fatal. Nearly all reported cases have occurred in patients with Crohn’s disease or UC, and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. A risk for the development for HSTCL in patients treated with TNF blockers cannot be excluded.

Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF-blocking agents, including SIMPONI®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

HEPATITIS B REACTIVATION

The use of TNF-blocking agents including SIMPONI® has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. In some instances, HBV reactivation occurring in conjunction with TNF-blocker therapy has been fatal. The majority of these reports have occurred in patients who received concomitant immunosuppressants.

All patients should be tested for HBV infection before initiating TNF-blocker therapy. For patients who test positive for hepatitis B surface antigen, consult a physician with expertise in the treatment of hepatitis B before initiating TNF-blocker therapy. Exercise caution when prescribing SIMPONI® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI®. Discontinue SIMPONI® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI®, and monitor patients closely.

HEART FAILURE

Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers, including SIMPONI®. Some cases had a fatal outcome. Exercise caution and monitor patients with heart failure. Discontinue SIMPONI® if new or worsening symptoms of heart failure appear.

DEMYELINATING DISORDERS

TNF-blocking agents, of which SIMPONI® is a member, have been associated with rare cases of new-onset or exacerbation of demyelinating disorders, including multiple sclerosis (MS) and Guillain-Barré syndrome. Cases of central demyelination, MS, optic neuritis, and peripheral demyelinating polyneuropathy have rarely been reported with SIMPONI®. Exercise caution in considering the use of SIMPONI® in patients with these disorders. Consider discontinuation if these disorders develop.

AUTOIMMUNITY

Treatment with TNF blockers, including SIMPONI®, may result in the formation of antinuclear antibodies and, rarely, in the development of a lupus-like syndrome. Discontinue treatment if symptoms suggestive of a lupus-like syndrome develop.

HEMATOLOGIC CYTOPENIAS

There have been reports of pancytopenia, leukopenia, neutropenia, and thrombocytopenia in patients receiving SIMPONI® in clinical trials. Additionally, aplastic anemia has been reported in patients receiving TNF-blocking agents, of which SIMPONI® is a member. Exercise caution when using SIMPONI® in patients who have or had significant cytopenias.

USE WITH OTHER DRUGS

The concomitant use of a TNF blocker and abatacept or anakinra was associated with a higher risk of serious infections; therefore the use of SIMPONI® in combination with these products is not recommended. Care should be taken when switching from one biologic to another since overlapping biological activity may further increase the risk of infection. A higher rate of serious infections has also been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. The concomitant use of SIMPONI® with biologics approved to treat RA, PsA, or AS is not recommended because of the possibility of an increased risk of infection.

VACCINATIONS/THERAPEUTIC INFECTIOUS AGENTS

People receiving SIMPONI® can receive vaccinations, except for live vaccines. Use of live vaccines could result in clinical infections, including disseminated infections. Administration of live vaccines to infants exposed to SIMPONI® in utero is not recommended for 6 months following the mother’s last SIMPONI® injection during pregnancy due to an increased risk of infection. It is recommended that therapeutic infectious agents not be given concurrently with SIMPONI® due to the possibility of clinical infections, including disseminated infections.

HYPERSENSITIVITY REACTIONS

Serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported with SIMPONI®, some occurring after the first dose. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI® immediately and institute appropriate therapy.

ADVERSE REACTIONS

The most serious adverse reactions were serious infections and malignancies.

Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 trials through Week 16, occurring in 7% and 6% of patients treated with SIMPONI® as compared with 6% and 5% of patients in the control group, respectively. The rate of injection-site reactions was 6% with patients treated with SIMPONI® compared with 2% of patients in the control group.

In the Phase 2/3 trials in UC evaluating SIMPONI®-treated patients, no new adverse drug reactions were identified, and the frequency of adverse drug reactions was similar to the safety profile observed in patients with RA, PsA, and AS.

Please read the full Prescribing Information and Medication Guide for SIMPONI®. Provide the Medication Guide to your patients and encourage discussion.

066808-170206