• SIMPONI ARIA® (golimumab)

    SIMPONI ARIA® (golimumab) 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) in patients 2 years of age and older
    • Adult patients with active Ankylosing Spondylitis (AS)
    • Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older

    SERIOUS INFECTIONS

    Patients treated with SIMPONI ARIA® (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 ARIA® if a patient develops a serious infection.

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

    • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before SIMPONI ARIA® use and during therapy. Initiate treatment for latent infection prior to SIMPONI ARIA® 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.

    Consider the risks and benefits of treatment with SIMPONI ARIA® prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI ARIA® 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 ARIA®, 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 ARIA® included sepsis, pneumonia, cellulitis, and abscess.

    MALIGNANCIES

    Malignancies, some fatal, have been reported in children, adolescents, and young adult patients treated with golimumab. 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 TNF blockers including the subcutaneous formulation of golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with patients in the control groups. In clinical trials, the incidence of malignancies other than lymphoma and non-melanoma skin cancer per 100 patient-years of follow-up was 0.56 (95% CI: 0.01, 3.11) in the SIMPONI ARIA® group compared with an incidence of 0 (95% CI: 0.00, 3.79) in the placebo group. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI ARIA®. 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 ulcerative colitis, 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 ARIA®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

    HEPATITIS B REACTIVATION

    The use of TNF blockers, of which SIMPONI ARIA® is a member, 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 ARIA® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI ARIA®. Discontinue SIMPONI ARIA® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI ARIA®, and monitor patients closely.

    CONGESTIVE HEART FAILURE

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

    DEMYELINATING DISORDERS

    Use of TNF blockers, including SIMPONI ARIA®, has 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 in patients treated with golimumab. Exercise caution in considering the use of SIMPONI ARIA® in patients with these disorders. Consider discontinuation if these disorders develop.

    AUTOIMMUNITY

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

    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 ARIA® 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 ARIA® with biologics approved to treat RA is not recommended because of the possibility of an increased risk of infection.

    HEMATOLOGIC CYTOPENIAS

    There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving SIMPONI ARIA®. Exercise caution when using SIMPONI ARIA® in patients who have or had significant cytopenias.

    VACCINATIONS/THERAPEUTIC INFECTIOUS AGENTS

    Live vaccines or therapeutic infectious agents should not be given with SIMPONI ARIA® due to the possibility of clinical infections, including disseminated infections.

    Update vaccinations prior to initiation of treatment in accordance with current vaccination guidelines. Advise patients to discuss with the physician before seeking any immunizations. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to SIMPONI ARIA®.

    HYPERSENSITIVITY REACTIONS

    Serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following administration of the subcutaneous formulation of golimumab and SIMPONI ARIA®, some occurring after the first dose. Hypersensitivity reactions including hives, pruritus, dyspnea, and nausea, were reported in association with infusions of SIMPONI ARIA®. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI ARIA® immediately and institute appropriate therapy.

    ADVERSE REACTIONS

    The most serious adverse reactions were serious infections and malignancies.

    The most common adverse reactions (incidence ≥ 3%) reported in clinical trials were: upper respiratory tract infection, alanine aminotransferase increase, viral infection, aspartate aminotransferase increase, neutrophil count decrease, bronchitis, hypertension, and rash. In the controlled phase of Trial RA, the rate of infusions associated with an infusion reaction was reported in 1.1% of SIMPONI ARIA® infusions compared with 0.2% of infusions in the control group.

    The adverse reactions observed in pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA) were consistent with the established safety profile of SIMPONI ARIA® in adult patients with RA and PsA.

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

    cp-51207v3

    INDICATIONS
Click on the left to see the Important Safety Information

INDICATIONS

IMPORTANT SAFETY INFORMATION

  • https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf
    https://www.janssenlabels.com/package-insert/product-patient-information/SIMPONI+ARIA-medication-guide.pdf

Help Your Patients Start and Stay on SIMPONI ARIA®

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Help Your Patients Start and Stay on SIMPONI ARIA®

We understand that you want to get your patients the help they may need while going through treatment. That’s why we’ve put together some support resources that can help them, whether they’re just starting a new medication or they’ve been taking it for years.

Janssen CarePath Patient Account

Your patients and their caregivers can create an online account at MyJanssenCarePath.com where they can learn about their insurance coverage. They can also:

  • Enroll in the Janssen CarePath Savings Program
  • Manage their benefits
  • Sign up for treatment reminders
  • Find support throughout their treatment journey

Care Coordination

Janssen CarePath gives your patients one-on-one support through our Care Coordinators. Our Care Coordinators will work closely with you and your patients to provide the support you direct and additional support that your patients may need.

Specialty Distributors/Pharmacies

Janssen CarePath can connect you with alternative ways to access SIMPONI ARIA®. Find a specialty distributor authorized to sell SIMPONI ARIA® directly to your office.

Janssen CarePath Care Coordinators can also:

  • Identify pharmacies to allow you to access SIMPONI ARIA® without direct purchase or billing
  • Investigate payers for potential third-party assignment of patients’ insurance benefits options, both pharmacy and major medical
  • Provide a listing of third-party pharmacy providers for shipment and billing of SIMPONI ARIA®

To learn more, please call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

Infusion Site Locator

Utilize the search capabilities of 2infuse.com to help you locate an infusion site convenient to your patient’s home or office. Searchable by city or ZIP code, this helpful site provides detailed search results organized by driving distance. This website also includes valuable information about the infusion sites such as business hours, insurance plans accepted, and medications infused.

Find an infusion center.

Are you an infusion center?

Register to list with 2infuse.com

Janssen Nurse Support

Even after you’ve spoken to your patient about infusion treatment with SIMPONI ARIA®, they may still have questions. Janssen Nurse Support* can help answer their questions about the infusion process and provide more information about how to prepare for their infusion and what they may expect during the infusion process.

Connect your patients with Janssen Nurse Support at 877-CarePath (877-227-3728), available Monday–Friday, 9:00 AM to 8:00 PM ET. At all other times, a nurse will typically return their call in 15 minutes.

*Janssen Nurse Support is limited to education for patients about their Janssen therapy, its administration, and/or their disease. It is intended to supplement a patient's understanding of their therapy, and is not intended to provide medical advice, replace a treatment plan from the patient's doctor or nurse, provide case management services, or serve as a reason to prescribe.

Emergency Outreach Services

In case of a natural disaster in which your office or infusion center is unable to provide treatment, a Janssen CarePath Care Coordinator can help ensure your patients have continued access to treatment. To enroll in this service, patients just need to call Janssen CarePath at 877-CarePath (877-227-3728), Monday–Friday, 8:00 AM to 8:00 PM ET.

Infusion Video

This video walks patients through the steps of the SIMPONI ARIA® infusion process–before, during, and after treatment–and explains what to expect during the infusion.

Education and Tools

Additional education and tools for patients to use in managing their treatment and condition can be found at SimponiAria.com:

  • Tips on getting the most out of each office visit and organizing their treatment plan
  • Information to help patients better prepare for each infusion visit
  • Tips on living with their condition

Internet Resources for Your Patients

There are many useful resources available online that may help your patients understand and manage their treatment with SIMPONI ARIA® and their diseases. You may find the websites listed here helpful as referrals in educating your patients about their condition.

The links provided here are for informational purposes only. No endorsement or sponsorship is implied.

SIMPONI ARIA® Patient Website

This website contains additional information about treatment with SIMPONI ARIA®. On this website, patients can also get helpful information about their condition.

Arthritis Foundation

The mission of the Arthritis Foundation is to improve lives through leadership in the prevention, control, and cure of arthritis and related diseases. This website includes education and online community resources for people with arthritis and their families.

Arthritis Today

The online home of the Arthritis Foundation’s “Arthritis Today” magazine is a great source of tips and information for people living with arthritis.

CreakyJoints

CreakyJoints provides treatment information, advice from professionals, and public forums for people living with arthritis to share their experiences.

Spondylitis Association of America

The Spondylitis Association of America is the first and largest resource for people affected by spondylitis. The website’s efforts help to advance education, research, and treatment for ankylosing spondylitis (AS) and related diseases. This site includes information and support for patients with AS and their families.

Call a Janssen CarePath Care Coordinator at 877-CarePath (877-227-3728), Monday−Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support available.

Sign up or log in to the Provider Portal at JanssenCarePathPortal.com where you can request and review benefits investigations, enroll eligible patients in the Janssen CarePath Savings Program, and view their Savings Program transactions.

Important Safety Information For

  • SIMPONI ARIA®

    SIMPONI ARIA® (golimumab) 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) in patients 2 years of age and older
    • Adult patients with active Ankylosing Spondylitis (AS)
    • Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older

    SERIOUS INFECTIONS

    Patients treated with SIMPONI ARIA® (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 ARIA® if a patient develops a serious infection.

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

    • Active tuberculosis (TB), including reactivation of latent TB. Patients frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before SIMPONI ARIA® use and during therapy. Initiate treatment for latent infection prior to SIMPONI ARIA® 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.

    Consider the risks and benefits of treatment with SIMPONI ARIA® prior to initiating therapy in patients with chronic or recurrent infection. Do not start SIMPONI ARIA® 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 ARIA®, 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 ARIA® included sepsis, pneumonia, cellulitis, and abscess.

    MALIGNANCIES

    Malignancies, some fatal, have been reported in children, adolescents, and young adult patients treated with golimumab. 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 TNF blockers including the subcutaneous formulation of golimumab, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with patients in the control groups. In clinical trials, the incidence of malignancies other than lymphoma and non-melanoma skin cancer per 100 patient-years of follow-up was 0.56 (95% CI: 0.01, 3.11) in the SIMPONI ARIA® group compared with an incidence of 0 (95% CI: 0.00, 3.79) in the placebo group. Cases of acute and chronic leukemia have been reported with TNF-blocker use, including SIMPONI ARIA®. 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 ulcerative colitis, 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 ARIA®. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.

    HEPATITIS B REACTIVATION

    The use of TNF blockers, of which SIMPONI ARIA® is a member, 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 ARIA® for patients identified as carriers of HBV and closely monitor for active HBV infection during and following termination of therapy with SIMPONI ARIA®. Discontinue SIMPONI ARIA® in patients who develop HBV reactivation, and initiate antiviral therapy with appropriate supportive treatment. Exercise caution when considering resumption of SIMPONI ARIA®, and monitor patients closely.

    CONGESTIVE HEART FAILURE

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

    DEMYELINATING DISORDERS

    Use of TNF blockers, including SIMPONI ARIA®, has 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 in patients treated with golimumab. Exercise caution in considering the use of SIMPONI ARIA® in patients with these disorders. Consider discontinuation if these disorders develop.

    AUTOIMMUNITY

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

    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 ARIA® 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 ARIA® with biologics approved to treat RA is not recommended because of the possibility of an increased risk of infection.

    HEMATOLOGIC CYTOPENIAS

    There have been reports of pancytopenia, leukopenia, neutropenia, agranulocytosis, aplastic anemia, and thrombocytopenia in patients receiving SIMPONI ARIA®. Exercise caution when using SIMPONI ARIA® in patients who have or had significant cytopenias.

    VACCINATIONS/THERAPEUTIC INFECTIOUS AGENTS

    Live vaccines or therapeutic infectious agents should not be given with SIMPONI ARIA® due to the possibility of clinical infections, including disseminated infections.

    Update vaccinations prior to initiation of treatment in accordance with current vaccination guidelines. Advise patients to discuss with the physician before seeking any immunizations. At least a 6-month waiting period following birth is recommended before the administration of any live vaccine to infants exposed in utero to SIMPONI ARIA®.

    HYPERSENSITIVITY REACTIONS

    Serious systemic hypersensitivity reactions (including anaphylaxis) have been reported following administration of the subcutaneous formulation of golimumab and SIMPONI ARIA®, some occurring after the first dose. Hypersensitivity reactions including hives, pruritus, dyspnea, and nausea, were reported in association with infusions of SIMPONI ARIA®. If an anaphylactic or other serious allergic reaction occurs, discontinue SIMPONI ARIA® immediately and institute appropriate therapy.

    ADVERSE REACTIONS

    The most serious adverse reactions were serious infections and malignancies.

    The most common adverse reactions (incidence ≥ 3%) reported in clinical trials were: upper respiratory tract infection, alanine aminotransferase increase, viral infection, aspartate aminotransferase increase, neutrophil count decrease, bronchitis, hypertension, and rash. In the controlled phase of Trial RA, the rate of infusions associated with an infusion reaction was reported in 1.1% of SIMPONI ARIA® infusions compared with 0.2% of infusions in the control group.

    The adverse reactions observed in pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA) were consistent with the established safety profile of SIMPONI ARIA® in adult patients with RA and PsA.

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

    cp-51207v3

    INDICATIONS

IMPORTANT SAFETY INFORMATION

INDICATIONS

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INDICATIONS

IMPORTANT SAFETY INFORMATION