Important Safety Information
Back
  • SIMPONI ARIA® (golimumab)

    INDICATIONS

    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

    IMPORTANT SAFETY INFORMATION

    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

Prescribing Information
Back
  • 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

ICD-10 Codes

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ICD-10 Codes

  1. Janssen CarePath
  2. SIMPONI ARIA®
  3. Reimbursement

The table below lists ICD-10 diagnosis codes that you may need for patients treated with SIMPONI ARIA®. These codes are not intended to be promotional or to suggest a use that is inconsistent with FDA-approved use. The list is not exhaustive and additional codes may apply. ICD-10 codes use 3 to 7 alpha and numeric characters. A code is invalid if it does not use the full number of characters required, including the seventh character, if applicable.

Click below to see the ICD-10 codes.

Click below to see the ICD-10 codes.

Rheumatoid Arthritis

ICD-10 Indication ICD-10 Code
Rheumatoid arthritis with rheumatoid factor M05.XXX
Rheumatoid myopathy with rheumatoid arthritis of unspecified site M05.40
More codes  
... right shoulder M05.411
... left shoulder M05.412
... unspecified shoulder M05.419
... right elbow M05.421
... left elbow M05.422

... unspecified elbow

M05.429
... right wrist M05.431
... left wrist M05.432
... unspecified wrist M05.439
... right hand M05.441
... left hand M05.442
... unspecified hand M05.449
... right hip M05.451
... left hip M05.452
... unspecified hip M05.459
... right knee M05.461
... left knee M05.462
... unspecified knee M05.469
... right ankle and foot M05.471
... left ankle and foot M05.472
... unspecified ankle and foot M05.479
... multiple sites M05.49
Rheumatoid polyneuropathy with rheumatoid arthritis of unspecified site M05.50
More codes  
... right shoulder M05.511
... left shoulder M05.512
... unspecified shoulder M05.519
... right elbow M05.521
... left elbow M05.522
... unspecified elbow M05.529
... right wrist M05.531
... left wrist M05.532
... unspecified wrist M05.539
... right hand M05.541
... left hand M05.542
... unspecified hand M05.549
... right hip M05.551
... left hip M05.552
... unspecified hip M05.559
... right knee M05.561
... left knee M05.562
... unspecified knee M05.569
... right ankle and foot M05.571
... left ankle and foot M05.572
... unspecified ankle and foot M05.579
... multiple sites M05.59
Rheumatoid arthritis with rheumatoid factor of unspecified site without organ or systems involvement M05.70
More codes  
... right shoulder ... M05.711
... left shoulder ... M05.712
... unspecified shoulder ... M05.719
... right elbow ... M05.721
... left elbow ... M05.722
... unspecified elbow ... M05.729
... right wrist ... M05.731
... left wrist ... M05.732
... unspecified wrist ... M05.739
... right hand ... M05.741
... left hand ... M05.742
... unspecified hand ... M05.749
... right hip ... M05.751
... left hip ... M05.752
... unspecified hip ... M05.759
... right knee ... M05.761
... left knee ... M05.762
... unspecified knee ... M05.769
... right ankle and foot ... M05.771
... left ankle and foot ... M05.772
... unspecified ankle and foot ... M05.779
... multiple sites ... MO5.79
... other specified site ... M05.7A
Other rheumatoid arthritis with rheumatoid factor of unspecified site M05.80
More codes  
... right shoulder M05.811
... left shoulder M05.812
... unspecified shoulder M05.819
... right elbow M05.821
... left elbow M05.822
... unspecified elbow M05.829
... right wrist M05.831
... left wrist M05.832
... unspecified wrist M05.839
... right hand M05.841
... left hand M05.842
... unspecified hand M05.849
... right hip M05.851
... left hip M05.852
... unspecified hip M05.859
... right knee M05.861
... left knee M05.862
... unspecified knee M05.869
... right ankle and foot M05.871
... left ankle and foot M05.872
... unspecified ankle and foot M05.879
... multiple sites M05.89
... other specified site M05.8A
Rheumatoid arthritis with rheumatoid factor, unspecified M05.9
Other rheumatoid arthritis M06.XXX
Rheumatoid arthritis without rheumatoid factor, unspecified site M06.00
More codes  
..., right shoulder M06.011
..., left shoulder M06.012
..., unspecified shoulder M06.019
..., right elbow M06.021
..., left elbow M06.022
..., unspecified elbow M06.029
..., right wrist M06.031
..., left wrist M06.032
..., unspecified wrist M06.039
..., right hand M06.041
..., left hand M06.042
..., unspecified hand M06.049
..., right hip M06.051
..., left hip M06.052
..., unspecified hip M06.059
..., right knee M06.061
..., left knee M06.062
..., unspecified knee M06.069
..., right ankle and foot M06.071
..., left ankle and foot M06.072
..., unspecified ankle and foot M06.079
..., vertebrae M06.08
..., multiple sites M06.09
..., other specified site M06.0A
Rheumatoid bursitis, unspecified site M06.20
More codes  
..., right shoulder M06.211
..., left shoulder M06.212
..., unspecified shoulder M06.219
..., right elbow M06.221
..., left elbow M06.222
..., unspecified elbow M06.229
..., right wrist M06.231
..., left wrist M06.232
..., unspecified wrist M06.239
..., right hand M06.241
..., left hand M06.242
..., unspecified hand M06.249
..., right hip M06.251
..., left hip M06.252
..., unspecified hip M06.259
..., right knee M06.261
..., left knee M06.262
..., unspecified knee M06.269
..., right ankle and foot M06.271
..., left ankle and foot M06.272
..., unspecified ankle and foot M06.279
..., vertebrae M06.28
..., multiple sites M06.29
Rheumatoid nodule, unspecified site M06.30
More codes  
..., right shoulder M06.311
..., left shoulder M06.312
..., unspecified shoulder M06.319
..., right elbow M06.321
..., left elbow M06.322
..., unspecified elbow M06.329
..., right wrist M06.331
..., left wrist M06.332
..., unspecified wrist M06.339
..., right hand M06.341
..., left hand M06.342
..., unspecified hand M06.349
..., right hip M06.351
..., left hip M06.352
..., unspecified hip M06.359
..., right knee M06.361
..., left knee M06.362
..., unspecified knee M06.369
..., right ankle and foot M06.371
..., left ankle and foot M06.372
..., unspecified ankle and foot M06.379
..., vertebrae M06.38
..., multiple sites M06.39
Other specified rheumatoid arthritis, unspecified site M06.80
More codes  
..., right shoulder M06.811
..., left shoulder M06.812
..., unspecified shoulder M06.819
..., right elbow M06.821
..., left elbow M06.822
..., unspecified elbow M06.829
..., right wrist M06.831
..., left wrist M06.832
..., unspecified wrist M06.839
..., right hand M06.841
..., left hand M06.842
..., unspecified hand M06.849
..., right hip M06.851
..., left hip M06.852
..., unspecified hip M06.859
..., right knee M06.861
..., left knee M06.862
..., unspecified knee M06.869
..., right ankle and foot M06.871
..., left ankle and foot M06.872
..., unspecified ankle and foot M06.879
..., vertebrae M06.88
..., multiple sites M06.89
..., other specified site M06.8A
Rheumatoid arthritis, unspecified M06.9
Juvenile arthritis M08
Code also any associated underlying condition:  
Unspecified juvenile rheumatoid arthritis of unspecified site M08.00
..., right shoulder M08.011
..., left shoulder M08.012
..., unspecified shoulder M08.019
..., right elbow M08.021
..., left elbow M08.022
..., unspecified elbow M08.029
..., right wrist M08.031
..., left wrist M08.032
..., unspecified wrist M08.039
..., right hand M08.041
..., left hand M08.042
..., unspecified hand M08.049
..., right hip M08.051
..., left hip M08.052
..., unspecified hip M08.059
..., right knee M08.061
..., left knee M08.062
..., unspecified knee M08.069
..., right ankle and foot M08.071
..., left ankle and foot M08.072
..., unspecified ankle and foot M08.079
..., multiple sites M08.09
..., other specified site M08.0A
Juvenile rheumatoid polyarthritis (seronegative) M08.3

Psoriatic Arthritis

ICD-10 Indication ICD-10 Code
Psoriasis L40
Arthropathic psoriasis, unspecified L40.50
Distal interphalangeal psoriatic arthropathy L40.51
Psoriatic arthritis mutilans L40.52
Psoriatic spondylitis L40.53
Juvenile psoriatic arthritis L40.54
Other psoriatic arthropathy L40.59

Ankylosing Spondylitis

ICD-10 Indication ICD-10 Code
Ankylosing spondylitis M45
Ankylosing spondylitis of multiple sites in spine M45.0
... occipito-atlanto-axial region M45.1
... cervical region M45.2
... cervicothoracic region M45.3
... thoracic region M45.4
... thoracolumbar region M45.5
... lumbar region M45.6
... lumbosacral region M45.7
... sacral and sacrococcygeal region M45.8
... unspecified sites in spine M45.9

Collected in 10/21 and may change.

This information is not a promise of coverage or payment. It is not intended to give reimbursement advice or increase reimbursement by any payer. Legal requirements and plan information can be updated frequently. Contact the plan for more information about current coverage, reimbursement policies, restrictions, or requirements that may apply.

For more information on ICD-10, visit the CMS website.

SOURCE
ICD-10-CM 2022: The Complete Official Codebook. American Medical Association, 2021.

Important Safety Information For

  • SIMPONI ARIA®

    INDICATIONS

    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

    IMPORTANT SAFETY INFORMATION

    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