Side Effects of Simponi Aria (Golimumab for Infusion), Warnings, Uses (2022)

SIDE EFFECTS

The most serious adverse reactions were:

  • Serious Infections [see WARNINGS AND PRECAUTIONS]
  • Malignancies [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety data described below are based on one, randomized, double-blind, controlled Phase 3 trial in patients with RA receiving SIMPONI ARIA by intravenous infusion (Trial RA). The protocol included provisions for patients taking placebo to receive treatment with SIMPONI ARIA at Week 16 or Week 24 either by patient response (based on uncontrolled disease activity) or by design, so that adverse events cannot always be unambiguously attributed to a given treatment. Comparisons between placebo and SIMPONI ARIA were based on the first 24 weeks of exposure.

Trial RA included 197 control-treated patients and 463 SIMPONI ARIA-treated patients (which includes control-treated patients who switched to SIMPONI ARIA at Week 16). The proportion of patients who discontinued treatment due to adverse reactions in the controlled phase of Trial RA through Week 24 was 3.5% for SIMPONI ARIA-treated patients and 0.5% for placebo-treated patients. Upper respiratory tract infection was the most common adverse reaction reported in the trial through Week 24 occurring in 6.5% of SIMPONI ARIA-treated patients as compared with 7.6% of control-treated patients, respectively.

Infections

Serious infections observed in SIMPONI ARIA-treated patients included sepsis, pneumonia, cellulitis, abscess, opportunistic infections, tuberculosis (TB), and invasive fungal infections. Cases of TB included pulmonary and extrapulmonary TB. The majority of the TB cases occurred in countries with a high incidence rate of TB [see WARNINGS AND PRECAUTIONS].

In the controlled phase of Trial RA through Week 24, infections were observed in 27% of SIMPONI ARIA-treated patients compared with 24% of control-treated patients, and serious infections were observed in 0.9% of SIMPONI ARIA-treated patients and 0.0% of control-treated patients. Through Week 24, the incidence of serious infections per 100 patient-years of follow-up was 2.2 (95% CI 0.61, 5.71) for the SIMPONI ARIA group, and 0 (0.00, 3.79) for the placebo group. In the controlled and uncontrolled portions of Trial RA, 958 total patient-years of follow-up with a median follow-up of approximately 92 weeks, the incidence per 100 patient-years of all serious infections was 4.07 (95% CI: 2.90, 5.57) in patients receiving SIMPONI ARIA [see WARNINGS AND PRECAUTIONS]. In the controlled and uncontrolled portions of Trial RA, in SIMPONI ARIA-treated patients, the incidence of active TB per 100 patient-years was 0.31 (95% CI: 0.06; 0.92) and the incidence of other opportunistic infections per 100 patient-years was 0.42 (95% CI: 0.11, 1.07).

Malignancies

One case of malignancy other than lymphoma and NMSC with SIMPONI ARIA was reported through Week 24 during the controlled phase of Trial RA. In the controlled and uncontrolled portions through approximately 92 weeks, the incidence of malignancies per 100 patient-years, other than lymphoma and NMSC, in SIMPONI ARIA-treated patients was 0.31 (95% CI: 0.06, 0.92) and the incidence of NMSC was 0.1 (95% CI: 0.00, 0.58).

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Liver Enzyme Elevations

There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF-blockers.

In the controlled phase of Trial RA, through Week 24, ALT elevations ≥ 5 x ULN occurred in 0.8% of SIMPONI ARIA-treated patients and 0% of control-treated patients and ALT elevations ≥ 3 x ULN occurred in 2.3% of SIMPONI ARIA-treated patients and 2.5% of control-treated patients.

In the controlled phase of Trial PsA, through Week 24, ALT elevations ≥ 5 x ULN occurred in 1.7% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients, and ALT elevations ≥ 3 x ULN to < 5 x ULN occurred in 2.9% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients.

Since many of the patients in the Phase 3 trials were also taking medications that cause liver enzyme elevations (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs], MTX, or isoniazid prophylaxis), the relationship between SIMPONI ARIA and liver enzyme elevation is not clear.

Autoimmune Disorders And Autoantibodies

At Week 20 in Trial RA, 17% of SIMPONI ARIA-treated patients and 13% of control patients were newly antinuclear antibody (ANA)-positive. Of these patients, one SIMPONI ARIA-treated patient and no control-treated patients had newly positive anti-dsDNA antibodies [see WARNINGS AND PRECAUTIONS].

Administration Reactions

In the controlled phase of Trial RA through Week 24, 1.1% of SIMPONI ARIA infusions were associated with an infusion reaction compared with 0.2% of infusions in the control group. The most common infusion reaction in SIMPONI ARIA-treated patients was rash. No serious infusion reactions were reported.

Other Adverse Reactions

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% in the SIMPONI ARIA + MTX group with a higher incidence than in the placebo + MTX group during the controlled period of Trial RA through Week 24.

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Table 1: Adverse Drug Reactions Reported by ≥ 1% of SIMPONI ARIA-Treated Patients and with a Higher Incidence than Placebo-Treated Patients in Trial RA through Week 24

Placebo + MTXSIMPONI ARIA + MTX
Patients treated197463
Adverse Reaction
Infections and infestations
Upper respiratory tract infection (such as upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis)12%13%
Viral infections (such as influenza and herpes)3%4%
Bacterial infections0%1%
Bronchitis1%3%
Vascular disorders
Hypertension2%3%
Skin and subcutaneous disorders
Rash1%3%
General disorders and administration site conditions
Pyrexia1%2%
Blood and lymphatic disorders
Leukopenia0%1%

Other And Less Common Clinical Trial Adverse Drug Reactions

Adverse drug reactions that do not appear in Table 1 or that occurred < 1% in SIMPONI ARIA-treated patients during Trial RA through Week 24 that do not appear in the Warnings and Precautions section included the following events listed by system organ class:

Infections and infestations: Superficial fungal infection, sinusitis, abscess, lower respiratory tract infection (pneumonia), pyelonephritis

Investigations: Alanine aminotransferase (ALT) increased, aspartate aminotransferase (AST) increased, neutrophil count decreased

Nervous system disorders: Dizziness, paresthesia

Gastrointestinal disorders: Constipation

Psoriatic Arthritis

Trial PsA evaluated 480 patients [see Clinical Studies]. The adverse reactions were similar to those observed in patients with RA, with the exception of psoriasis (new onset or worsening, palmar/plantar and pustular), which occurred in <1% of SIMPONI ARIA-treated patients. The incidence of the adverse reactions reported in Trial PsA were similar to Trial RA with the exceptions of higher incidence in SIMPONI ARIA for ALT increased (7.9% vs. 2.1% in placebo), AST increased (5.4% vs. 2.1% in placebo), and neutrophil count decreased (4.6% vs. 2.1% in placebo).

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Ankylosing Spondylitis

Trial AS evaluated 208 patients [see Clinical Studies]. The adverse reactions were similar to those reported in patients with RA, with the exception of the higher incidence of ALT increased, which occurred in 2.9% of SIMPONI ARIA-treated patients compared with none of the placebotreated patients.

Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis And Psoriatic Arthritis

Trial pJIA evaluated 127 patients with JIA with active polyarthritis [see Use In Specific Populations and Clinical Studies]. The adverse reactions observed were consistent with the established safety profile of SIMPONI ARIA in adult patients with RA and PsA.

Immunogenicity

As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to golimumab in the trials described below with the incidence of antibodies in other trials or to other products may be misleading.

Using an enzyme immunoassay (EIA) method, antibodies to golimumab were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial RA, of which all were neutralizing antibodies.

A drug-tolerant enzyme immunoassay (drug-tolerant EIA) method for detecting antibodies to golimumab was developed and validated. This method is approximately 16-fold more sensitive than the original EIA method with less interference from golimumab in serum. Through approximately 6 months, the incidence of antibodies to golimumab with the drug-tolerant EIA method for Trials RA, PsA, AS, and pJIA was 21%, 19%, 19% and 31%, respectively. Where tested, approximately one-third to one-half were neutralizing.

Patients with RA, PsA, AS and pJIA who developed antibodies to golimumab generally had lower trough steady-state serum concentrations of golimumab [see CLINICAL PHARMACOLOGY].

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of golimumab. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to golimumab exposure:

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General Disorders and Administration Site Conditions: Infusion-related reactions [see WARNINGS AND PRECAUTIONS]

Neoplasm benign and malignant: Melanoma, Merkel cell carcinoma [see WARNINGS AND PRECAUTIONS]

Immune system disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction) [see WARNINGS AND PRECAUTIONS], sarcoidosis

Respiratory, thoracic and mediastinal disorders: Interstitial lung disease

Skin and subcutaneous tissue disorders: Skin exfoliation, lichenoid reactions, bullous skin reactions

Read the entire FDA prescribing information for Simponi Aria (Golimumab for Infusion)

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FAQs

Side Effects of Simponi Aria (Golimumab for Infusion), Warnings, Uses? ›

Mild side effects that have been reported with Simponi and Simponi Aria include:
  • upper respiratory infection, such as the common cold.
  • viral infection, such as flu or herpes.
  • high blood pressure.
  • increased levels of liver enzymes*†
  • injection or infusion site reactions.
  • skin rash*
Feb 22, 2022

Does Simponi Aria have a black box warning? ›

WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA (5.1).

Does Simponi weaken immune system? ›

SIMPONI is a medicine that affects your immune system. SIMPONI can lower the ability of your immune system to fight infections. Some people have serious infections while taking SIMPONI, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body.

What are the side effects of golimumab? ›

Less common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.
  • burning or stinging of the skin.
Apr 1, 2022

How safe is Simponi Aria? ›

Using Simponi or Simponi Aria raises the risk of certain cancers, including leukemia, lymphoma, and skin cancer. Both drugs have a boxed warning about this side effect. These are serious warnings from the FDA. Reports of new cancers in clinical trials for Simponi and Simponi Aria were extremely rare.

Is golimumab safe? ›

Conclusions: SC golimumab safety up to 3 years remained consistent with that of other TNF antagonists. Golimumab 100 mg showed numerically higher incidences of serious infections, demyelinating events and lymphoma than 50 mg; safety follow-up up to year 5 continues.

What's the difference between Simponi and SIMPONI ARIA? ›

Simponi and Simponi Aria for psoriatic arthritis

Simponi is approved for use in adults alone or in combination with methotrexate. Simponi Aria is approved to treat PsA in adults as well. But the medication can also be used in children ages 2 years and older. PsA is a type of autoimmune condition.

How much does SIMPONI ARIA cost? ›

The cost for Simponi Aria intravenous solution (50 mg/4 mL) is around $2,115 for a supply of 4 milliliters, depending on the pharmacy you visit. Prices are for cash paying customers only and are not valid with insurance plans.

Is SIMPONI ARIA an immunosuppressant? ›

SIMPONI ARIA is a medicine that affects your immune system. SIMPONI ARIA can lower the ability of your immune system to fight infections. Some people have serious infections while receiving SIMPONI ARIA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body.

Does SIMPONI affect the heart? ›

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.

Does SIMPONI cause fatigue? ›

FDA expands Simponi Aria labeling to include fatigue in RA, PsA.

Does Simponi Aria make you tired? ›

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, numbness/tingling of the hands/feet, unsteadiness, unexplained muscle weakness, vision changes, muscle/joint pain, butterfly-shaped rash on the nose and cheeks, symptoms of heart failure (including shortness of breath, ...

Does Simponi cause depression? ›

In clinical trials, serious depression including suicidality has been reported in patients treated with SIMPONI. Depression has also been reported in the postmarketing setting and is described in published medical literature.

Does Simponi cause high blood pressure? ›

Check with your doctor as soon as possible if any of the following side effects occur: flu-like symptoms (sudden lack of energy, fever, cough, sore throat) high blood pressure.

Can Simponi cause hair loss? ›

Hair loss isn't a side effect of Simponi or Simponi Aria. Hair loss wasn't a side effect reported for either drug in studies. However, methotrexate, which may be prescribed with Simponi or Simponi Aria, can cause hair loss. If you're experiencing hair loss that bothers you, talk with your doctor or pharmacist.

Can Simponi cause liver damage? ›

There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF blockers.

How long has Simponi Aria been on the market? ›

On October 20, 2017, the US Food and Drug Administration (FDA) approved golimumab (Simponi Aria; Janssen) for the treatment of adults with active psoriatic arthritis or with active ankylosing spondylitis.

Can you take ibuprofen with SIMPONI? ›

Interactions between your drugs

No interactions were found between ibuprofen and Simponi Aria.

Can Simponi Aria cause pancreatitis? ›

According to the findings, at week 16, 32.4% of patients receiving Simponi Aria, and 23.3% who were receiving placebo had one or more adverse event. The reported adverse events included infection, nasopharyngitis, pancreatitis, and pneumonia.

Is golimumab an immunosuppressant? ›

Golimumab is a human monoclonal antibody which is used as an immunosuppressive medication and sold under the brand name Simponi. Golimumab targets tumor necrosis factor alpha (TNF-alpha), a pro-inflammatory molecule and hence is a TNF inhibitor.

What are the benefits of Simponi aria? ›

Simponi Aria Improves Mental and Physical Health in Patients with Rheumatoid Arthritis. RA drug found to improve physical and emotional well-being among patients. RA drug found to improve physical and emotional well-being among patients.

Is Simponi aria better than Humira? ›

Humira has an average rating of 6.3 out of 10 from a total of 639 ratings on Drugs.com. 54% of reviewers reported a positive effect, while 32% reported a negative effect. Simponi has an average rating of 6.2 out of 10 from a total of 93 ratings on Drugs.com.

Do you have to take methotrexate with Simponi aria? ›

When treating RA, SIMPONI® is taken with another medicine called methotrexate, as directed. Studies have found that when methotrexate is taken with some biologic treatments, like SIMPONI®, the 2 medicines together may help to control the symptoms of RA.

What is the safest drug for RA? ›

Hydroxychloroquine. Hydroxychloroquine is an antimalarial drug which is relatively safe and well-tolerated agent for the treatment of rheumatoid arthritis.

Does Medicare pay for Simponi Aria infusions? ›

Do Medicare prescription drug plans cover Simponi Aria? No. In general, Medicare prescription drug plans (Part D) do not cover this drug.

Are biologics better than methotrexate? ›

Biologics plus methotrexate improved symptoms more than methotrexate alone. Biologics plus methotrexate improved symptoms more than methotrexate alone. Biologics plus methotrexate did not improve symptoms more than biologics alone. Biologics plus DMARDs improved symptoms more than DMARDs alone.

What happens after first Simponi Aria infusion? ›

After injecting a dose, you may also experience pain, irritation, or itching at the injection site. Simponi Aria is given as an IV infusion. During and after receiving a dose, a rash can occur. This was the most common infusion reaction that people using Simponi Aria reported.

How long does it take for Simponi to start working? ›

When does it start to work? It varies. Some patients notice progress after a few days, and many have a handle on symptoms within six weeks. Other people take longer to respond.

What are three of the newest drugs for arthritis pain? ›

The newest drugs for the treatment of rheumatoid arthritis are the Janus kinase (JAK) inhibitors, which are FDA approved under the brand names Rinvoq, Olumiant, and Xeljanz.

Does Simponi cause hair loss? ›

Hair loss isn't a side effect of Simponi or Simponi Aria. Hair loss wasn't a side effect reported for either drug in studies. However, methotrexate, which may be prescribed with Simponi or Simponi Aria, can cause hair loss. If you're experiencing hair loss that bothers you, talk with your doctor or pharmacist.

People taking Simponi can develop serious infections that target organ systems or can be at an increased risk of infection from bacteria, fungi, and viruses.. Serious side effects to watch out for while taking Simponi include:. Chest pain Shortness of breath Having trouble swallowing or breathing Hives and swollen eyes, lips, mouth, throat, or tongue Symptoms of heart failure , including swelling in the ankles or feet, trouble breathing, unusual tiredness Signs of infection, such as fever, chills, cough, persistent sore throat, unusual sweating Symptoms of liver damage, including dark urine, persistent nausea or vomiting, stomach or abdominal pain, or yellow eyes or skin Weakness, numbness, or tingling of the arms or legs Rash spreading on the cheek and appearing on other body parts Red scaly patches, change in overall skin appearance, pus-filled bumps on the skin Blisters Unsteadiness Vision changes. Infections: Let your medical provider know if you have an infection or if you're being treated for symptoms of infection such as a fever, fatigue, or diarrhea.. Simponi can interact with other medications you may be taking, which can decrease the drug's efficacy or increase your risk of developing serious side effects.. Before starting treatment with Simponi, let your healthcare provider know about any other medications, supplements, or vitamins you might be taking.. A higher rate of infections has also occurred in people who take other biologic drugs, like those commonly used for rheumatoid arthritis, while taking Simponi.. Knowing what side effects may come up while taking Simponi can help you recognize life-threatening signs quickly so you can get medical help.. If you experience any serious adverse effects, your healthcare provider may tell you to stop taking this medication and recommend another drug that works better for you.

Infections In controlled Phase 3 trials through Week 16 in RA, PsA,. and AS, infections were observed in 28% of SIMPONI-treated patients compared to. 25% of control-treated patients.. In the controlled Phase 2/3 trial through Week 6 in UC,. 3.4% of SIMPONI-treated patients had injection site reactions compared with. 1.5% in control-treated patients.. SIMPONI ± DMARDsPlacebo ± DMARDsPatients treated1659639 Adverse ReactionInfections and infestations Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis, and rhinitis)16%13%Viral infections (such as influenza and herpes)5%3%Bronchitis2%1%Superficial fungal infections2%1%Sinusitis2%1% General disorders and administration site conditions Injection site reaction (injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation, paresthesia)6%2% Investigations Alanine aminotransferase increased4%3%Aspartate aminotransferase increased3%2% Vascular disorders Hypertension3%2% Nervous system disorders Dizziness2%1%Paresthesia2%1% Gastrointestinal disorders Constipation1%<1% a Patients may have taken concomitant MTX,. sulfasalazine, hydroxychloroquine, low dose corticosteroids (≤ 10 mg of. prednisone/day or equivalent), and/or NSAIDs during the trials).. Other Clinical Trial Adverse Drug Reactions In Ulcerative. Colitis Clinical Trials In the Phase 2/3 trials in UC evaluating 1233. 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.. Based on the drug tolerant EIA method, 246 (23%) of. SIMPONI-treated patients across the Phase 3 RA, PsA and AS trials, antibodies. to golimumab were detected in 59 (16%), 106 (28%), and 81 (24%) patients,. respectively.

The most common side effects of Simponi include:. People taking Simponi can develop serious infections that target organ systems or can be at an increased risk of infection from bacteria, fungi, and viruses.. Infections: Let your medical provider know if you have an infection or if you're being treated for symptoms of infection such as a fever, fatigue, or diarrhea.. Hepatitis B : This infection can be activated if you're carrying the virus while you are taking this drug.. resulting in anemia or serious bleeding problems.. Additional warnings: If you have a history of multiple sclerosis , liver problems, or issues with your blood count, notify your healthcare provider before you start taking this drug.. Simponi can interact with other medications you may be taking, which can decrease the drug's efficacy or increase your risk of developing serious side effects.. Before starting treatment with Simponi, let your healthcare provider know about any other medications, supplements, or vitamins you might be taking.. Also, keep your medical team updated if you start any new medication during the course of your Simponi treatment.. Also, people taking Simponi should avoid getting live vaccines because they can cause infections if your immune system is suppressed.. Before starting treatment, talk to your practitioner about potential side effects.. Knowing what side effects may come up while taking Simponi can help you recognize life-threatening signs quickly so you can get medical help.. If you experience any serious adverse effects, your healthcare provider may tell you to stop taking this medication and recommend another drug that works better for you.

Golimumab may also be used for purposes not listed in this medication guide.. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.. Using golimumab may increase your risk of developing autoimmune disorders or cancer, including skin cancer.. Your baby could have an increased risk of infection for up to 6 months if you use golimumab during pregnancy.. If you use golimumab during pregnancy, your newborn baby should not receive a live vaccine for at least 6 months after you last received a dose of golimumab.. Golimumab may also be injected under the skin once every 2 to 4 weeks.. Call your doctor for medical advice about side effects.. Tell your doctor about all your other medicines, especially:

After stopping golimumab treatment, HBV carriers must be monitored for signs and symptoms of active infection for several months.. Patients who are taking immunosuppressive drugs (eg, corticosteroids or methotrexate) concurrently are more at risk for infection.. Patients who have taken golimumab or TNF blockers are more likely to develop active tuberculosis.. Patients with active infection might show negative histoplasmosis tests (antigen, antibody) Signs and symptoms of infection require close monitoring.. Caution should be exercised (consider risks versus benefits) when considering use in the elderly, patients taking concomitant immunosuppressants, patients with chronic or recurrent infection, patients who have been exposed to tuberculosis, patients with a history of opportunistic infection, patients with comorbid conditions that predispose them to infections (eg, diabetes), or residence/travel from areas of endemic mycoses (blastomycosis, coccidioidomycosis, histoplasmosis).patients with an active infection, including localized infection, which is clinically important.. Patients who get a new infection during treatment should not receive therapy.. Patients with first negative tuberculin skin test, patients receiving treatment for latent or active tuberculosis should be monitored for the possibility of developing tuberculosis.. Anti-tuberculosis treatment may be considered if a course of treatment is not possible for patients with a history or risk factors of active or latent tuberculosis.. Before starting treatment for patients who have been exposed, it is important to properly evaluate the patient.. CBC with differential latent TB screening (prior to initiating and periodically during therapy) HBV screening (prior to initiating [all patients]; during and for several months following therapy [HBV carriers]) Monitor improvement of symptoms and physical function assessments Signs/symptoms of infection (before, during, and after therapy) Signs/symptoms/worsening of heart failure Symptoms of hypersensitivity reaction Symptoms of a lupus-like syndrome Signs/symptoms of malignancy (eg, splenomegaly, hepatomegaly, abdominal pain, persistent fever, night sweats, weight loss) including periodic skin examination

kleine runde rosa Pille k 56 Die Studie RA umfasste 197 mit der Kontrollgruppe behandelte Patienten und 463 mit SIMPONI ARIA behandelte Patienten (einschließlich der mit der Kontrollgruppe behandelten Patienten, die in Woche 16 auf SIMPONI ARIA umgestellt wurden).. Der Anteil der Patienten, die die Behandlung aufgrund von Nebenwirkungen in der kontrollierten Phase der Studie RA bis Woche 24 abbrachen, betrug 3,5 % bei den mit SIMPONI ARIA behandelten Patienten und 0,5 % bei den mit Placebo behandelten Patienten.. Infektionen der oberen Atemwege waren die am häufigsten in der Studie bis Woche 24 berichtete Nebenwirkung, die bei 6,5 % der mit SIMPONI ARIA behandelten Patienten im Vergleich zu 7,6 % der mit der Kontrollgruppe behandelten Patienten auftrat.. In der kontrollierten Phase der Studie RA bis Woche 24 wurden Infektionen bei 27 % der mit SIMPONI ARIA behandelten Patienten im Vergleich zu 24 % der mit der Kontrollgruppe behandelten Patienten beobachtet, und schwere Infektionen wurden bei 0,9 % der mit SIMPONI ARIA behandelten Patienten und 0,0 % beobachtet.. In der kontrollierten Phase der Studie RA bis Woche 24 wurden ALT-Erhöhungen ≥ 5 x ULN traten bei 0,8% der mit SIMPONI ARIA behandelten Patienten und 0% der mit der Kontrollgruppe behandelten Patienten auf und ALT-Erhöhungen ≥ 3 x ULN trat bei 2,3 % der mit SIMPONI ARIA behandelten Patienten und bei 2,5 % der mit der Kontrollgruppe behandelten Patienten auf.. Reaktionen der Verwaltung In der kontrollierten Phase der Studie RA bis Woche 24 waren 1,1 % der SIMPONI ARIA-Infusionen mit einer Infusionsreaktion verbunden, verglichen mit 0,2 % der Infusionen in der Kontrollgruppe.. Tabelle 1: Unerwünschte Arzneimittelwirkungen, die von ≥ 1 % der mit SIMPONI ARIA behandelten Patienten und mit einer höheren Inzidenz als die mit Placebo behandelten Patienten in der Studie mit RA bis Woche 24. Die Nebenwirkungen ähnelten denen, die bei Patienten mit RA berichtet wurden, mit Ausnahme der höheren Inzidenz von ALT-Erhöhungen, die bei 2,9 % der mit SIMPONI ARIA behandelten Patienten im Vergleich zu keinem der mit Placebo behandelten Patienten auftraten.

Trial RA included 197 control-treated patients and 463 SIMPONI ARIA-treated patients (which includes control-treated patients who switched to SIMPONI ARIA at Week 16).. The proportion of patients who discontinued treatment due to adverse reactions in the controlled phase of Trial RA through Week 24 was 3.5% for SIMPONI ARIA-treated patients and 0.5% for placebo-treated patients.. Upper respiratory tract infection was the most common adverse reaction reported in the trial through Week 24 occurring in 6.5% of SIMPONI ARIA-treated patients as compared with 7.6% of control-treated patients, respectively.. In the controlled phase of Trial RA through Week 24, infections were observed in 27% of SIMPONI ARIA-treated patients compared with 24% of control-treated patients, and serious infections were observed in 0.9% of SIMPONI ARIA-treated patients and 0.0% of control-treated patients.. In the controlled phase of Trial RA, through Week 24, ALT elevations ≥ 5 × ULN occurred in 0.8% of SIMPONI ARIA-treated patients and 0% of control-treated patients and ALT elevations ≥ 3 × ULN occurred in 2.3% of SIMPONI ARIA-treated patients and 2.5% of control-treated patients.. In the controlled phase of Trial PsA, through Week 24, ALT elevations ≥ 5 × ULN occurred in 1.7% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients, and ALT elevations ≥ 3 × ULN to < 5 × ULN occurred in 2.9% of SIMPONI ARIA-treated patients and <1% of placebo-treated patients.. At Week 20 in Trial RA, 17% of SIMPONI ARIA-treated patients and 13% of control patients were newly antinuclear antibody (ANA)-positive.. Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% in the SIMPONI ARIA + MTX group with a higher incidence than in the placebo + MTX group during the controlled period of Trial RA through Week 24.. Table 1: Adverse Drug Reactions Reported by ≥ 1% of SIMPONI ARIA-Treated Patients and with a Higher Incidence than Placebo-Treated Patients in Trial RA through Week 24 Placebo + MTXSIMPONI ARIA + MTXPatients treated197463Adverse ReactionInfections and infestations Upper respiratory tract infection (such as upper respiratory tract infection, nasopharyngitis, pharyngitis , laryngitis, and rhinitis)12%13% Viral infections (such as influenza and herpes )3%4% Bacterial infections0%1% Bronchitis 1%3%Vascular disorders Hypertension 2%3%Skin and subcutaneous disorders Rash1%3%General disorders and administration site conditions Pyrexia1%2%Blood and lymphatic disorders Leukopenia0%1%. Adverse drug reactions that do not appear in Table 1 or that occurred < 1% in SIMPONI ARIA-treated patients during Trial RA through Week 24 that do not appear in the Warnings and Precautions section included the following events listed by system organ class:. The incidence of the adverse reactions reported in Trial PsA were similar to Trial RA with the exceptions of higher incidence in SIMPONI ARIA for ALT increased (7.9% vs. 2.1% in placebo), AST increased (5.4% vs. 2.1% in placebo), and neutrophil count decreased (4.6% vs. 2.1% in placebo).. The adverse reactions were similar to those reported in patients with RA, with the exception of the higher incidence of ALT increased, which occurred in 2.9% of SIMPONI ARIA-treated patients compared with none of the placebo-treated patients.. Using an enzyme immunoassay (EIA) method, antibodies to golimumab were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial RA, of which all were neutralizing antibodies.

Some people have serious infections while receiving Simponi Aria, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body.. You should not start receiving Simponi Aria if you have any kind of infection unless your doctor tells you to.. After receiving Simponi Aria, call your doctor right away if you have any symptoms of an infection.. If you get an infection while receiving treatment with Simponi Aria your doctor will treat your infection and may need to stop your Simponi Aria treatment.. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Simponi Aria: a fever feel very tired have a cough have flu-like symptoms warm, red, or painful skin. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Simponi Aria and during treatment with Simponi Aria.. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are receiving Simponi Aria.. Tell your doctor if you have any of the following symptoms while receiving or after receiving Simponi Aria: cough that does not go away low grade fever weight loss loss of body fat and muscle (wasting). Your doctor should do blood tests before you start treatment with Simponi Aria and while you are receiving Simponi Aria.. If you have heart failure before starting Simponi Aria, your condition should be watched closely during treatment with Simponi Aria.. Rarely, people receiving TNF-blocker medicines, including Simponi Aria, have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome.. Liver problems can happen in people who receive TNF-blocker medicines, including Simponi Aria.

SIMPONI ARIA ® was evaluated in medical studies for joint symptoms, functional health, well-being and fatigue.. Please select a condition to learn more about SIMPONI ARIA ® results in medical studies.. In a medical study of 395... See More patients with RA, 59% of patients treated with SIMPONI ARIA ® when taken with methotrexate (MTX) had a 20% improvement in symptoms of RA (joint pain, stiffness, and swelling) at 14 weeks, compared to 25% of the 197 patients treated with MTX alone.. In a medical study, some ... See More patients treated with SIMPONI ARIA ® when taken with MTX showed improvement in both physical and emotional well-being, compared to patients treated with MTX alone, as measured by a general health assessment that includes these 8 areas: PHYSICAL WELL-BEING Physical Functioning: Limitations in performing physical activities Role Limitations (Physical): Physical challenges that limit your daily activities Body Pain: General body pain experienced General Health: How you feel about your overall health EMOTIONAL WELL-BEING Social Limitations: Any effects that physical or emotional health problems have on your social life Role Limitations (Emotional): Emotional challenges that limit your daily activities Energy and Fatigue: The energy or fatigue that you experience General Emotional Health: How you feel, emotionally, most of the time. Treatment with SIMPONI... See More ARIA ® when taken with MTX resulted in improvement in fatigue in some patients.. In a medical study, 75% of... See More 241 patients treated with SIMPONI ARIA ® had a 20% improvement in symptoms of PsA (joint pain, stiffness, and swelling) at 14 weeks, compared to 22% of 239 patients treated with placebo.. 59% of 196 patients treated with... See More SIMPONI ARIA ® had 75% improvement in skin symptoms of PsA (plaque thickness, redness, and scaling) at 14 weeks, compared to 14% of 198 patients treated with placebo.. In a medical study, some ... See More patients treated with SIMPONI ARIA ® showed improvement in both physical and emotional well-being, compared to patients treated with placebo, as measured by a general health assessment that includes these 8 areas: PHYSICAL WELL-BEING Physical Functioning: Limitations in performing physical activities Role Limitations (Physical): Physical challenges that limit your daily activities Body Pain: General body pain experienced General Health: How you feel about your overall health EMOTIONAL WELL-BEING Social Limitations: Any effects that physical or emotional health problems have on your social life Role Limitations (Emotional): Emotional challenges that limit your daily activities Energy and Fatigue: The energy or fatigue that you experience General Emotional Health: How you feel, emotionally, most of the time. Treatment with SIMPONI... See More ARIA ® resulted in improvement in fatigue in some patients.. In a medical study, some ... See More patients treated with SIMPONI ARIA ® showed improvement in both physical and emotional well-being, compared to patients treated with placebo, as measured by a general health assessment that includes these 8 areas: PHYSICAL WELL-BEING Physical Functioning: Limitations in performing physical activities Role Limitations (Physical): Physical challenges that limit your daily activities Body Pain: General body pain experienced General Health: How you feel about your overall health EMOTIONAL WELL-BEING Social Limitations: Any effects that physical or emotional health problems have on your social life Role Limitations (Emotional): Emotional challenges that limit your daily activities Energy and Fatigue: The energy or fatigue that you experience General Emotional Health: How you feel, emotionally, most of the time. Then you’ll receive your infusions every 8 weeks—that’s as few as 6 times a year.. Serious and sometimes fatal events may occur.. Other possible serious side effects may include lymphoma, a rare and fatal cancer called hepatosplenic T-cell lymphoma, skin cancer, other cancers, hepatitis B, heart failure, nervous system problems, lupus-like symptoms, or allergic reactions.. The most common side effects of SIMPONI ARIA ® include:

In the controlled phase of Trial RA through Week 24, infections were observed in 27% of SIMPONI ARIA-treated patients compared with 24% of control-treated patients, and serious infections were observed in 0.9% of SIMPONI ARIA-treated patients and 0.0% of control-treated patients.. In the controlled phase of Trial RA, through Week 24, ALT elevations ≥ 5 x ULN occurred in 0.8% of SIMPONI ARIA-treated patients and 0% of control-treated patients and ALT elevations ≥ 3 x ULN occurred in 2.3% of SIMPONI ARIA-treated patients and 2.5% of control-treated patients.. Placebo + MTXSIMPONI ARIA + MTXPatients treated197463Adverse Reaction Infections and infestations Upper respiratory tract infection (such as upper respiratory tract infection, nasopharyngitis,. pharyngitis, laryngitis, and rhinitis)12%13% Viral infections (such as influenza and herpes)3%4% Bacterial infections0%1% Bronchitis1%3% Vascular disorders Hypertension2%3% Skin and subcutaneous disorders Rash1%3% General disorders and administration site. conditions Pyrexia1%2% Blood and lymphatic disorders Leukopenia0%1% Other And Less Common Clinical Trial Adverse Drug Reactions Adverse drug reactions that do not appear in Table 1 or that occurred < 1% in SIMPONI ARIA-treated patients during Trial RA through Week 24 that do not appear in the Warnings and Precautions section included the following events listed by system organ class:. In the controlled phase of Trial RA through Week 24, infections were observed in 27% of SIMPONI ARIA-treated patients compared with 24% of control-treated patients, and serious infections were observed in 0.9% of SIMPONI ARIA-treated patients and 0.0% of control-treated patients.. Placebo + MTXSIMPONI ARIA + MTXPatients treated197463Adverse Reaction Infections and infestations Upper respiratory tract infection (such as upper respiratory tract infection, nasopharyngitis,. pharyngitis, laryngitis, and rhinitis)12%13% Viral infections (such as influenza and herpes)3%4% Bacterial infections0%1% Bronchitis1%3% Vascular disorders Hypertension2%3% Skin and subcutaneous disorders Rash1%3% General disorders and administration site. conditions Pyrexia1%2% Blood and lymphatic disorders Leukopenia0%1% Other And Less Common Clinical Trial Adverse Drug Reactions Adverse drug reactions that do not appear in Table 1 or that occurred < 1% in SIMPONI ARIA-treated patients during Trial RA through Week 24 that do not appear in the Warnings and Precautions section included the following events listed by system organ class:

Injection Site Reaction. After stopping golimumab treatment, HBV carriers must be monitored for signs and symptoms of active infection for several months.. If there is a reactivation of the virus, it is important to stop therapy and start antiviral therapy.. You may experience reactions within one hour after IV infusion.. Patients who receive golimumab have a higher risk of serious reactions.. Patients who are taking immunosuppressive drugs (eg, corticosteroids or methotrexate) concurrently are more at risk for infection.. Patients with active infection might show negative histoplasmosis tests (antigen, antibody) Signs and symptoms of infection require close monitoring.. Caution should be exercised (consider risks versus benefits) when considering use in the elderly, patients taking concomitant immunosuppressants, patients with chronic or recurrent infection, patients who have been exposed to tuberculosis, patients with a history of opportunistic infection, patients with comorbid conditions that predispose them to infections (eg, diabetes), or residence/travel from areas of endemic mycoses (blastomycosis, coccidioidomycosis, histoplasmosis).patients with an active infection, including localized infection, which is clinically important.. Patients who get a new infection during treatment should not receive therapy.. TNF-blockers are known for causing lymphoma, other malignancies that could be life-threatening.. If a patient develops a malignancy, consider whether continuing treatment is possible.. Tuberculosis can develop in patients who have received golimumab.. Anti-tuberculosis treatment may be considered if a course of treatment is not possible for patients with a history or risk factors of active or latent tuberculosis.

What is this medication?. This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.. How should I use this medication?. If you are to give your own medicine at home, you will be taught how to prepare and give this medicine under the skin.. Do not take your medicine more often than directed.. Do not take this medicine with any of the following medications:. This medicine may also interact with the following medications:. If your doctor prescribes any medicine for TB, you should start taking the TB medicine before starting this medicine.. Call your doctor or health care professional if you get a cold or other infection while receiving this medicine.. If you give your medicine by injection under the skin: If you miss a dose, take it as soon as you can.. Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):. Where should I keep my medication?. DISCLAIMER: This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment.. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications.. are allergic to golimumab or any ingredients of the medication are allergic to latex or any components of the medication container have a serious infection such as sepsis (an infection in the bloodstream), tuberculosis, an abscess, or an opportunistic infection (a type of infection that affects people with weakened immune systems) have moderate to severe congestive heart failure. flu-like symptoms (sudden lack of energy, fever, cough, sore throat) high blood pressure red scaly patches or raised bumps filled with pus redness, pain, swelling, itching, warmth, and bruising at the injection site signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding) signs of a urinary tract infection such as difficult or painful urination, or blood in the urine symptoms of heart failure (shortness of breath or swelling of the feet or legs) symptoms of lupus (rash on the cheeks or other body areas; sun sensitivity; joint or muscle pain; fatigue; chest pain; shortness of breath; or swelling of the feet, ankles, or legs) symptoms of nervous system problems (such as arm or leg weakness, vision changes, dizziness, or numbness or tingling in any part of the body). Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.. If you have a history of CHF or are at risk of developing CHF, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.. If you have a history of hepatitis B infection, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.. If you have a history of chronic or frequent infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.. Tuberculosis: Some people who have had tuberculosis (a lung infection) in the past have had this infection return when they are using golimumab.If you have a history of tuberculosis, or have come into recent contact with someone who has tuberculosis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.. stop taking one of the medications, change one of the medications to another, change how you are taking one or both of the medications, or leave everything as is.

Golimumab is also used to treat ulcerative colitis (UC) in adults when other medicines have not worked or could not be tolerated.. Golimumab is also used to treat ulcerative colitis (UC) in adults when other medicines have not worked or could not be tolerated.. Call your pharmacist for new medicine.. Call your doctor right away if you have signs of infection such as:. infections, cold or flu symptoms; abnormal liver function tests; high blood pressure; rash; or pain, itching, redness, or swelling where the medicine was injected.. Tell your doctor about all your other medicines, especially:

Serious - Use Alternative. hepatitis a/b vaccine golimumab decreases effects of hepatitis a/b vaccine by pharmacodynamic antagonism.. hepatitis a/typhoid vaccine golimumab decreases effects of hepatitis a/typhoid vaccine by pharmacodynamic antagonism.. Immunosuppressive drugs may reduce the immune response to influenza vaccine.. Immunosuppressive drugs may reduce the immune response to influenza vaccine.. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.. Immunosuppressive drugs may reduce the immune response to influenza vaccine.. Immunosuppressive drugs may reduce the immune response to influenza vaccine.. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections

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