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Simponi Aria

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Simponi Aria

Simponi Aria

Simponi Aria Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Simponi Aria (golimumab) for infusion is a monoclonal antibody used in combination with methotrexate to treat adult patients with moderately to severely active rheumatoid arthritis. Common side effects include infections, high blood pressure (hypertension), rash, and fever.

The Simponi Aria dosage regimen is 2 mg per kg given as an intravenous infusion over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter, given in combination with methotrexate. Simponi Aria may interact with abatacept, anakinra, rituximab, "live" vaccines, or golimumab. Tell your doctor all medications and supplements you use and all vaccines you recently received. During pregnancy, Simponi Aria should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Simponi Aria (golimumab) for infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Simponi Aria FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most serious adverse reactions were:

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 1). 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 1 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 1 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 1 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 1, 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 (CI: 2.90, 5.57) in patients receiving SIMPONI ARIA [see WARNINGS AND PRECAUTIONS]. In the controlled and uncontrolled portions of Trial 1, 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 1. 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 (CI: 0.06, 0.92) and the incidence of NMSC was 0.1 (95% CI: 0.00, 0.58).

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 1, through Week 24, ALT elevations ≥ 5 x ULN occurred in 0.6% of SIMPONI ARIA-treated patients and 0% of control-treated patients and ALT elevations ≥ 3 x ULN occurred in 2.4% of SIMPONI ARIA-treated patients and 2.5% of control-treated patients.

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

Autoimmune Disorders And Autoantibodies

The use of TNF-blockers, of which SIMPONI ARIA is a member, has been associated with the formation of autoantibodies and, rarely, with the development of a lupus-like syndrome.

At Week 20 in Trial 1, 17% of SIMPONI ARIA-treated patients and 13% of control patients were newly ANA-positive (at titers of 1:160 or greater). Of these patients, one SIMPONI ARIA-treated patient and no control-treated patients had newly positive anti-dsDNA antibodies.

Administration Reactions

In the controlled phase of Trial 1 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.

Immunogenicity

Antibodies to SIMPONI ARIA were detected in 13 (3%) golimumab-treated patients following IV administration of SIMPONI ARIA in combination with MTX through Week 24 of Trial 1.

All patients who were positive for antibodies to golimumab had neutralizing antibodies based on an in vitro cell-based assay. The small number of patients positive for antibodies to SIMPONI ARIA limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures.

The data above reflect the percentage of patients whose test results were considered positive for antibodies to SIMPONI ARIA in an ELISA assay. The ELISA assay is subject to interference by co-present golimumab and thus the results are an underestimate of the rate of product immunogenicity and are in addition highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SIMPONI ARIA with the incidence of antibodies to other products may be misleading.

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 1 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 1 through Week 24

  SIMPONI ARIA + MTX Placebo + MTX
Patients treated 463 197
Adverse Reaction    
Infections and Infestations
  Upper respiratory tract infection (such as upper respiratory tract infection, nasopharyngitis, pharyngitis, laryngitis, and rhinitis) 13% 12%
  Viral infections (such as influenza and herpes) 4% 3%
  Bacterial infections 1% 0%
  Bronchitis 3% 1%
Vascular disorders
  Hypertension 3% 2%
Skin and subcutaneous disorders
  Rash 3% 1%
General disorders and administration site conditions
  Pyrexia 2% 1%
Blood and lymphatic disorders
  Leukopenia 1% 0%

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 1 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 increased, aspartate aminotransferase increased, neutrophil count decreased

Nervous system disorders: Dizziness, paresthesia

Gastrointestinal disorders: Constipation

Post-marketing Experience

There is no post-marketing experience available for SIMPONI ARIA. The following adverse reactions have been identified during post-approval use of the subcutaneous formulation 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.

Neoplasm Benign and Malignant: Melanoma [see WARNINGS AND PRECAUTIONS]

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

Skin and subcutaneous tissue disorders: Skin exfoliation

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

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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