Simponi Side Effects

Generic Name: golimumab

Please note - some side effects for Simponi may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Simponi - for the Consumer

Simponi

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Simponi:

Cold sores; hoarseness; mild itching, pain, redness, or swelling at the injection site; mild sore throat; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur when using Simponi:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine or stools; butterfly-shaped rash on the nose and cheeks; chest pain; dark urine; diarrhea; fainting; fast or irregular heartbeat; increased sensitivity to the sun; loss of appetite; mental or mood changes; muscle pain or weakness; new or worsening joint pain; new or worsening red, scaly patches or raised bumps filled with pus on the skin; numbness, burning, or tingling; open sore that does not heal; painful or frequent urination; pale stools; persistent cough; red, swollen, or blistered skin; severe or persistent headache or dizziness; severe or persistent stomach pain; severe or persistent pain, swelling, or redness at the injection site; shortness of breath; signs of infection (eg, fever, chills, or persistent sore throat; muscle aches; warm, red, or painful skin or sores); swelling of the ankles, hands, or feet; unexplained weight loss; unusual bruising or bleeding; unusual lumps; unusual tiredness or weakness; unusually pale skin; vision changes; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Simponi Side Effects - for the Professional

Simponi

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.

Clinical Studies Experience

The safety data described below are based on 5 pooled, randomized, double-blind, controlled Phase 3 trials in patients with RA, PsA, and AS (Studies RA-1, RA-2, RA-3, PsA, and AS) [see Clinical Studies (14.1, 14.2 and 14.3)]. These 5 trials included 639 control-treated patients and 1659 Simponi-treated patients including 1089 with RA, 292 with PsA, and 278 with AS. The proportion of patients who discontinued treatment due to adverse reactions in the controlled Phase 3 trials through Week 16 in RA, PsA and AS was 2% for Simponi-treated patients and 3% for placebo-treated patients. The most common adverse reactions leading to discontinuation of Simponi in the controlled Phase 3 trials through Week 16 were sepsis (0.2%), alanine aminotransferase increased (0.2%), and aspartate aminotransferase increased (0.2%).

The most serious adverse reactions were:

• Serious Infections [see Warnings and Precautions (5.1)]
• Malignancies [see Warnings and Precautions (5.2)]

Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 RA, PsA and AS trials through Week 16, occurring in 7% and 6% of Simponi-treated patients as compared with 6% and 5% of control-treated patients, respectively.

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 [for Serious Infections, see Warnings and Precautions (5.1)].

Liver Enzyme Elevations

There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF-blockers. In controlled Phase 3 trials of Simponi in patients with RA, PsA, and AS through Week 16, ALT elevations ≥ 5 × ULN occurred in 0.2% of control-treated patients and 0.7% of Simponi-treated patients and ALT elevations ≥ 3 × ULN occurred in 2% of control-treated patients and 2% of Simponi-treated patients. Since many of the patients in the Phase 3 trials were also taking medications that cause liver enzyme elevations (e.g., NSAIDs, MTX), the relationship between Simponi and liver enzyme elevation is not clear.

Autoimmune Disorders and Autoantibodies

The use of TNF-blockers, including Simponi, has been associated with the formation of autoantibodies and, rarely, with the development of a lupus-like syndrome. In the controlled Phase 3 trials in patients with RA, PsA, and AS through Week 14, there was no association of Simponi treatment and the development of newly positive anti-dsDNA antibodies.

Injection Site Reactions

In controlled Phase 3 trials through Week 16 in RA, PsA and AS, 6% of Simponi-treated patients had injection site reactions compared with 2% of control-treated patients. The majority of the injection site reactions were mild and the most frequent manifestation was injection site erythema. In controlled Phase 2 and 3 trials in RA, PsA, and AS, no patients treated with Simponi developed anaphylactic reactions.

Immunogenicity

Antibodies to Simponi were detected in 57 (4%) of Simponi-treated patients across the Phase 3 RA, PsA, and AS trials through Week 24. Similar rates were observed in each of the three indications. Patients who received Simponi with concomitant MTX had a lower proportion of antibodies to Simponi than patients who received Simponi without MTX (approximately 2% versus 7%, respectively). Of the patients with a positive antibody response to Simponi in the Phase 2 and 3 trials, most were determined to have neutralizing antibodies to golimumab as measured by a cell-based functional assay. The small number of patients positive for antibodies to Simponi 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 in an ELISA assay, and are 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 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 ± DMARD group and with a higher incidence than in the placebo ± DMARD group during the controlled period of the 5 pooled Phase 3 trials through Week 16 in patients with RA, PsA, and AS.

Table 1. Adverse Drug Reactions Reported by ≥ 1% of Simponi-Treated Patients and with a Higher Incidence than Placebo-Treated Patients in the Phase 3 Trials of RA, PsA, and AS through Week 16*

	Simponi ± DMARDs	Placebo ± DMARDs
* Patients may have taken concomitant MTX, sulfasalazine, hydroxychloroquine, low dose corticosteroids (≤ 10 mg of prednisone/day or equivalent), and/or NSAIDs during the trials).
Patients treated	1659	639
Adverse Reaction
Infections and Infestations
Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis, and rhinitis)	16%	13%
Viral infections (such as influenza and herpes)	5%	3%
Bronchitis	2%	1%
Superficial fungal infections	2%	1%
Sinusitis	2%	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 increased	4%	3%
Aspartate aminotransferase increased	3%	2%
Vascular disorders
Hypertension	3%	2%
Nervous system disorders
Dizziness	2%	1%
Paresthesia	2%	1%
Gastrointestinal Disorders
Constipation	1%	<1%

Less common clinical trial adverse drug reactions

Adverse drug reactions that occurred <1% in Simponi-treated patients during the Simponi clinical trials that do not appear in the Warnings and Precautions section included the following events listed by system organ class:

Infections and infestations: Septic shock, atypical mycobacterial infection, pyelonephritis, arthritis bacterial, bursitis infective

Neoplasms benign, malignant and unspecified: leukemia

Skin and subcutaneous tissue disorders: psoriasis (new onset or worsening, palmar/plantar and pustular), vasculitis (cutaneous)

Vascular disorders: Vasculitis (systemic)

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of Simponi. 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 Simponi exposure.

Immune System Disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction) [see Warnings and Precautions (5.10)].

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Side Effects by Body System - for Healthcare Professionals

Other

Other side effects have included serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most commonly reported with TNF blockers.

Other

Other side effects have included the reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers (i.e., surface antigen positive).

Oncologic

Oncologic side effects have included an increase in the development of lymphoma in patients treated with TNF blockers including golimumab.

Cardiovascular

Cardiovascular side effects have included cases of worsening congestive heart failure (CHF) and new onset CHF. Hypertension has also been reported.

Nervous system

Nervous system side effects have included cases of new onset or exacerbation of central nervous system (CNS) demyelinating disorders, including multiple sclerosis (MS). Paraesthesia and dizziness has also been reported.

Hepatic

Hepatic side effects have included severe hepatic reactions including acute liver failure in patients receiving TNF blockers such as golimumab. Elevations of alanine aminotransferase and aspartate aminotransferase have been reported with the use of golimumab. A small number of deaths which have been attributed hepatosplenic T Cell Lymphoma have been reported in patients receiving other TNF blockers.

Hematologic

Hematologic side effects have included reports of pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia in patients receiving TNF blockers.

Immunologic

Immunologic side effects have included the formation of autoantibodies and, rarely, with the development of a lupus-like syndrome. Cases of new onset psoriasis, including pustular psoriasis and palmoplantar psoriasis, have been reported with the use of TNF blockers, including golimumab.

Respiratory

Respiratory side effects have included upper respiratory tract infection, nasopharyngitis, bronchitis, sinusitis, influenza, pharyngitis, and rhinitis.

Local

Local side effects have included injection site erythema.

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