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Simponi

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Simponi Injection

Simponi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Simponi (golimumab injection) is used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is sometimes used with another medication called methotrexate (Rheumatrex, Trexall). It works by blocking a protein (tumor necrosis factor or TNF) found in the body's immune system that causes joint swelling and damage. Common side effects include redness, itching, pain, or swelling at the injection site.

The Simponi dose regimen is 50 mg administered by subcutaneous (SC) injection once a month. Simponi may interact with abatacept, anakinra, rituximab, blood thinners, cyclosporine, digoxin, theophylline, seizure medications, or heart rhythm medications. Tell your doctor all medications you use. During pregnancy, Simponi should be used only when prescribed. It is unknown if this drug passes into breast milk. Because of the potential risk to the infant, consult your doctor before breastfeeding.

Our Simponi (golimumab injection) 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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Simponi in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using golimumab and call your doctor right away if you have any of these symptoms of lymphoma:

  • fever, night sweats, weight loss, tiredness;
  • feeling full after eating only a small amount;
  • pain in your upper stomach that may spread to your shoulder;
  • easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using golimumab and call your doctor at once if you have any of these other serious side effects:

  • signs of infection (fever, chills, sore throat, flu symptoms, stomach pain, diarrhea, muscle aches);
  • shortness of breath with swelling of your ankles or feet;
  • chest pain, ongoing cough, coughing up mucus or blood;
  • cold sores;
  • vision changes, neck stiffness, seizure;
  • numbness or tingly feeling, weakness in your legs;
  • loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • joint pain or swelling with fever, swollen glands, muscle aches, nausea, vomiting, chest pain, unusual thoughts or behavior, and/or seizure (convulsions); or
  • patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • dizziness; or
  • redness where you injected the medicine.

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.

Read the entire detailed patient monograph for Simponi (Golimumab Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Simponi Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Redness, itching, pain, or swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

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 swelling ankles/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/vomiting/loss of appetite, stomach/abdominal pain, yellow eyes/skin).

Get medical help right away if you have any very serious side effects, including: chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Simponi (Golimumab Injection)»

What is Prescribing information?

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

Simponi FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 5 pooled, randomized, double-blind, controlled Phase 3 trials in patients with RA, PsA, and AS (Trials RA-1, RA-2, RA-3, PsA, and AS) [see Clinical Studies]. 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 safety data in 1233 SIMPONI-treated patients with ulcerative colitis from 3 pooled, randomized, double-blind, controlled Phase 2/3 trials are also described below (Trials UC-1, UC-2, and UC-3) [see Clinical Studies]. 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 in RA, PsA and AS through Week 16 were sepsis (0.2%), alanine aminotransferase increased (0.2%), and aspartate aminotransferase increased (0.2%). The most common adverse drug reactions leading to discontinuation through Week 60 of the UC trials in patients who received SIMPONI induction and 100 mg during maintenance compared with patients who received SIMPONI induction and placebo during maintenance were tuberculosis (0.3% vs 0.6%) and anemia (0.3% vs 0%), respectively.

The most serious adverse reactions were:

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 the WARNINGS AND PRECAUTIONS section. In the controlled Phase 2/3 trial of SIMPONI induction through Week 6 in UC, the rates of infections were similar in SIMPONI 200/100 mg-treated patients and placebo-treated patients, or approximately 12%. Through Week 60, the incidence per patient year of infections was similar in patients who received SIMPONI induction and 100 mg during maintenance compared with patients who received SIMPONI induction and placebo during the maintenance portion of the UC trial.

Demyelinating Disorders

In the controlled Phase 2/3 trial of SIMPONI induction through Week 6, no cases of demyelination were observed in SIMPONI 200/100 mg-treated patients or placebo-treated patients. Through Week 60, there were no cases of demyelination in the SIMPONI 100 mg group during maintenance. One case of CNS demyelination was observed in the placebo maintenance group in a patient who received SIMPONI 400/200 mg during induction.

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 x ULN occurred in 0.2% of control-treated patients and 0.7% of SIMPONI-treated patients and ALT elevations ≥ 3 x ULN occurred in 2% of control-treated patients and 2% of SIMPONI-treated patients. Since many of the patients in the Phase 3 trials for RA, PsA, and AS were also taking medications that cause liver enzyme elevations (e.g., NSAIDs, MTX), the relationship between SIMPONI and liver enzyme elevation is not clear.

In Phase 2/3 UC trials, the incidence of ALT elevations ≥ 5 x ULN was similar in SIMPONI-treated patients and placebo-treated patients, or approximately 1%, with an average duration of follow-up of 46 weeks and 18 weeks, respectively. ALT elevations ≥ 3 x ULN occurred in 2.0% of SIMPONI-treated patients compared with 1.5% of placebo-treated patients with an average duration of follow-up of 46 weeks and 18 weeks, respectively.

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. In Phase 3 trials in RA, PsA, and AS through 1 year of follow up, 4.0% of SIMPONI-treated patients and 2.6% of control patients were newly ANA-positive (at titers of 1:160 or greater). The frequency of anti-dsDNA antibodies at 1 year of follow up was uncommon in patients who were anti-dsDNA negative at baseline. Through Week 60 of the UC trials, 3.5% of patients who received SIMPONI induction and 100 mg during maintenance were newly ANA-positive (at titers of 1:160 or greater) compared with 3.5% of patients who received SIMPONI induction and placebo during the maintenance portion of the UC trial. The frequency of anti-dsDNA antibodies at 1 year of follow up in patients who were anti-dsDNA negative at baseline was 0.5% in patients receiving SIMPONI induction and 100 mg during maintenance compared with 0% in patients who received SIMPONI induction and placebo during maintenance.

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 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. The majority of the injection site reactions were mild and moderate and the most frequent manifestation was injection site erythema.

In controlled Phase 2 and 3 trials in RA, PsA, AS, and Phase 2/3 UC trials, 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).

The presence of serum concentrations of golimumab can interfere with the detection of antibodies to SIMPONI leading to inconclusive results. In UC trials, 34 (3%), 341 (28%) and 823 (69%) of SIMPONI-treated subjects were positive, negative and inconclusive for antibodies to SIMPONI, respectively. Treatment with concomitant immunomodulators (AZA, 6-MP and MTX) resulted in a lower proportion of patients with antibodies to SIMPONI than patients receiving SIMPONI without immunomodulators (2% versus 4%, 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 16a

  SIMPONI ± DMARDs Placebo ± DMARDs
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%
aPatients may have taken concomitant MTX, sulfasalazine, hydroxychloroquine, low dose corticosteroids ( ≤ 10 mg of prednisone/day or equivalent), and/or NSAIDs during the trials).

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)

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.

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], sarcoidosis

Neoplasms benign, malignant and unspecified: Melanoma [see WARNINGS AND PRECAUTIONS]

Respiratory, thoracic and mediastinal disorders: Interstitial lung disease

Skin and subcutaneous tissue disorders: Skin exfoliation, rash

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

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Simponi Injection - User Reviews

Simponi Injection User Reviews

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Report Problems to the Food and Drug Administration

 

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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