Golimumab (Simponi Aria®) is a human IgG1κ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα), a cytokine protein. Golimumab is an antibody with human-derived antibody variable and constant regions. Golimumab binds to both soluble and transmembrane bioactive forms of TNFα, blocking the binding of TNFα to its receptors and inhibiting the biologic activity of TNFα.
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Patient Medication Guide
Full Prescribing Information
Golimumab is indicated for adults with moderately to severely active rheumatoid arthritis in combination with methotrexate
Rheumatoid Arthritis (RA)
- Golimumab is dosed at 2mg/kg as an IV infusion over 30 minutes at weeks 0 and 4 and then every 8 weeks thereafter.
- Golimumab should be given in combination with methotrexate. Other non-biologic DMARDS, corticosteroids, and nonsteroidal anti-inflammatory drugs (NSAIDS) and/or other analgesics may be continued during treatment.
Specific contraindications have not been determined.
Warnings and Precautions
- Serious Infections – If a serious infection develops, discontinue golimumab until the infection is controlled.
- Hepatitis B reactivation – Monitor HBV carriers during and several months after therapy. If reactivation occurs, stop golimumab and begin anti-viral therapy.
- Malignancies – Patients with highly active forms of rheumatoid arthritis and other chronic inflammatory diseases who are exposed to immunosuppressant therapy may be at a higher risk for developing lymphomas than the general population. Risks and benefits of treatment should be evaluated in patients with a known malignancy.
- Congestive heart failure (CHF) – Closely monitor patients with CHF that are initiated on golimumab. Discontinue golimumab if new or worsening signs of CHF appear.
- Demyelinating disorder – New onset or exacerbation of demyelinating disorders may occur. Discontinuing golimumab should be considered if these disorders develop.
- Use with abatacept – Not recommended due to greater risk of serious infection and lack of improved clinical benefit for treatment of rheumatoid arthritis
- Use with anakinra – Not recommended due to increased risk of serious infections and no additional benefit of combination therapy.
- Switching between biological disease modifying anti rheumatic drugs (DMARDs) – Caution should be taken due to increased risk of infection from overlapping biological activity
- Hematologic cytopenia – Caution should be taken in patients who have or have had significant cytopenias
- Live vaccination – Avoid use with golimumab
- Therapeutic infectious agents – Avoid use with golimumab
- Hypersensitivity reaction – Discontinue golimumab if anaphylaxis or other serious allergic reaction occurs
Most common adverse reactions (>3%):
- Upper respiratory tract infections, viral infection, bronchitis, hypertension, and rash
- Confirm the following:
Ask the patient if he/she:
- Negative PPD
- Positive PPD with negative chest radiograph or at least 4 weeks post-initiation of latent tuberculosis infection treatment
- Negative hepatitis B serologic tests
- Has a current or recent infection or illness
- Is taking antibiotics
- Has an upcoming surgery
If the answer is yes to any of these questions, notify the ordering provider before initiating the infusion therapy.
- Calculate the dose of golimumab based on 2 mg/kg and the patient’s weight. Each 4 mL vial contains 50 mg of golimumab.
- Verify that the solution in each vial is colorless to light yellow. It may contain a few fine particles. Do not use if there is opaque particles or discoloration is present.
- Dilute the total volume of golimumab to a final infusion volume of 100mL with 0.9% w/v sodium chloride. Gently mix the diluted solution. Discard any unused golimumab solution in remaining in the vials.
- Prior to infusion visually inspect the diluted golimumab solution for any particulate matter or discoloration. Do not use if these exist.
- Once diluted the infusion solution can be stored for 4 hours at room temperature.
Medication Administration and Monitoring
- Use an infusion set with an in-line, sterile, nonpyrogenic, low binding filter (pore size 0.22 micrometer or less).
- Do not infuse golimumab concomitantly in the same IV line with other agents. No physical biochemical or compatibility studies have been conducted.
- Infuse the diluted solution over 30 minute
Updated January 2017 - ARP Practice Committee
DISCLAIMER:The information contained in this biologic reference guide is offered solely for purposes of providing health care professionals with a quick and initial reference. Before prescribing or administering any drug contained in this biologic reference guide, health professionals should read the manufacturer’s complete prescribing information in order to be informed of the various clinical considerations to be taken into account. The American College of Rheumatology is providing this information as a benefit and service in furtherance of its educational mission. By providing this information, ACR is not endorsing or recommending any of the listed companies or any of their drugs or other products. The information contained in the biologic reference guides reflect the conclusions of the individual companies and not those of the ACR which specifically disclaims any responsibility or liability for the use of such information and/or for the performance of any of the drugs listed in this biologic reference guide.