golimumab (Rx)

Brand and Other Names:Simponi, Simponi Aria
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

SC solution (prefilled syringe/autoinjector)

  • Simponi
  • 50mg/0.5mL
  • 100mg/1mL

IV solution (vial)

  • Simponi Aria
  • 50mg/4mL
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Rheumatoid Arthritis

Indicated for moderately-to-severely active rheumatoid arthritis in combination with methotrexate

Simponi: 50 mg SC qMonth

Simponi Aria: 2 mg/kg IV infused over 30 minutes at weeks 0 and 4, then q8weeks

Psoriatic Arthritis

Indicated alone or in combination with methotrexate for active psoriatic arthritis

50 mg SC qMonth

Ankylosing Spondylitis

Indicated for active ankylosing spondylitis with or without methotrexate

50 mg SC qMonth

Ulcerative Colitis

Indicated for adults with moderate-to-severe ulcerative colitis that is resistant to prior treatment or requires continuous corticosteroid therapy

Initial: 200 mg SC at Week 0, followed by 100 mg SC at Week 2, THEN

Maintenance: 100 mg SC q4weeks

<18 years: Safety and efficacy not established

Polyarticular Juvenile Idiopathic Arthritis (Orphan)

Orphan designation for treatment of polyarticular juvenile idiopathic arthritis in pediatric patients aged ≤16 yr

Sponsor

  • Janssen Research & Development, LLC; Welsh & McKean Roads; P. O. Box 776; Spring House, PA 19477
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Interactions

Interaction Checker

and golimumab

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Upper respiratory infections (13-16%)

            1-10%

            Injection site reactions, SC (6%)

            Increased ALT/AST (3-4%)

            Viral infections (4-5%)

            Hypertension (3%)

            Bronchitis (2-3%)

            Rash (3%)

            Sinusitis (2%)

            Superficial fungal infections (2%)

            Dizziness (2%)

            Paresthesia (2%)

            Pyrexia (2%)

            Leukopenia (1%)

            Bacterial infections (1%)

            Constipation (1%)

            Postmarketing Reports

            Neoplasm benign and malignant: Melanoma, Merkel cell carcinoma

            Immune system disorders: Serious systemic hypersensitivity reactions (including anaphylactic reaction), sarcoidosis

            Respiratory, thoracic and mediastinal disorders: Interstitial lung disease

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

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            Warnings

            Black Box Warnings

            Serious infection risk

            • Increased risk for developing serious infections resulting in hospitalization or death; most patients were taking concomitant immunosuppressants (eg, methotrexate, corticosteroids)
            • Patients older than 65 years may be at greater risk
            • Discontinue if patient develops serious infection or sepsis
            • Reported infections include:
            • 1) Active TB, including reactivation of latent TB (frequently present with disseminated or extrapulmonary disease); test for latent TB before use and during therapy; treat latent infection prior to use
            • 2) Invasive fungal infections (eg, histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, pneumocystosis); may present with disseminated, rather than localized, disease; antigen/antibody testing for histoplasmosis may be negative in some patients with active infection; initiate empiric antifungal therapy if severe systemic illness develops
            • 3) Other bacterial (eg, Legionella, Listeria), mycobacterial (eg, tuberculosis), and viral (eg, hepatitis B) opportunistic pathogens

            Malignancy

            • Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers
            • Manufacturer required to report all malignancies to FDA in order for complete and consistent analysis

            Contraindications

            Active serious infection

            Concomitant live vaccines

            Cautions

            Risk of infections, reactivation of latent hepatitis/TB; interrupt if serious infection develops (eg, bacterial sepsis, severe invasive fungal infections, opportunistic infections)

            Infection risk increases when coadministered with abatacept, anakinra, or rituximab

            May decrease humoral response to live-virus vaccines (eg, MMR)

            Administration of live virus vaccines and therapeutic agents (eg, BCG bladder instillation) may result in disseminated infections

            Increased risk of lymphoma and other cancers reported in children and adolescents

            Occurrence of leukemia and new-onset psoriasis in patients treated with TNF blockers

            Skin cancer (melanoma, Merkel cell carcinoma) reported with TNF blockers; perform periodic skin examination for all patients, particularly those with risk factors for skin cancer

            Enhanced safety surveillance requirements to capture malignancy data: Manufacturers required to report all malignancies to FDA in order for complete and consistent analysis

            Risk of exacerbation of or new onset heart failure; discontinue therapy if worsening symptoms occur; fatal outcomes reported in patients with congestive heart failure

            Risk of exacerbation of or new onset demyelinating disease

            Lupus-like syndrome may occur; discontinue therapy if it develops

            Given with or without methotrexate depending on indication

            No added benefits, but increased adverse effects, if given with other immunosuppressive biologics

            Serious systemic hypersensitivity reactions including anaphylaxis may occur

            Hepatosplenic T-cell lymphomas (HSTCL)

            • Rare postmarketing cases reported primarily in adolescent and young adult patients with Crohn disease and ulcerative colitis treated with TNF blockers
            • Reports have also included a patient being treated for psoriasis and 2 patients being treated for rheumatoid arthritis
            • HSTCL is an aggressive, rare type of T-cell lymphoma (usually fatal)
            • Most reported cases with TNF blockers have occurred with concomitant treatment with azathioprine or 6-mercaptopurine, although there have been cases reported receiving azathioprine or mercaptopurine alone
            • The following HSTCL cases have been identified in the FDA Adverse Event Reporting System (AERS) database, the literature, and the HSTCL Cancer Survivors' Network: infliximab (20), etanercept (1), adalimumab (2), infliximab/adalimumab (5), certolizumab (0), golimumab (0), azathioprine (12), and mercaptopurine (3)
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled trials in pregnant women; monoclonal antibodies are transported across the placenta during the third trimester and may affect immune response in the in utero exposed infant

            Use during pregnancy only if clearly needed

            Another TNF-blocking monoclonal antibody administered during pregnancy was detected for up to 6 months in the serum of infants; consequently, these infants may be at increased risk of infection

            Live vaccines administration to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last dose during pregnancy

            Lactation

            There is no information regarding the presence in human milk, the effects on breastfed infants, or the effects on milk production

            Maternal IgG is known to be present in human milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Human anti-TNF-alpha monoclonal antibody, blocks inflammatory activity of TNF-alpha

            Absorption

            Bioavailability: 53% (SC)

            Peak Plasma Time (50 mg dose): 2-6 days

            Peak Plasma Concentration: 2.5 mcg/mL

            Distribution

            Vd: 58-126 mL/kg

            Elimination

            Half Life: 2 wk

            Clearance: 4.0-6.7 mL/kg/day

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            Administration

            IV Preparation

            Inspect vial; solution is colorless to light yellow and opalescent

            The solution may develop a few fine translucent particles, as golimumab is a protein; do not use if opaque particles, discoloration or other foreign particles are present

            Dilute calculated dose volume with 0.9% NaCl to a final volume of 100 mL; alternatively, 0.45% NaCl Injection, USP can also be used; gently mix (DO NOT SHAKE)

            Discard any unused drug remaining in the vials

            IV Administration

            Use only an infusion set with an in-line, sterile, nonpyrogenic, low protein-binding filter (pore size 0.22 micrometer or less)

            Do not administer concomitantly in same IV line with other agents

            Infuse over 30 minutes

            SC Preparation & Administration

            Warm by sitting at room temperature for 30 min; do NOT heat or microwave

            If multiple injections required, administer at different site on the body

            Rotate injection sites for each administration

            Do not administer in area where the skin is tender, bruised, red, or hard

            Storage

            Refrigerate unopened IV and SC products at 2-8ºC (36-46ºF); do not freeze

            Keep the product in the original carton to protect from light until the time of use

            Once diluted, IV infusion solution may be stored for 4 hr at room temperature

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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