Dosing & Uses
Dosage Forms & Strengths
SC solution (prefilled syringe/autoinjector)
IV solution (vial)
- Simponi Aria
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
Indicated alone or in combination with methotrexate for active psoriatic arthritis
50 mg SC qMonth
Indicated for active ankylosing spondylitis with or without methotrexate
50 mg SC qMonth
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
- Janssen Research & Development, LLC; Welsh & McKean Roads; P. O. Box 776; Spring House, PA 19477
Serious - Use Alternative
Significant - Monitor Closely
Upper respiratory infections (13-16%)
Injection site reactions, SC (6%)
Increased ALT/AST (3-4%)
Viral infections (4-5%)
Superficial fungal infections (2%)
Bacterial infections (1%)
Neoplasm benign and malignant: Melanoma
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
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
- 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
Active serious infection
Concomitant live vaccines
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
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)
Pregnancy & Lactation
Pregnancy Category: B
Lactation: not known if excreted in breast milk, do not nurse
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.
Mechanism of Action
Human anti-TNF-alpha monoclonal antibody, blocks inflammatory activity of TNF-alpha
Bioavailability: 53% (SC)
Peak Plasma Time (50 mg dose): 2-6 days
Peak Plasma Concentration: 2.5 mcg/mL
Vd: 58-126 mL/kg
Half Life: 2 wk
Clearance: 4.0-6.7 mL/kg/day
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
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
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
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.