Adult Dosing
Rheumatoid Arthritis
- Simponi: 50 mg SC once a month in combination with methotrexate
- Simponi Aria: 2 mg/kg IV infused over 30 minutes at weeks 0 and 4, then q8weeks in combination with methotrexate
Psoriatic Arthritis, Ankylosing Spondylitis
- 50 mg SC once a month, with or without methotrexate
Moderately to severely active Ulcerative Colitis
- 200 mg SC at wk 0, followed by 100 mg at wk 2, and a maintenance dose of 100 mg q4 wks thereafter
Notes:- Corticosteroids, non-biologic DMARDs and/or NSAIDs may be continued during golimumab treatment
- Evaluate the patients for active tuberculosis and test for latent infection, prior to initiating and regularly during golimumab therapy
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
- Invasive fungal infections such as histoplasmosis, coccidioidomycosis, aspergillosis, and pneumocystosis have been reported during therapy. Patients may present with disseminated, rather than localized, disease [US Black Box Warning]
- Closely monitor for the development of signs and symptoms of infection during and after golimumab treatment, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiation of therapy [US Black Box Warning]
- Active tuberculosis, including reactivation of latent tuberculosis has been observed during therapy. Patients with tuberculosis have frequently presented with disseminated or extra pulmonary disease [US Black Box Warning]
- Lymphomas and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including golimumab [US Black Box Warning]
- Treatment should not be initiated in patients with an active infection, including clinically important localized infections
- Consider carefully the risks and benefits of treatment prior to initiating therapy in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of an opportunistic infection; who have traveled or resided in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose to infections
- Reactivation of tuberculosis or new tuberculosis infections have been reported in patients receiving TNF-blockers and also in patients who have previously received treatment for latent or active tuberculosis
- Anti-tuberculosis therapy should be considered prior to initiation of golimumab in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed and in patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection
- Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient
- Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients having severe systemic illness with risk for invasive fungal infections
- Golimumab therapy has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis-B carriers. In patients with HBV reactivation, discontinue therapy and initiate antiviral therapy with appropriate supportive treatment
- Consider the risks and benefits of TNF-blocker therapy prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer
- Merkel cell carcinoma has been reported with TNF blockers; perform periodic skin examination for all patients, particularly those with risk factors for skin cancer
- Worsening congestive heart failure (CHF) and new onset CHF have been observed during therapy. Use with caution in patients with CHF and monitor patients closely during therapy. Discontinue the drug if new or worsening symptoms of CHF appear
- New onset or exacerbation of central nervous system (CNS) demyelinating disorders and peripheral demyelinating disorders have been associated with TNF-blockers. Discontinue therapy if these disorders develop
- Avoid co-administration of abatacept or anakinra with golimumab
- Pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia have been reported in patients receiving golimumab therapy. Use with caution in patients who have significant cytopenias
- Patients may receive vaccinations during golimumab therapy, except for live vaccines
Cautions: Use cautiously in
- Myelosuppression
- Concurrent immunosuppressants
- Hypersensitivity to latex (prefilled syringe, autoinjector forms)
Pregnancy Category:B
Breastfeeding: Because no information is available regarding golimumab use during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 11 January 2011). As per manufacturer's data, it is unknown whether golimumab is excreted in breast milk. Manufacturer recommends discontinuation of nursing or discontinuation of therapy, taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Simponi 50 MG/0.5ML SOLN [Syringe] (JANSSEN BIOTECH)
0.5 0.5ml = $2022.89
1.5 0.5ml = $6065.17
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
