Golimumab
Pronunciation: (goe-LIM-ue-mab)Class: Monoclonal antibody
Trade Names:
Simponi
- Injection, solution 50 mg per 0.5 mL
Pharmacology
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Binds to both soluble and transmembrane bioactive forms of human tumor necrosis factor–alpha (TNF-alpha), preventing the binding of TNF-alpha to its receptors, thereby inhibiting the biological activity of TNF-alpha.
Pharmacokinetics
Absorption
Following subcutaneous injection, T max ranges from 2 to 6 days. C max is approximately 2.5 mcg/mL. Absolute bioavailability is approximately 53%.
Distribution
Distributed primarily in the circulatory system with limited extravascular distribution.
Elimination
Mean terminal half-life is approximately 2 wk.
Special Populations
Renal Function ImpairmentNo studies have been conducted.
Hepatic Function ImpairmentNo studies have been conducted.
ElderlyNo differences were observed based on age.
GenderNo dosage adjustment is needed based on gender.
RaceNo differences in pharmacokinetics have been observed based on race.
Indications and Usage
Treatment of moderate to severe active rheumatoid arthritis in combination with methotrexate; treatment of active psoriatic arthritis as monotherapy or in combination with methotrexate; treatment of active ankylosing spondylitis.
Contraindications
Standard considerations.
Dosage and Administration
AdultsSubcutaneous 50 mg once per month.
General Advice
- Prior to injection, allow the prefilled syringe or auto-injector to sit at room temperature for 30 minutes.
- Discard any leftover product remaining in the prefilled syringe or prefilled auto-injector.
- Do not inject into areas where the skin is tender, bruised, red, or hard.
- Injection sites should be rotated.
- Do not shake.
Storage/Stability
Store refrigerated at 36° to 46°F. Do not freeze. Protect from light. Do not shake.
Drug Interactions
Abatacept, anakinraDo not coadminister with golimumab.
CYP substrates with a narrow therapeutic index (eg, cyclosporine, theophylline, warfarin)Monitor the response and drug concentrations of CYP substrates with a narrow therapeutic index when starting or stopping golimumab.
Live vaccinesDo not coadminister live vaccines.
TNF antagonistsRisk of infection may be increased; do not coadminister.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Dizziness (2%); paresthesia, pyrexia (1%).
EENT
Nasopharyngitis (6%); pharyngitis, rhinitis (1%).
Lab Tests
Increased ALT (4%); increased AST (3%).
Local
Injection-site reactions (6%); injection-site erythema (3%).
Respiratory
Upper respiratory tract infection (7%); bronchitis, sinusitis (2%).
Miscellaneous
Golimumab antibodies (4%); hypertension (3%); influenza (2%); oral herpes (1%).
Precautions
WarningsPatients treated with golimumab are at increased risk for developing serious infections that may lead to hospitalization or death. These patients are frequently taking concomitant immunosuppressants (eg, corticosteroids, methotrexate). Infections include active tuberculosis (TB), invasive fungal infections, or bacterial, viral, or other infections caused by opportunistic pathogens. Discontinue treatment in patients who develop serious infection or sepsis. |
MonitorClosely monitor for development of signs or symptoms of infection during and after treatment, including possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Closely monitor patients who are carriers of hepatitis B virus for signs of active hepatitis B virus infection throughout therapy and for several months after completion of therapy. Closely monitor patients with CHF and discontinue treatment if new or worsening symptoms of CHF appear. |
Pregnancy
Category B .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Elderly
No overall differences in safety or efficacy have been observed in patients 65 yr of age and older compared with younger subjects.
CHF
Worsening of CHF and new-onset CHF have been reported with TNF-blockers.
Demyelinating disorders
Use of TNF-blockers has been associated with new onset or exacerbation of CNS demyelinating disorders (eg, multiple sclerosis).
Hematologic events
Pancytopenia, leukopenia, neutropenia, aplastic anemia, and thrombocytopenia have been reported with TNF-blockers during postmarketing experience.
Hepatitis B reactivation
Reactivation of hepatitis B virus has been reported in patients who are chronic hepatitis B carriers.
Latex
Needle cover on the prefilled syringe and the prefilled syringe on the auto-injector contain natural rubber, a derivative of latex, which should not be handled by persons sensitive to latex.
Malignancies
Lymphomas have occurred.
Vaccinations
Patients may receive vaccinations, except for live vaccines.
Overdosage
Symptoms
There were no overdoses in clinical studies.
Patient Information
- Instruct patients to notify their health care provider if they develop any symptoms of infection.
- Advise patients sensitive to latex that the needle cover on the prefilled syringe and the prefilled auto-injector contain natural rubber, a derivative of latex.
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More Golimumab resources
golimumab Subcutaneous - Includes detailed dosage instructions.
Compare Golimumab with other medications for the treatment of:
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
