Herbal Spotlight
|
|
 golimumab |
| Simponi |
|
| |
Pharmaceutical
company:
Centocor Ortho Biotech, Inc.
www.centocor.com |
NEW WARNING
Centocor Ortho Biotech has issued a "Dear Health Care Professional" letter about safety information related to the risk of serious fungal infections associated with their tumor necrosis factor-alpha (TNF-alpha)–blocking human monoclonal antibody, golimumab (Simponi). Golimumab is indicated for treatment of moderate to severe rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (alone or in combination with methotrexate), and ankylosing spondylitis. The Food and Drug Administration (FDA) has reported that TNF-alpha blockers, such as golimumab, certolizumab pegol (Cimzia), etanercept (Enbrel), adalimumab (Humira), and infliximab (Remicade) may impede recognition of histoplasmosis and other invasive fungal infections. The benefits of using golimumab should be weighed against the potential risks.
The prescribing information provides the following information about TNF-alpha blockers, including golimumab:
- TNF-alpha blockers place patients at risk for invasive fungal infections, including histoplasmosis, coccidioidomycosis, blastomycosis, candidiasis, aspergillosis, pneumocystosis, and other opportunistic fungal infections.
- Suspect an invasive fungal infection if the patient develops a serious illness and he resides or travels where mycoses are endemic.
- Monitor the patient for signs of invasive fungal infection during and after treatment.
- Encourage the patient to report signs of infection (fever, malaise, weight loss, sweats, cough, and dyspnea).
- If the patient develops an infection, consult an infectious disease doctor, discontinue therapy, and begin empiric antifungal therapy until the pathogen is identified. Therapy may be restarted after recovery, as ordered, if the benefits outweigh the risks of treatment.
Report adverse reactions to Centocor Ortho Biotech at
1-800-457-6399 and to the FDA's MedWatch Adverse Event Reporting Program at 1-800-FDA-1088.
|
