* Golimumab, a monoclonal antibody, has been approved to treat moderate-to-severe ulcerative colitis in adults who've been resistant to prior treatment or who need continuous steroid therapy.
* Because of the immune suppression from golimumab, patients receiving the drug are at increased risk for serious infections.
The monoclonal antibody -golimumab (Simponi) has been approved to treat moderate-to-severe ulcerative colitis in adults who have been resistant to other treatment or who require continuous steroid therapy. The product was already approved for use in treating rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Golimumab specifically blocks tumor necrosis factor-[alpha] (TNF-[alpha]) at its receptors. TNF-[alpha] has a role in causing abnormal inflammatory and immune responses.
The new indication is based on data from two clinical trials in which golimumab was found to increase the likelihood of clinical response, clinical remission, and improved endoscopic appearance of the mucosa in comparison with placebo. In the treatment of ulcerative colitis, the drug is administered subcutaneously at week 0 and week 2 and then every four weeks.
The most common adverse -effects of golimumab therapy are upper respiratory infection and redness at the injection site. Because of its immunosuppressive action, patients receiving golimumab are at increased risk for -serious infections. A boxed warning in the prescribing information states that patients are at increased risk for tuberculosis, bacterial sepsis, invasive fungal infections, and other opportunistic infections, as well as lymphoma and other malignancies. Patients receiving golimumab are also at increased risk for reactivation of hepatitis B infection, heart failure, nervous system disorders, and allergic reactions.
Before a patient begins golimumab therapy, the nurse should confirm that she or he doesn't have latent tuberculosis. If latent tuberculosis is present, it should be treated prior to the start of golimumab therapy. Patients should also be tested for hepatitis B viral infection before beginning golimumab therapy. Nurses shouldn't initiate golimumab treatment in any patient with active infection, and they should assess for latex allergies because the needle cover on the prefilled syringes contains dry natural rubber. Patients should be taught how to self-administer golimumab subcutaneously. Specific instructions are included in the package insert, and a medication guide comes with each filled prescription. Nurses should also instruct patients to notify their prescriber immediately if they develop symptoms of an infection.
Complete Food and Drug Administration prescribing information is available at http://1.usa.gov/11RmGWj.