k medical eva luation immediately.
Latex Sensitivity Allergies
ENBREL® is provided as a single-use prefilled syringe, a single-use prefilled SureClick autoinjector, or a multiple-use vial. The patient or caregiver should be informed that the needle cap on the prefilled syringe and on the SureClick autoinjector contains dry natural rubber (a derivative of latex), which should not be handled by persons sensitive to latex.
Administration of ENBREL®
If a patient or caregiver is to administer ENBREL®, the patient or caregiver should be instructed in injection techniques and how to measure and administer the correct dose (see the ENBREL® (etanercept) “Patient Instructions for Use” insert). The first injection should be performed under the supervision of a qualified health care professional. The patient’s or caregiver’s ability to inject subcutaneously should be assessed. Patients and caregivers should be instructed in the technique as well as proper syringe and needle disposal, and be cautioned against reuse of needles and syringes. A puncture-resistant container for disposal of needles, syringes, and autoinjectors should be used. If the product is intended for multiple use, additional syringes, needles, and alcohol swabs will be required.
Patients with Heart Failure
Two large clinical trials eva luating the use of ENBREL® in the treatment of heart failure were terminated early due to lack of efficacy. Results of one study suggested higher mortality in patients treated with ENBREL® compared to placebo. Results of the second study did not corroborate these observations. Analyses did not identify specific factors associated with increased risk of adverse outcomes in heart failure patients treated with ENBREL® (see ADVERSE REACTIONS: Patients with Heart Failure). There have been post-marketing reports of worsening of congestive heart failure (CHF), with and without identifiable precipitating factors, in patients taking ENBREL®. There have also been rare reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Some of these patients have been under 50 years of age. Physicians should exercise caution when using ENBREL® in patients who also have heart failure, and monitor patients carefully.
Immunosuppression
Anti-TNF therapies, including ENBREL®, affect host defenses against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses. In a study of 49 patients with RA treated with ENBREL®, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations. The impact of treatment with ENBREL® on the development and course of malignancies, as well as active and/or chronic infections, is not fully understood (see WARNINGS: Malignancies, ADVERSE REACTIONS: Infections, andMalignancies). The safety and efficacy of ENBREL® in patients with immunosuppression or chronic infections have not been eva luated.
Immunizations
Most psoriatic arthritis patients receiving ENBREL® were able to mount effective B-cell immune responses to pneumococcal polysaccharide vaccine, but titers in aggregate were moderately lower and fewer patients had two-fold rises in titers compared to patients not receiving ENBREL®. The clinical significance of this is unknown. Patients recei |
