Enbrel

[etanercept]

Patient Info
Information for Patients

ENBREL® is provided as a single-use prefilled syringe or multiple-use vial. The needle cover on the single-use prefilled syringe contains dry natural rubber (latex), which should not be handled by persons sensitive to this substance. 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 Information” 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 and syringes should be used. If the product is intended for multiple use, additional syringes, needles, and alcohol swabs will be required.

Patients with Heart Failure

Text Continues Below

---

Two large clinical trials evaluating 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 pre-existing cardiovascular disease. Some of these patients have been under 50years of age. Physicians should exercise caution when using ENBREL® in patients who also haveheart failure, and monitor patients carefully.

Page:  1 | 2 | 3 | 4 | 5 | Next >>