etanercept, Enbrel (cont.)

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PREGNANCY: Studies have not been conducted in pregnant women. Animal studies using doses 60-100 times human doses did not reveal toxicity to the fetus. Since animal studies are not always predictive of human response, etanercept is only used in pregnant women when there is a clear need.

NURSING MOTHERS: It is unknown whether etanercept is excreted in human breast milk. Because of the risk of serious effects in the infant, a decision should be made whether to discontinue nursing or etanercept.

SIDE EFFECTS: The most common side effects are mild to moderate itching, pain, swelling, and redness at the site of injection. Headache, dizziness, nasal and throat irritation also occur.

TNF alpha has an important role in the responses of the immune system to infections. Thus, blocking the action of TNF alpha with etanercept may worsen or increase the occurrence of infections such as tuberculosis, bacterial sepsis, invasive fungal infections (such as histoplasmosis), and other opportunistic infections (infections that occur primarily in patients with suppressed immune systems). Patients with serious infections should not receive etanercept, and etanercept should be discontinued if a patient develops a serious infection. Etanercept should be used with caution in patients prone to infection, such as those with advanced or poorly controlled diabetes. Children should receive their recommended immunizations before treatment with etanercept.

Some reported associated conditions may or may not be related to etanercept. Since etanercept has been on the market, there have been reports of cancer, multiple sclerosis, myelitis, optic neuritis in patients using the drug. For this reason, etanercept is not recommended for persons with preexisting disease of the central nervous system (brain and/or spinal cord) or for those with multiple sclerosis, myelitis, or optic neuritis. Additionally, rare cases of seriously low blood counts (pancytopenia) have been reported in patients using etanercept. New cases or worsening of congestive heart failure may occur.

Reference: FDA Prescribing Information

Last Editorial Review: 7/19/2011

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