Raloxifene (Evista) Contraindications and Precautions
- breast-feeding
- pregnancy
- thromboembolic disease
- children
- females
- hepatic disease
- hypertriglyceridemia
- surgery
Raloxifene (Evista) Contraindications and Precautions
Raloxifene is classified as FDA pregnancy category X. It is contraindicated in women during pregnancy or in women who may become pregnant. Fetal anomalies, fetal development retardation, and decreased neonatal survival may occur when raloxifene is administered to pregnant women (see Adverse Reactions). Raloxifene is not indicated for use in premenopausal females. Safety has not been established and its use is not recommended in this population.
Raloxifene should be avoided in women who are breast-feeding due to the potential risk to the newborn, although it is not known if the drug is excreted in human milk.
Raloxifene is contraindicated in patients with acute thromboembolism or a past history of thromboembolic disease, including patients with a history of deep vein thrombosis, pulmonary embolism, or retinal vein thrombosis. An increased risk of thromboembolic events has been observed in women taking raloxifene (see Adverse Reactions). The drug should be discontinued at least 72 hours prior to and during prolonged immobilization (e.g., post-surgery recovery, prolonged bed rest); raloxifene should be resumed only after a patient is fully ambulatory. In addition, patients should be advised to avoid long periods of restricted movement during travel. The risk and benefit of raloxifene therapy should be considered carefully in patients at risk for thromboembolic events.
Raloxifene should be used with caution in patients with hepatic disease. In patients with cirrhosis (serum bilirubin 0.6 - 2 mg/dl), plasma raloxifene concentrations are approximately 2.5 times higher than in patients without hepatic impairment. Safety and efficacy have not been evaluated in patients with severe hepatic insufficiency.
Women with a history of hypertriglyceridemia (> 5.6 mmol/l or > 500 mg/dl) should have serum triglycerides monitered during raloxifene therapy. Limited clinical data suggests that women with a history of hypertriglyceridemia in response to oral estrogen or estrogen plus progestin may develop increased levels of triglycerides during raloxifene treatment.
The concurrent use of raloxifene and systemic estrogen or hormone replacement therapy has not been studied in prospective clinical trials. Thus, concomitant use of raloxifene with systemic estrogens is not recommended.
Raloxifene has not been adequately studied in women with a history of breast cancer. Studies are currently underway to evaluate the efficacy of raloxifene in preventing breast cancer. Safety and efficacy have also not been evaluated in men.
Raloxifene is not associated with endometrial proliferation, breast enlargement, or breast pain. Any unexplained uterine bleeding or breast abnormality should be thoroughly investigated.
Raloxifene should not be used in children.
[ Last revised: 9/11/2002 6:21:00 PM ]
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