Celvista Special Precautions

Stroke: The risk-benefit balance of raloxifene in postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation, should be considered when prescribing raloxifene. In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events taking raloxifene, the incidence of stroke, myocardial infarction, hospitalized acute coronary syndrome, cardiovascular mortality, or overall mortality was comparable to placebo. However, there was an increase in mortality due to stroke. The incidence of stroke mortality was 1.5 per 1000 women per year for placebo versus 2.2 per 1000 women per year for raloxifene.
Raloxifene is associated with an increased risk for venous thromboembolic events (deep vein thrombosis and pulmonary embolism) that is similar to the reported risk associated with current use of hormone replacement therapy. The risk-benefit balance should be considered in patients at risk of venous thromboembolic events of any aetiology. CELVISTA should be discontinued in the event of an illness or a condition leading to a prolonged period of immobilisation. Discontinuation should happen as soon as possible in case of the illness, or from 3 days before the immobilization occurs. Therapy should not be restarted until the initiating condition has resolved and the patient is fully mobile.
In a study of postmenopausal women with documented coronary heart disease or at increased risk for coronary events, raloxifene did not affect the incidence of myocardial infarction, hospitalized acute coronary syndrome, overall mortality, including overall cardiovascular mortality, or stroke compared to placebo. However, there was an increased in death due to stroke in women assigned to raloxifene. The incidence of stroke mortality was 2.2 per 1000 women per year for raloxifene versus 1.5 per 1000 women per year for placebo (see Adverse Reactions). This finding should be considered when prescribing raloxifene for postmenopausal women with a history of stroke or other significant stroke risk factors, such as transient ischemic attack or atrial fibrillation.
There is no evidence of endometrial proliferation. Any uterine bleeding during CELVISTA therapy is unexpected and should be fully investigated by a specialist. The two most frequent diagnoses associated with uterine bleeding during raloxifene treatment were endometrial atrophy and benign endometrial polyps. In postmenopausal women who received raloxifene treatment for 4 years, benign endometrial polyps were reported in 0.9% compared to 0.3% in women who received placebo treatment.
Raloxifene is metabolised primarily in the liver. Efficacy of raloxifene has not been studied in patients with impaired liver function. Single doses of raloxifene given to patients with cirrhosis and mild hepatic impairment (Child-Pugh class A) with total serum bilirubin ranging from 0.6 to 2.0 mg/dL produced plasma concentrations of raloxifene which were approximately 2.5 times higher than the controls. The increase correlated with total bilirubin concentrations. Until safety and efficacy have been evaluated further in patients with hepatic insufficiency, the use of CELVISTA is not recommended in this patient population. Serum total bilirubin, gamma-glutamyl transferase, alkaline phosphatase, ALT and AST should be closely monitored during treatment if elevated values are observed.
Estrogen-induced hypertriglyceridemia: In patients with a history of oral estrogen-induced hypertriglyceridemia (>5.6 mmol/L), raloxifene may be associated with a marketed increase in serum triglycerides. Patients with this medical history should have serum triglycerides monitored when taking raloxifene.
The safety of CELVISTA in patients with breast cancer has not been adequately studied. No data are available on the concomitant use of CELVISTA and agents used in the treatment of early or advanced breast cancer. Therefore, CELVISTA should be used for osteoporosis treatment and prevention only after the treatment of breast cancer, including adjuvant therapy, has been completed.
Concurrent Use of Systemic Hormone Therapy: Safety information regarding the concurrent use of raloxifene and systemic hormone therapy (estrogen with or without progestin) is limited and therefore concomitant use of raloxifene with systemic estrogen is not recommended.
CELVISTA is not effective in reducing vasodilatation (hot flushes), or other symptoms of the menopause associated with estrogen deficiency.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
There is no indication for use of raloxifene in males.
Effects on ability to drive and use machines: Raloxifene has no known effect on driving or the ability to use machinery.