Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Estracyt should be used with caution in patients with a history of thrombophelebitis, thrombosis or thromboembolic disorders, especially if associated with estrogen therapy. Caution should also be used in patients with cardiovascular disease, cerebral vascular disease and coronary artery disease.

Glucose Tolerance – Because glucose tolerance may be decreased, diabetic patients should be carefully followed while receiving Estracyt.

Elevated blood pressure – Because hypertension may occur, blood pressure should be monitored periodically.

Fluid retention – Exacerbation of pre-existing or incipient peripheral oedema or congestive heart disease has been seen in some patients receiving Estracyt therapy. Other conditions which might be influenced by fluid retention, such as epilepsy, migraine, or renal dysfunction, require careful observation.

Calcium/phosphorous metabolism – Estracyt may influence the metabolism of calcium and phosphorous and should be used with caution in patients with metabolic bone diseases that are associated with hypercalcemia or in patients with renal insufficiency. Serum calcium should be performed at regular intervals. Patients with prostate cancer and osteoblastic metastases are at risk for hypocalcaemia and should have calcium levels closely monitored.

Estracyt may be poorly metabolized in patients with impaired liver function and should be administered with caution in such patients. Liver function tests should be performed at regular intervals.

Note: since certain endocrine and hepatic functions are influenced by estrogen-containing drugs the corresponding laboratory test values will be affected.

Use with caution in patients with moderate to severe bone marrow depression.
Blood count should be performed at regular intervals.

Immunosuppressant Effects/Increased Susceptibility to Infections - Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including Estracyt, may result in serious or fatal infections. Vaccination with a live vaccine should be avoided in patients receiving Estracyt. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.

Effects on Driving

4.7   Effects on ability to drive and use machines
The effect of estramustine on the ability to drive or use machinery has not been systematically evaluated.