Tapros 3M

Tapros 3M Special Precautions

leuprorelin

Manufacturer:

Takeda
Full Prescribing Info
Special Precautions
Endometriosis: In administration of Tapros 3M, care should be taken to differentiate a similar disease (malignant tumor, etc) from endometriosis, uterine myoma. If during administration of Tapros 3M, any growing phyma is found or no improvement is seen in the clinical symptom, the administration should be discontinued.
In the early period after the 1st administration of Tapros 3M, a transient elevation of the serum level of estrogen may occur owing to the stimulating effect of Tapros 3M, as a highly active LH-RH derivative, on the pituitary-gonad system, resulting in a transient aggravation of clinical condition. However, such an aggravation usually disappears in the course of continued administration.
Since a depressed state like climacteric disturbance may occur, the patient's condition should be closely observed.
Prostate Cancer: Since Tapros 3M is an agent for endocrine therapy, use of this drug for prostate cancer should be limited to patients for whom treatment with Tapros 3M is considered appropriate under the supervision of a physician who has adequate knowledge and experience in medication for cancer.
In the earlyy period after the 1st administration ofTapros 3M, a transient elevation of the serum level of testosterone may occur owing to the stimulating effect of Tapros 3M, as a highly active LH-RH derivative, on the pituitary-gonad system, resulting in a transient aggravation of bone pain, etc. In such a case, symptomatic treatment should be given. Since ureteral obstruction or spinal cord compression may occur, this drug should be carefully administered and close observation should be made during the 1st month after initiation of administration, and if any of such symptoms occur, appropriate measures should be taken.
Since a depressed state occur, the patient's condition should be closely observed.
Breast Cancer: Since Tapros 3M is an agent for endocrine therapy, use of this drug for premenopausal breast cancer should be limited to patients for whom treatment with Tapros 3M is considered appropriate under the supervision of a physician who has adequate knowledge and experience in medication for cancer.
In the early period after the 1st administration of Tapros 3M, a transient elevation of the serum level of estrogen may occur owing to the stimuiating effect of Tapros 3M, as a highly active LH-RH derivative, on the pituitary-gonad system, resulting in a transient aggravation of bone pain, etc. In such a case, symptomatic treatment should be given. In antitumor effect is not obtained with Tapros 3M and any progression of the tumor is observed, the administration should be discontinued.
Since a depressed state like climateric disturbance may occur, the patient's condition should be closely observed.
Other Precautions: All Indications: It has been reported that the benign pituitary adenoma was observed in rats in a study in which Tapros 3M was administered SC in doses of 0.8, 3.6 and 16 mg (as leuprorelin acetate)/kg at 4-week intervals for 1 year and another study in which an aqueous injectable solution of leuprorelin acetate was similarly administered in doses of 0.6, 1.5 and 4 mg/kg/day for 2 years.
Endometriosis and Breast Cancer: It has been reported that the administration of Tapros 3M brought about venous thrombosis or pulmonary embolism.
Prostate Cancer: It has been reported that the administration of Tapros 3M brought about cerebral infarction, venous thrombosis or pulmonary embolism.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in