Tapros Depot

Tapros Depot Special Precautions

leuprorelin

Manufacturer:

Takeda
Full Prescribing Info
Special Precautions
For All Indications: It has been reported that the benign pituitary adenoma was observed in rats in a study in which Tapros Depot was administered SC in dose of 0.8, 3.6 and 16 mg (as leuporelin 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 0.6, 1.5, 4 mg/kg daily for 2 years.
Endometriosis, Uterine Myoma (Fibroid): In administration of Tapros Depot, care should be taken to differentiate a similar disease (malignant tumor) from endometriosis, uterine myoma. If during administration, 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 first administration of Tapros Depot, a transient elevation of the serum level of estrogen may occur owing to the stimulating effect, 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 depressed state like climateric disturbance may occur, the patient's condition should be closely observed.
In administration of Tapros Depot to patients with submucous myoma, bleeding symptom may worsen. Therefore, close observation should be made. The patient should be instructed to contact the attending physician in case of any aggravation of the bleeding symptom.
Central Percocious Puberty: In the early period after the first administration of Tapros Depot, a transient elevation of the serum level of gonadropin hormone may occur owing to the stimulating effect, 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.
LH-RH test should be performed at regular intervals. When suppression of the action of LH and FSH in blood is not achieved. In the administration of Tapros Depot should be discontinued.
Prostate Cancer and Breast Cancer: Since Tapros Depot is an agent for endocrine therapy, use for prostate/premenopausal breast cancer should be limited to patients for whom treatment 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 first administration of Tapros Depot, a transient elevation of the serum level of estrogen may occur owing to the stimulating effect, 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 depressed state like climateric disturbance may occur, the patient's condition should be closely observed.
Endometriosis, Uterine Myoma (Fibroid), Central Precocious Puberty, Breast Cancer: It has been reported that the administration of Tapros Depot brought about venous thrombosis or pulmonary embolism.
Prostate Cancer: It has been reported that the administration of Tapros Depot brought about cerebral infarction, venous thrombosis or pulmonary embolism.
Use in children: The safety of Tapros Depot in prematures, newborns and nursing infants has not been established.
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