Tapros Depot

Tapros Depot Warnings

leuprorelin

Manufacturer:

Takeda
Full Prescribing Info
Warnings
Since Tapros Depot is a sustained-release preparation with its action lasting 4 weeks, administration at an interval exceeding 4 weeks may lead to the recurrence of an increase in the serum level of gonadotropic hormone due to the pituitary-gonad system stimulating effect of this drug, resulting in a transient aggravation of the clinical condition. Therefore, the method of administering once every 4 weeks should be observed.
Endometriosis, Uterine Myoma (Fibroid): The incidence of adverse reaction generally tends to increase with an increase in dose. Thus, in setting the dose, careful attention should be paid to the body weight.
Before any prescription of Tapros Depot, it is mandatory to verify that the patient is not pregnant. During the period of the treatment, the patient should be instructed to prevent conception with the use of nonhormonal methods.
It is advised, as for every other Gn-RH analogues, to monitor the patients suffering from osteoporosis during prolonged use.
A decrease in bone mass may occur owing to estrogen reducing effect of Tapros Depot. Therefore, as a rule, it should not be administered to patients with endometriosis or uterine myoma for >6 months. (The safety of administration for >6 months has not been established). When it is inevitable to administer Tapros Depot for a long period or to resume its administration, it should be carefully administered after the bone mass is examined as far as possible.
Breast Cancer: When starting treatment with Tapros Depot, absence/presence of hormone receptor expression should be confirmed as a rule. When hormone receptor expression is confirm to be negative, Tapros Depot should not be used.
Before starting the treatment, it should be confirmed that the patient is not pregnant. During the period of treatment with Tapros Depot, the patient should be instructed to prevent conception with the use of a nonhormonal method. A decrease in bone mass may occur owing to estrogen reducing effect of Tapros Depot. Therefore, when administered for a long period, Tapros Depot should be carefully administered after bone mass is examined as far as possible.
Uterine Myoma (Fibroid): It should be noted that the treatment of uterine myoma with Tapros Depot is not radical treatment. Therefore, it should be used as a means of providing conservative treatment until operation or providing premenopausal conservative treatment. For hypogastralgia and low back pain, the effect is not observed at the early period after administration. During such a period, therefore, appropriate symptomatic treatment should be given.
Prostate Cancer: Patient who have already had renal dysfunction due to spinal cord compression or urethral obstruction or those may be risk of developing of such manifestation. There is a possibility that the symptoms or underlying diseases are aggravated with the elevation of serum testosterone level in the early period after the first administration.
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