Tapros 3M

Tapros 3M Warnings

leuprorelin

Manufacturer:

Takeda
Full Prescribing Info
Warnings
Since Tapros 3M is a sustained-release preparation with its action lasting 12 weeks, administration at an interval exceeding 12 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 12 weeks should be observed.
Endometriosis: The incidence of adverse reactions generally tends to increase with an increase in dose. Thus, in selling the dose, careful attention should be paid to the body weight.
Before any prescription of Tapros 3M, 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 when prolonged use.
A decrease in bone mass may occur owing to estrogen reducing effect of Tapros 3M. Therefore, as a rule, this drug 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 this drug 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 3M, absence/presence of hormone receptor expression should be confirmed as a rule. When hormone receptor expression is confirmed to be negative, Tapros 3M should not be used.
Before starting treatment, it should be confirmed that the patient is not pregnant. During the period of treatment with Tapros 3M, the patient should be instructed to prevent conception with the use of a nonhonmonal method.
A decrease in bone mass may occur owing to estrogen reducing effect of Tapros 3M. Therefore, when this drug is administered for a long period, it should be carefully administered after bone mass is examined as far as possible.
Prostate Cancer: Patient who have already had renal dysfunction due to spinal cord compression or urethral obstruction or those may be at risk of developing such manifestation. There is a possibility that the symptoms or underlying disease are aggravated with the elevation of serum testosterone level in the early period after the 1st administration.
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