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Takeda's "Leuplin® PRO for Injection Kit 22.5 mg" Now Available for the Treatment of Prostate Cancer/Premenopausal Breast Cancer in Japan

December 15, 2015

Osaka, Japan, December 15, 2015—Takeda Pharmaceutical Company Limited ("Takeda") today announced that “Leuplin®PRO for Injection Kit 22.5 mg” (hereafter 24-week depot formulation), the 24-week depot formulation of “Leuplin®” (generic name: leuprorelin acetate; hereafter “Leuplin”), is now available in Japan for the treatment of prostate cancer and premenopausal breast cancer.

Leuplin is an LH-RH agonist that consistently stimulates the pituitary gland, resulting in suppressed production of male/female hormone. Leuplin is used as a treatment for hormone-dependent diseases such as prostate cancer and premenopausal breast cancer, and it is currently available in the United States, Europe, and Asia. The 24-week depot formulation becomes available for the first time in the world for the treatment of premenopausal breast cancer.

The 24-week depot formulation can maintain stable blood concentration by sustained release using Takeda's unique microcapsule formulation technology through 24 weeks with a single injection. The new formulation providing sustained efficacy over a 24-week period will be a valuable addition to the available dosing options and provides the added benefit of less frequent dosing thus helping reduce the burden of treatment for patients with prostate cancer and premenopausal breast cancer.

“Given the high unmet needs that remain among patients with prostate cancer and premenopausal breast cancer, we have continued the Research and Development with our drug delivery for Leuplin even after its launch in Japan in 1992,” said Masato Iwasaki, Ph.D., Director and President, Japan Pharma Business Unit of Takeda. “We are confident that the new 24-week depot formulation will help ease the various burden of treatment for patients with prostate cancer and premenopausal breast cancer”.

Overview of the 24-week depot formulation 

Brand name Leuplin®PRO for Injection Kit 22.5 mg
Generic name Leuprorelin acetate
Indications      Prostate cancer
Premenopausal breast cancer
Dosage and administration Usually, for adults, 22.5 mg of Leuprorelin Acetate is subcutaneously administered once every 24 weeks.
When using Leuplin® PRO, it should be used after suspending it completely by transferring the whole quantity of the vehicle into the powder part, by pressing the plunger rod, with the injection needle held upward, with caution against foaming.
Drug price ¥ 105,039


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Tsuyoshi Tada
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