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August 19, 2021

Launch of UPASITA® IV Injection Syringe for the Treatment of Secondary Hyperparathyroidism in Dialysis Patients

SANWA KAGAKU KENKYUSHO CO., LTD.
Kissei Pharmaceutical Co., Ltd. 


SANWA KAGAKU KENKYUSHO Co., Ltd. (Head Office: Nagoya, President and CEO: Shusaku Isono, Suzuken Group, ; "SANWA KAGAKU") will launch UPASITA® IV Injection Syringes (generic name: Upacicalcet Sodium Hydrate; "UPASITA®") for the treatment of secondary hyperparathyroidism in patients on hemodialysis on August 20, 2021.

UPASITA® acts on calcium sensing receptor in the parathyroid and suppresses excessive secretions of parathyroid hormones (PTH). UPASITA® is administered by intravenous injection to dialysis patients through dialysis circuit and it is possible to adjust the dose and control the medication under the control of physicians or medical staffs.

Regarding provision of medical and drug information, SANWA KAGAKU is in a co-promotion agreement in Japan with Kissei Pharmaceutical Co., Ltd. (Head Office: Matsumoto, Nagano; Chairman and CEO: Mutsuo Kanzawa ; "Kissei").
SANWA KAGAKU will handle the production, marketing, and distribution of the Product while SANWA KAGAKU and Kissei collaboratively promote it to medical institutions in the field in accordance with the agreement. Through the co-promotion activity in the field, SANWA KAGAKU and Kissei will contribute to the treatment of dialysis patients suffering from secondary hyperparathyroidism.


《Reference》


About secondary hyperparathyroidism (SHPT)
SHPT is one of the complications that occur as chronic kidney disease (chronic kidney failure) progresses and is a pathological condition where excessive PTH is secreted by the parathyroid gland. It has been reported that excessive secretion of parathyroid hormone promotes efflux of phosphorus and calcium from the bone into the blood, thereby increasing the risk of developing bone fractures and arteriosclerosis due to calcification of the cardiovascular system and affecting the vital prognosis.

Product Summary of UPASITA® IV Injection Syringe for Dialysis
Brand name:
UPASITA® IV Injection Syringe for Dialysis 25μg
UPASITA® IV Injection Syringe for Dialysis 50μg
UPASITA® IV Injection Syringe for Dialysis 100μg
UPASITA® IV Injection Syringe for Dialysis 150μg
UPASITA® IV Injection Syringe for Dialysis 200μg
UPASITA® IV Injection Syringe for Dialysis 250μg
UPASITA® IV Injection Syringe for Dialysis 300μg

Generic Name (JAN):
Upacicalcet Sodium Hydrate

Indications:
Secondary hyperparathyroidism in patients on hemodialysis

Dosage and Administration:
In adults, UPASITA® is usually administered into venous line of the dialysis circuit at the end of dialysis session during rinse back at a dose of 25 μg sodium upacicalcet 3 times a week as a starting dose.
The starting dose can be 50 μg depending on the concentration of serum calcium.
Thereafter, the dose may be adjusted in a range from 25 to 300 μg while parathyroid hormone (PTH) and serum calcium level should be carefully monitored in patients.

Date of Marketing Approval in Japan:
June 23, 2021

Date of Drug Price Listing:
August 12, 2021

Date of Launch in Japan:
August 20, 2021

MAH:
SANWA KAGAKU KENKYUSHO Co., Ltd.

Partner:
Kissei Pharmaceutical Co., Ltd.