News Release
For Immediate Release
January 9, 2019
Sawai Pharmaceutical Co., Ltd.

MHLW Approves New Indication for ARGATROBAN Injection

Osaka, Japan – January 9, 2019 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka,Japan, President: Mitsuo Sawai) today received approval of partial change applications by theMinistry of Health, Labour and Welfare (MHLW) for ARGATROBAN Injection 10 mg [SAWAI]*.
This approval expands the indication of ARGATROBAN Injection 10 mg [SAWAI] to include thesame uses as their brand equivalents.
* Brand products: Novastan® HI Injection 10 mg / 2 mL and Slonnon® HI Injection 10 mg / 2 mL
“Indications and Usage” and “Dosage and Administration” after approvals are described below(New approval is underlined);
Indications and Usage
1. Improvement of neurological symptoms (motor paralysis) and activities of daily living (walking,standing, maintaining a sitting position, diet) associated with the following diseases:･Acute cerebral thrombosis within 48 hours after the onset of symptoms (excluding lacunartype)
2. Improvement of ulcers of the extremities, pain at rest, and cold sensation associated withchronic arterial occlusion (Buerger's disease and arteriosclerosis obliterans)
3. Prevention of blood coagulation in extracorporeal circuit in the following patients (duringhaemodialysis)･Patients with congenital antithrombin III deficiency･Patients with decreased antithrombin III(When antithrombin III decreased to less than 70% within the normal range, and heparin
sodium or heparin calcium did not improve clotting (residual blood) in the extracorporeal
circulation.)･Patients with heparin-induced thrombocytopenia (HIT) type II
4. Prevention of blood coagulation undergoing percutaneous coronary intervention in patients withheparin-induced thrombocytopenia (HIT) type II (including cases at risk of developing)
5. Prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia (HIT) type II
Dosage and Administration
1. Improvement of neurologic symptoms (motor paralysis) and activities of daily living (walking,standing, maintaining a sitting position, diet) associated with the following diseases:･Acute cerebral thrombosis within 48 hours after the onset of symptoms (excluding lacunartype)In general, for adults, 6 ampules (60 mg as argatroban hydrate) diluted with an appropriate
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volume of fluid are administered by continuous intravenous injection once daily over a period of
24 hours for the first 2 days. One ampule (10 mg as argatroban hydrate) diluted with anappropriate volume of fluid is administered by intravenous injection twice a day for the next 5days, in the morning and evening, over a period of 3 hours. The dosage may be adjusted
according to the patient's age and symptoms.
2. Improvement of ulcers of the extremities, pain at rest, and cold sensation in patients withchronic arterial occlusion (Buerger's disease and arteriosclerosis obliterans)
In general, for adults, 1 ampule (10 mg as argatroban hydrate) diluted with an appropriate
volume of fluid is administered by intravenous injection twice a day over a few hours. The
dosage may be adjusted according to the patient's age and symptoms.
3. Prevention of blood coagulation in extracorporeal circuit in the following patients (duringhaemodialysis)･Patients with congenital antithrombin III deficiency･Patients with decreased antithrombin III(When antithrombin III decreased to less than 70% within the normal range, and heparin
sodium or heparin calcium did not improve clotting (residual blood) in the extracorporealcirculation.)･Patients with heparin-induced thrombocytopenia (HIT) type II
In general, for adults, 1 ampule (10 mg as argatroban hydrate) is administered into the circuit at
the beginning of extracorporeal circulation, followed by 2.5 ampules (25 mg as argatroban
hydrate) administered every hour after extracorporeal circuit start. The dosage may be adjustedfor individual patients based on prolongation of coagulation time, blood clot in the circuit(residual blood), dialysis efficiency, and hemostasis at the end of dialysis. The standard dosage
is 0.5 to 4 ampules (5 to 40 mg as argatroban hydrate) per hour.
4. Prevention of blood coagulation undergoing percutaneous coronary intervention in patients withheparin-induced thrombocytopenia (HIT) type II (including cases at risk of developing)In general, for adults, 0.1 mg/kg as argatroban hydrate diluted with an appropriate volume offluid is administered (can be administrated undiluted) intravenously over a period of 3 to 5minutes, and 6 μg/kg/minute as argatroban hydrate is administered by continuous intravenous
infusion for 4 hours after surgery. If continuous anticoagulation is required, the dosage should
be reduced to 0.7 μg/kg/minute. This dosage of continuous intravenous infusion is just anapproximate standard, the dosage may be adjusted appropriately under coagulation monitoring.
5. Prophylaxis of thrombosis in patients with heparin-induced thrombocytopenia (HIT) type II
In general, for adults, 0.7 μg/kg/minute as argatroban hydrate diluted with an appropriate
volume of fluid is administered (can be administrated undiluted) by intravenous injection
followed continuous infusion. Start at a low dosage in patients with hepatic function disorder orat risk of bleeding. In addition, the dosage may be adjusted based on the activated partial
thromboplastin time (aPTT), and determined for individual patients.

◆ Contact information ◆PR / IR Group, Corporate Strategy Department, Sawai Pharmaceutical Co., Ltd
E-mail：koho@sawai.co.jp
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