MHLW Approves Additional Indications for METHOTREXATE Capsules
Osaka, Japan – June 18, 2019 – Sawai Pharmaceutical Co., Ltd. (Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change application by the Ministry of Health, Labour and Welfare (MHLW) for METHOTREXATE Capsules 2 mg [SAWAI]*. This approval expands the indications of METHOTREXATE products to include the same uses as their brand equivalents.
* Brand products: RHEUMATREX® (Methotrexate) Capsules 2 mg
“Indications and Usage” and “Dosage and Administration” after approval are described below (New approval is underlined);
Indications and Usage
- Rheumatoidarthritis
- Psoriasis vulgaris, which is not adequately responsive to topicaltherapies
- Psoriasis arthropathica, pustular psoriasis, or erythrodermicpsoriasis
- Juvenile idiopathic arthritis associated with jointsymptoms
Dosage and Administration
- Rheumatoid arthritis,
- Psoriasis vulgaris, which is not adequately responsive to topical therapies,
- Psoriasis arthropathica, pustular psoriasis, or erythrodermic psoriasis. The usual dose of Methotrexate is 6 mg per week and orally administered once or as a divided dose two or three times. When given in a divided dose, administer every 12 hours from the first day to the second day. In the case of one or two divided doses, discontinue for the remaining 6 days, and in the case of three divided doses, discontinue for the remaining 5 days. This is repeated every week. It is necessary to adjust the dosage appropriately depending patient’s age, symptoms, tolerability, response to this drug. The dosage should not exceed 16 mg per week.
- Juvenile idiopathic arthritis associated with joint symptoms.The usual dose of Methotrexate is 4 to 10 mg/m2 per week and orally administered once or as a divided dose two or three times. When given in a divided dose, administer every 12 hours from the first day to the second day. In the case of one or two divided doses, discontinue for the remaining 6 days, and in the case of three divided doses, discontinue for the remaining 5 days. This is repeated every week.
It is necessary to adjust the dosage appropriately depending patient’s age, symptoms, tolerability, and response to this drug.
The product announced in this press release are not approved by the Food & Drug Administration for sale and distribution in the United States.
About Sawai
Founded in 1929, Sawai Pharmaceutical Co., Ltd. has grown into one of the leading generics companies in Japan. Guided by its corporate philosophy, “Always Putting Patients First,” Sawai markets more than 310 high-quality generic drugs with 760 strengths and reliably delivers them to patients throughout Japan. In 2017, Sawai acquired US-based Upsher-Smith Laboratories, LLC marking its first step in overseas expansion to become a globally recognized generic pharmaceutical company. For more information, visit: https://www.sawai.co.jp/en/.
For further information please contact:
PR/IR group, koho@sawai.co.jp