Osaka, Japan –November 21, 2018 – Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) today received approval of partial change applications by the Ministry of Health, Labour and Welfare (MHLW) for LEVOFOLINATE I.V. Infusion 25 mg [SAWAI] and 100 mg [SAWAI]*.
This approval expands the indication of LEVOFOLINATE I.V. Infusion 25 mg [SAWAI] and 100 mg [SAWAI] to include the same uses as their brand equivalents.
* Brand products: ISOVORIN® I.V. Infusion 25 mg and 100 mg
“Indications and Usage” and “Dosage and Administration” after approvals are as below;
| Indications and Usage (New approval is underlined) |
- Levofolinate and 5-Fluorouracil therapy
- Enhancing the effect of 5-fluorouracil for the treatment of gastric cancer (which is inoperable or recurrent) and colorectal cancer
- Levofolinate and 5-Fluorouracil continuous intravenous combination therapy
- Enhancing the effect of 5-fluorouracil for the treatment of colorectal cancer, small intestine cancer and pancreatic cancer not amenable to curative resection
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| Dosage and Administration (New approval is underlined) |
- Levofolinate and 5-Fluorouracil therapy
- In general, for adults, 250 mg/m2 (body surface) as levofolinate is administered by intravenous drip infusion at one time over a period of 2 hours. 600 mg/m2 (body surface) as 5-fluorouracil is administered by bolus intravenous injection at one time within 3 minutes, 1 hour after beginning the levofolinate infusion. Repeat 6 times during 1 week, followed by a 2 week break. This is 1 cycle.
- Levofolinate and 5-Fluorouracil continuous intravenous combination therapy for colorectal cancer
- (1) In general, for adults, 100 mg/m2 (body surface) as levofolinate is administered by intravenous drip infusion at one time over a period of 2 hours. Immediately followed by 400 mg/m2 (body surface) as 5-fluorouracil is administered by intravenous injection at one time and 600 mg/m2 (body surface) as 5-fluorouracil is administered by continuous intravenous injection at one time over a period of 22 hours. This is continued for 2 days and repeated every 2 weeks.
- (2) In general, for adults, 250 mg/m2 (body surface) as levofolinate is administered by intravenous drip infusion at one time over a period of 2 hours. Immediately followed by 2600 mg/m2 (body surface) as 5-fluorouracil is administered by continuous intravenous injection at one time over a period of 24 hours. Repeat 6 times during 1 week, followed by a 2 week break. This is 1 cycle.
- (3) In general, for adults, 200 mg/m2 (body surface) as levofolinate is administered by intravenous drip infusion at one time over a period of 2 hours. Immediately followed by 400 mg/m2 (body surface) as 5-fluorouracil is administered by intravenous injection at one time and 2400 to 3000 mg/m2 (body surface) as 5-fluorouracil is administered by continuous intravenous injection at one time over a period of 46 hours. This is continued every 2 weeks.
- Levofolinate and 5-Fluorouracil continuous intravenous combination therapy for small intestine cancer and pancreatic cancer not amenable to curative resection
- In general, for adults, 200 mg/m2 (body surface) as levofolinate is administered by intravenous drip infusion at one time over a period of 2 hours. Immediately followed by 400 mg/m2 (body surface) as 5-fluorouracil is administered by intravenous injection at one time and 2400 mg/m2 (body surface) as 5-fluorouracil is administered by continuous intravenous injection at one time over a period of 46 hours. This is continued every 2 weeks.
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