News Release
For Immediate Release
November 21, 2018
Sawai Pharmaceutical Co., Ltd.

MHLW Approves New Indication for LEVOFOLINATE I.V. Infusion

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] and100 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 listed below;
1. Levofolinate and 5-Fluorouracil therapy
Enhancing the effect of 5-fluorouracil for the treatment of gastriccancer (which is inoperable or recurrent) and colorectal cancer
Indications and Usage(New approval is underlined)

2. Levofolinate and 5-Fluorouracil continuous intravenous
combination therapy
Enhancing the effect of 5-fluorouracil for the treatment ofcolorectal cancer, small intestine cancer and pancreatic cancer
not amenable to curative resection
1. 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 isadministered 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. ThisDosage and Administration(New approval is underlined)is 1 cycle.
2. Levofolinate

and5-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 administeredby intravenous injection at one time and 600 mg/m2 (bodysurface) as 5-fluorouracil is administered by continuousNews Releaseintravenous 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 administeredby continuous intravenous injection at one time over a periodof 24 hours. Repeat 6 times during 1 week, followed by a 2week 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 administeredby intravenous injection at one time and 2400 to 3000 mg/m2(bodysurface)as

5-fluorouracil

isadministeredbycontinuous intravenous injection at one time over a period of
46 hours. This is continued every 2 weeks.
3. Levofolinate

and

5-Fluorouracil

continuous

intravenous

combination therapy for small intestine cancer and pancreaticcancer 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 aperiod of 2 hours. Immediately followed by 400 mg/m2 (bodysurface) as 5-fluorouracil is administered by intravenous
injection at one time and 2400 mg/m2 (body surface) as
5-fluorouracil is administeredby continuous intravenous

injection at one time over a period of 46 hours. This is continued
every 2 weeks.

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