LONSURF- trifluridine and tipiracil tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIFLURIDINE (UNII: RMW9V5RW38) (TRIFLURIDINE - UNII:RMW9V5RW38), TIPIRACIL HYDROCHLORIDE (UNII: 4H59KLQ0A4) (TIPIRACIL - UNII:NGO10K751P)

Available from:

Taiho Pharmaceutical Co., Ltd.

INN (International Name):

TRIFLURIDINE

Composition:

TRIFLURIDINE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LONSURF, as a single agent or in combination with bevacizumab, is indicated for the treatment of adult patients with metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. LONSURF is indicated for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. None. Risk Summary Based on animal data and its mechanism of action [see Clinical Pharmacology (12.2)] , LONSURF can cause fetal harm. LONSURF caused embryo-fetal lethality and embryo-fetal toxicity in pregnant rats when given during gestation at doses resulting in exposures lower than or similar to human exposures at the recommended clinical dose (see Data) . There are no available data on

Product summary:

LONSURF 15 mg/6.14 mg tablets are supplied as white, biconvex, round, film-coated tablet, imprinted with ‘15’ on one side, and ‘102’ and ’15 mg’ on the other side, in gray ink. The tablets are packaged in HDPE bottles with child resistant closures in the following presentations: LONSURF 20 mg/8.19 mg tablets are supplied as pale red, biconvex, round, film-coated tablet, imprinted with ‘20’ on one side, and ‘102’ and ‘20 mg’ on the other side, in gray ink. The tablets are packaged in HDPE bottles with child resistant closures in the following presentations: Store at 20°C to 25°C (68°F to 77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures.1 If stored outside of original bottle, discard after 30 days.

Authorization status:

New Drug Application

Summary of Product characteristics

LONSURF- TRIFLURIDINE AND TIPIRACIL TABLET, FILM COATED
TAIHO PHARMACEUTICAL CO., LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LONSURF SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LONSURF.
LONSURF (TRIFLURIDINE AND TIPIRACIL) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
RECENT MAJOR CHANGES
Indications and Usage (1.1)
8/2023
Dosage and Administration (2)
8/2023
Warnings and Precaution (5.1)
8/2023
INDICATIONS AND USAGE
LONSURF is a combination of trifluridine, a nucleoside metabolic
inhibitor, and tipiracil, a thymidine
phosphorylase inhibitor, indicated for the treatment of adult patients
with:
metastatic colorectal cancer as a single agent or in combination with
bevacizumab who have been
previously treated with fluoropyrimidine-, oxaliplatin- and
irinotecan-based chemotherapy, an anti-VEGF
biological therapy, and if RAS wild-type, an anti-EGFR therapy. (1.1)
metastatic gastric or gastroesophageal junction adenocarcinoma
previously treated with at least two
prior lines of chemotherapy that included a fluoropyrimidine, a
platinum, either a taxane or irinotecan,
and if appropriate, HER2/neu-targeted therapy. (1.2)
DOSAGE AND ADMINISTRATION
Recommended Dosage: 35 mg/m /dose orally twice daily with food on Days
1 through 5 and Days 8
through 12 of each 28-day cycle. (2.1)
DOSAGE FORMS AND STRENGTHS
Tablets:
15 mg trifluridine/6.14 mg tipiracil (3)
20 mg trifluridine/8.19 mg tipiracil (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Severe Myelosuppression: Obtain complete blood counts prior to and on
Day 15 of each cycle. Withhold
and resume at next lower LONSURF dosage as recommended. (2.1, 5.1)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of
reproductive potential of the potential
risk to a fetus and to use effective contraception. (5.2, 8.1, 8.3)
ADVERSE REACTIONS
The most common adverse reactions or laboratory abnormalities for
single agent LONSURF (≥10%) are
neutropenia, anemia, thrombocytope