Screening report
LONSURF (TRIFLURIDINE AND TIPIRACIL)
“…in TAGS Figure 3 15 REFERENCES 1. “OSHA Hazardous Drugs”. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING LONSURF 15 mg/6.14 mg…”
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“…LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 Table 1 shows the calculated initial daily dose based on body surface area (BSA). Table 1: R…”
“…LONSURF is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1 If stored outside of original bottle, discard after 30 days. 17 PATIENT COUNSELING INFORMATION Advise the…”
“…have been performed. Trifluridine/tipiracil was genotoxic in a reverse mutation test in bacteria, a chromosomal aberration test in mammalian-cultured cells, and a micronucleus…”
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“…final dose. Males Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with LONSURF and for…”
“…in a reverse mutation test in bacteria, a chromosomal aberration test in mammalian-cultured cells, and a micronucleus test in mice. Animal studies did not indicate an effect of triflur…”
“…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 ef…”
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“…[see Dosage and Administration (2.2) ] . 5.2 Embryo-Fetal Toxicity Based on animal studies and its mechanism of action, LONSURF can cause fetal harm when administered to a pregn…”
“…a pregnant woman. Trifluridine/tipiracil caused embryo-fetal lethality and embryo-fetal toxicity in pregnant rats when orally administered during gestation at dosage levels resulti…”
“…on placebo. Additional Clinical Experience Interstitial lung disease was reported in 15 (0.2%) patients, 3 of which were fatal, among approximately 7,000 patients exposed to LONSURF in cli…”
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“…None. ( 4 ) 5 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…”
“…contraception. ( 5.2 , 8.1 , 8.3 ) 5.1 Severe Myelosuppression In the 1114 patients who received LONSURF as a single agent, LONSURF caused severe or life-threatening myelosuppression…”
“…a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. ( 1.2 ) 1.1 Metastatic Colorectal Cancer LONSURF, as a si…”
Set aside: found but not counted (1)
For information only. This is a count of how many of the six NIOSH hazard-criteria appear in this label after negated and supporting-only statements are set aside. Findings from animal studies count, as NIOSH’s definition counts them, and are tagged “Animal data”. It is not a hazard determination, and the drug-class hint is not counted.