Screening report
Hepzato Kit (MELPHALAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION)
“…HEPZATO once reconstituted. HEPZATO is a hazardous drug 1 . Follow applicable special handling and disposal procedures. Reconstitution and Dilution Instructions: Rapidly (in 5…”
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“…with DoR≥12 months 4 30 % 15 REFERENCES 1 OSHA Hazardous Drugs. OSHA. http://www.osha.gov/hazardous-drugs 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied The HEPZATO KIT includes…”
“…be stored at room temperature. Melphalan is a hazardous drug. Follow applicable special handling and disposal procedures. 1 HEPZATO is light sensitive. Retain in original carton un…”
“…abdominal pain and diarrhea are common. ( 5.5 ) Carcinogenic/Mutagenic effects: Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and…”
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“…common. ( 5.5 ) Carcinogenic/Mutagenic effects: Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma, have been reported in patient…”
“…5.5 ) Carcinogenic/Mutagenic effects: Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma, have been reported in patients wi…”
“…and diarrhea are common. ( 5.5 ) Carcinogenic/Mutagenic effects: Secondary malignancies, including acute nonlymphocytic leukemia, myeloproliferative syndrome, and carcinoma,…”
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“…Pharmacology ( 12.1 ) ]. Melphalan is a genotoxic drug and can cause chromatid or chromosome damage in humans [see ( 13.1 ) ]. In animal studies, melphalan was embry…”
Animal study“…administered to a pregnant woman. Melphalan is genotoxic, targets actively dividing cells, and was embryolethal and teratogenic in rats. Advise pregnant women of the potentia…”
“…or chromosome damage in humans. ( 5.6 ) Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive…”
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“…and with cumulative dose [see ( 13.1 )] . 5.7 Embryo-Fetal Toxicity Based on animal studies and its mechanism of action, melphalan can cause fetal harm when administered to a pre…”
“…[see Warnings and Precautions ( 5.6 )]. Embryo-Fetal Toxicity Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions ( 5.7 ) and ( 8.1 )]. A…”
“…in premenopausal women, resulting in persistent amenorrhea in approximately 9% of patients. Reversible or irreversible testicular suppression has also been reported [see ( 8.3…”
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“…function in premenopausal women, resulting in amenorrhea in a significant number of patients. Males Reversible and irreversible testicular suppression has been reported in male…”
“…firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex, PVC or DEHP. Rx only EXCEL is a registered trademark of B. Braun M…”
“…hormone syndrome has been observed. Nephrotoxicity and adult respiratory distress syndrome have been reported. The principal toxic effect is bone marrow suppression. H…”
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“…Acid WARNING: PERI-PROCEDURAL COMPLICATIONS, MYELOSUPPRESSION Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur v…”
“…REMS [see Warnings and Precautions ( 5.2 )]. Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Monitor hematologic laboratory…”
Set aside: found but not counted (7)
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.