Screening report
GRAFAPEX (TREOSULFAN)
“…prior to intravenous infusion. GRAFAPEX is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Use aseptic technique to prepare GRAFAPEX. Calculate the…”
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“…Figure 1 Figure 2 Figure 3 15 REFERENCES “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied GRAFAPEX…”
“…infusion after reconstitution WARNING: Hazardous Drug One Single-dose Vial. Discard Unused Portion. Rx only One Single-dose Vial Vial Label - GRAFAPEX™ 1 g NDC 59137 -335- 0…”
“…malignancy with use of GRAFAPEX. Treosulfan is carcinogenic and genotoxic [see ( 13.1 )] . The risk of secondary malignancy is increased in patients with Fanconi anemia and ot…”
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“…and manage medically as required. ( 5.4 ) Secondary Malignancies: There is an increased risk of a secondary malignancy with use of GRAFAPEX. ( 5.5 ) Increased Early Morbidity and M…”
“…Malignancies: There is an increased risk of a secondary malignancy with use of GRAFAPEX. ( 5.5 ) Increased Early Morbidity and Mortality at Dosages Higher than Recommended: Avoid excee…”
“…study has been conducted. Treosulfan was mutagenic in the in vitro bacterial mutagenicity assay (Ames test) and clastogenic in the in vitro micronucleus assay in human…”
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“…was mutagenic in the in vitro bacterial mutagenicity assay (Ames test) and clastogenic in the in vitro micronucleus assay in human lymphocytes. No dedicated animal fer…”
“…use of GRAFAPEX. Treosulfan is carcinogenic and genotoxic [see ( 13.1 )] . The risk of secondary malignancy is increased in patients with Fanconi anemia and other DNA breaka…”
“…suggesting it can cause embryotoxicity and teratogenicity. 8.2 Lactation Risk Summary There is no data on the presence of treosulfan or its metabolites in human milk, the e…”
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“…g/m 2 daily for three consecutive days. ( 5.6 ) Embryo-fetal toxicity: Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use e…”
“…10 g/m 2 daily for three consecutive days. 5.7 Embryo-Fetal Toxicity Based on its mechanism of action, GRAFAPEX can cause fetal harm when administered to a pregnant woman because…”
“…vesicle, prostate, and uterus, as well as spermatogenesis reduction and arrest, uterine atrophy, and reduced or absent corpora lutea and follicles. 14 CLINICAL STUDIES The effic…”
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“…for 1 week after the last dose [see ( 8.2 )]. Infertility GRAFAPEX can impair fertility in females and males, and may cause temporary or permanent infertility [see ( 8.3 )] .…”
“…and males, and may cause temporary or permanent infertility [see ( 8.3 )] . Manufactured for: Medexus Pharma, Inc. Chicago, Illinois 60606 USA GRAFAPEX™ is a trademark of medac…”
“…treosulfan TREOSULFAN TREOSULFAN WARNING: MYELOSUPPRESSION GRAFAPEX causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic stem cell transplantatio…”
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“…GRAFAPEX causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic stem cell transplantation is required to prevent potentially fatal complicatio…”
“…fatal complications of the prolonged myelosuppression. Monitor hematologic laboratory parameters [see Warnings and Precautions ( 5.1 )] . WARNING: MYELOSUPPRESSION See full…”
“…12.1 Mechanism of Action Treosulfan is an alkylating agent. DNA alkylation is thought to be responsible for the cytotoxic activities of treosulfan. Treosulfan showed hematopoieti…”
Set aside: found but not counted (4)
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.