REMS FDA Documents #1^FDA Documents #2
thalidomide
Form | Strength |
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CAPSULE, ORAL | 50 mg |
Per policy, these hazardous drugs have special waste requirements. | |
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Generic (Brand) | Waste Requirements |
thalidomide (Thalomid) | Hazardous Waste ⇒ BLACK BUCKET |
USP <800> Hazardous Drugs | ||||||
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Per Policy, these drugs have special handling requirements (any drug with an "AOR" is exempt from these requirements under normal circumstances). | ||||||
generic (Brand) Route | Relative Risk Level | AOR? | NIOSH 2024 Table | MSHI?↑ | Warnings | |
thalidomide (Thalomid) PO | High | N/A | 1↑ | Yes | ||
NIOSH Supplemental information (2016): N/A FDA Pregancy Category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits; |