REMS FDA Documents #1^FDA Documents #2
mycophenolate mofetil IV
Form | Strength |
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POWDER FOR INJECTION, INTRAVENOUS | 500 mg |
Per policy, these hazardous drugs have special waste requirements. | |
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Generic (Brand) | Waste Requirements |
mycophenolate mofetil (CellCept) | 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 | |
mycophenolate mofetil (CellCept) IV | High | N/A | 1↑ | Yes | ||
NIOSH Supplemental information (2016): Black Box warning for embryo fetal toxicity, malignancies, and serious ifections; increased risk of first-trimester pregnancy loss and increased risk of congenital malformations; Special warning: Tablets should not be crushed and capsules should not be opened or crushed. Avoid inhalation or direct contact with skin or mucous membranes of the powder contained in capsules and oral suspension (before or after constitution). If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water FDA Pregancy Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks; |