FormWeb • mycophenolate mofetil PO (suspension)

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mycophenolate mofetil PO (suspension)

mycophenolate mofetil PO (suspension)

REMS FDA Documents #1
REMS FDA Documents #2

Brand names: CellCept

Form	Strength
SUSPENSION, ORAL	200 mg/mL

Display Immunosuppressive Agents Class: 924400

Medication comments:

USP <800> Hazardous Drug Assessment of Risk (AOR)
Per policy, these drugs are exempt from USP <800> handling requirements under normal circumstances. The following outlines must be followed.
generic (Brand) Route [Packaging: Manufacturer ⇒ Dispense]	Activities
mycophenolate mofetil (Cellcept) PO [BULK ⇒ UD]	200 mg / mL suspension	Stock @ IDBH? N NIOSH Table 1^↑
Pharmacy: Receiving / Storage / Preparation Exposure Risk: low	• Handling/preparation PPE Requirements: do not handle while pregnant; single CX gloves, gown
	• Receiving from Distributor: Standard
	• Pharmacy Storage Area: Packaging Area
	• Packaging/Reconstitution Location: Repackage area
	• Compounding (Non-Sterile/Sterile) Location: n/a
	• Omnicell Load: No
Transport	• Transport (dose is placed inside a plastic sealable bag): Standard
Nursing: Storage / Administration Exposure Risk: low	• Handling/administration PPE Requirements: Single pair of CX approved gloves. Wash hands after handling
	• Storage of Finished dose in Nursing Area/Procedural Area: Patient Med Drawer
	• Signage on Patient Door Required: No
	• Manipulation of Dosage Form: Done in Pharmacy
	• Special Manipulation for Administration: do not handle while pregnant
Disposal / Spills	• Disposal of Drug Waste: Full- black bin , Trace/packaging- yellow bin
	• Disposol of Used PPE: yellow bin
	• Spill management: Wear CX gloves items used to clean up spill should be placed in a sealed bag and put in yellow bin
NIOSH Supplemental Information: BBW for embry of fetal toxicity,malignancies,and serious infections,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 directcontact with skin or mucous membranse of the powder contained in capsules and oral suspension. If such contact occurs,wash thoroughly with soap and water, rinse eyes with plain water

Last updated: Jun. 11, 2025

Black Box Warnings Embryofetal Toxicity, Malignancies, and Serious Infections

UpToDate Lexidrug

Pharmacy Contact Info:

Main Inpatient Pharmacy: ext 4599, 3503
Fax: 704-878-7283

Director of Pharmacy - Randi Raynor, PharmD: ext 4501
Clinical Coordinator - Laura Rollings, PharmD: ext 4597
Pharmacy Informaticist - Stephen Pringle, PharmD: ext 7645
Pharmacy Technician Supervisor - Amy Wingler, CPhT: ext 7385
Pharmacy Automation Coordinator (Omnicell) - Melissa Fulford, CPhT: ext 3556

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