AHFS Class:

90:28.08.92 Antimetabolites, Immunosuppressive Therapy, Miscellaneous

Mycophenolate mofetil hydrochloride is available as a lyophilized powder in vials containing 500 mg of mycophenolate mofetil along with polysorbate 80 25 mg and citric acid 5 mg.³⁵¹⁶; ³⁵¹⁹ Sodium hydroxide may have been added during manufacturing to adjust pH.³⁵¹⁶; ³⁵¹⁹

Manufacturers recommend the use of dextrose 5% for reconstitution and dilution of the drug.³⁵¹⁶; ³⁵¹⁹ Individuals who handle or prepare mycophenolate mofetil hydrochloride solutions should use care and take precautions to avoid contact with the drug solution.³⁵¹⁶; ³⁵¹⁹ Each vial should be reconstituted with 14 mL of dextrose 5% and gently shaken to dissolve the drug.³⁵¹⁶; ³⁵¹⁹ The reconstituted solution must be further diluted with dextrose 5% to yield a solution with a final mycophenolate mofetil concentration of 6 mg/mL.³⁵¹⁶; ³⁵¹⁹ The volumes of dextrose 5% to be used for the dilution of 1- and 1.5-g doses of the reconstituted solution are 140 and 210 mL, respectively.³⁵¹⁶; ³⁵¹⁹ The solution should be inspected for particulate matter and discoloration.³⁵¹⁶; ³⁵¹⁹

pH

The pH of the reconstituted solution ranges from 2.4 to 4.1³⁵¹⁶ or 2.7 to 4.1.³⁵¹⁹

Trade Name(s)

CellCept

Mycophenolate mofetil hydrochloride is administered by slow intravenous infusion over a minimum of 2 hours into either a central line or peripheral vein.³⁵¹⁶; ³⁵¹⁹ The drug should not be administered by rapid or bolus administration.³⁵¹⁶; ³⁵¹⁹

Mycophenolate mofetil hydrochloride is a white to off-white lyophilized powder that forms slightly yellow solution upon reconstitution and dilution.³⁵¹⁶; ³⁵¹⁹ Intact vials of the drug should be stored at controlled room temperature³⁵¹⁹ or at 25°C with excursions permitted from 15 to 30°C.³⁵¹⁶ Dextrose 5% is the manufacturer-recommended diluent for reconstitution and dilution of mycophenolate mofetil hydrochloride; all other solutions are stated to be incompatible.³⁵¹⁶; ³⁵¹⁹ Reconstituted solutions and solution diluted for infusion also may be kept at 25°C.³⁵¹⁶; ³⁵¹⁹ Manufacturers indicate that administration of the diluted drug should begin within 4 hours after reconstitution and dilution of the drug.³⁵¹⁶; ³⁵¹⁹

Freezing Solutions

Mycophenolate mofetil hydrochloride (Hoffmann-La Roche, Accord) prepared at mycophenolate mofetil concentrations of 1, 4, and 10 mg/mL in dextrose 5% (Grifols) and stored in polypropylene bags was stable for 35 days when frozen at -15 to -25°C.³⁵²⁰

Sorption

Mycophenolate mofetil hydrochloride (Hoffmann-La Roche, Accord) prepared at mycophenolate mofetil concentrations of 1, 4, and 10 mg/mL in dextrose 5% using a closed-system transfer device (CSTD) (Equashield) demonstrated negligible amounts of sorption to the CSTD.³⁵²⁰

Solution Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.