Mycophenolate Mofetil Prescribing Information
- Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning[see Warnings and Precautions ,.Use in Special Populations ]
- Increased risk of development of lymphoma and other malignancies, particularly of the skin[see Warnings and Precautions ].
- Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes.[see Warnings and Precautions ]
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney
Mycophenolate mofetil is available in the following dosage form and strength:
For injection | 500 mg mycophenolate mofetil white to off-white lyophilized powder, in a single-dose vial for reconstitution |
Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Mycophenolate mofetil for injection is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN).
The following adverse reactions are discussed in greater detail in other sections of the label:
Embryofetal Toxicity
[see Warnings and Precautions ]Lymphomas and Other Malignancies
[see Warnings and Precautions ]Serious Infections
[see Warnings and Precautions ]Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia
[see Warnings and Precautions ]- Gastrointestinal Complications[see Warnings and Precautions ]
- Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions ]
Mycophenolate mofetil is an antimetabolite immunosuppressant. It is the 2-morpholinoethyl ester of mycophenolic acid (MPA), an immunosuppressive agent; inosine monophosphate dehydrogenase (IMPDH) inhibitor.
The chemical name for mycophenolate mofetil (MMF) is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate. It has a molecular formula of C23H31NO7, a molecular weight of 433.50, and the following structural formula:
MMF is a white to off-white crystalline powder. It is slightly soluble in water (43 μg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). It is freely soluble in acetone, soluble in methanol, and sparingly soluble in ethanol. The apparent partition coefficient in 1 -octanol/water (pH 7.4) buffer solution is 238. The pKa values for MMF are 5.6 for the morpholino group and 8.5 for the phenolic group.
MMF hydrochloride has a solubility of 65.8 mg/mL in 5% Dextrose Injection USP (D5W). The pH of the reconstituted solution is 2.4 to 4.1.
Mycophenolate mofetil for injection is the hydrochloride salt of MMF. The chemical name for the hydrochloride salt of MMF is 2-morpholinoethyl (E)-6-(1,3-dihydro-4-hydroxy-6-methoxy-7-methyl-3-oxo-5-isobenzofuranyl)-4-methyl-4-hexenoate hydrochloride. It has a molecular formula of C23H31NO7 HC1 and a molecular weight of 469.96.
Mycophenolate mofetil for injection is available as a sterile white to off-white lyophilized powder in single-dose vials containing MMF hydrochloride for administration by intravenous infusion only. Each vial of mycophenolate mofetil for injection contains mycophenolate mofetil hydrochloride equivalent to 500 mg of mycophenolate mofetil. The inactive ingredients are polysorbate 80, 25 mg, and citric acid, 5 mg. Sodium hydroxide or hydrochloric acid may have been used in the manufacture of mycophenolate mofetil to adjust the pH. Reconstitution and dilution with 5% Dextrose Injection USP yields a clear colorless to slightly yellow color solution of MMF, 6 mg/mL