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 for Oral Suspension, USP is available in the following dosage form and strength:
For oral suspension: 35 g mycophenolate mofetil white or almost white powder, 200 mg/mL upon reconstitution.
Mycophenolate mofetil is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product
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 [seeWarnings and Precautions]
- Serious Infections [seeWarnings and Precautions]
- Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [seeWarnings and Precautions]
- Gastrointestinal Complications [seeWarnings and Precautions]
- Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions ]
- Hypersensitivity Reactions [see Warnings and Precautions ()]
5.8 Hypersensitivity ReactionsPostmarketing cases of hypersensitivity reactions, including angioedema and anaphylaxis, have been reported with mycophenolate mofetil. These reactions generally occurred within hours to the next day after initiating mycophenolate mofetil. If signs or symptoms of hypersensitivity reaction occur, discontinue mycophenolate mofetil; treat and monitor until symptoms resolve[see Contraindications ].
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 an empirical formula of C23H31NO7, a molecular weight of 433.49 g/mole, 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.
Mycophenolate mofetil is available for oral administration as a powder for oral suspension which, when reconstituted, contains 200 mg/mL of MMF.
Inactive ingredients in Mycophenolate Mofetil for Oral Suspension, USP include aspartame, citric acid anhydrous, colloidal silicon dioxide, methylparaben, sodium citrate dihydrate, sorbitol, de-oiled soy lecithin, tutti-frutti flavor, and xanthan gum.