MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Immunosuppressant

Brand names: Mycophenolate Mofetil

Intravenous

Mechanism of Action

12.1 Mechanism of Action Mycophenolate mofetil (MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of guanosine nucleotide synthesis and blocks DNA synthesis. The mechanism of action of MPA is multifaceted and includes effects on cellular checkpoints responsible for metabolic programming of lymphocytes. MPA shifts transcriptional activities in lymphocytes from a proliferative state to catabolic processes. In vitro studies suggest that MPA modulates transcriptional activities in human CD4 + T-lymphocytes by suppressing the Akt/mTOR and STAT5 pathways that are relevant to metabolism and survival, leading to an anergic state of T-cells whereby the cells become less responsive to antigenic stimulation. Additionally, MPA enhanced the expression of negative

Indications

1 INDICATIONS AND USAGE Mycophenolate Mofetil [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 [see Clinical Studies (14.1) ]

heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ]

heart or liver transplants

in combination with other immunosuppressants. ( 1 )

Contraindications

• 4 CONTRAINDICATIONS Allergic reactions to Mycophenolate Mofetil have been observed
• therefore
• Mycophenolate Mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF)
• mycophenolic acid or any component of the drug product ( 4 )•Patients allergic to Polysorbate 80 (present in Mycophenolate Mofetil IV) ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Blood Dyscrasias (Neutropenia, Red Blood Cell Aplasia): Monitor with blood tests; consider treatment interruption or dose reduction
1 Embryofetal Toxicity Use of MMF during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney and nervous system
Females of reproductive potential must be made aware of these risks and must be counseled regarding pregnancy prevention and planning
2 Lymphoma and Other Malignancies Patients receiving immunosuppressants, including Mycophenolate Mofetil, are at increased risk of developing lymphomas and other malignancies, particularly of the skin [see Adverse Reactions (6

Known Side Effects

9 documented side effects by frequency

Drug Not Working

>10%

Diarrhea

1-10%

Fever

1-10%

Nausea

0.1-1%

Fatigue

0.1-1%

Condition Worsened

0.1-1%

Shortness of Breath

0.1-1%

Vomiting

0.1-1%

Headache

0.1-1%

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Compare With

10 available comparisons

Formulations

Dosage Forms

Tablet

Route

Intravenous