Drug Guide
Mycophenolate Mofetil Hydrochloride
Classification
Therapeutic: Immunosuppressant
Pharmacological: Antimetabolite
FDA Approved Indications
- Prevention of organ rejection in renal, cardiac, and hepatic transplant recipients
Mechanism of Action
Inhibits inosine monophosphate dehydrogenase, an enzyme critical for de novo guanine nucleotide synthesis in lymphocytes, thereby suppressing T and B lymphocyte proliferation.
Dosage and Administration
Adult: Based on weight and clinical condition; typically 1-1.5 g twice daily, with adjustments as needed.
Pediatric: Use is limited; consult specific pediatric dosing guidelines.
Geriatric: Adjust dose based on renal function and tolerance.
Renal Impairment: Dose adjustment required based on renal function.
Hepatic Impairment: Use with caution; no specific dose adjustment guideline available.
Pharmacokinetics
Absorption: Well absorbed orally; bioavailability approximately 94%.
Distribution: Widely distributed, protein-bound approximately 97%.
Metabolism: Converted to active form, mycophenolic acid, by esterase enzymes; further metabolized via glucuronidation.
Excretion: Primarily through renal route; approximately 93% of the dose recovered in urine.
Half Life: Approximately 16-18 hours in adults.
Contraindications
- Hypersensitivity to mycophenolate mofetil or any component.
- Pregnancy (category D); contraindicated unless the potential benefit justifies the potential risk to the fetus.
Precautions
- Use with caution in patients with active infections or malignancies. Monitor for leukopenia, anemia, and thrombocytopenia.
Adverse Reactions - Common
- Gastrointestinal disturbances (nausea, diarrhea, vomiting) (Common)
- Leukopenia, anemia, thrombocytopenia (Common)
- Increased risk of infections (Common)
Adverse Reactions - Serious
- Liver function abnormalities (Less common)
- Progressive multifocal leukoencephalopathy (PML) - rare but severe (Rare)
- Malignancies (lymphomas, skin cancers) (Rare)
Drug-Drug Interactions
- Azathioprine, other immunosuppressants, antacids containing magnesium or aluminum, cholestyramine
Drug-Food Interactions
- Avoid high-fat meals close to dosing to optimize absorption.
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor complete blood count, renal and liver function regularly. Watch for signs of infection.
Diagnoses:
- Risk for infection
- Impaired skin integrity
Implementation: Administer with food to reduce gastrointestinal side effects. Educate patient on infection prevention.
Evaluation: Assess blood counts, kidney, and liver function periodically; monitor for adverse reactions.
Patient/Family Teaching
- Take medication exactly as prescribed.
- Report symptoms of infection, unusual bleeding, or signs of liver dysfunction.
- Avoid pregnancy during treatment and for at least six weeks after discontinuation.
Special Considerations
Black Box Warnings:
- Increased risk of pregnancy loss and congenital malformations; strict contraception required for women of childbearing potential.
- Increased risk of infections, including opportunistic infections and lymphomas.
Genetic Factors: N/A
Lab Test Interference: May cause false-positive test results for certain urine catecholamines.
Overdose Management
Signs/Symptoms: Gastrointestinal symptoms, leukopenia, increased risk of infection.
Treatment: Supportive care; no specific antidote. Hemodialysis may be considered, but efficacy is uncertain.
Storage and Handling
Storage: Store at 20-25°C (68-77°F); protect from moisture.
Stability: Stable under recommended storage conditions.