Recommended Dosage of Mycophenolate Mofetil for Interstitial Lung Disease
For interstitial lung disease, mycophenolate mofetil should be administered at a dose of 1.5-2 grams per day (typically divided as 750-1000 mg twice daily) with a maximum of 3 grams per day in severe cases. This dosing recommendation is based on evidence from clinical guidelines and research studies on connective tissue disease-related interstitial lung disease.
Dosing Considerations
Standard Dosing
- Initial dose: Start at 500 mg twice daily
- Target maintenance dose: 1.5-2 g/day (750-1000 mg twice daily)
- Maximum dose: 3 g/day in severe cases 1
Population-Specific Adjustments
- Asian patients: Consider lower dosing (2 g/day total) due to evidence suggesting Asians may require lower doses for similar efficacy 2, 3
- Non-Asian patients: May require higher dosing (up to 3 g/day total) 2
Evidence Supporting This Recommendation
The Scleroderma Lung Study II (SLS II) used mycophenolate mofetil at a target dose of 1500 mg twice daily (3 g/day total) for 24 months in treating scleroderma-related interstitial lung disease 1. This regimen demonstrated significant improvements in lung function with better tolerability compared to cyclophosphamide.
A retrospective study examining MMF in connective tissue disease-related ILD showed preservation and slight improvement in lung function parameters using similar dosing 4. Specifically, this study demonstrated increases in forced vital capacity (FVC), total lung capacity, and diffusing capacity after initiating MMF therapy.
Another study specifically examining scleroderma-associated ILD found that MMF at doses >1 g/day for ≥6 months was associated with significant improvement in vital capacity after 12 months of treatment (+159 mL; +4% of predicted normal value) 5.
Administration and Monitoring
- Administration: Divide the daily dose into two equal doses given 12 hours apart
- Formulations: Available as oral suspension, capsules, and tablets 2
- Monitoring:
- Complete blood count weekly for the first month, then monthly
- Liver function tests monthly
- Monitor for gastrointestinal side effects (nausea, vomiting, diarrhea)
- Watch for signs of infection
Side Effects and Management
Common side effects include:
- Gastrointestinal: Nausea, vomiting, diarrhea, abdominal cramping (most common)
- Hematologic: Anemia, leukopenia, thrombocytopenia (less common)
- Genitourinary: Urgency, frequency, dysuria (rare)
For patients experiencing significant GI side effects, consider:
- Switching to enteric-coated mycophenolate sodium (720-1080 mg twice daily, equivalent to 1-1.5 g twice daily of MMF) 2, 3
- Taking medication with food
- Temporary dose reduction with subsequent gradual increase
Important Precautions
- Pregnancy: Contraindicated in pregnancy (Category D) and during lactation due to risk of severe congenital malformations 2
- Contraception: Women of childbearing potential should use two reliable forms of birth control 2, 3
- Infection risk: Increased susceptibility to viral and bacterial infections 2
- Malignancy risk: Theoretical increased risk of cutaneous malignancy and lymphoma with long-term use 2
Clinical Response Expectations
- Initial response may be delayed (4-8 weeks)
- Maximum benefit typically observed after 3-6 months of therapy
- Treatment is often continued long-term (2+ years) for sustained benefit
By following these dosing recommendations and monitoring guidelines, mycophenolate mofetil can be effectively used to treat interstitial lung disease while minimizing potential adverse effects.