Mycophenolic acid delayed-release tablets are an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant
Use in combination with cyclosporine and corticosteroids
Limitations of Use
Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably
Dose
- In adults: 720 mg by mouth, twice daily (1440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake.
- In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m 2by mouth, twice daily (up to a maximum of 720 mg twice daily).
- Do not crush, chew, or cut tablet prior to ingestion.
Contraindications
History of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients
Warnings & Precautions
- New or Reactivated Viral Infections: Consider reducing immunosuppression.
- Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatment interruption or dose reduction.
- Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease.
- Hypersensitivity Reactions: Discontinue mycophenolic acid delayed-release tablets, treat and monitor until signs and symptoms resolve.
- Immunizations: Avoid live attenuated vaccines.
- Patients with Hereditary Deficiency of Hypoxanthine-guanine Phosphoribosyl-transferase (HGPRT): May cause exacerbation of disease symptoms; avoid use.
- Blood Donation: Avoid during therapy and for 6 weeks thereafter.
- Semen Donation: Avoid during therapy and for 90 days thereafter.
Adverse Reactions
Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain.
