Mycophenolic Acid
Generic Name: mycophenolic acid
Brand Names:
Mycophenolic Acid
11 DESCRIPTION Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C 17 H 19 O 6 Na.
Overview
11 DESCRIPTION Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt. Its empirical formula is C 17 H 19 O 6 Na.
Uses
1 INDICATIONS AND USAGE • 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. ( 1.1 ) • Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: • Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
Dosage
2 DOSAGE AND ADMINISTRATION • In adults: 720 mg by mouth, twice daily (1,440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. ( 2.1 ) • In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m 2 by mouth, twice daily (up to a maximum of 720 mg twice daily). ( 2.2 ) • Do not crush, chew, or cut tablet prior to ingestion. ( 2.3 ) 2.1 Dosage in Adult Kidney Transplant Patients The recommended dose of mycophenolic acid delayed-release tablets are 720 mg administered twice daily (1,440 mg total daily dose).
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. • Embryo-Fetal Toxicity [see Boxed Warning, Warnings and Precautions ( 5.1 ) ] • Lymphomas and Other Malignancies [see Boxed Warning, Warnings and Precautions ( 5.3 ) ] • Serious Infections [see Boxed Warning, Warnings and Precautions ( 5.4 ) ] • New or Reactivated Viral Infections [see Warnings and Precautions ( 5.5) ] • Blood Dyscrasias, Including Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 ) ] • Serious GI Tract Complications [see Warnings and Precautions ( 5.7 ) ] • Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions ( 5.8 )] • Rare Hereditary Deficiencies [see Warnings and Precautions ( 5.10 ) ] Most common adver...
Interactions
7 DRUG INTERACTIONS • Antacids with Magnesium and Aluminum Hydroxides: Decreases concentrations of MPA; concomitant use is not recommended. ( 7.1 ) • Azathioprine: Competition for purine metabolism; concomitant administration is not recommended. ( 7.2 ) • Cholestyramine, Bile Acid Sequestrates, Oral Activated Charcoal, and Other Drugs that Interfere with Enterohepatic Recirculation: May decrease MPA concentrations; concomitant use is not recommended. ( 7.3 ) • Sevelamer: May decrease MPA concentrations; concomitant use is not recommended. ( 7.4 ) • Cyclosporine: May decrease MPA concentrations; exercise caution when switching from cyclosporine to other drugs or from other drugs to cyclosporine.
Warnings
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS • Use during pregnancy is associated with increased risks of 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 ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 ) ]. 5 WARNINGS AND PRECAUTIONS • New or Reactivated Viral Infections: Consider reducing immunosuppression. ( 5.5 ) • Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatment interruption or dose reduction. ( 5.6 ) • Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease. ( 5.7 ) • Immunizations: Avoid live attenuated vaccines. ( 5.9 ) • Patients with Hereditary Deficiency of Hypoxanthine-guanine Phosphoribosyl-transferase (HGPRT): May cause exacerbation of disease symptoms; avoid use. ( 5.10 ) • Blood Donation: Avoid during therapy and for 6 weeks thereafter. ( 5.11 ) • Semen Donation: Avoid during therapy and for 90 days thereafter. 4 CONTRAINDICATIONS Known hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. ( 4.1 ) 4.1 Hypersensitivity Reactions Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients.
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolic acid delayed-release tablets treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Mycophenolic Acid Delayed-Release Tablets, USP : 360 mg tablet: Pale orange-red colored, oval shaped, biconvex, film coated tablets imprinted “MA 360" with black ink on one side and plain on other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium.
Frequently Asked Questions
What is Mycophenolic Acid used for?▼
1 INDICATIONS AND USAGE • 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. ( 1.1 ) • Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: • Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed-release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.
What are the side effects of Mycophenolic Acid?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label. • Embryo-Fetal Toxicity [see Boxed Warning, Warnings and Precautions ( 5.1 ) ] • Lymphomas and Other Malignancies [see Boxed Warning, Warnings and Precautions ( 5.3 ) ] • Serious Infections [see Boxed Warning, Warnings and Precautions ( 5.4 ) ] • New or Reactivated Viral Infections [see Warnings and Precautions ( 5.5) ] • Blood Dyscrasias, Including Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 ) ] • Serious GI Tract Complications [see Warnings and Precautions ( 5.7 ) ] • Acute Inflammatory Syndrome Associated with Mycophenolate Products [see Warnings and Precautions ( 5.8 )] • Rare Hereditary Deficiencies [see Warnings and Precautions ( 5.10 ) ] Most common adver...
Can I take Mycophenolic Acid during pregnancy?▼
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolic acid delayed-release tablets treatment. To report a pregnancy or obtain information about the registry, visit www.mycophenolateREMS.com or call 1-800-617-8191.
What are the important warnings for Mycophenolic Acid?▼
WARNING: EMBRYO-FETAL TOXICITY, MALIGNANCIES, and SERIOUS INFECTIONS • Use during pregnancy is associated with increased risks of 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 ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 ) ]. 5 WARNINGS AND PRECAUTIONS • New or Reactivated Viral Infections: Consider reducing immunosuppression. ( 5.5 ) • Blood Dyscrasias, including Pure Red Cell Aplasia (PRCA): Monitor for neutropenia or anemia; consider treatment interruption or dose reduction. ( 5.6 ) • Serious GI Tract Complications (gastrointestinal bleeding, perforations and ulcers): Administer with caution to patients with active digestive system disease. ( 5.7 ) • Immunizations: Avoid live attenuated vaccines. ( 5.9 ) • Patients with Hereditary Deficiency of Hypoxanthine-guanine Phosphoribosyl-transferase (HGPRT): May cause exacerbation of disease symptoms; avoid use. ( 5.10 ) • Blood Donation: Avoid during therapy and for 6 weeks thereafter. ( 5.11 ) • Semen Donation: Avoid during therapy and for 90 days thereafter. 4 CONTRAINDICATIONS Known hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. ( 4.1 ) 4.1 Hypersensitivity Reactions Mycophenolic acid delayed-release tablets are contraindicated in patients with a hypersensitivity to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.