Myfortic 180 mg/1
mycophenolic acid · TABLET, DELAYED RELEASE · Novartis Pharmaceuticals Corporation
Myfortic is a prescription tablet containing mycophenolic acid that is used to prevent organ rejection in transplant patients. It works by suppressing the immune system to help protect the transplanted organ from being attacked by the body's natural defenses.
Key Facts
- Brand Name
- Myfortic
- Generic Name
- mycophenolic acid
- NDC Code (Product)
0078-0385- Manufacturer
- Novartis Pharmaceuticals Corporation
- Strength
- 180 mg/1
- Dosage Form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- NDA050791
- Marketing Start
- 02/27/2004
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Myfortic is 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 : Myfortic 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 Myfortic ® (mycophenolic acid) is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Myfortic is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant. Myfortic is to be used in combination with cyclosporine and corticosteroids. 1.2 Limitations of Use Myfortic delayed-release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
Dosage & Administration
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 Myfortic is 720 mg administered twice daily (1,440 mg total daily dose). 2.2 Dosage in Pediatric Kidney Transplant Patients The recommended dose of Myfortic in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m 2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). 2.3 Administration Myfortic tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology (12.3)] . Myfortic tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating. Pediatric patients with a BSA o…
Contraindications
4 CONTRAINDICATIONS Myfortic is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients [see Warnings and Precautions (5.9), Adverse Reactions (6.2)] . History of hypersensitivity, including anaphylaxis, to mycophenolate sodium, mycophenolic acid (MPA), mycophenolate mofetil, or to any of its excipients. ( 4 )
Drug 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. ( 7.5 ) Norfloxacin and Metronidazole: May decrease MPA concentrations; concomitant use with both drugs is not recommended. ( 7.6 ) Rifampin: May decrease MPA concentrations; concomitant use is not recommended unless the benefit outweighs the risk. ( 7.7 ) Hormonal Contraceptives: May reduce the effectiveness of oral contraceptives. Additional barrier contraceptive methods must be used. ( 5.2 , 7.8 ) Acyclovir, Valacyclovir, Ganciclovir, Valganciclovir, and Other Drugs that Undergo Renal Tubular Secre…
Adverse Reactions
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)] Hypersensitivity Reactions [see Warnings and Precautions (5.9)] Rare Hereditary Deficiencies [see Warnings and Precautions (5.11)] Most common adverse reactions (≥ 20%): anemia, leukopenia, constipation, nausea, diarrhea, vomiting, dyspepsia, urinary tract infection, CMV infection, insomnia, and postoperative pain. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clin…
Frequently Asked Questions
What is Myfortic used for?
Myfortic is a prescription tablet containing mycophenolic acid that is used to prevent organ rejection in transplant patients. It works by suppressing the immune system to help protect the transplanted organ from being attacked by the body's natural defenses.
Is Myfortic a controlled substance?
Myfortic is not classified as a controlled substance by the DEA.
What is the generic name for Myfortic?
The generic name for Myfortic is mycophenolic acid. There are 12 other brand versions of mycophenolic acid.
What is the NDC code for Myfortic 180 mg/1?
The NDC (National Drug Code) for Myfortic 180 mg/1 is 0078-0385, listed by Novartis Pharmaceuticals Corporation.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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