Mycophenolate Mofetil 500 mg/20mL
Mycophenolate Mofetil hydrochloride · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · BPI Labs LLC
Mycophenolate mofetil is an immunosuppressant medication given by injection that helps prevent the body's immune system from rejecting transplanted organs and is also used to treat certain autoimmune conditions. This intravenous form delivers 500 mg of the medication per vial for patients who cannot take it by mouth.
Key Facts
- Brand Name
- Mycophenolate Mofetil
- Generic Name
- Mycophenolate Mofetil hydrochloride
- NDC Code (Product)
54288-141- Manufacturer
- BPI Labs LLC
- Strength
- 500 mg/20mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA214283
- Marketing Start
- 03/08/2023
Recall History
Par Pharmaceutical, Inc.
Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
VistaPharm LLC
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Attix Pharmaceuticals Inc
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Genentech, Inc.
Short Fill: some bottles contained less than 120-count per labeled claim.
Aidapak Services, LLC
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as the following drug: PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg, NDC 16714058501, Pedigree: W003761, EXP: 6/26/2014.
Aidapak Services, LLC
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Tablet, 500 mg may be potentially mis-labeled as the following drug: MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 00004025901, Pedigree: AD49414_1, EXP: 5/17/2014.
Aidapak Services, LLC
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may have potentially been mislabeled as one of the following drugs: ATORVASTATIN CALCIUM, Tablet, 80 mg, NDC 00378212277, Pedigree: W003213, EXP: 6/14/2014; PROPRANOLOL HCL, Tablet, 10 mg, NDC 23155011010, Pedigree: AD65317_1, EXP: 5/24/2014.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Aidapak Services, LLC
Labeling: Label Mixup: MYCOPHENOLATE MOFETIL, Capsule, 250 mg may be potentially mis-labeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52412_11, EXP: 5/17/2014.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies (14.1) ] , heart [see Clinical Studies (14.2) ] or liver transplants [see Clinical Studies (14.3) ], in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION ADULTS DOSAGE Kidney Transplant 1 g twice daily, orally ( 2.2 ) Heart Transplant 1.5 g twice daily orally ( 2.3 ) Liver Transplant 1.5 g twice daily orally ( 2.4 ) PEDIATRICS Kidney Transplant 600 mg/m 2 orally twice daily, up to maximum of 2 g daily ( 2.2 ) Heart Transplant 600 mg/m 2 orally twice daily, (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily,daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g) ( 2.4 ) Reduce or interrupt dosing in the event of neutropenia. ( 2.5 ) See full prescribing information (FPI) for: adjustments for renal impairment and neutropenia ( 2.5 ) 2.1 Important Administration Instructions Mycophenolate mofetil should not be used without the supervision of a physician with experience in immunosuppressive therapy. Mycophenolate Mofetil Capsules and Tablets Mycophenolate mofetil oral dosage forms (capsules or tablets) should not be used interchangeably with mycophenolic acid delayed-release tablets without supervision of a physician with experience in immunosuppressive therapy because the rates of absorption following the administration of myco…
Contraindications
4 CONTRAINDICATIONS Allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product. Hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product ( 4 )
Drug Interactions
7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce mycophenolate mofetil efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) Mycophenolate mofetil may reduce effectiveness of oral contraceptives. Use of additional barrier contraceptive methods is recommended. ( 7.2 ) See FPI for other important drug interactions. ( 7 ) 7.1 Effect of Other Drugs on Mycophenolate Mofetil Table 7 Drug Interactions with Mycophenolate mofetil that Affect Mycophenolic Acid (MPA) Exposure Antacids with Magnesium or Aluminum Hydroxide Clinical Impact Concomitant use with an antacid containing magnesium or aluminum hydroxide decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce mycophenolate mofetil efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after mycophenolate mofetil administration. Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may r…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Embryofetal Toxicity [see Warnings and Precautions (5.1) ] Lymphomas and Other Malignancies [see Warnings and Precautions 5.2) ] Serious Infections [see Warnings and Precautions (5.3) ] Blood Dyscrasias: Neutropenia, Pure Red Cell Aplasia [see Warnings and Precautions (5.4) ] Gastrointestinal Complications [see Warnings and Precautions (5.5) ] Acute Inflammatory Syndrome Associated with Mycophenolate Products s [see Warnings and Precautions (5.7) ] The most common adverse reactions in clinical trials (20 % or greater) include diarrhea, leukopenia, infection, vomiting, and there is evidence of a higher frequency of certain types of infections e.g., opportunistic infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare Inc. at 1-866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.com 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not…
Frequently Asked Questions
What is Mycophenolate Mofetil used for?
Mycophenolate mofetil is an immunosuppressant medication given by injection that helps prevent the body's immune system from rejecting transplanted organs and is also used to treat certain autoimmune conditions. This intravenous form delivers 500 mg of the medication per vial for patients who cannot take it by mouth.
Is Mycophenolate Mofetil a controlled substance?
Mycophenolate Mofetil is not classified as a controlled substance by the DEA.
What is the generic name for Mycophenolate Mofetil?
The generic name for Mycophenolate Mofetil is Mycophenolate Mofetil hydrochloride. There are 1 other brand versions of Mycophenolate Mofetil hydrochloride.
What is the NDC code for Mycophenolate Mofetil 500 mg/20mL?
The NDC (National Drug Code) for Mycophenolate Mofetil 500 mg/20mL is 54288-141, listed by BPI Labs LLC.