Drugplain

CellCept 500 mg/1

Mycophenolate Mofetil · TABLET, FILM COATED · Genentech, Inc.

1 Recall on Record
Plain English

CellCept is a tablet, film coated containing mycophenolate mofetil at 500 mg/1, taken oral. Manufactured by Genentech, Inc..

Key Facts

Brand Name
CellCept
Generic Name
Mycophenolate Mofetil
NDC Code (Product)
0004-0260
Manufacturer
Genentech, Inc.
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
NDA050723
Marketing Start
06/19/1997

Recall History

1 Recall on Record
Class III09/27/2012

Genentech, Inc.

Short Fill: some bottles contained less than 120-count per labeled claim.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use18,833 reports
drug ineffective11,002 reports
product use in unapproved indication7,193 reports
diarrhoea6,786 reports
pyrexia5,577 reports
pneumonia5,167 reports
cytomegalovirus infection4,820 reports
fatigue4,428 reports
nausea4,402 reports
condition aggravated4,341 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE CELLCEPT [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. CELLCEPT 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 or intravenously (IV) over no less than 2 h ( 2.2 ) Heart Transplant 1.5 g twice daily orally or IV, over no less than 2 h ( 2.3 ) Liver Transplant 1.5 g twice daily orally or 1g twice daily IV over no less than 2 h ( 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 or 15 mL of oral suspension) ( 2.3 ) Liver Transplant 600 mg/m 2 orally twice daily (starting dose) up to a maximum of 900 mg/m 2 twice daily (3 g or 15 mL of oral suspension) ( 2.4 ) CELLCEPT Intravenous is an alternative when patients cannot tolerate oral medication. Administer within 24 hours following transplantation, until patients can tolerate oral medication, up to 14 days. ( 2.1 ) 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 ), preparation of oral suspension and IV solution. ( 2.6 ) 2.1 Important Administration Instructions CELLCEPT should not be used wit…

Contraindications

4 CONTRAINDICATIONS CELLCEPT is contraindicated in patients with a history of hypersensitivity, including anaphylaxis, to mycophenolate mofetil (MMF), mycophenolic acid (MPA) or any component of the drug product [see Warnings and Precautions (5.8) ] . CELLCEPT Intravenous is contraindicated in patients who are allergic to Polysorbate 80 (TWEEN). History of hypersensitivity, including anaphylaxis, to mycophenolate mofetil, mycophenolic acid or any component of the drug product ( 4 ) Patients allergic to Polysorbate 80 (present in CELLCEPT IV) ( 4 )

Drug Interactions

7 DRUG INTERACTIONS See FPI for drugs that may interfere with systemic exposure and reduce CELLCEPT efficacy: antacids with magnesium or aluminum hydroxide, proton pump inhibitors, drugs that interfere with enterohepatic recirculation, telmisartan, calcium-free phosphate binders. ( 7.1 ) CELLCEPT 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 CELLCEPT Table 7 Drug Interactions with CELLCEPT 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 CELLCEPT efficacy. Prevention or Management Administer magnesium or aluminum hydroxide containing antacids at least 2h after CELLCEPT administration. Proton Pump Inhibitors (PPIs) Clinical Impact Concomitant use with PPIs decreases MPA systemic exposure [see Clinical Pharmacology (12.3) ] , which may reduce CELLCEPT efficacy. Prevention or Management Monitor patients for alterat…

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 [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] 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 Genentech at 1-888-835-2555 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 …

Frequently Asked Questions

What is CellCept used for?

CellCept contains Mycophenolate Mofetil. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is CellCept a controlled substance?

CellCept is not classified as a controlled substance by the DEA.

What is the generic name for CellCept?

The generic name for CellCept is Mycophenolate Mofetil. There are 11 other brand versions of Mycophenolate Mofetil.

What is the NDC code for CellCept 500 mg/1?

The NDC (National Drug Code) for CellCept 500 mg/1 is 0004-0260, listed by Genentech, Inc..

Product NDC

0004-0260

Package NDC

0004-0260-01

Other CellCept Dosages

Other Mycophenolate Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)