Drug Safety-related Labeling Changes (SrLC)
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Guide
Drug Safety-related Labeling Changes (SrLC) Database
| ANDA | Abbreviated New Drug Application |
| BLA | Biologics License Application |
| CDER | Center for Drug Evaluation and Research |
| MG | Medication Guide |
| NDA | New Drug Application |
| PCI | Patient Counseling Information |
| PI | Patient Information |
| PLR | Physician Labeling Rule |
| PLLR | Pregnancy and Lactation Labeling Rule |
| Italics | For the most part, italics indicate an FDA comment such as:
Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section. |
| Underlines | Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text. |
Sections
| BW | Box Warning |
| WP | Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format) |
| AR | Adverse Reactions (in pre-PLR format, this may be a subheading under precautions). |
| DI | Drug Interactions (in pre-PLR format, this may be a subheading under precautions). |
| USP | Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format. |
| PCI/PI/MG | Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events. |
Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.
Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.
CELLCEPT (NDA-050722)
(MYCOPHENOLATE MOFETIL)
Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)
06/06/2022 (SUPPL-51)
10/22/2021 (SUPPL-45)
5 Warnings and Precautions
5.3 Serious Infections(Additions and/or revisions underlined)
Patients receiving immunosuppressants, including CELLCEPT, are at increased risk of developing bacterial, fungal, protozoal and new or reactivated viral infections, including opportunistic infections. The risk increases with the total immunosuppressive load. These infections may lead to serious outcomes, including hospitalizations and death [see Adverse Reactions (6.1, 6.2)].
Serious viral infections reported include:
Polyomavirus-associated nephropathy (PVAN), especially due to BK virus infection
JC virus-associated progressive multifocal leukoencephalopathy (PML), and
Cytomegalovirus (CMV) infections: CMV seronegative transplant patients who receive an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease.
Viral reactivation in patients infected with Hepatitis B and C
COVID-19
Consider dose reduction or discontinuation of CELLCEPT in patients who develop new infections or reactivate viral infections, weighing the risk that reduced immunosuppression represents to the functioning allograft.
(Newly added information)
Acute inflammatory syndrome (AIS) has been reported with the use of MMF and mycophenolate products, and some cases have resulted in hospitalization. AIS is a paradoxical pro-inflammatory reaction characterized by fever, arthralgias, arthritis, muscle pain and elevated inflammatory markers including, C-reactive protein and erythrocyte sedimentation rate, without evidence of infection or underlying disease recurrence. Symptoms occur within weeks to months of initiation of treatment or a dose increase. After discontinuation, improvement of symptoms and inflammatory markers are usually observed within 24 to 48 hours.
Monitor patients for symptoms and laboratory parameters of AIS when starting treatment with mycophenolate products or when increasing the dosage. Discontinue treatment and consider other treatment alternatives based on the risk and benefit for the patient.
6 Adverse Reactions
(Newly added information)
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)]
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
Medication Guide(Additions and/or revisions underlined)
Viral infections that can happen with CELLCEPT include:
o Shingles, other herpes infections, and cytomegalovirus (CMV). CMV can cause serious tissue and blood
infections.
o BK virus. BK virus can affect how your kidney works and cause your transplanted kidney to fail.
o Hepatitis B and C viruses. Hepatitis viruses can affect how your liver works. Talk to your doctor about how
hepatitis viruses may affect you.
o COVID-19
Especially tell your doctor if you take:
• birth control pills (oral contraceptives). See “What is the most important information I should know about
CELLCEPT?”
• sevelamer (Renagel, Renvela). These products should be taken at least 2 hours after taking CELLCEPT.
• acyclovir (Zovirax), valacyclovir (Valtrex), ganciclovir (CYTOVENE-IV, Vitrasert), valganciclovir (VALCYTE).
• rifampin (Rifater, Rifamate, Rimactane, Rifadin).
• Inflammatory reactions. Some people taking CELLCEPT may have an inflammatory reaction with fever, joint
stiffness, joint pain, and muscle pain. Some of these reactions may require hospitalization.This reaction could
happen within weeks to months after your treatment with CELLCEPT starts or if your dose is increased. Call your
doctor right away if you experience these symptoms.
The most common side effects of CELLCEPT include:
• fast heartbeat
• swelling of the lower legs, ankles and feet
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Acute Inflammatory Syndrome
(Newly added subsection)
Inform patients that acute inflammatory reactions have been reported in some patients who received CELLCEPT. Some reactions were severe, requiring hospitalization. Advise patients to contact their physician if they develop fever, joint stiffness, joint pain or muscle pains [see Warnings and Precautions (5.7)].