ns occurred in patients with CLL treated with REVLIMID (5.5).
Second Primary Malignancies (SPM): Higher incidences of SPM were observed in controlled trials of patients with MM receiving REVLIMID (5.6).
Hepatotoxicity: Hepatic failure including fatalities; monitor liver function. Stop REVLIMID and eva luate if hepatotoxicity is suspected (5.7).
Allergic Reactions, including fatalities: Hypersensitivity, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; discontinue REVLIMID if reactions are suspected. Do not resume REVLIMID if these reactions are verified (5.8).
Tumor lysis syndrome (TLS) including fatalities: Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions (5.9).
Tumor flare reaction: Serious tumor flare reactions have occurred during investigational use of REVLIMID for chronic lymphocytic leukemia and lymphoma (5.10, 6.3).
Impaired Stem Cell mobilization: A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with REVLIMID has been reported. Consider early referral to transplant center (5.11).
ADVERSE REACTIONS
MM: Most common adverse reactions (≥20%) include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor (6.1).
MDS: Most common adverse reactions (>15%) include thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, and epistaxis (6.1).
MCL: Most common adverse reactions (≥15%) include neutropenia, thrombocytopenia, fatigue, diarrhea, anemia, nausea, cough, pyrexia, rash, dyspnea, pruritus, constipation, peripheral edema and leukopenia (6.1).
To report SUSPECTED ADVERSE REACTIONS contact Celgene Corporation at 1-888-423-5436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Digoxin: Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy (7.1).
Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis (7.2).
USE IN SPECIFIC POPULATIONS
Lactation: Advise women not to breastfeed. (8.2).
Renal Impairment: Adjust the starting dose of REVLIMID for patients based on creatinine clearance value (2.4).
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 2/2017
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM
1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
1.2 Myelodysplastic Syndromes
1.3 Mantle Cell Lymphoma
1.4 Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Multiple Myeloma
2.2 Myelodysplastic Syndromes
2.3 Mantle Cell Lymphoma
2.4 Starting Dose for Renal Impairment
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Pregnancy
4.2 Allergic Reactions
5 WARNINGS AND PRE
