lmonary embolism: Physicians and patients should be observant for signs and symptoms of thromboembolism (5.4, 6.1).
Allergic Reactions: include hypersensitivity, angioedema, Stevens-Johnson syndrome, and toxic epidermal necrolysis. In some cases these allergic reactions may be fatal. Discontinue REVLIMID if any such reactions are suspected (5.5). REVLIMID should not be resumed following discontinuation for these reactions.
Tumor lysis syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. Monitor patients at risk of TLS (i.e., those with high tumor burden) and take appropriate precautions (5.6).
Tumor flare reaction: Serious tumor flare reactions have occurred during investigational use of REVLIMID for chronic lymphocytic leukemia and lymphoma (5.7).
ADVERSE REACTIONS
MM: Most common adverse reactions (≥20%) include fatigue, neutropenia, constipation, diarrhea, muscle cramp, anemia, pyrexia, peripheral edema, nausea , back pain, upper respiratory tract infection, dyspnea, dizziness, thrombocytopenia, tremor and rash (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 (6.2).
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 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 venous thromboembolic events (VTE). (7.3)
USE IN SPECIFIC POPULATIONS
Patients with Renal Insufficiency: Adjustment of the starting dose of REVLIMID is recommended in patients with moderate or severe renal impairment and in patients on dialysis (2.1, 2.2).
See 17 for PATIENT COUNSELING INFORMATION and the FDA-approved Medication Guide
-------------------------------------------------------
Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
WARNING: FETAL RISK, HEMATOLOGIC TOXICITY, and DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
1INDICATIONS AND USAGE
1.1Multiple Myeloma
1.2Myelodysplastic Syndromes
2DOSAGE AND ADMINISTRATION
2.1 Multiple Myeloma
2.2Myelodysplastic Syndromes
3DOSAGE FORMS AND STRENGTHS
4CONTRAINDICATIONS
4.1Pregnancy
4.2Allergic Reactions
5WARNINGS AND PRECAUTIONS
5.1Fetal Risk
5.2 Reproductive Risk and Special Prescribing Requirements (RevAssist Program)
5.3 Hematologic Toxicity
5.4 Deep Vein Thrombosis and Pulmonary Embolism
5.5 Allergic Reactions
5.6 Tumor Lysis Syndrome
5.7 Tumor Flare Reaction
6.ADVERSE REACTIONS
6.1Clinical Trials Experience in Multiple Myeloma
6.2 Clinical Trials Experience in Myelodysplastic Syndromes
6.3Postmarketing Experience
7DRUG INTERACTIONS
7.1Digoxin
7.2Warfarin
7.3Concomitant Therapies That May Increase the Risk of Thrombosis
8USE IN SPECIFIC POPULATIONS
8.1Pregnancy
8.3Nursing Mo |
