5.1 Embryo-Fetal Toxicity 

5.2 REVLIMID REMS Program

5.3 Hematologic Toxicity 

5.4 Venous and Arterial Thromboembolism

5.5 Increased Mortality in Patients with CLL

5.6 Second Primary Malignancies

5.7 Hepatotoxicity

5.8 Allergic Reactions

5.9 Tumor Lysis Syndrome

5.10 Tumor Flare Reaction

5.11 Impaired Stem Cell Mobilization

5.12 Thyroid Disorders

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience 

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Digoxin

7.2 Concomitant Therapies That May Increase the Risk of Thrombosis 

7.3 Warfarin

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Multiple Myeloma

14.2 Myelodysplastic Syndromes (MDS) with a Deletion 5q Cytogenetic Abnormality 

14.3 Mantle Cell Lymphoma

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

16.3 Handling and Disposal

17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE

1.1 Multiple Myeloma
 
REVLIMID in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM).

REVLIMID is indicated as maintenance therapy in patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT).

1.2 Myelodysplastic Syndromes
 
REVLIMID is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

1.3 Mantle Cell Lymphoma
 
REVLIMID is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.

1.4 Limitations of Use
 
REVLIMID is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials [see Warnings and Precautions (5.5)].
2 DOSAGE AND ADMINISTRATION

REVLIMID should be taken orally at about the same time each day, either with or without food. REVLIMID capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed.

2.1 Multiple Myeloma
 
REVLIMID Combination Therapy

The recommended starting dose of REVLIMID is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients > 75 years old, the starting dose of dexamethasone may be reduced [see Clinical Studies (14.1)]. Treatment should be continued until disease progression or unacceptable toxicity.

In patients who are not eligible for auto-HSCT, treatment should continue until disease progr