Indicated for the treatment of patients with:

Multiple Myeloma:

• REVLIMID in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM).

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

Myelodysplastic Syndromes:

• REVLIMID is indicated for the treatment of adult 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.

Mantle Cell Lymphoma:

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

Follicular Lymphoma:

• REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL).

Marginal Zone Lymphoma:

• REVLIMID in combination with a rituximab product, is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL).

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

REVLIMID is available only through a restricted distribution program called the REVLIMID REMS program (formerly known as the “RevAssist program”).

In people who have mantle cell lymphoma (MCL), there may be a risk of dying sooner (early death) when taking REVLIMID.

In a prospective randomized clinical trial in the first line treatment of patients with chronic lymphocytic leukemia, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil.

In clinical trials In patients with multiple myeloma (MM) receiving REVLIMID, there an increase of hematologic plus solid tumor second primary malignancies notably AML and MDS have been observed.

Patients must not donate blood during treatment with REVLIMID and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to REVLIMID.

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medication that may increase risk of bleeding. 

Venous thromboembolic events (VTE [DVT and PE]) and arterial thromboembolic events (ATE, myocardial infarction and stroke) are increased in patients treated with REVLIMID.Thromboprophylaxis is recommended. 

Hepatic failure, including fatal cases, has occurred in patients treated with lenalidomide in combination with dexamethasone.

Fatal instances of tumor lysis syndrome have been reported during treatment with lenalidomide.

Tumor flare reaction (TFR) has occurred during investigational use of REVLIMID for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash. Monitoring and evaluation for TFR is recommended in patients with MCL, FL, or MZL. Tumor flare reaction may mimic progression of disease (PD).

A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with REVLIMID has been reported. In patients who are auto-HSCT candidates, referral to a transplant center should occur early in treatment to optimize the timing of the stem cell collection. In patients who received more than 4 cycles of a REVLIMID containing treatment or for whom inadequate numbers of CD 34+ cells have been collected with G-CSF alone, G-CSF with cyclophosphamide or the combination of GCSF with a CXCR4 inhibitor may be considered.

Both hypothyroidism and hyperthyroidism have been reported.

Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis.

For non-hematologic Grade 3/4 toxicities judged to be related to REVLIMID, hold treatment and restart at the physician’s discretion at next lower dose level when toxicity has resolved to Grade 2 or below.

Permanently discontinue REVLIMID for angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reactions.

Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis.–Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving REVLIMID.

The addition of pembrolizumab to a thalidomide analogue plus dexamethasone, a use for which no PD-1 or PD-L1 blocking antibody is indicated, resulted in increased mortality.

When digoxin was co-administered with multiple doses of REVLIMID (10 mg/day) the digoxin Cmax and AUCinf were increased by 14%.

Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning REVLIMID therapy, during therapy, during dose interruptions and for at least 4 weeks after completing therapy. Females must commit either to abstain continuously from heterosexual sexual intercourse or to use two methods of reliable birth control, beginning 4 weeks prior to initiating treatment with REVLIMID, during therapy, during dose interruptions and continuing for 4 weeks following discontinuation of REVLIMID therapy.

Two negative pregnancy tests must be obtained prior to initiating therapy. The first test should be performed within 10-14 days and the second test within 24 hours prior to prescribing REVLIMID therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or every 2 weeks in females with irregular menstrual cycles.

Lenalidomide is present in the semen of patients receiving the drug. Therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 4 weeks after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm.

There is no information regarding the presence of lenalidomide in human milk, the effects of REVLIMID on the breastfed child, or the effects of REVLIMID on milk production. Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children from REVLIMID, advise women not to breastfeed during treatment with REVLIMID.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Chronic lymphocytic leukemia. GoToSource 

• Transfusion-dependent low-or intermediate-1-risk myelodysplastic syndromes (MDS) without the deletion 5q abnormality. GoToSource

• Monotherapy for multiple myeloma. GoToSource

• Systemic light chain amyloidosis. GoToSource

• Advanced pancreatic cancer. GoToSource 

• Recurrent ovarian cancer. GoToSource

• Erythema nodosum leprosum, prurigo nodularis, actinic prurigo, discoid lupus erythematosus, aphthous stomatitis, Behçet’s syndrome and graft-versus-host disease. GoToSource

• HIV-related mouth and throat ulcers and Kaposi’s sarcoma. GoToSource

Deep vein thrombosis (blood clot in deep vein in body). GoToSource

Pulmonary embolism (blockage in lung artery). GoToSource

Peripheral edema (accumulation of fluid in body tissues), tremors, bradycardia (slow heart rate) and hepatic enzyme elevation (indicates Inflamed or injured liver). GoToSource

Arterial thrombosis (blood clot inside a blood vessel), myocardial infarction and stroke. GoToSource

Second primary malignancies (particularly acute myelogenous leukemia and hodgkin lymphoma). GoToSource

Increased mortality when used in patients with chronic lymphocytic leukemia. GoToSource

Neutropenia (low count of neutrophils, a type of white blood cell), anemia, osteonecrosis (death of bone tissue) of the jaw and dyspnea (shortness of breath). GoToSource

Inflammatory syndrome (inflammatory state affecting the whole body) and serum sickness (hypersensitivity reaction). GoToSource

Graft-versus-host disease (donor bone marrow or stem cells attack the recipient). GoToSource

Tumor lysis syndrome (metabolic disorder). GoToSource

Acquired hemophilia A. GoToSource

Hypothyroidism (underactive thyroid gland). GoToSource

Peripheral neuropathy (nerve damage). GoToSource

Atrial fibrillation and asthenia (lack of energy and strength). GoToSource

Acute lung injury. GoToSource

Birth defects and death. GoToSource

Liver failure. GoToSource

Erythema multiforme, stevens-johnson syndrome and toxic epidermal necrolysis (life-threatening skin conditions). GoToSource

Cataracts and hyperglycemia. GoToSource

Lawsuits filed for stevens-johnson syndrome and toxic epidermal necrolysis.