The following adverse events which have occurred in other indications and not described above have been reported (5%-10%) in patients treated with REVLIMID monotherapy for mantle cell lymphoma.

General disorders and administration site conditions: Chills
Musculoskeletal and connective tissue disorders: Pain in extremity
Nervous system disorders: Dysgeusia, headache, neuropathy peripheral
Infections and infestations: Respiratory tract infection, sinusitis, nasopharyngitis
Skin and subcutaneous tissue disorders: Dry skin, night sweats

The following serious adverse events not described above and reported in 2 or more patients treated with REVLIMID monotherapy for mantle cell lymphoma.

Respiratory, thoracic, and mediastinal disorders: Chronic obstructive pulmonary disease
Infections and infestations:Clostridium difficile colitis, sepsis
Neoplasms benign, malignant and unspecified (including cysts and polyps): Basal cell carcinoma
Cardiac disorder: Supraventricular tachycardia

6.2 Postmarketing Experience
 
The following adverse drug reactions have been identified from the worldwide post-marketing experience with REVLIMID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure [see Warnings and Precautions Section (5.7 to 5.10, and 5.12)]
Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis
Immune system disorders: Angioedema, acute graft-versus-host disease (following allogeneic hematopoietic transplant)
Neoplasms benign, malignant and unspecified (incl cysts and polyps): Tumor lysis syndrome, tumor flare reaction
Respiratory, thoracic and mediastinal disorders: Pneumonitis
Hepatobiliary disorders: Hepatic failure (including fatality), toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, mixed cytolytic/cholestatic hepatitis, transient abnormal liver laboratory tests
Infections and infestations: Viral reactivation (such as hepatitis B virus and herpes zoster)
Endocrine disorders:  Hypothyroidism, hyperthyroidism

7 DRUG INTERACTIONS

7.1 Digoxin
 
When digoxin was co-administered with multiple doses of REVLIMID (10 mg/day) the digoxin Cmax and AUCinf were increased by 14%. Periodic monitoring of digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of REVLIMID.

7.2 Concomitant Therapies That May Increase the 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 [see Warnings and Precautions (5.4)].

7.3 Warfarin
 
Co-administration of multiple doses of REVLIMID (10 mg/day) with a single dose of warfarin (25 mg) had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin. Expected changes in laboratory assessments of PT and INR were observed after warfarin administration, but these changes were not affected by concomitant REV