Uncommon

Acquired Fanconi syndrome
 Common

Renal failure

Uncommon

Renal tubular necrosis
 
Reproductive System and Breast Disorders
 Common

Erectile Dysfunction
 
General disorders and administration site conditions

 Very Common

Fatigue, Oedema (including peripheral oedema), Pyrexia, Influenza like illness syndrome (including pyrexia, myalgia, musculoskeletal pain, headache and rigors)

Common

Chest Pain, Lethargy
 Common

Fatigue
 
Injury, poisoning and procedural complications
 Common

Contusion^

^See section 4.8c.

In addition to the above adverse drug reactions identified from the pivotal trials, the following table is derived from data gathered during post-marketing experience.

Table 2: Summary of adverse drug reactions identified from post-marketing data in patients treated with lenalidomide

System organ class
 Reactions/frequency
 
Neoplasms benign, malignant and unspecified
 Rare: Tumour lysis syndrome
 
Respiratory, Thoracic and Mediastinal Disorders
 Unknown: Interstitial pneumonitis
 
Gastrointestinal disorders
 Unknown: Pancreatitis
 
Skin and subcutaneous system disorders
 Uncommon: Angioedema

Rare: Stevens-Johnson Syndrome^, toxic epidermal necrolysis^

^see section 4.8c

c. Description of selected adverse reactions

Teratogenicity

Lenalidomide is structurally related to thalidomide. Thalidomide is a known human teratogenic active substance that causes severe life-threatening birth defects. Lenalidomide induced in monkeys malformations similar to those described with thalidomide (see sections 4.6 and 5.3). If lenalidomide is taken during pregnancy, a teratogenic effect of lenalidomide in humans is expected.

Neutropenia and thrombocytopenia

The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 4 neutropenia (5.1% in lenalidomide/dexamethasone-treated patients compared with 0.6% in placebo/dexamethasone-treated patients). Grade 4 febrile neutropenia episodes were observed infrequently (0.6% in lenalidomide/dexamethasone-treated patients compared to 0.0% in placebo/dexamethasone treated patients).

The combination of lenalidomide with dexamethasone in multiple myeloma patients is associated with a higher incidence of grade 3 and grade 4 thrombocytopenia (9.9% and 1.4%, respectively, in lenalidomide/dexamethasone-treated patients compared to 2.3% and 0.0% in placebo/dexamethasonetreated patients).

Venous thromboembolism

The combination of lenalidomide with dexamethasone is associated with an increased risk of DVT and PE in patients with multiple myeloma (see section 4.5). Concomitant administration of erythropoietic agents or previous history of DVT may also increase thrombotic risk in these patients.

Myocardial Infarction

Myocardial infarction has been reported in patients receiving lenalidomide, particularly in those with known risk factors.

Common:
 Febrile neutropenia, pancytopenia, leucopenia*, lymphopenia*
Uncommon:
 Granulocytopenia, haemolytic anaemia, autoimmune haemolytic anaemia, ha