Revlimid Side Effects

Generic Name: lenalidomide

Please note - some side effects for Revlimid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Revlimid - for the Consumer

Revlimid

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Revlimid:

Back pain; constipation; cough; diarrhea; dizziness; dry mouth or skin; headache; increased sweating or night sweats; loss of appetite; nausea; stuffy or runny nose; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; hoarseness; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stools or vomit; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; muscle cramps; muscle or joint pain; pain, numbness, tingling, tenderness, or swelling of the arms or legs; painful or difficult urination; red, swollen, blistered, or peeling skin; severe tiredness or weakness; shortness of breath; stomach pain; unusual bruising or bleeding.

Revlimid Side Effects - for the Professional

Revlimid

Myelodysplastic Syndromes

A total of 148 patients received at least 1 dose of 10 mg lenalidomide in the del 5q MDS clinical study. At least one adverse event was reported in all of the 148 patients who were treated with the 10 mg starting dose of Revlimid® (lenalidomide). The most frequently reported adverse events were related to blood and lymphatic system disorders, skin and subcutaneous tissue disorders, gastrointestinal disorders, and general disorders and administrative site conditions.

Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events observed. The next most common adverse events observed were diarrhea (48.6%; 72/148), pruritus (41.9%; 62/148), rash (35.8%; 53/148) and fatigue (31.1%; 46/148). Table 4 summarizes the adverse events that were reported in ≥ 5% of the Revlimid® (lenalidomide) treated patients in the del 5q MDS clinical study. Table 5 summarizes the most frequently observed Grade 3 and Grade 4 adverse reactions regardless of relationship to treatment with Revlimid® (lenalidomide). In the single-arm studies conducted, it is often not possible to distinguish adverse events that are drug-related and those that reflect the patient’s underlying disease.

In other clinical studies of Revlimid® (lenalidomide) in MDS patients, the following serious adverse events (regardless of relationship to study drug treatment) not described in Table 4 or 5 were reported:

Blood and lymphatic system disorders: warm type hemolytic anemia, splenic infarction, bone marrow depression NOS, coagulopathy, hemolysis NOS, hemolytic anemia NOS, refractory anemia

Cardiac disorders: cardiac failure congestive, atrial fibrillation, angina pectoris, cardiac arrest, cardiac failure NOS, cardio-respiratory arrest, cardiomyopathy NOS, myocardial infarction, myocardial ischemia, atrial fibrillation aggravated, bradycardia NOS, cardiogenic shock, pulmonary edema NOS, supraventricular arrhythmia NOS, tachyarrhythmia, ventricular dysfunction

Ear and labyrinth disorders: vertigo

Endocrine disorders: Basedow’s disease

Gastrointestinal disorders: gastrointestinal hemorrhage NOS, colitis ischemic, intestinal perforation NOS, rectal hemorrhage, colonic polyp, diverticulitis NOS, dysphagia, gastritis NOS, gastroenteritis NOS, gastroesophageal reflux disease, obstructive inguinal hernia, irritable bowel syndrome, melena, pancreatitis due to biliary obstruction, pancreatitis NOS, perirectal abscess, small intestinal obstruction NOS, upper gastrointestinal hemorrhage

General disorders and administration site conditions: disease progression NOS, fall, gait abnormal, intermittent pyrexia, nodule, rigors, sudden death

Hepatobiliary disorders: hyperbilirubinemia, cholecystitis acute NOS, cholecystitis NOS, hepatic failure

Immune system disorders: hypersensitivity NOS

Infections and infestations: infection NOS, bacteremia, central line infection, clostridial infection NOS, ear infection NOS, Enterobacter sepsis, fungal infection NOS, herpes viral infection NOS, influenza, kidney infection NOS, Klebsiella sepsis, lobar pneumonia NOS, localized infection, oral infection, Pseudomonas infection NOS, septic shock, sinusitis acute NOS, sinusitis NOS, Staphylococcal infection, urosepsis

Injury, poisoning and procedural complications: femur fracture, transfusion reaction, cervical vertebral fracture, femoral neck fracture, fractured pelvis NOS, hip fracture, overdose NOS, post procedural hemorrhage, rib fracture, road traffic accident, spinal compression fracture

Investigations: blood creatinine increased, culture NOS negative, hemoglobin decreased, liver function tests NOS abnormal, troponin I increased

Metabolism and nutrition disorders: dehydration, gout, hypernatremia, hypoglycemia NOS

Musculoskeletal and connective tissue disorders: arthritis NOS, arthritis NOS aggravated, gouty arthritis, neck pain, chondrocalcinosis pyrophosphate

Neoplasms benign, malignant and unspecified: acute leukemia NOS, acute myeloid leukemia NOS, bronchoalveolar carcinoma, lung cancer metastatic, lymphoma NOS, prostate cancer metastatic

Nervous system disorders: cerebrovascular accident, aphasia, cerebellar infarction, cerebral infarction, depressed level of consciousness, dysarthria, migraine NOS, spinal cord compression NOS, subarachnoid hemorrhage NOS, transient ischemic attack

Psychiatric disorders: confusional state

Renal and urinary disorders: renal failure NOS, hematuria, renal failure acute, azotemia, calculus ureteric, renal mass NOS

Reproductive system and breast disorders: pelvic pain NOS

Respiratory, thoracic and mediastinal disorders: bronchitis NOS, chronic obstructive airways disease exacerbated, respiratory failure, dyspnea exacerbated, interstitial lung disease, lung infiltration NOS, wheezing

Skin and subcutaneous tissue disorders: acute febrile neutrophilic dermatosis

Vascular system disorders: deep vein thrombosis, hypotension NOS, aortic disorder, ischemia NOS, thrombophlebitis superficial, thrombosis

Multiple Myeloma

Data were evaluated from 691 patients in two studies who received at least one dose of Revlimid® (lenalidomide)/dexamethasone (346 patients) or placebo/dexamethasone (345 patients).

In the Revlimid® (lenalidomide)/dexamethasone treatment group, 151 patients (45%) underwent at least one dose interruption with or without a dose reduction of Revlimid® (lenalidomide) compared to 21% in the placebo/dexamethasone treatment group. Of these patients who had one dose interruption with or without a dose reduction, 50% in the Revlimid® (lenalidomide)/dexamethasone treatment group underwent at least one additional dose interruption with or without a dose reduction compared to 21% in the placebo/dexamethasone treatment group. Most adverse events and Grade 3/4 adverse events were more frequent in patients who received the combination of Revlimid® (lenalidomide)/dexamethasone compared to placebo/dexamethasone.

Table 6 summarizes the number and percentage of patients with Grade 1-4 adverse events reported in ≥10% of patients in either treatment group in Studies 1 and 2.

Table 7 summarizes the Grade 3/4 adverse events reported in ≥2% of patients in either treatment group in Studies 1 and 2.

Thrombotic Events

In the pooled analysis, thrombotic or thromboembolic events, including deep vein thrombosis, pulmonary embolism, thrombosis, and intracranial venous sinus thrombosis, were reported more frequently in patients treated with Revlimid® (lenalidomide)/dexamethasone combination. The number of patients experiencing a thrombotic event in the combination arm were 43/346 (12%) compared with those in the placebo/dexamethasone arm 14/345 (4%).

In these and other clinical studies of Revlimid® (lenalidomide) in patients with multiple myeloma, the following serious adverse events (considered related to study drug treatment) not described in Table 7 were reported:

Blood and lymphatic system disorders: pancytopenia, anemia NOS aggravated

Cardiac disorders: cardiac failure congestive, atrial flutter, pulmonary edema

Endocrine disorders: adrenal insufficiency NOS, acquired hypothyroidism

Eye disorders: blindness

Gastrointestinal disorders: abdominal pain NOS, colitis pseudomembranous, gastritis NOS, gastrointestinal hemorrhage NOS, peptic ulcer hemorrhage, upper gastrointestinal hemorrhage

General disorders and administration site conditions: performance status decreased

Hepatobiliary disorders: hepatic failure, hepatitis toxic

Infections and infestations: bronchopneumonia NOS, cellulitis, Pneumocystis carinii pneumonia, sepsis NOS, bursitis infective NOS, cellulitis staphylococcal, Enterobacter bacteremia, Escherichia sepsis, gastrointestinal infection NOS, herpes zoster, herpes zoster ophthalmic, infection NOS, lung infection NOS, neutropenic sepsis, pneumonia bacterial NOS, pneumonia cytomegaloviral, pneumonia pneumococcal, pneumonia primary atypical, pneumonia staphylococcal, septic shock, streptococcal sepsis, subacute endocarditis, urinary tract infection NOS

Investigations: International normalized ratio increased, weight decreased, blood creatinine increased, body temperature increased, c-reactive protein increased, hemoglobin decreased, white blood cell count decreased

Metabolism and nutrition disorders: dehydration, diabetes mellitus NOS, diabetes with hyperosmolarity, diabetic ketoacidosis

Musculoskeletal and connective tissue disorders: myopathy steroid, back pain, myopathy

Nervous system disorders: dizziness, memory impairment, brain edema, cerebral infarction, cerebral ischemia, cerebrovascular accident, encephalitis NOS, intracranial hemorrhage NOS, intracranial venous sinus thrombosis NOS, leukoencephalopathy, somnolence, tremor

Psychiatric disorders: mental status changes, delirium, delusion NOS, insomnia, psychotic disorder NOS

Renal and urinary disorders: Fanconi syndrome acquired, hematuria, renal failure acute, renal failure NOS, renal tubular necrosis, urinary retention

Respiratory, thoracic and mediastinal disorders: bronchopneumopathy, hypoxia

Skin and subcutaneous tissue disorders: rash NOS, skin desquamation NOS

Vascular system disorders: phlebitis NOS, venous thrombosis NOS limb, circulatory collapse, hypertension NOS, hypotension NOS, orthostatic hypotension, peripheral ischemia

Side Effects by Body System

Hematologic

Thrombotic or thromboembolic events, including deep vein thrombosis, pulmonary embolism, thrombosis, and intracranial venous sinus thrombosis were reported more frequently in patients treated with the lenalidomide/dexamethasone combination. The number of patients experiencing a thrombotic event in the combination arm were 43/346 (12%) compared with those in the placebo/dexamethasone arm 14/345 (4%).

Hematologic side effects including thrombocytopenia (61.5%), neutropenia (58.8%), anemia (11.5%), leukopenia (8.1%), febrile neutropenia (5.4%), warm type hemolytic anemia, splenic infarction, bone marrow depression, coagulopathy, hemolysis, hemolytic anemia, pancytopenia, aggravated anemia, decreased hemoglobin, and refractory anemia have been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (48.6%), constipation (23.6%), nausea (23.6%), abdominal pain (12.2%), vomiting (10.1%), upper abdominal pain (8.1%), dry mouth (6.8%), loose stools (6.1%), gastrointestinal hemorrhage, ischemic colitis, intestinal perforation, rectal hemorrhage, colonic polyp, diverticulitis, dysphagia, gastritis, gastroenteritis, gastroesophageal reflux disease, obstructive inguinal hernia, irritable bowel syndrome, melena, pancreatitis (due to biliary obstruction), pancreatitis (not otherwise specified), perirectal abscess, pseudomembranous colitis, peptic ulcer hemorrhage, oral infection, small intestinal obstruction, and upper gastrointestinal hemorrhage have been reported.

Dermatologic

Dermatologic side effects including pruritus (41.9%), rash (35.8%), dry skin (14.2%), contusion (8.1%), night sweats (8.1%), increased sweating (6.8%), ecchymosis (5.4%), erythema (5.4%), skin desquamation, and acute febrile neutrophilic dermatosis have been reported. Twelve reports of Stevens-Johnson syndrome and one report of toxic epidermal necrolysis have also been reported.

Rashes have been characterized as morbilliform, urticarial, dermatitic, acneform, and undefined.

General

General side effects including fatigue (31.1%), pyrexia (20.9%), peripheral edema (20.3%), asthenia (14.9%), edema (10.1%), pain (6.8%), rigors (6.1%), chest pain (5.4%), disease progression, fall, abnormal gait, intermittent pyrexia, nodule, rigors, and sudden death have been reported.

Respiratory

Respiratory side effects including nasopharyngitis (23.0%), cough (19.6%), dyspnea (16.9%), pharyngitis (15.5%), epistaxis (14.9%), upper respiratory tract infections (14,9%), pneumonia (11.5%), sinusitis (8.1%), exertional dyspnea (6.8%), rhinitis (6.8%), bronchitis (6.1%), acute sinusitis, exacerbated chronic obstructive airways disease, respiratory failure, exacerbated dyspnea, interstitial lung disease, lobar pneumonia, lung infiltration, wheezing, bronchopneumopathy, hypoxia, and sinusitis have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (21.6%), back pain (20.9%), muscle cramps (18.2%), limb pain (10.8%), myalgia (8.8%), peripheral swelling (8.1%), femur fracture, femoral neck fracture, fractured pelvis, hip fracture, rib fracture, arthritis, aggravated arthritis, gouty arthritis, neck pain, cervical vertebral fracture, chondrocalcinosis pyrophosphate, steroid myopathy, myopathy, and spinal compression fracture have been reported.

Nervous system

Nervous system side effects including dizziness (19.6%), headache (19.6%), hypoesthesia (6.8%), dysgeusia (6.1%), peripheral neuropathy (5.4%), cerebrovascular accident, aphasia, cerebellar infarction, depressed level of consciousness, dysarthria, migraine, spinal cord compression, subarachnoid hemorrhage, transient ischemic attack, dizziness, memory impairment, brain edema, cerebral infarction, cerebral ischemia, cerebrovascular accident, encephalitis, intracranial hemorrhage, intracranial venous sinus thrombosis, leukoencephalopathy, somnolence, and tremor have been reported.

Renal

Renal side effects have included urinary tract infection (10.8%), dysuria (6.8%), increased blood creatinine, renal failure, hematuria, acute renal failure, azotemia, ureteric calculus, renal mass, Fanconi syndrome, renal tubular necrosis, urinary retention, and kidney infection.

Metabolic

Metabolic side effects including hypokalemia (10.8%), hypomagnesemia (6.1%), dehydration, gout, hypernatremia, diabetes mellitus, diabetes with hyperosmolarity, diabetic ketoacidosis, and hypoglycemia have been reported.

Other

Other side effects have included anorexia (10.1%), cellulitis (5.4%), vertigo, infection, bacteremia, central line infection, clostridial infection, ear infection, Enterobacter sepsis, fungal infection, herpes viral infection, influenza, Klebsiella sepsis, localized infection, Pseudomonas infection, septic shock, Staphylococcal infection, urosepsis, transfusion reaction, post procedural hemorrhage, pelvic pain, and road traffic accident.

Psychiatric

Psychiatric side effects including insomnia (10.1%), depression (5.4%), mental status changes, delirium, delusion, psychotic disorder, and confusional state have been reported.

Hepatic

Hepatic side effects including increased alanine aminotransferase (8.1%), hyperbilirubinemia, acute cholecystitis, cholecystitis, toxic hepatitis, hepatic failure, and abnormal liver function tests have been reported. A case of severe hepatotoxicity has also been reported.

Endocrine

Endocrine side effects have included acquired hypothyroidism (6.8%), adrenal insufficiency, and Basedow's disease.

Cardiovascular

Cardiovascular side effects including hypertension (6.1%) palpitations (5.4%), congestive cardiac failure, atrial fibrillation, angina pectoris, cardiac arrest, thromboembolism, cardiac failure (not otherwise specified), cardiorespiratory arrest, atrial flutter, cardiomyopathy, myocardial infarction, myocardial ischemia, aggravated atrial fibrillation, bradycardia, cardiogenic shock, pulmonary edema, supraventricular arrhythmia, tachyarrhythmia, ventricular dysfunction, increased troponin I, deep vein thrombosis, hypotension, aortic disorder, ischemia, superficial thrombophlebitis, and thrombosis have been reported.

One study has reported that treatment of multiple myeloma with lenalidomide and high-dose dexamethasone is associated with an increased risk of venous thrombosis and that concomitant administration of erythropoietic agents may further increase the risk of thrombosis.

Hypersensitivity

Hypersensitivity side effects have included hypersensitivity (not otherwise specified).

Oncologic

Oncologic side effects including acute leukemia, acute myeloid leukemia, bronchoalveolar carcinoma, lung cancer metastatic, lymphoma, and metastatic prostate cancer have been reported.

Ocular

Ocular side effects including blindness have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.