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Lenalidomide: Drug information

Lenalidomide: Drug information
(For additional information see "Lenalidomide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
REMS Drugs COVID-19 Safety Alert March 2020

Due to challenges with completion of required laboratory testing or imaging studies for REMS drugs because of self-isolation or quarantine during the COVID-19 public health emergency, the FDA is recommending health care providers prescribing and/or dispensing REMS drugs consider whether there are compelling reasons or not to complete these requirements during this public health emergency and weigh with the patient the benefits and risks of continuing treatment in the absence of the laboratory testing and imaging studies. The FDA will not take action against sponsors and others during the public health emergency for failing to adhere to REMS requirements.

Further information may be found at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-update-patient-access-certain-rems-drugs-during-covid-19.

ALERT: US Boxed Warning
Embryo-fetal toxicity:

Do not use lenalidomide 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 lenalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide treatment. To avoid embryo-fetal exposure to lenalidomide, it is only available under a restricted distribution program called Lenalidomide REMS program.

Information about the Lenalidomide REMS program is available at http://www.lenalidomiderems.com or by calling the manufacturer's toll-free number 1-888-423-5436.

Hematologic toxicity:

Lenalidomide can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with deletion 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for deletion 5q myelodysplastic syndromes should have their complete blood cell counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and arterial thromboembolism:

Lenalidomide has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with lenalidomide and dexamethasone therapy. Monitor for and advise patients about the signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient's underlying risk factors.

Brand Names: US
  • Revlimid
Brand Names: Canada
  • APO-Lenalidomide;
  • JAMP-Lenalidomide;
  • NAT-Lenalidomide;
  • REDDY-Lenalidomide;
  • Revlimid;
  • SANDOZ Lenalidomide;
  • TARO-Lenalidomide
Pharmacologic Category
  • Angiogenesis Inhibitor;
  • Antineoplastic Agent
Dosing: Adult

Note: Thromboprophylaxis is recommended when used in combination with chemotherapy and/or dexamethasone for the treatment of multiple myeloma and may be offered to other high-risk patients when clinically appropriate; thromboprophylaxis regimen should be based on assessment of patient- and disease-specific risk factors as well as concomitant therapy (ASCO [Key 2020]). Institute appropriate management if at risk for tumor lysis syndrome.

Chronic lymphocytic leukemia, relapsed/refractory

Chronic lymphocytic leukemia, relapsed/refractory (off-label use): Oral: 10 mg once daily beginning on day 9 of cycle 1; administer continuously in combination with cyclic rituximab (Badoux 2013). Refer to protocols for dosage adjustment details.

Diffuse large B-cell lymphoma, relapsed/refractory

Diffuse large B-cell lymphoma, relapsed/refractory (off-label use): Oral: 25 mg once daily for 21 days of a 28-day treatment cycle for up to 1 year (Wiernik 2008) or 25 mg once daily for 21 days of a 28-day treatment cycle (in combination with tafasitamab) for up to 12 cycles, followed by tafasitamab monotherapy until disease progression or unacceptable toxicity (Salles 2020). Refer to protocols for dosage adjustment details.

Follicular lymphoma, previously treated

Follicular lymphoma, previously treated: Oral: 20 mg once daily for 21 days of a 28-day treatment cycle (in combination with rituximab) for up to 12 cycles (Leonard 2019).

Mantle cell lymphoma, relapsed or progressive

Mantle cell lymphoma, relapsed or progressive: Oral: 25 mg once daily for 21 days of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity (Goy 2013).

Marginal zone lymphoma, previously treated

Marginal zone lymphoma, previously treated: Oral: 20 mg once daily for 21 days of a 28-day treatment cycle (in combination with rituximab) for up to 12 cycles (Leonard 2019).

Multiple myeloma

Multiple myeloma: Oral: 25 mg once daily for 21 days of a 28-day treatment cycle (in combination with dexamethasone [consider a reduced dexamethasone dose in patients >75 years of age]). In patients not eligible for autologous stem cell transplantation, continue until disease progression or unacceptable toxicity occurs; in transplant eligible patients, hematopoietic stem cell mobilization should occur within 4 cycles of a lenalidomide-containing therapy.

Multiple myeloma, maintenance therapy following autologous stem cell transplant

Multiple myeloma, maintenance therapy following autologous stem cell transplant: Oral: 10 mg once daily (begin after adequate hematologic recovery [ANC ≥1,000/mm3; platelets ≥75,000/mm3]); continue until disease progression or unacceptable toxicity occurs. If tolerated, may increase dose to 15 mg once daily after 3 cycles (each cycle is 28 days). A minimum of 2 years of lenalidomide maintenance therapy is recommended (ASCO/CCO [Mikhael 2019]).

Off-label dosing: 10 mg once daily for 21 days of a 28-day treatment cycle until relapse (Palumbo 2010).

Multiple myeloma, newly diagnosed

Multiple myeloma, newly diagnosed (off-label combinations): Oral: 25 mg once daily for 21 days of a 28-day cycle (in combination with daratumumab and dexamethasone) until disease progression or unacceptable toxicity occurs (Facon 2019) or 25 mg once daily for 21 days of a 28-day cycle (in combination with ixazomib and dexamethasone) for 18 cycles (or until disease progression or unacceptable toxicity, whichever occurs first), followed by 10 mg once daily for 21 days of a 28-day cycle (in combination with ixazomib) until disease progression or unacceptable toxicity (Facon 2021) or 25 mg once daily for 14 days of a 21-day cycle (in combination with bortezomib and dexamethasone) for 8 cycles (Kumar 2012; Richardson 2010) or 25 mg once daily for 14 days of a 21-day cycle (in combination with bortezomib and dexamethasone) for 8 cycles, followed by 25 mg once daily for 21 days of a 28-day cycle (in combination with dexamethasone) until disease progression or unacceptable toxicity (Durie 2017; Durie 2020) or 25 mg once daily for 21 days of a 28-day cycle (in combination with carfilzomib and dexamethasone) for up to 8 cycles (Jakubowiak 2012; Kazandjian 2018; Korde 2015), followed by maintenance lenalidomide 10 mg once daily for 21 days of a 28-day cycle for 2 years (Kazandjian 2018) or 25 mg once daily for 21 days of a 28-day cycle (in combination with dexamethasone) for 9 induction cycles, followed by maintenance therapy of 10 mg once daily for 21 days of a 28-day cycle (lenalidomide monotherapy) until disease progression or unacceptable toxicity (Larocca 2021). Refer to protocols for dosage adjustment details.

Multiple myeloma, relapsed

Multiple myeloma, relapsed (off-label combinations): Oral: 25 mg once daily for 21 days of 28-day cycle (in combination with carfilzomib and dexamethasone) until disease progression or unacceptable toxicity occurs (Stewart 2015) or 25 mg once daily for 21 days of a 28-day cycle (in combination with daratumumab and dexamethasone) until disease progression or unacceptable toxicity occurs; refer to the International Myeloma Working Group recommendations for Dosing in Renal Impairment (Dimopoulos 2016a; Dimopoulos 2016b). Refer to protocols for dosage adjustment details.

Myelodysplastic syndrome with deletion 5q

Myelodysplastic syndrome with deletion 5q: Oral: 10 mg once daily, continue until disease progression or unacceptable toxicity occurs.

Myelodysplastic syndrome, lower risk, without deletion 5q

Myelodysplastic syndrome, lower risk, without deletion 5q (off-label use): Oral: 10 mg once daily (Raza 2008). Refer to protocols for dosage adjustment details.

Smoldering myeloma, high risk

Smoldering myeloma, high risk (off-label use): Oral: 25 mg once daily for 21 days of a 28-day treatment cycle; continue until disease progression or unacceptable toxicity for up to 2 years (Lonial 2020).

Systemic light chain amyloidosis

Systemic light chain amyloidosis (off-label use): Oral: 15 mg once daily for 21 days of a 28-day cycle (in combination with dexamethasone) (Nair 2012; Sanchorawala 2007).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Lenalidomide Dose Adjustments for Altered Kidney Functiona

CrCl

If the usual dose is 25 mg once daily (eg, mantle cell lymphoma, multiple myeloma [combination therapy with dexamethasone]b)

If the usual dose is 20 mg once daily (eg, follicular lymphoma, marginal zone lymphoma)

If the usual dose is 15 mg once daily (eg, systemic light chain amyloidosisc) (no formal published recommendation; suggestions expert opinion only)

If the usual dose is 10 mg once daily (eg, myelodysplastic syndrome, multiple myeloma [maintenance treatment after autologous stem cell transplant])

a Maintain appropriate number of treatment days per cycle based on indication and/or protocol.

b Patients with multiple myeloma and decreased CrCl may experience an improvement in kidney function (often during the first cycle of therapy) when treatment with lenalidomide is initiated; frequent CrCl measurement and subsequent dose adjustment should be considered (Chen 2020).

c Monitor kidney function closely, as acute kidney injury (usually occurring within the first 8 weeks of lenalidomide therapy) occurred in ~66% of patients in one report (Specter 2010).

d It may be preferable to use full doses down to a CrCl of 50 mL/minute, as underdosing has been suggested (Chen 2020), and other multiple myeloma studies have successfully used full dose lenalidomide in patients with CrCl ≥50 mL/minute (Bridoux 2016; Dimopoulos 2010; Dimopoulos 2016; Mikhael 2018).

e Approximately 30% removed during a 4-hour hemodialysis session (Chen 2007; manufacturer's labeling).

f Dimopoulos 2016b.

g Based on expert opinion.

h Chen 2007.

i Lichtman 2014.

CrCl >60 mL/minute

No dosage adjustment necessary.

No dosage adjustment necessary.

No dosage adjustment necessary.

No dosage adjustment necessary.

CrCl 30 to 60 mL/minute

Initial: 10 mg once daily; if treating multiple myeloma, may increase to 15 mg once daily after 2 cycles if tolerating treatment.d

Initial: 10 mg once daily; if treating follicular lymphoma or marginal zone lymphoma may increase to 15 mg once daily after 2 cycles if tolerating treatment.

Initial: 10 mg once daily; further individualize based on tolerance and response.g

Initial: 5 mg once daily; further individualize dose based on tolerance and response.

CrCl 15 to <30 mL/minute

Initial: 15 mg every other day; if treating multiple myeloma, may increase dose to 10 mg once daily if tolerating treatment.f

Initial: 5 mg once daily.

Initial: 5 mg once daily; further individualize based on tolerance and response.g

Initial: 2.5 mg once daily; further individualize dose based on tolerance and response.

CrCl <15 mL/minute

Initial: 5 mg once daily.

Initial: 5 mg once daily.

Initial: 5 mg once daily; further individualize dose based on tolerance and response.g

Initial: 2.5 mg once daily; further individualize dose based on tolerance and response.

Hemodialysis, intermittent (thrice weekly)e

Initial: 5 mg once daily; when scheduled dose falls on a dialysis day administer after dialysis

or

Initial: 15 mg 3 times weekly after dialysis on dialysis days.h

Initial: 5 mg once daily; when scheduled dose falls on a dialysis day, administer after dialysis.

Initial: 5 mg once daily; when scheduled dose falls on a dialysis day, administer after dialysis; further individualize dose based on tolerance and response.g

or

Initial: 10 mg 3 times weekly after dialysis on dialysis daysi; further individualize dose based on tolerance and response.g

Initial: 2.5 mg once daily; when scheduled dose falls on a dialysis day administer after dialysis; further individualize dose based on tolerance and response.

Peritoneal dialysis

Initial: 5 mg once daily (no data).g

Initial: 5 mg once daily (no data).g

Initial: 5 mg once daily (no data)g; further individualize dose based on tolerance and response.g

Initial: 2.5 mg once daily (no data)g; further individualize dose based on tolerance and response.

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) and minimal residual kidney function unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neutropenia, thrombocytopenia) due to drug accumulation is important.

Oral: There are no data available to guide specific dosing recommendations. However, lenalidomide is likely removed by CRRT, therefore, dosing as for patients with CrCl 15 to <30 mL/minute is suggested with close monitoring (expert opinion).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations and consideration of initial loading doses. Close monitoring of response and adverse reactions (eg, neutropenia, thrombocytopenia) due to drug accumulation is important.

Oral:

PIRRT days: There are no data available to guide specific dosing recommendations. However, lenalidomide is likely removed by PIRRT, therefore, dosing as for patients with CrCl 15 to <30 mL/minute is suggested with close monitoring; administer dose after PIRRT session has ended (expert opinion).

Non-PIRRT days: Dose as for CrCl <15 mL/minute (expert opinion).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied). However, lenalidomide undergoes minimal hepatic metabolism.

Hepatotoxicity during treatment: Interrupt lenalidomide for abnormal hepatic function tests; may consider resuming treatment at a lower dose upon return to baseline.

Dosing: Older Adult

Refer to adult dosing. Due to the potential for decreased renal function in the elderly, select dose carefully and closely monitor renal function.

Dosing: Adjustment for Toxicity: Adult

Nonhematologic toxicities:

Dermatologic toxicities:

Skin rash, grade 2 or 3: Consider interrupting or discontinuing treatment.

Grade 4 rash, exfoliative or bullous rash, or other severe dermatologic reactions such as suspected Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms: Permanently discontinue treatment.

Hypersensitivity: Angioedema or anaphylaxis: Permanently discontinue treatment.

Thromboembolism:Signs/symptoms of thromboembolism (shortness of breath, chest pain, or arm or leg swelling): Patients should seek prompt medical attention.

Tumor flare reaction:

Grade 1 or 2: Continue therapy at physician's discretion; may consider symptom management with corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) and/or analgesic therapy.

Grade 3 or 4: Interrupt therapy until resolved to ≤ grade 1; consider symptom management with corticosteroids, NSAIDs and/or analgesic therapy.

Other toxicities: For additional treatment-related grade 3/4 toxicities, hold treatment and restart (if appropriate) at next lower dose level when toxicity has resolved to ≤ grade 2.

Hematologic toxicities: Note: Hematologic toxicity may require the use of blood product support and/or growth factors.

Follicular lymphoma and marginal zone lymphoma:

Platelets <50,000/mm3: Hold treatment, check CBC weekly.

When platelets return to ≥50,000/mm3: Resume treatment at 5 mg below previous dose. If starting dose was 20 mg/day, do not dose below 5 mg daily; if starting dose was 10 mg/day, do not dose below 2.5 mg daily.

ANC <1,000/mm3 for at least 7 days or associated with fever (≥38.5°C [101°F]): Hold treatment, check CBC weekly.

ANC <500/mm3: Hold treatment, check CBC weekly.

When ANC returns to ≥1,000/mm3: Resume treatment at 5 mg below previous dose. If starting dose was 20 mg/day, do not dose below 5 mg daily; if starting dose was 10 mg/day, do not dose below 2.5 mg daily.

Mantle cell lymphoma:

Platelets <50,000/mm3: Hold treatment, check CBC weekly.

When platelets return to ≥50,000/mm3: Resume treatment at 5 mg below previous dose; do not dose below 5 mg daily.

ANC <1,000/mm3 for at least 7 days or associated with fever (≥38.5°C [101°F]): Hold treatment, check CBC weekly.

ANC <500/mm3: Hold treatment, check CBC weekly.

When ANC returns to ≥1,000/mm3: Resume treatment at 5 mg below previous dose; do not dose below 5 mg daily.

Multiple myeloma:

Combination therapy with dexamethasone:

Platelets <30,000/mm3: Hold treatment, check CBC weekly.

When platelets return to ≥30,000/mm3: Resume at next lower dose; do not dose below 2.5 mg daily.

For each additional occurrence of platelets <30,000/mm3: Hold treatment.

When platelets return to ≥30,000/mm3: Resume treatment at next lower dose; do not dose below 2.5 mg daily.

ANC <1,000/mm3: Hold treatment, check CBC weekly.

When ANC returns to ≥1,000/mm3 (with neutropenia as only toxicity): Resume at 25 mg daily or initial starting dose.

When ANC returns to ≥1,000/mm3 (with additional toxicities): Resume at next lower dose; do not dose below 2.5 mg daily.

For each additional occurrence of ANC <1,000/mm3: Hold treatment.

When ANC returns to ≥1,000/mm3: Resume treatment at next lower dose; do not dose below 2.5 mg daily.

Maintenance following autologous stem cell transplant:

Platelets <30,000/mm3: Hold treatment, check CBC weekly.

When platelets return to ≥30,000/mm3: Resume at next lower dose; maintain continuous daily dosing.

Additional occurrence of platelets <30,000/mm3 (and current dose is 5 mg once daily): Hold treatment.

When platelets return to ≥30,000/mm3 (and current dose is 5 mg once daily): Resume treatment at 5 mg daily on days 1 to 21 of a 28-day cycle; do not dose below 5 mg daily on days 1 to 21 of a 28-day cycle.

ANC <500/mm3: Hold treatment, check CBC weekly.

When ANC returns to ≥500/mm3: Resume at next lower dose; maintain continuous daily dosing.

Subsequent occurrence of ANC <500/mm3 (and current dose is 5 mg daily): Hold treatment.

When ANC returns to ≥500/mm3: Resume treatment at 5 mg daily on days 1 to 21 of a 28-day cycle; do not dose below 5 mg daily on days 1 to 21 of a 28-day cycle.

Myelodysplastic syndromes:

Thrombocytopenia developing within 4 weeks of beginning treatment at 10 mg daily:

Baseline platelets ≥100,000/mm3:

If platelets <50,000/mm3: Hold treatment.

When platelets return to ≥50,000/mm3: Resume treatment at 5 mg daily.

Baseline platelets <100,000/mm3:

If platelets fall to 50% of baseline: Hold treatment.

If baseline ≥60,000/mm3 and platelet level returns to ≥50,000/mm3: Resume at 5 mg daily.

If baseline <60,000/mm3 and platelet level returns to ≥30,000/mm3: Resume at 5 mg daily.

Thrombocytopenia developing after 4 weeks of beginning treatment at 10 mg daily:

Platelets <30,000/mm3 or <50,000/mm3 with platelet transfusions: Hold treatment.

When platelets return to ≥30,000/mm3 (without hemostatic failure): Resume at 5 mg daily.

Thrombocytopenia developing during treatment at 5 mg daily:

Platelets <30,000/mm3 or <50,000/mm3 with platelet transfusions: Hold treatment.

When platelets return to ≥30,000/mm3 (without hemostatic failure): Resume at 2.5 mg once daily.

Neutropenia developing within 4 weeks of beginning treatment at 10 mg daily:

For baseline ANC ≥1,000/mm3:

ANC <750/mm3: Hold treatment.

When ANC returns to ≥1,000/mm3: Resume at 5 mg daily.

For baseline ANC <1,000/mm3:

ANC <500/mm3: Hold treatment.

When ANC returns to ≥500/mm3: Resume at 5 mg daily.

Neutropenia developing after 4 weeks of beginning treatment at 10 mg daily:

ANC <500/mm3 for ≥7 days or associated with fever (≥38.5°C [101°F]): Hold treatment.

When ANC returns to ≥500/mm3: Resume at 5 mg daily.

Neutropenia developing during treatment at 5 mg daily:

ANC <500/mm3 for ≥7 days or associated with fever (≥38.5°C [101°F]): Hold treatment.

When ANC returns to ≥500/mm3: Resume at 2.5 mg once daily.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Revlimid: 2.5 mg [contains fd&c blue #2 (indigotine)]

Revlimid: 5 mg

Revlimid: 10 mg, 15 mg, 20 mg [contains fd&c blue #2 (indigotine)]

Revlimid: 25 mg

Generic: 5 mg, 10 mg, 15 mg, 25 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Revlimid: 2.5 mg [contains fd&c blue #2 (indigotine)]

Revlimid: 5 mg

Revlimid: 10 mg, 15 mg, 20 mg [contains fd&c blue #2 (indigotine)]

Revlimid: 25 mg

Generic: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg

Prescribing and Access Restrictions

In Canada, distribution is restricted through RevAid (www.RevAid.ca or 1-888-738-2431).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880s065lbl.pdf#page=48, must be dispensed with this medication.

Administration: Adult

Oral: Administer at about the same time each day with water; administer with or without food. Swallow capsule whole; do not break, open, or chew.

Missed doses: May administer a missed dose if within 12 hours of usual dosing time. If greater than 12 hours, patient should skip dose for that day and resume usual dosing the following day. Patient should not take 2 doses to make up for a missed dose.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2016 [group 2]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Follicular lymphoma (previously treated): Treatment of previously treated follicular lymphoma (in combination with a rituximab product) in adults.

Mantle cell lymphoma (relapsed or progressive): Treatment of mantle cell lymphoma in adults that has relapsed or progressed after 2 prior therapies (one of which included bortezomib).

Marginal zone lymphoma (previously treated): Treatment of previously treated marginal zone lymphoma (in combination with a rituximab product) in adults.

Multiple myeloma: Treatment of multiple myeloma (in combination with dexamethasone) in adults; maintenance therapy following autologous hematopoietic stem cell transplantation in adults.

Myelodysplastic syndromes: Treatment of adults with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q (del 5q) cytogenetic abnormality with or without additional cytogenetic abnormalities.

Limitations of use: Lenalidomide is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Use: Off-Label: Adult

Chronic lymphocytic leukemia, relapsed or refractory; Diffuse large B-cell lymphoma, relapsed or refractory; Multiple myeloma, newly diagnosed; Myelodysplastic syndrome without deletion 5q; Smoldering myeloma (high risk); Systemic light chain amyloidosis

Medication Safety Issues
Sound-alike/look-alike issues:

Lenalidomide may be confused with leflunomide, pomalidomide, thalidomide.

Revlimid may be confused with revefenacin, Thalomid.

High alert medication:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

International issues:

Revlimid may be confused with Revolade, a brand name for eltrombopag [Canada].

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. May vary based on indication.

>10%:

Cardiovascular: Peripheral edema (16% to 20%)

Central nervous system: Fatigue (11% to 34%), dizziness (20%), headache (9% to 20%), paresthesia (13%)

Dermatologic: Pruritus (MDS: 42%; MCL: 17%), skin rash (8% to 36%), xeroderma (≤11%)

Endocrine & metabolic: Weight loss (13%), hypokalemia (7% to 13%)

Gastrointestinal: Diarrhea (MM maintenance, MDS: 39% to 49%; MCL: 31%), nausea (11% to 30%), constipation (13% to 24%), gastroenteritis (23%), decreased appetite (14%), abdominal pain (10% to 12%), vomiting (6% to 12%)

Genitourinary: Urinary tract infection (4% to 11%)

Hematologic & oncologic: Thrombocytopenia (24% to 62%; grades 3/4: 13% to 50%), neutropenia (49% to 61%; grades 3/4: 43% to 54%), leukopenia (8% to 32%; grades 3/4: 5% to 24%), anemia (MCL: 31%, grades 3/4: 11%, MDS, MM maintenance: 9% to 12%, grades 3/4: 4% to 6%)

Infection: Influenza (13%)

Neuromuscular & skeletal: Muscle spasm (MM maintenance: 33%; MCL: 13%), asthenia (14% to 30%), arthralgia (MDS: 22%; MCL: 8%), back pain (13% to 21%), muscle cramps (18%), limb pain (11%)

Respiratory: Bronchitis (MM: 44%; MDS: 6%), nasopharyngitis (≤35%), cough (20% to 28%), pneumonia (12% to 17%), dyspnea (6% to 17%; includes exacerbation), pharyngitis (16%), epistaxis (15%), upper respiratory tract infection (11% to 15%), rhinitis (7% to 15%), sinusitis (≤14%)

Miscellaneous: Fever (21% to 23%; may be intermittent)

1% to 10%:

Cardiovascular: Edema (10%), hypotension (7%), hypertension (6%), chest pain (5%), palpitations (5%), deep vein thrombosis (2% to 4%), pulmonary embolism (1% to 2%), cardiac failure

Central nervous system: Insomnia (10%), peripheral neuropathy (5% to 10%), hypoesthesia (7%), pain (7%), myasthenia (6%), rigors (6%), chills, lethargy, vertigo

Dermatologic: Night sweats (8%), diaphoresis (7%), ecchymoses (5%), erythema of skin (5%), cellulitis (2% to 5%)

Endocrine & metabolic: Dehydration (7%), hypothyroidism (7%), hypomagnesemia (6%), hypocalcemia (3%), hyponatremia (2%)

Gastrointestinal: Anorexia (10%), upper abdominal pain (7% to 8%), xerostomia (7%), dysgeusia (6%), loose stools (6%), oral herpes simplex infection

Genitourinary: Dysuria (7%), urolithiasis (ureter)

Hematologic & oncologic: Tumor flare (10%), bruise (8%), lymphocytopenia (4% to 7%; grades 3/4: 4%), febrile neutropenia (2% to 6%; grades 3/4: 2% to 6%), pancytopenia (4%; grades 3/4: 2%), squamous cell carcinoma of skin (3%), granulocytopenia (grades 3/4: 2%), myelodysplastic syndrome (≤1%)

Hepatic: Increased serum alanine aminotransferase (8%), hyperbilirubinemia (1%)

Hypersensitivity: Hypersensitivity reaction

Infection: Herpes zoster infection (10%), infection (6%), sepsis (1% to 2%; including enterobacter, klebsiella, staphylococcus), bacteremia (1%)

Neuromuscular & skeletal: Myalgia (7% to 9%), swelling of extremities (8%), musculoskeletal pain (7%)

Renal: Renal failure syndrome (4%)

Respiratory: Oropharyngeal pain (10%), dyspnea on exertion (7%), pleural effusion (7%), rhinorrhea (5%), pulmonary infection (3%), hypoxia (2%), respiratory distress (1%), respiratory tract infection

Miscellaneous: Physical health deterioration (2%), troponin increased in blood specimen (troponin I)

Frequency not defined:

Cardiovascular: Acute myocardial infarction, angina pectoris, arterial thromboembolism, atrial fibrillation (including exacerbation), bradycardia, cardiac disorder (aortic disorder), cardiogenic shock, cardiomyopathy, cerebral infarction, cerebrovascular accident, ischemia, ischemic heart disease, septic shock, subarachnoid hemorrhage, superficial thrombophlebitis, supraventricular cardiac arrhythmia, supraventricular tachycardia, tachyarrhythmia, thrombosis, transient ischemic attacks, venous thromboembolism, ventricular dysfunction

Central nervous system: Abnormal gait, aphasia, cerebellar infarction, confusion, depression, dysarthria, falling, impaired consciousness, migraine, spinal cord compression

Dermatologic: Erythema multiforme, erythematous rash, exfoliative dermatitis, follicular rash, macular eruption, maculopapular rash, papular rash, pruritic rash, pustular rash, Sweet's syndrome

Endocrine & metabolic: Gout, gouty arthritis, Graves' disease, hypernatremia, hypoglycemia

Gastrointestinal: Biliary obstruction, cholecystitis (may be acute), Clostridioides difficile associated diarrhea, Clostridioides difficile colitis, colonic polyps, diverticulitis of the gastrointestinal tract, dysphagia, gastritis, gastrointestinal hemorrhage, gastrointestinal pain, gastrointestinal reflux disease, infection of mouth, inguinal hernia (obstructive), intestinal obstruction (small intestine), intestinal perforation, irritable bowel syndrome, ischemic colitis, lower abdominal pain, melena, pancreatitis

Genitourinary: Abscess of rectum and/or peri-rectal area, azotemia, hematuria, pelvic pain, urinary tract infection with sepsis

Hematologic & oncologic: Acquired blood coagulation disorder, acute leukemia, basal cell carcinoma of skin, bone marrow depression, bronchogenic carcinoma, decreased hemoglobin, hemolysis, hemolytic anemia, malignant lymphoma, malignant neoplasm of lung, myeloid leukemia (acute), postprocedural hemorrhage, progression of cancer, prostate carcinoma, rectal hemorrhage, splenic infarction, warm antibody immunohemolytic anemia

Hepatic: Abnormal hepatic function tests (may be transient), hepatic failure

Hypersensitivity: Transfusion reaction

Infection: Fungal infection, herpes virus infection, kidney infection, localized infection, pseudomonas infection, staphylococcal infection

Local: Catheter infection

Neuromuscular & skeletal: Arthritis (including exacerbation), bone fracture (femur, femoral neck, pelvis, hip, rib, spinal compression), calcium pyrophosphate deposition disease, neck pain

Otic: Otic infection

Renal: Acute renal failure, increased serum creatinine

Respiratory: Acute sinusitis, chronic obstructive pulmonary disease (includes exacerbation), interstitial pulmonary disease, lobar pneumonia, pulmonary edema, pulmonary infiltrates, respiratory failure, wheezing

Miscellaneous: Accidental injury (traffic accident), mass (renal), nodule

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, cholestatic hepatitis, drug reaction with eosinophilia and systemic symptoms, graft versus host disease, hematologic disease (impaired stem cell mobilization), hepatic cytolysis, hyperthyroidism, organ transplant rejection, pneumonitis, progressive multifocal leukoencephalopathy, reactivation of HPV, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxic hepatitis, tumor lysis syndrome

Contraindications

Severe hypersensitivity (eg, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide or any component of the formulation; pregnancy

Canadian labeling: Additional contraindications (not in the US labeling): Platelet count <50,000/mm3 (in MDS patients); hypersensitivity to thalidomide or pomalidomide; females capable of becoming pregnant; breastfeeding; male patients unable to follow or comply with required contraceptive measures

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Hematologic toxicity (neutropenia and thrombocytopenia) occurs in a majority of patients (grade 3/4: 80% in patients with del 5q myelodysplastic syndrome).

• CNS effects: May cause dizziness or fatigue; caution patients about performing tasks that require mental alertness (eg, operating machinery, driving).

• Dermatologic reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported; may be fatal. DRESS may manifest as a cutaneous reaction (eg, rash, exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications, which may include hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis. Patients with a history of grade 4 rash with thalidomide should not receive lenalidomide.

• Hepatotoxicity: Hepatic failure, including fatalities, has occurred in patients treated with combination lenalidomide and dexamethasone therapy; may have hepatocellular, cholestatic, or mixed characteristics. Risk factors may include preexisting viral liver disease, elevated liver enzymes at baseline, and concomitant medications.

• Hypersensitivity: Hypersensitivity, including angioedema and anaphylactic reactions, have been reported.

• Secondary malignancy: Second primary malignancies, including hematologic (primarily acute myeloid leukemia and myelodysplastic syndrome [MDS]) and solid tumor malignancies, and non-melanoma skin cancers, have been reported with lenalidomide when used for the treatment of MDS and multiple myeloma; the incidence may be higher when lenalidomide is used in combination with an alkylating agent.

• Thromboembolic events: Lenalidomide has been associated with a significant increase in risk for arterial and venous thromboembolic events in multiple myeloma patients treated with lenalidomide and dexamethasone combination therapy. Deep vein thrombosis (DVT), pulmonary embolism (PE), myocardial infarction (MI), and stroke have occurred; signs and symptoms of thromboembolism include shortness of breath, chest pain, or arm or leg swelling. Erythropoietin-stimulating agents (ESAs) and estrogens may contribute to thromboembolic risk; use with caution. Patients with a prior history of arterial thromboembolic events may be at greater risk; minimize modifiable factors such as hyperlipidemia, hypertension, and smoking.

• Thyroid disorders: Both hypothyroidism and hyperthyroidism have been reported with lenalidomide use.

• Tumor flare: Tumor flare reactions, including fatalities, have been observed in studies of lenalidomide for the treatment of chronic lymphocytic leukemia (CLL) and lymphomas; clinical presentation includes low grade fever, pain, rash, and tender lymph node swelling. In patients with mantle cell lymphoma, follicular lymphoma, and/or marginal zone lymphoma, tumor flare may mimic disease progression. In clinical trials, the majority of tumor flare events occurred in the first cycle of therapy.

• Tumor lysis syndrome: Tumor lysis syndrome (with fatalities) has been reported with lenalidomide. Patients with a high tumor burden may be at risk for tumor lysis syndrome.

Disease-related concerns:

• Heart failure: In a scientific statement from the American Heart Association, lenalidomide has been determined to be an agent that may either cause direct myocardial toxicity or exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]).

• Mantle cell lymphoma: An increased incidence of early deaths (within 20 weeks) was reported in one study of patients receiving lenalidomide for the treatment of mantle cell lymphoma. Risk factors for early death include high tumor burden, mantle cell lymphoma international prognostic index (MIPI) score at diagnosis, and high WBC count (≥10,000/mm3) at baseline.

• Multiple myeloma: An increase in mortality was noted in 2 clinical studies in patients with multiple myeloma who received pembrolizumab in combination with a thalidomide analogue and dexamethasone. Pembrolizumab should not be used to treat multiple myeloma in combination with a thalidomide analogue and dexamethasone unless as part of a clinical trial.

• Renal impairment: Use with caution in patients with renal impairment; may experience an increased rate of toxicities due to reduced clearance and increased half-life.

• Stem cell mobilization: Lenalidomide use (≥4 cycles) may decrease the number of CD34+ cells collected for autologous stem cell transplant. Transplant eligible patients receiving lenalidomide should be referred to an appropriate transplant center in order to optimize the timing of stem cell collection. Cyclophosphamide in combination with G-CSF or G-CSF in combination with a CXC chemokine receptor 4 inhibitor (eg, plerixafor) may be considered when CD34+ cell collection is impaired.

Special populations:

• Older adult: Certain adverse reactions (DVT, PE, atrial fibrillation, renal failure) are more likely in patients >65 years of age; in some studies, the incidence of grade 3 or 4 adverse reactions was higher in older adults.

• Pediatric: If used in patients between 12 to 18 years of age, the parent or legal guardian must agree to ensure compliance with the Lenalidomide REMS program.

Other warnings/precautions:

• Appropriate use: In a clinical trial comparing lenalidomide versus chlorambucil single agent therapy in patients >65 years of age with chronic lymphocytic leukemia patients (not an FDA-approved indication), increased mortality was observed in the lenalidomide treatment arm. Atrial fibrillation, cardiac failure, and MI were observed more frequently in lenalidomide-treated patients; lenalidomide (alone or in combination) is not currently recommended for first-line treatment of CLL.

• REMS program: Due to the embryo-fetal risk, lenalidomide is only available through a restricted program under the Lenalidomide REMS program. Prescribers and pharmacies must be certified with the program to prescribe or dispense lenalidomide. Lenalidomide should only be prescribed to patients (male and female) who can understand and comply with the conditions of the Lenalidomide REMS program.

• Blood donation: Patients should be advised not to donate blood during therapy and for 1 month following completion of therapy.

• Lactose intolerance: Product may contain lactose; avoid use in patients with congenital lactase deficiency, glucose-galactose malabsorption, or glucose intolerance.

Metabolism/Transport Effects

Substrate of P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abatacept: Anti-TNF Agents may enhance the immunosuppressive effect of Abatacept. Risk X: Avoid combination

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Anakinra: Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination

Bisphosphonate Derivatives: Angiogenesis Inhibitors (Systemic) may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor therapy

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Canakinumab: Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid combination

Certolizumab Pegol: Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. Risk X: Avoid combination

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification

COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA vaccine at least 28 days after the primary vaccine dose. Patients should also receive 2 booster doses of mRNA vaccine - one 2 months after the 2nd (additional) dose and another 4 months after the first booster dose. Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups based on the brand of mRNA vaccine received. See CDC guidance for details. Risk D: Consider therapy modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification

DexAMETHasone (Systemic): May enhance the thrombogenic effect of Lenalidomide. Management: Consider using venous thromboembolism prophylaxis (eg, low-molecular weight heparin or warfarin [INR 2.0-3.0]) in patients with multiple myeloma who are receiving lenalidomide and dexamethasone. Risk D: Consider therapy modification

Digoxin: Lenalidomide may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Erythropoiesis-Stimulating Agents: May enhance the thrombogenic effect of Lenalidomide. Risk C: Monitor therapy

Estrogen Derivatives: May enhance the thrombogenic effect of Lenalidomide. Risk C: Monitor therapy

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Pembrolizumab: May enhance the adverse/toxic effect of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. Risk X: Avoid combination

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification

Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If post-exposure rabies vaccination is required during immunosuppressant therapy, administer a 5th dose of vaccine and check for rabies antibodies. Risk D: Consider therapy modification

Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification

Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification

Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tocilizumab: May enhance the immunosuppressive effect of Anti-TNF Agents. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Risk X: Avoid combination

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination

Reproductive Considerations

[US Boxed Warning]: In females of reproductive potential, obtain 2 negative pregnancy tests before starting lenalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide treatment. To avoid embryo-fetal exposure to lenalidomide, it is only available under a restricted distribution program called Lenalidomide REMS program.

Patients who could become pregnant should be treated only if they are able to comply with the conditions of the Lenalidomide REMS program. Patients who could become pregnant must avoid pregnancy beginning 4 weeks prior to therapy, during therapy, during therapy interruptions, and for at least 4 weeks after therapy is discontinued. Two forms of effective/reliable contraception (eg, tubal ligation, IUD, hormonal birth control methods, male latex or synthetic condom, diaphragm, or cervical cap) or total abstinence from heterosexual intercourse must be used by females who are not infertile or who have not had a hysterectomy. A negative pregnancy test (sensitivity of at least 50 milliunits/mL) 10 to 14 days prior to therapy, within 24 hours prior to beginning therapy, weekly during the first 4 weeks, and every 4 weeks (every 2 weeks for females with irregular menstrual cycles) thereafter is required for females of reproductive potential. Lenalidomide must be immediately discontinued for a missed period, abnormal pregnancy test or abnormal menstrual bleeding; refer patient to a reproductive toxicity specialist if pregnancy occurs during treatment. False-positive pregnancy tests have been reported during lenalidomide therapy (Castaneda 2018).

Lenalidomide is also present in semen. Patients (including those vasectomized) with partners who could become pregnant should use a latex or synthetic condom during any sexual contact with patients who could become pregnant, during lenalidomide treatment, during treatment interruptions, and for 4 weeks after discontinuation. Patients should not donate sperm during, for 4 weeks after treatment, and during lenalidomide therapy interruptions.

Pregnancy Considerations

Use is contraindicated in pregnancy. [US Boxed Warning]: Do not use lenalidomide 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. To avoid embryo-fetal exposure to lenalidomide, it is only available under a restricted distribution program called Lenalidomide REMS program.

A pregnancy exposure registry has been created to monitor outcomes in females exposed to lenalidomide during pregnancy and female partners of male patients and to understand the root cause for the pregnancy. The pregnancy exposure registry may be contacted at 1-888-423-5436. The parent or legal guardian for patients between 12 and 18 years of age must agree to ensure compliance with the required guidelines. Any suspected fetal exposure should be reported to the FDA via the MedWatch program (1-800-FDA-1088) and to REM Call Center (1-888-423-5436).

Breastfeeding Considerations

It is not known if lenalidomide is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

CBC with differential (mantle cell lymphoma - weekly for the first cycle, every 2 weeks during cycles 2 to 4 and monthly thereafter; myelodysplastic syndrome - weekly for first 8 weeks and at least monthly thereafter; multiple myeloma - weekly for the first 2 cycles, every 2 weeks during the third cycle and monthly thereafter; follicular and marginal zone lymphoma – weekly for the first 3 weeks in cycle 1 and every 2 weeks in cycles 2 to 4 and monthly thereafter); serum creatinine, LFTs (periodically). Thyroid function tests (TSH at baseline then every 2 to 3 months during lenalidomide treatment [Hamnvik 2011]). ECG when clinically indicated. Monitor for signs and symptoms of infection (if neutropenic), bleeding or bruising, hepatotoxicity, secondary malignancies, thromboembolism (eg, shortness of breath, chest pain, arm or leg swelling), dermatologic toxicity, tumor lysis syndrome, or hypersensitivity. Monitor for tumor flare reaction in patients with mantle cell lymphoma, follicular lymphoma, and/or marginal zone lymphoma. Monitor adherence.

Patients who could become pregnant: Pregnancy test 10 to 14 days and 24 hours prior to initiating therapy, weekly during the first 4 weeks of treatment, then every 2 to 4 weeks through 4 weeks after therapy discontinued.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Lenalidomide has immunomodulatory, antiangiogenic, and antineoplastic characteristics via multiple mechanisms. It selectively inhibits secretion of proinflammatory cytokines (potent inhibitor of tumor necrosis factor-alpha secretion); enhances cell-mediated immunity by stimulating proliferation of anti-CD3 stimulated T cells (resulting in increased IL-2 and interferon gamma secretion); inhibits trophic signals to angiogenic factors in cells. Inhibits the growth of myeloma, myelodysplastic, and lymphoma tumor cells by inducing cell cycle arrest and cell death. The addition of lenalidomide to rituximab increases antibody dependent cell-mediated cytotoxicity in follicular lymphoma and marginal zone lymphoma and increases tumor cell apoptosis in follicular lymphoma (compared to rituximab alone).

Pharmacokinetics

Protein binding: ~30%.

Half-life elimination: 3 to 5 hours.

Time, to peak, plasma: MDS or myeloma patients: 0.5 to 6 hours.

Excretion: Urine (~82%; as unchanged drug).

Pharmacokinetics: Additional Considerations

Altered kidney function: The half-life is increased 3-fold in moderate to severe renal impairment and increased ~4.5-fold in hemodialysis patients, compared to healthy patients. There is a 66% to 75% decrease in drug clearance in patients with moderate and severe renal impairment compared with healthy subjects. Hemodialysis patients had an 80% decrease in drug clearance compared with healthy subjects.

Pricing: US

Capsules (Lenalidomide Oral)

5 mg (per each): $949.88

10 mg (per each): $949.88

15 mg (per each): $949.88

25 mg (per each): $949.88

Capsules (Revlimid Oral)

2.5 mg (per each): $999.87

5 mg (per each): $999.87

10 mg (per each): $999.87

15 mg (per each): $999.87

20 mg (per each): $999.87

25 mg (per each): $999.87

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Immunomide (EG);
  • Ladevina (AR, VN);
  • Leavdo (TW);
  • Lenangio (IN);
  • Lenu (TW);
  • Linamide (BD);
  • Revlimid (AE, AT, AU, BB, BE, BH, CH, CL, CR, CY, CZ, DE, DK, DO, EC, EE, ES, FR, GB, GR, GT, HK, HN, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LB, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PH, PL, PT, QA, RO, RU, SE, SG, SI, SK, SV, TH, TR, TW)


For country abbreviations used in Lexicomp (show table)
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Attal M, Lauwers-Cances V, Marit G, et al. Lenalidomide maintenance after stem-cell transplantation for multiple myeloma. N Engl J Med. 2012;366(19):1782-1791. [PubMed 22571202]
  3. Badoux XC, Keating MJ, Wen S, et al. Phase II study of lenalidomide and rituximab as salvage therapy for patients with relapsed or refractory chronic lymphocytic leukemia. J Clin Oncol. 2013;31(5):584-591. [PubMed 23270003]
  4. Barlogie B, Shaughnessy J, Tricot G, et al. Treatment of multiple myeloma. Blood. 2004;103(1):20-32. [PubMed 12969978]
  5. Bridoux F, Chen N, Moreau S, et al. Pharmacokinetics, safety, and efficacy of lenalidomide plus dexamethasone in patients with multiple myeloma and renal impairment. Cancer Chemother Pharmacol. 2016;78(1):173-182. doi:10.1007/s00280-016-3068-9 [PubMed 27286995]
  6. Castaneda C, Minton N, Mezo M, et al. False-positive pregnancy tests in females of reproductive potential receiving lenalidomide in the United States. Leuk Lymphoma. 2018;59(4):1025‐1026. doi:10.1080/10428194.2017.1361030 [PubMed 28792264]
  7. Chanan-Khan A, Miller KC, Musial L, et al. Clinical efficacy of lenalidomide in patients with relapsed or refractory chronic lymphocytic leukemia: results of a phase II study. J Clin Oncol. 2006;24(34):5343-5349. [PubMed 17088571]
  8. Chen CI, Cao Y, Trudel S, et al. An open-label, pharmacokinetic study of lenalidomide and dexamethasone therapy in previously untreated multiple myeloma (MM) patients with various degrees of renal impairment - validation of official dosing guidelines. Leuk Lymphoma. 2020;61(8):1860-1868. doi:10.1080/10428194.2020.1747064 [PubMed 32476520]
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