Dosing & Uses
Dosage Forms & Strengths
capsule (Revlimid, generic)
- 2.5mg
- 5mg
- 10mg
- 15mg
- 20mg
- 25mg
Myelodysplastic Syndromes
Indicated for 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
10 mg PO qDay; treatment is modified based upon clinical and laboratory findings
Continue treatment until disease progression or unacceptable toxicity
Multiple Myeloma
Treatment
- Indicated in combination with dexamethasone for treatment of multiple myeloma (MM)
- 25 mg PO qDay on Days 1-21 of repeated 28-day cycles (use with dexamethasone)
- Ineligible for auto-HSCT: Continue until disease progression or unacceptable toxicity
-
Dexamethasone schedule
- 40 mg PO qDay on Days 1-4, 9-12, and 17-20 of each 28-day cycle for first 4 cycles, THEN
- 40 mg PO qDay on Days 1-4 every 28 days
- Age >75 yr: 20 mg PO qDay on Days 1, 8, 15, and 22 of each 28-day cycle
Maintenance
- Indicated as maintenance therapy for MM following autologous hematopoietic stem cell transplantation (auto-HSCT)
- Initiate after adequate hematologic recovery (ie, ANC ≥1000/mcL and/or platelet counts ≥75,000/mcL)
- Starting dose: 10 mg PO qDay continuously (ie, Day 1-28 of repeated 28-day cycles) until disease progression or unacceptable toxicity
- After 3 cycles: May increase dose to 15 mg PO qDay if tolerated
- Hematopoietic stem cell mobilization should occur within 4 cycles of a lenalidomide-containing therapy
Mantle Cell Lymphoma
Indicated for MCL in patients whose disease has relapsed or progressed after 2 prior therapies, 1 of which included bortezomib
25 mg PO qDay on Days 1-21 of repeated 28-day cycles; treatment is modified based on clinical or laboratory findings
Continue until disease progression or unacceptable toxicity
Follicular Lymphoma or Marginal Zone Lymphoma
Indicated in combination with a rituximab product, for treatment of patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL)
Rituximab 375mg/m² IV qWeek in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28-day cycle from Cycles 2-5
Lenalidomide 20 mg PO qDay on Days 1-21 every 28 days up to 12 cycles
Refer to prescribing information for rituximab for dosing
Dosage Modifications (MDS)
Thrombocytopenia within 4 weeks at starting dose 10 mg/day
-
Baseline ≥100,000/mcL
- Platelets count falls to <50,000/mcL: Interrupt treatment
- Platelets returns to ≥50,000/mcL: Resume at 5 mg/day
-
Baseline <100,000/mcL
- Platelets count falls to 50% of baseline: Interrupt treatment
- If baseline platelets ≥60,000/mcL and returns to ≥50,000/mcL: Resume at 5 mg/day
- If baseline platelets <60,000/mcL and returns to ≥30,000/mcL: Resume at 5 mg/day
Thrombocytopenia after 4 weeks
-
At starting dose 5 mg/day
- Platelets count <30,000/mcL or <50,000/mcL with platelet transfusions: Interrupt treatment
- Platelets return to ≥30,000/mcL (without hemostatic failure): Resume at 2.5 mg/day
-
At starting dose 10 mg/day
- Platelets count <30,000/mcL or <50,000/mcL with platelet transfusions: Interrupt treatment
- Platelets count return to ≥30,000/mcL (without hemostatic failure): Resume at 5 mg/day
Neutropenia within 4 weeks at starting dose 10 mg/day
-
Baseline ANC <1,000/mcL
- ANC falls to <750/mcL: Interrupt treatment
- ANC return to ≥1,000/mcL: Resume at 5 mg/day
-
Baseline ANC >1,000/mcL
- ANC falls to <500/mcL: interrupt treatment
- ANC return to ≥500/mc/L: Resume at 5 mg/day
Neutropenia after 4 weeks
-
At starting dose 5 mg/day
- ANC <500/mcL for ≥7 days or with fever (≥38.5°C): Interrupt treatment
- ANC return to ≥500/mcL: Resume at 2.5 mg/day
-
At starting dose 10 mg/day
- ANC <500/mcL for ≥7 days or with fever (≥38.5°C): Interrupt treatment
- ANC return to ≥500/mcL: Resume at 5 mg/day
Other grade 3-4 toxicities
- Interrupt treatment and resume at physicians discretion at next lower dose when toxicity has resolved to grade ≤2
Renal impairment
- CrCl >60 mL/min: No dosage adjustment necessary
- CrCl 30-60 mL/min: 5 mg PO qDay
- CrCl <30 mL/min (nondialysis dependent): 2.5 mg PO qDay
- CrCl <30 mL/min (dialysis dependent): 2.5 mg PO qDay; on dialysis days, administer following dialysis
Dosage Modifications (MM)
Renal impairment
-
MM treatment starting dose
- Follow same cycle, but decrease dose as listed below
- CrCl >60 mL/min: Dose adjustment not necessary
- CrCl 30-60 mL/min: 10 mg PO qDay; consider escalating the dose to 15 mg/day after 2 cycles if the patient tolerates the 10 mg dose without dose-limiting toxicities
- CrCl <30 mL/min (not requiring dialysis): 15 mg PO every other day
- CrCl <30 mL/min (requiring dialysis): 5 mg PO qDay; on dialysis days, administer following dialysis
-
MM maintenance dose
- Follow same cycle, but decrease or increase based on patient tolerance
- CrCl >60 mL/min: Dose adjustment not necessary
- CrCl 30-60 mL/min: 5 mg PO qDay
- CrCl <30 mL/min (not requiring dialysis): 2.5 mg PO every other day
- CrCl <30 mL/min (requiring dialysis): 2.5 mg PO qDay; on dialysis days, administer following dialysis
Thrombocytopenia
-
During treatment
- Platelets count fall to <30,000/mcL: Interrupt treatment and following weekly CBC
- Platelets return to ≥30,000/mcL: Restart at next lower dose, but not <2.5 mg/day
- For each subsequent drop <30,000/mcL: Interrupt treatment, then when ≥30,000/mcL, resume at next lower dose, but not <2.5 mg/day
-
During maintenance
- Platelets fall to <30,000/mcL: Interrupt treatment and following weekly CBC
- Platelets return to ≥30,000/mcL: Resume at next lower dose, continuously for Days 1-28 of repeated 28-day cycle
-
During maintenance at 5 mg/day
- Platelets fall to <30,000/mcL: Interrupt treatment; do not dose <5 mg/day for Days 1-21 of 28-day cycle
- Platelets return to ≥30,000/mcL: Resume at 5 mg/day for Days 1-21 of 28-day cycle; do not dose <5 mg/day daily for Days 1-21 of 28-day cycle
Neutropenia
-
During treatment
- ANC falls to <1,000/mcL: Interrupt treatment, add G-CSF, follow CBC weekly
- ANC returns to ≥1,000/mcL and neutropenia is the only toxicity: Resume at 25 mg/day or initial starting dose
- ANC returns to ≥1,000/mcL with other toxicity: Resume at next lower dose, but <2.5 mg/day mg/day
- For each subsequent drop <1,000/mcL: Interrupt treatment, then when ≥1,000/mcL, resume at next lower dose, but not <2.5 mg/day
-
During maintenance
- ANC falls to <500/mcL: Interrupt treatment; follow CBC weekly
- ANC returns to ≥500/mcL: Resume at next lower dose continuously for days 1-28 of repeated 28-day cycle
-
During maintenance at 5 mg/day
- ANC falls to <500/mcL: Interrupt treatment; do not dose <5 mg/day for Days 1-21 of 28-day cycle
- ANC returns to ≥500/mcL: Resume at 5 mg/day for Days 1-21 of 28-day cycle; do not dose <5 mg/day daily for Days 1-21 of 28-day cycle
Other grade 3-4 toxicities
-
During treatment or maintenance
- Interrupt treatment and resume at physicians discretion at next lower dose when toxicity has resolved to grade ≤2
Dosage Modifications (MCL)
Thrombocytopenia
- Platelets falls to <50,000/mcL: Interrupt treatment
- Platelets return to ≥50,000/mcL: Resume at 5 mg/day less than previous dose; do not dose below 5 mg/day
Neutropenia
- ANC falls to <1,000/mcL for at least 7 days OR <1,000/mcL with fever (≥38.5°C) OR ANC <500/mcL: Interrupt treatment and follow weekly CBC
- ANC returns to ≥1,000/mcL: Resume at 5 mg/day less than previous dose; do not dose below 5 mg/day
Other grade 3-4 toxicities
- Interrupt treatment and resume at physicians discretion at next lower dose when toxicity has resolved to grade ≤2
Renal impairment
- Follow same cycle, but decrease dose as listed below
- CrCl 30-60 mL/min: 10 mg PO qDay
- CrCl <30 mL/min: 15 mg PO q48hr
- ESRD: 5 mg PO qDay; on dialysis days, administer following dialysis
Dosage Modifications (FL or MZL)
Thrombocytopenia
- Platelets falls <50,000/mcL: Interrupt dose and follow CBC weekly
- Platelets return to ≥50,000/mcL: If starting dose was 20 mg qDay, resume at 5 mg less than previous dose; do not dose below 5 mg qDay; if starting dose was 10 mg qDay, resume at 5 mg less than previous dose; do not dose below 2.5 mg qDay
Neutropenia
- ANC falls to <1000/mcL for ≥7 days, OR falls to <1000/mcL with a temperature ≥38.5°C, orOR falls <500/mcL: Interrupt dose and follow CBC weekly
- ANC returns to ≥1,000/mcL: If starting dose was 20 mg qDay, resume at 5 mg less than previous dose; do not dose below 5 mg qDay; if starting dose was 10 mg qDay, resume at 5 mg less than previous dose; do not dose below 2.5 mg qDay
Other grade 3 or 4 toxicities
- Other grade 3 or 4 toxicities: Hold dose and restart at physician's discretion at next lower dose level when toxicity has resolved to grade ≤2
Renal impairment
- CrCl 30-60 mL/min: 10 mg PO qDay; after 2 cycles, may increase to 15 mg qDay if patient has tolerated therapy
- CrCl <30 mL/min: 5 mg PO qDay
- ESRD: 5 mg PO qDay; on dialysis days, administer following dialysis
Orphan Designations Indications
Diffuse large-cell B lymphoma
Chronic lymphocytic leukemia: In July 2013, the FDA halted clinical trials because of significant safety concerns; the ORIGIN trial (NCT00910910) showed higher rates of death in patients treated with lenalidomide compared to those treated with chlorambucil
Orphan sponsor
- Celgene Corporation; 400 Connell Drive, Suite 7000; Berkley Heights, New Jersey 07922
Dosing Considerations
Limitations on use
- Not indicated for and is not recommended for the treatment of patients with CLL outside of controlled clinical trials
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- anakinra
anakinra increases toxicity of lenalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.
Serious - Use Alternative (6)
- deferiprone
deferiprone, lenalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- etrasimod
etrasimod, lenalidomide. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod.
- palifermin
palifermin increases toxicity of lenalidomide by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, lenalidomide. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- selinexor
selinexor, lenalidomide. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- vedolizumab
vedolizumab and lenalidomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections
Monitor Closely (12)
- acalabrutinib
acalabrutinib, lenalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- cholera vaccine
lenalidomide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- denosumab
lenalidomide, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- dichlorphenamide
dichlorphenamide and lenalidomide both decrease serum potassium. Use Caution/Monitor.
- fingolimod
lenalidomide increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
lenalidomide, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- ponesimod
ponesimod and lenalidomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- siponimod
siponimod and lenalidomide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
lenalidomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, lenalidomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, lenalidomide. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- zidovudine
lenalidomide, zidovudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of myelosuppression.
Minor (2)
- food
food decreases levels of lenalidomide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Decreased Cmax, but AUC unaffected.
- tocilizumab
tocilizumab, lenalidomide. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Additive immunosuppression; risk of serious infection. (Theoretical interaction).
Adverse Effects
>10%
Thrombocytopenia (62%)
Neutropenia (59%)
Diarrhea (48%)
Pruritus (42%)
Nausea (35%)
Rash (35%)
Fatigue (31%)
Constipation (24%)
Arthralgia (22%)
Back pain (21%)
Peripheral edema (21%)
Pyrexia (21%)
Dizziness (20%)
Headache (20%)
Cough (19%)
Muscle cramp (18%)
Dyspnea (17%)
URTI (15%)
Anemia (12%)
Pneumonia (12%)
UTI (11%)
1-10% (critical AEs)
Tumor flare reaction - MCL (10%)
Abdominal pain (8%)
Leukopenia (8%)
Myalgia (8%)
Pain (7%)
Bronchitis (6%)
Rhinitis (6%)
Febrile neutropenia (5%)
Peripheral neuropathy (5%)
Postmarketing Reports
Endocrine disorders: Hypothyroidism, hyperthyroidism
Hepatobiliary disorders: Hepatic failure (including fatality), toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, mixed cytolytic/cholestatic hepatitis, transient abnormal liver laboratory tests
Immune system disorders: Angioedema, acute graft-versus-host disease (following allogeneic hematopoietic transplant), solid organ transplant rejection
Infections and infestations: Viral reactivation (eg, hepatitis B, Herpes zoster), progressive multifocal leukoencephalopathy (PML)
Neoplasms benign, malignant and unspecified (including cysts and polyps): Tumor lysis syndrome, tumor flare reaction
Respiratory, thoracic and mediastinal disorders: Pneumonitis
Skin and subcutaneous tissue disorders: Stevens-Johnson Syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)
Warnings
Black Box Warnings
Embryo-fetal toxicity
- Thalidomide analogue, caused limb abnormalities in a developmental monkey study similar to birth defects caused by thalidomide in humans
- Avoid during pregnancy; if taken during pregnancy, likely to cause birth defects or fetal death
- Prevent pregnancy during treatment by the use of two reliable methods of contraception In females of reproductive potential, obtain 2 negative pregnancy tests before starting treatment
- Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after treatment
- Only available through a restricted distribution program, REVLIMID REMS program; information is available at www.celgeneriskmanagement.com or by calling the manufacturer’s toll-free number 1-888-423-5436
Hematologic toxicity (neutropenia and thrombocytopenia)
- Associated with significant neutropenia and thrombocytopenia
- 80% of patients with deletion 5q myelodysplastic syndromes (MDS) had to have a dose delay/reduction during the major study; 34% had to have a 2nd dose delay/reduction
- Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study
- Patients on therapy for del 5q myelodysplastic syndromes should monitor CBC weekly for the first 8 weeks of therapy and at least monthly thereafter; reduce dose when necessary
- Patients may require dose interruption and/or reduction
- Patients may require use of blood product support and/or growth factors
Venous and arterial thrombosis
- 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 receiving lenalidomide with dexamethasone
- Monitor for signs and symptoms of thromboembolism; advise patients to seek immediate medical care if they develop symptoms (eg, shortness of breath, chest pain, arm or leg swelling)
- Antithrombotic prophylaxis is recommended; choice of regimen should be based on an assessment of the patient’s underlying risks
Contraindications
Pregnancy; sexually active women of childbearing potential not using 2 forms of contraception
Demonstrated hypersensitivity (eg, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis)
Cautions
Risk of hematologic toxicity; can cause significant neutropenia and thrombocytopenia (see Dosage Modifications)
Use caution in renal impairment
Increases risk of mortality in patients with CLL with monotherapy; therapy not indicated and not recommended in CLL outside of controlled clinical trials
Fatal instances of tumor lysis syndrome reported
Patients must not donate blood during treatment and for 4 weeks following discontinuation of drug because blood might be given to pregnant female patient whose fetus must not be exposed to drug
Tumor flare reaction (TFR) has occurred during investigational use for CLL and lymphoma, and is characterized by tender lymph node swelling, low grade fever, pain and rash; tumor flare may mimic progression of disease; may continue treatment if grade 1 or 2 TFR (treat with corticosteroids, NSAIDs, and/or narcotic analgesics), hold treatment for grade 3 or 4 TFR until resolves to ≤Grade 1
Hepatic failure, including fatal cases, has occurred when administered in combination with dexamethasone; the mechanism of drug-induced hepatotoxicity is unknown; pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors; monitor liver enzymes periodically; stop therapy upon elevation of liver enzymes; after return to baseline values, treatment at a lower dose may be considered
Patients treated with lenalidomide (with melphalan and stem cell transplantation) had higher incidence of second primary malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin lymphoma, compared to patients in the control arms who received similar therapy but did not receive lenalidomide
Monitor patients for development of second primary malignancies; take into account both potential benefit of therapy and risk of second primary malignancies when considering therapy
Impaired stem cell mobilization reported; refer patients who are auto-HSCT candidates to a transplant center early in treatment to optimize the timing of the stem cell collection; patients who received more than 4 cycles of 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 reported: measure thyroid function before initiating and during therapy
Tumor lysis syndrome reported with therapy; monitor patients at risk closely; take appropriate preventive approaches
Increased mortality was observed in 2 randomized clinical trials in patients with multiple myeloma when pembrolizumab was added to a thalidomide analogue and dexamethasone; treatment with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials
Venous and arterial thromboembolism
- Increased risk of DVT, PE, MI, and stroke associated with therapy
- Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g. hyperlipidemia, hypertension, smoking)
- Thromboprophylaxis is recommended; the regimen of thromboprophylaxis should be based on an assessment of the patient’s underlying risks; instruct patients to report immediately any signs and symptoms suggestive of thrombotic events; ESAs and estrogens may further increase risk of thrombosis and their use should be based on a benefit-risk decision in patients receiving therapy
Hematologic toxicity
- 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; patients receiving therapy should have their complete blood counts assessed periodically
- Monitor complete blood counts (CBC) in patients receiving therapy in combination with dexamethasone or as maintenance therapy for MM every 7 days (weekly) for first 2 cycles, on Days 1 and 15 of Cycle 3, and every 28 days (4 weeks) thereafter
- Monitor CBC, in patients taking therapy, for MCL weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter
- Monitor complete blood counts (CBC) in patients receiving therapy for FL or MZL weekly for the first 3 weeks of Cycle 1 (28 days), every 2 weeks during Cycles 24, and then monthly thereafter
Angioedema and serious dermatologic reactions
- Angioedema and severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) 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; these events can be fatal
- Patients with prior history of Grade 4 rash associated with thalidomide treatment should not receive lenalidomide
- Consider interrupting or discontinuing for Grade 2-3 skin rash
- Discontinue for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions
Drug interactions overview
-
Digoxin
- Coadministration of lenalidomide (multiple doses of 10 mg/day) with digoxin may increase plasma levels of digoxin; monitor digoxin plasma levels based on clinical judgement and standard practices
-
Therapies that increase risk of thrombosis
- Use erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, with caution after making a benefit-risk assessment in patients receiving lenalidomide
-
Warfarin
- Coadministration of lenalidomide with a single-dose of warfarin had no effect on the pharmacokinetics of lenalidomide or R- and S-warfarin
- Expected changes in PT and INR were observed after warfarin administration
- Unknown whether an interaction between dexamethasone and warfarin
- Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin
Pregnancy & Lactation
Pregnancy
Contraindicated during pregnancy (see Contraindications and Black Box Warnings)
Based on the mechanism of action and findings from animal studies, lenalidomide can cause embryo-fetal harm when administered to a pregnant female and is contraindicated during pregnancy
Thalidomide analogue; thalidomide is a human teratogen, inducing a high frequency of severe and life-threatening birth defects such as amelia (absence of limbs), phocomelia (short limbs), bone hypoplasticity, absence of bones, external ear abnormalities (including anotia, microtia, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects
Mortality at or shortly after birth has been reported in ~40% of infants
Contraception
Females
- Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception (eg, tubal ligation, IUD, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants]), or partner’s vasectomy, and 1 additional effective contraceptive method (eg, male latex or synthetic condom, diaphragm, or cervical cap)
- Contraception must begin 4 weeks prior to initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following discontinuation of therapy
- Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy
- Females of reproductive potential should be referred to a qualified provider of contraceptive methods, if needed
Males
- Present in the semen of males; therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking lenalidomide and for up to 4 weeks after discontinuing, even if they have undergone a successful vasectomy
- Male patients taking lenalidomide must not donate sperm
Pregnancy registry
- There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide during pregnancy as well as female partners of male patients who are exposed
- This registry is also used to understand the root cause for the pregnancy
- Report any suspected fetal exposure to lenalidomide to the FDA via the MedWatch program at 1-800-FDA-1088 and also to the manufacturer at 1-888-423-5436
Lactation
Unknown if distributed into human breast milk
Because of the potential for adverse reactions in breastfed infants from lenalidomide, advise women not to breastfeed during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Thalidomide analog; immunomodulatory and antiangiogenic; inhibits secretion of proinflammatory cytokines; enhances cell-mediated immunity by stimulating proliferation of anti-CD3 stimulated T cells
Pharmacokinetics
Half-life: 3 hr
Peak plasma time: 0.5-6 hr
Protein bound: 30%
Excretion: urine (82%)
Dialyzable: No
Administration
Oral Administration
Take at about the same time each day
Swallow capsule whole with water; do not open capsule, chew, or break
May take with or without food
Monitor: CBC, Hgb, Hct, pregnancy testing, renal and hepatic function
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Revlimid oral - | 15 mg capsule |  | |
| Revlimid oral - | 2.5 mg capsule |  | |
| Revlimid oral - | 5 mg capsule |  | |
| Revlimid oral - | 25 mg capsule |  | |
| Revlimid oral - | 20 mg capsule |  | |
| Revlimid oral - | 10 mg capsule |  | |
| lenalidomide oral - | 2.5 mg capsule |  | |
| lenalidomide oral - | 25 mg capsule |  | |
| lenalidomide oral - | 15 mg capsule |  | |
| lenalidomide oral - | 2.5 mg capsule |  | |
| lenalidomide oral - | 20 mg capsule |  | |
| lenalidomide oral - | 20 mg capsule |  | |
| lenalidomide oral - | 20 mg capsule |  | |
| lenalidomide oral - | 10 mg capsule |  | |
| lenalidomide oral - | 5 mg capsule |  | |
| lenalidomide oral - | 10 mg capsule |  | |
| lenalidomide oral - | 5 mg capsule |  | |
| lenalidomide oral - | 15 mg capsule |  | |
| lenalidomide oral - | 25 mg capsule |  | |
| lenalidomide oral - | 5 mg capsule |  | |
| lenalidomide oral - | 20 mg capsule |  | |
| lenalidomide oral - | 2.5 mg capsule |  | |
| lenalidomide oral - | 25 mg capsule |  | |
| lenalidomide oral - | 20 mg capsule |  | |
| lenalidomide oral - | 15 mg capsule |  | |
| lenalidomide oral - | 10 mg capsule |  | |
| lenalidomide oral - | 2.5 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
lenalidomide oral
LENALIDOMIDE - ORAL
(LEN-a-LID-oh-mide)
COMMON BRAND NAME(S): Revlimid
WARNING: Lenalidomide is very similar to thalidomide, a drug which has caused severe (possibly fatal) birth defects when used during pregnancy. If lenalidomide is taken during pregnancy, it may also cause severe (possibly fatal) birth defects. Women who are pregnant or who may become pregnant must not use lenalidomide. Women must have two negative pregnancy tests before starting lenalidomide (the first test 10 to 14 days before the first dose and the second test within 24 hours before the first dose). Women must also continue to have pregnancy tests regularly during treatment (every 2 to 4 weeks).Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 4 weeks before starting lenalidomide, during use, and for 4 weeks after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late or if you have irregular bleeding, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor right away.Because lenalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Continue using condoms and other birth control as directed until 4 weeks after lenalidomide treatment has been stopped.You should have a blood test for hepatitis B virus before starting treatment. Some people with this virus may have a serious flare-up when using lenalidomide.To receive this medication in the United States, you must understand, agree to, and carefully follow the requirements of the Lenalidomide REMS Program. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.This medication may cause a low number of white blood cells and platelets. Your doctor will monitor you closely while you take this medication and may adjust the dose of the medication or stop the medication based on your lab test results. Get medical help right away if you develop any of the following symptoms: signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough), easy bleeding/bruising.Lenalidomide may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you smoke, or have a history of blood clots, high blood pressure, or high cholesterol, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. To lower your risk, your doctor may prescribe an additional medication. Before using lenalidomide, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if you have any signs of a blood clot, including: shortness of breath, chest/jaw/left arm pain, unusual sweating, confusion, pain/swelling/redness in the groin/calf, sudden/severe headaches, trouble speaking, weakness on one side of the body, sudden vision changes.
USES: Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS). Lenalidomide may lessen the need for blood transfusions.Lenalidomide is not recommended for the treatment of a certain type of cancer (chronic lymphocytic leukemia) because of the increased risk of serious heart-related side effects and death. If you have this type of cancer, talk to your doctor about the risks of using this medication.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking lenalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow this medication whole with water. For treatment of certain conditions, you may be instructed to take this medication in cycles (once daily for 21 days, then stopping the medication for 7 days). The dosage is based on your medical condition, response to treatment, and lab test results. Be sure to follow your doctor's directions carefully.Do not open, chew, or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.Use this medication regularly to get the most benefit from it. Remember to take it at the same time each day.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.
SIDE EFFECTS: See also Warning section.Diarrhea, stomach/abdominal pain, nausea/vomiting, loss of appetite, constipation, dizziness, dry skin, dry mouth, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression), increased thirst/urination, shaking (tremor), numbness/tingling of arms/legs, fast/slow/irregular heartbeat, symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Some people treated with this medication may rarely get other cancers. Consult your doctor for more details.Lenalidomide sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.People taking lenalidomide may have worsening of their symptoms (tumor flare reaction). If you have tender/swollen lymph nodes, fever, pain, or rash, contact your doctor right away.This drug helps many people live longer. However, some people who have used lenalidomide have died sooner than expected, especially if they had high white blood cell or tumor cell counts. Talk with your doctor about the risks and benefits of using this medication.Lenalidomide may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.Lenalidomide can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: See also Warning section.Before taking lenalidomide, tell your doctor or pharmacist if you are allergic to it; or to thalidomide; or if you have any other allergies. This product may contain inactive ingredients (such as lactose), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease (such as hepatitis B), thyroid disease, chicken pox and shingles (herpes zoster infection), organ transplant.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Lenalidomide can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using lenalidomide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Do not donate blood or sperm while using lenalidomide and for 4 weeks after stopping this drug.Older adults may be more sensitive to the side effects of this drug.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.Lenalidomide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, stop taking lenalidomide and tell your doctor right away. If you are male and have had unprotected sex with a woman who is or can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors right away.It is unknown if lenalidomide passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as complete blood count, kidney/liver/thyroid function, blood mineral levels, pregnancy test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember if it is less than 12 hours after the time you would usually take it. If more than 12 hours have passed, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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