Lenalid is used to treat anemia (low red blood cells) in patients with a certain type of myelodysplastic syndrome (MDS). Patients with MDS may have very low red blood cell counts and require blood transfusions.
Lenalid is also used in combination with dexamethasone to treat multiple myeloma (plasma cell cancer).
Lenalid is also used to treat mantle cell lymphoma (MCL) in patients who have been treated previously with bortezomib plus one additional medicine that did not work well.
This medicine is available only with your doctor's prescription and through a special restricted distribution program called the Lenalid® REMS program.
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, Lenalid is used in certain patients with the following medical condition:
Multiple myeloma, first-line treatment, in combination with dexamethasone (treatment of bone marrow cancer; used together with dexamethasone).
Lenalid indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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1.1 Multiple Myeloma
Lenalid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM).
Myelodysplastic Syndromes
Lenalid is indicated for the treatment of patients with 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.
Mantle Cell Lymphoma
Lenalid is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Limitations of Use:
Lenalid is not indicated and is not recommended for the treatment of patients with CLL outside of controlled clinical trials.
How should I use Lenalid?
Use Lenalid as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Lenalid comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Lenalid refilled.
Take Lenalid by mouth with or without food.
Swallow Lenalid whole with water. Do not break, crush, chew, or open before swallowing.
Take Lenalid at about the same time each day to get the most benefit from it.
Do not open the capsules or handle them more than needed. If you touch a broken capsule or the medicine inside of the capsule, wash the area with soap and water. If a broken capsule or the medicine inside comes into contact with your eyes, flush thoroughly with water.
If you miss a dose of Lenalid and it has been less than 12 hours since the missed dose, take it as soon as you remember. If it has been more than 12 hours since the missed dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Lenalid.
Uses of Lenalid in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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: Lenalid is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
Off Label Uses
Chronic lymphocytic leukemia, relapsed or refractory
Data from a phase 2 study in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), support the use of Lenalid (in combination with cyclic rituximab) in the treatment of patients with CLL.
Lenalid description
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Lenalid (initially known as CC-5013 and marketed as Lenalid® by Celgene) is a derivative of thalidomide introduced in 2004. It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic modality, but has also shown efficacy in the hematological disorders known as the myelodysplastic syndromes. [Wikipedia] FDA approved on December 27, 2005.
Lenalid dosage
Lenalid Dosage
Generic name: Lenalid 2.5mg
Dosage form: capsule
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Lenalid should be taken orally at about the same time each day, either with or without food. Lenalid capsules should be swallowed whole with water. The capsules should not be opened, broken, or chewed.
Multiple Myeloma
Multiple Myeloma
The recommended starting dose of Lenalid is 25 mg orally once daily on Days 1-21 of repeated 28-day cycles in combination with dexamethasone. Refer to Section 14.1 for specific dexamethasone dosing. For patients > 75 years old, the starting dose of dexamethasone may be reduced. Treatment should be continued until disease progression or unacceptable toxicity.
In patients who are not eligible for autologous stem cell transplantation (ASCT), treatment should continue until disease progression or unacceptable toxicity. For patients who are ASCT-eligible, hematopoietic stem cell mobilization should occur within 4 cycles of a Lenalid-containing therapy.
Dose Adjustments for Hematologic Toxicities During Multiple Myeloma Treatment
Dose modification guidelines, as summarized in Table 1 below, are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicity judged to be related to Lenalid.
Table 1: Dose Adjustments for Hematologic Toxicities for MM
Platelet counts
Thrombocytopenia in MM
When Platelets
Recommended Course
Fall to <30,000/mcL
Interrupt Lenalid treatment, follow CBC weekly
Return to ≥30,000/mcL
Resume Lenalid at next lower dose. Do not dose below 2.5 mg daily
For each subsequent drop <30,000/mcL
Interrupt Lenalid treatment
Return to ≥30,000/mcL
Resume Lenalid at next lower dose. Do not dose below 2.5 mg daily
Absolute Neutrophil counts (ANC)
Neutropenia in MM
When Neutrophils
Recommended Course
Fall to <1000/mcL
Interrupt Lenalid treatment, follow CBC
weekly
Return to ≥1,000/mcL and neutropenia is the only toxicity
Resume Lenalid at 25 mg daily or initial
starting dose
Return to ≥1,000/mcL and if other toxicity
Resume Lenalid at next lower dose. Do
not dose below 2.5 mg daily
For each subsequent drop <1,000/mcL
Interrupt Lenalid treatment
Return to ≥1,000/mcL
Resume Lenalid at next lower dose. Do not dose below 2.5 mg daily
Other Toxicities in MM
For other Grade 3/4 toxicities judged to be related to Lenalid, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MM:
.
Myelodysplastic Syndromes
The recommended starting dose of Lenalid is 10 mg daily. Treatment is continued or modified based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During MDS Treatment
Patients who are dosed initially at 10 mg and who experience thrombocytopenia should have their dosage adjusted as follows:
Platelet counts
If thrombocytopenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS
If baseline ≥100,000/mcL
When Platelets
Recommended Course
Fall to <50,000/mcL
Interrupt Lenalid treatment
Return to ≥50,000/mcL
Resume Lenalid at 5 mg daily
If baseline <100,000/mcL
When Platelets
Recommended Course
Fall to 50% of the baseline value
Interrupt Lenalid treatment
If baseline ≥60,000/mcL and
returns to ≥50,000/mcL
Resume Lenalid at 5 mg daily
If baseline <60,000/mcL and
returns to ≥30,000/mcL
Resume Lenalid at 5 mg daily
If thrombocytopenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS
When Platelets
Recommended Course
<30,000/mcL or <50,000/mcL
with platelet transfusions
Interrupt Lenalid treatment
Return to ≥30,000/mcL
(without hemostatic failure)
Resume Lenalid at 5 mg daily
Patients who experience thrombocytopenia at 5 mg daily should have their dosage adjusted as follows:
If thrombocytopenia develops during treatment at 5 mg daily in MDS
When Platelets
Recommended Course
<30,000/mcL or <50,000/mcL
with platelet transfusions
Interrupt Lenalid treatment
Return to ≥30,000/mcL
(without hemostatic failure)
Resume Lenalid at 2.5 mg daily
Patients who are dosed initially at 10 mg and experience neutropenia should have their dosage adjusted as follows:
Absolute Neutrophil counts (ANC)
If neutropenia develops WITHIN 4 weeks of starting treatment at 10 mg daily in MDS
If baseline ANC ≥1,000/mcL
When Neutrophils
Recommended Course
Fall to <750/mcL
Interrupt Lenalid treatment
Return to ≥1,000/mcL
Resume Lenalid at 5 mg daily
If baseline ANC <1,000/mcL
When Neutrophils
Recommended Course
Fall to <500/mcL
Interrupt Lenalid treatment
Return to ≥500/mcL
Resume Lenalid at 5 mg daily
If neutropenia develops AFTER 4 weeks of starting treatment at 10 mg daily in MDS
When Neutrophils
Recommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C)
Interrupt Lenalid treatment
Return to ≥500/mcL
Resume Lenalid at 5 mg daily
Patients who experience neutropenia at 5 mg daily should have their dosage adjusted as follows:
If neutropenia develops during treatment at 5 mg daily in MDS
When Neutrophils
Recommended Course
<500/mcL for ≥7 days or <500/mcL
associated with fever (≥38.5°C)
Interrupt Lenalid treatment
Return to ≥500/mcL
Resume Lenalid at 2.5 mg daily
Other Grade 3 / 4 Toxicities in MDS
For other Grade 3/4 toxicities judged to be related to Lenalid, hold treatment and restart at the physician's discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MDS:
.
Mantle Cell Lymphoma
The recommended starting dose of Lenalid is 25 mg/day orally on Days 1-21 of repeated 28-day cycles for relapsed or refractory mantle cell lymphoma. Treatment should be continued until disease progression or unacceptable toxicity.
Treatment is continued, modified or discontinued based upon clinical and laboratory findings.
Dose Adjustments for Hematologic Toxicities During MCL Treatment
Dose modification guidelines as summarized below are recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia or other Grade 3 or 4 toxicities considered to be related to Lenalid.
Platelet counts
Thrombocytopenia during treatment in MCL
When Platelets
Recommended Course
Fall to <50,000/mcL
Interrupt Lenalid treatment and follow
CBC weekly
Return to ≥50,000/mcL
Resume Lenalid at 5 mg less than the
previous dose. Do not dose below 5 mg daily
Absolute Neutrophil counts (ANC)
Neutropenia during treatment in MCL
When Neutrophils
Recommended Course
Fall to <1000/mcL for at least 7 days
OR
Falls to < 1,000/mcL with an associated temperature ≥ 38.5°C
OR
Falls to < 500 /mcL
Interrupt Lenalid treatment and follow
CBC weekly
Return to ≥1,000/mcL
Resume Lenalid at 5 mg less than the
previous dose. Do not dose below 5 mg daily
Other Grade 3 / 4 Toxicities in MCL
For other Grade 3/4 toxicities judged to be related to Lenalid, hold treatment and restart at the physician’s discretion at next lower dose level when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MCL:
.
Starting Dose for Renal Impairment in MM, MDS or MCL
Since Lenalid is primarily excreted unchanged by the kidney, adjustments to the starting dose of Lenalid are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis. Based on a pharmacokinetic study in patients with renal impairment due to non-malignant conditions, Lenalid starting dose adjustment is recommended for patients with CLcr < 60 mL/min. The recommendations for initial starting doses for patients with MDS or MCL, and MM are as follows:
Table 2: Starting Dose Adjustments for Patients with Renal Impairment in MDS or MCL
Category
Renal Function (Cockcroft-
Gault)
Dose in MCL
Dose in MDS
Moderate Renal
Impairment
CLcr 30-60 mL/min
10 mg
Every 24 hours
5 mg
Every 24 hours
Severe Renal Impairment
CLcr < 30 mL/min (not
requiring dialysis)
15 mg
Every 48 hours
2.5 mg
Every 24 hours
End Stage Renal Disease
CLcr < 30 mL/min (requiring
dialysis)
5 mg
Once daily. On dialysis
days, administer the dose
following dialysis.
2.5 mg
Once daily. On dialysis days,
administer the dose following
dialysis.
Table 3: Starting Dose Adjustments for Patients with Renal Impairment in MM
Category
Renal Function (Cockcroft-
Gault)
Dose in MM
Moderate Renal
Impairment
CLcr 30-50 mL/min
10 mg
Every 24 hours
Severe Renal Impairment
CLcr < 30 mL/min (not
requiring dialysis)
15 mg
Every 48 hours
End Stage Renal Disease
CLcr < 30 mL/min (requiring
dialysis)
5 mg
Once daily. On dialysis
days, administer the dose
following dialysis.
Moderate renal impairment for MM: Consider escalating the dose to 15 mg after 2 cycles if the patient tolerates the 10 mg dose of Lenalid without dose-limiting toxicity.
After initiation of Lenalid therapy, subsequent Lenalid dose increase or decrease is based on individual patient treatment tolerance, as described elsewhere.
Results from human in vitro studies show that Lenalid is neither metabolized by nor inhibits or induces the cytochrome P450 pathway suggesting that Lenalid is not likely to cause or be subject to P450-based metabolic drug interactions.
Digoxin
When digoxin was co-administered with multiple doses of Lenalid (10 mg/day) the digoxin Cmax and AUC0-∞ were increased by 14%. Periodic monitoring of digoxin plasma levels, in accordance with clinical judgment and based on standard clinical practice in patients receiving this medication, is recommended during administration of Lenalid.
Concomitant Therapies That May Increase The Risk Of Thrombosis
Erythropoietic agents, or other agents that may increase the risk of thrombosis, such as estrogen containing therapies, should be used with caution after making a benefit-risk assessment in patients receiving REVLI ID.
Warfarin
Co-administration of multiple dose Lenalid (10 mg) with single dose warfarin (25 mg) had no effect on the pharmacokinetics of total Lenalid or R-and S-warfarin. Expected changes in laboratory assessments of PT and INR were observed after warfarin administration, but these changes were not affected by concomitant Lenalid administration. It is not known whether there is an interaction between dexamethasone and warfarin. Close monitoring of PT and INR is recommended in multiple myeloma patients taking concomitant warfarin.
The following adverse reactions are described in detail in other sections of the prescribing information:
Embryo-Fetal Toxicity
Neutropenia and thrombocytopenia
Venous and arterial thromboembolism
Increased Mortality in Patients with CLL
Second Primary Malignancies
Hepatotoxicity
Allergic Reactions
Tumor Lysis Syndrome
Tumor Flare Reactions
Impaired Stem Cell Mobilization
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Trials Experience
Specific Populations
Newly Diagnosed Multiple Myeloma
Data were evaluated from 1613 patients in a large phase 3 study who received at least one dose of Lenalid with low dose dexamethasone (Rd) given for 2 different durations of time (i.e., until progressive disease [Arm Rd Continuous; N=532] or for up to eighteen 28-day cycles [72 weeks, Arm Rd18; N=540] or who received melphalan, prednisone and thalidomide (Arm MPT; N=541) for a maximum of twelve 42-day cycles (72 weeks). The median treatment duration in the Rd Continuous arm was 80.2 weeks (range 0.7 to 246.7) or 18.4 months (range 0.16 to 56.7).
In general, the most frequently reported adverse reactions were comparable in Arm Rd Continuous and Arm Rd18, and included diarrhea, anemia, constipation, peripheral edema, neutropenia, fatigue, back pain, nausea, asthenia, and insomnia. The most frequently reported Grade 3 or 4 reactions included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia. The highest frequency of infections occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%). There were more grade 3 and 4 and serious adverse reactions of infection in Arm Rd Continuous than either Arm MPT or Rd18.
In the Rd Continuous arm, the most common adverse reactions leading to dose interruption of Lenalid were infection events (28.8%); overall, the median time to the first dose interruption of Lenalid was 7 weeks. The most common adverse reactions leading to dose reduction of Lenalid in the Rd Continuous arm were hematologic events (10.7%); overall, the median time to the first dose reduction of Lenalid was 16 weeks. In the Rd Continuous arm, the most common adverse reactions leading to discontinuation of Lenalid were infection events (3.4%).
In both Rd arms, the frequencies of onset of adverse reactions were generally highest in the first 6 months of treatment and then the frequencies decreased over time or remained stable throughout treatment, except for cataracts. The frequency of onset of cataracts increased over time with 0.7% during the first 6 months and up to 9.6% by the 2nd year of treatment with Rd Continuous.
Table 4 summarizes the adverse reactions reported for the Rd Continuous, Rd18, and MPT treatment arms.
Table 4: All Adverse Reactions in ≥ 5.0% and Grade 3/4 Adverse Reactions in ≥ 1.0% of Patients in the Rd Continuous or Rd18 Arms*
System organ class Preferred term
All Adverse Reactions-MCL trial Grade 3/4 AEs – All treatment-emergent Grade 3/4 AEs in 2 or more subjects
$-MCL trial Serious AEs – All treatment-emergent SAEs in 2 or more subjects
@-AEs where at least one resulted in a fatal outcome
%-AEs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases)
#-All PTs under SOC of Infections except for rare infections of Public Health interest will be considered listed
+-All PTs under HLT of Rash will be considered listed
The following adverse events which have occurred in other indications and not described above have been reported (5%-10%) in patients treated with Lenalid monotherapy for mantle cell lymphoma.
General disorders and administration site conditions: Chills
Musculoskeletal and connective tissue disorders: Pain in extremity
Nervous system disorders: Dysgeusia, headache, neuropathy peripheral
Infections and infestations: Respiratory tract infection, sinusitis, nasopharyngitis
Skin and subcutaneous tissue disorders: Dry skin, night sweats
The following serious adverse events not described above and reported in 2 or more patients treated with Lenalid monotherapy for mantle cell lymphoma.
Respiratory, Thoracic, and Mediastinal Disorders: Chronic obstructive pulmonary disease
Infections and Infestations:Clostridium difficile colitis, sepsis
Neoplasms benign, malignant and unspecified (including cysts and polyps): Basal cell carcinoma
Cardiac Disorder: Supraventricular tachycardia
Postmarketing Experience
The following adverse drug reactions have been identified from the worldwide post-marketing experience with Lenalid: Allergic conditions (angioedema, SJS, TEN), tumor lysis syndrome (TLS) and tumor flare reaction (TFR), pneumonitis, hepatic failure, including fatality, toxic hepatitis, cytolytic hepatitis, cholestatic hepatitis, and mixed cytolytic/cholestatic hepatitis and transient abnormal liver laboratory tests. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cases of hypothyroidism and hyperthyroidism have also been reported. Optimal control of thyroid function is recommended before start of treatment. Baseline and ongoing monitoring of thyroid function is recommended.
Lenalid can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of Lenalid can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use Lenalid if you are pregnant.
For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking Lenalid and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking Lenalid. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking Lenalid, you will have a pregnancy test every 4 weeks.
Stop using Lenalid and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
For Men: You must not cause a woman to become pregnant while you are taking Lenalid because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy.
Lenalid is available only under a special program called RevAssist. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control measures as required by the program.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give Lenalid to another person, even if he or she has the same disorder for which you are being treated.
Do not donate blood or sperm while you are using Lenalid.
DailyMed. "LENALIDOMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Lenalid are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Lenalid. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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2 consumers reported age
Users
%
46-60
2
100.0%
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