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LENA
Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR). Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.
Treatment of patients with symptomatic anemia due to Low- or Intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality
lenalidomide
ODB Limited Use
(lenalidomide - For the treatment of patients with anemia due to myelodysplastic syndrome (MDS), according to clinical criteria)
(ODB Formulary
)
| lenalidomide | 10 mg | PO | Days 1 to 21 |
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Minimal – No routine prophylaxis; PRN recommended
Other Supportive Care:
Also refer to CCO Antiemetic Recommendations.
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Patients must be registered and meet all conditions of lenalidomide's controlled distribution program, including contraception.
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Prophylaxis for venous thromboembolism is recommended in patients at risk (e.g. low dose aspirin 81-100 mg PO daily or enoxaparin 40 mg SC daily).
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Careful consideration and monitoring must be taken with erythropoietin stimulating agents (ESAs), since the concomitant use of ESAs with lenalidomide may potentiate the risk of thrombosis. RBC or platelet transfusions with lenalidomide dose reductions/interruptions may be appropriate in severe / symptomatic anemia or thrombocytopenia.
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Consider G-CSF as secondary prophylaxis.
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Optimal control of thyroid function is recommended prior to starting treatment.
Doses should be modified according to the protocol by which the patient is being treated.
Dosage with toxicity
Dose levels (days 1 to 21): 10mg daily, 5mg daily, 5mg every other day
Dosage with Hematologic Toxicity
Discontinue treatment if no erythroid response within 4 months of therapy initiation (less than 50% reduction in transfusion requirements or, if not transfused, less than 10 g/L rise in hemoglobin)
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If myelosuppression develops within 4 weeks of starting treatment at 10 mg daily |
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Baseline Counts (X109/L) |
Counts during therapy (X109/L) |
Action |
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Platelets |
AND/ OR |
ANC* |
Platelets |
AND/ OR |
ANC |
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≥ 100
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≥ 1 |
< 50 |
<0.75 |
Hold |
Restart at 5mg/day when platelets ≥ 50 and ANC ≥ 1 |
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≥60 to <100 |
<1 |
↓ 50% of baseline |
<0.50 |
Hold |
Restart at 5mg/day when platelets ≥ 50 and ANC ≥ 0.5 |
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< 60** |
Hold |
Restart at 5mg/day when platelets ≥ 30 and ANC ≥ 0.5 |
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If myelosuppression develops after 4 weeks of starting treatment at 10 mg daily |
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Counts during therapy (X109/L) |
Action |
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Platelets |
AND/ OR |
ANC |
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<30, or <50 requiring transfusion |
<0.5 ≥ 7 days or with fever (≥38.5oC) |
Hold |
Restart at 5mg/day when platelets ≥ 30 (without bleeding) and ANC ≥ 0.5 |
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If myelosuppression develops during treatment at 5mg daily |
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Counts during therapy (X109/L) |
Action |
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Platelets |
AND/ OR |
ANC |
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<30, or <50 requiring transfusion |
<0.5 ≥ 7 days or with fever (≥38.5oC) |
Hold |
Restart at 5mg/ EVERY OTHER DAY when platelets ≥ 30 (without bleeding) and ANC ≥ 0.5 |
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Non-Hematologic Toxicities
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Toxicity |
Action |
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≥Grade 3 non-hematological |
Hold; restart with ↓ 1 dose level when ≤Grade 2 |
| Grade 2 to 3 rash |
Hold or consider discontinuing Discontinue if Stevens-Johnson syndrome suspected |
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↑ LFTs |
Hold Consider restarting at a lower dose when ≤ baseline levels |
| Pneumonitis | Hold and investigate if suspected; discontinue if confirmed |
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Angioedema, OR Grade 4 skin rash, OR Exfoliative or bullous rash, OR Suspected Stevens-Johnson Syndrome, Toxic epidermal necrolysis or DRESS |
Discontinue |
| Solid organ transplant rejection | Discontinue |
Hepatic Impairment
Population pharmacokinetics suggest no dosage adjustment is necessary in mild hepatic impairment (total bilirubin > 1 to < 1.5 x ULN or AST > ULN). No data available for moderate to severe hepatic impairment.
Renal Impairment
Lenalidomide clearance is decreased while exposure is increased in renal impairment.
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Creatinine Clearance (mL/min) |
Starting dose in MDS patients |
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30 to <60 |
5mg daily |
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< 30 (not requiring dialysis) |
5mg every other day |
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< 30 (requiring dialysis) |
5mg 3 times a week following each dialysis |
Dosage in the Elderly
The incidences of serious and non-serious adverse events are significantly higher in patients > 65 years (constipation, confusion, dyspnea, atrial fibrillation, diarrhea, fatigue, pulmonary embolism, syncope). May be related to renal impairment. Monitor geriatric patients closely, especially cardiac and renal function. Dose modification based on degree of renal impairment is required.
Refer to lenalidomide drug monograph(s) for additional details of adverse effects
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Very common (≥ 50%) |
Common (25-49%) |
Less common (10-24%) |
Uncommon (< 10%), but may be severe or life-threatening |
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Refer to lenalidomide drug monograph(s) for additional details
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Lenalidomide is not a substrate, inhibitor or inducer of CYP450; co-administration with substrates or inhibitors of this enzyme is unlikely to result in significant drug interactions.
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Digoxin may increase Cmax; caution and monitor digoxin levels.
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Additive risk of thromboembolism with hormonal therapy, including contraception. Caution and monitor; consider alternative contraception and prophylaxis with anticoagulants.
Refer to lenalidomide drug monograph(s) for additional details
Administration:
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Drug available by outpatient prescription in pharmacy registered with a controlled distribution program.
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Oral self-administration; swallow capsules whole; they should not be broken, chewed, or opened. Do not extensively handle the capsules.
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Give capsules preferably with water, either with or without food. Do not remove from blister packs until ready to take the dose. Note: Females who could become pregnant, or who plan to become pregnant can handle lenalidomide capsules if they are using latex gloves.
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If a dose is missed, it may be taken up to 12 hours after the time it is normally taken. Otherwise, skip this and take the next dose on the following day at its usual scheduled time.
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Store capsules at room temperature (15 to 30°C).
Contraindications:
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Patients with hypersensitivity (including severe rash) to lenalidomide, pomalidomide, thalidomide or any ingredient in the formulation.
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MDS patients with platelet counts < 50 x 109/L. MDS patients with grade 3 or 4 thrombocytopenia or grade 4 neutropenia were excluded from clinical trials.
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Pregnant and breastfeeding women.
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Women at risk of being pregnant and male patients who do not comply with contraception requirements (see Pregnancy section)
Other Warnings/Precautions:
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Lenalidomide contains lactose; carefully consider use in patients with hereditary galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.
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Use with caution and consider venous thromboembolism prophylaxis when used in combination with corticosteroids or thrombogenic agents, such as hormones and erythropoietin. (see adverse effects section)
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Exercise caution in patients with risk factors for arterial thromboembolism (e.g. hypertension and hyperlipidemia), or risk factors for atrial fibrillation. (e.g. electrolyte abnormalities, pre-existing heart disease, hypertension, infection).
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Use with caution in patients with high tumour burden; monitor closely and use appropriate precautions for tumour lysis syndrome.
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Use with caution and monitor closely in patients with previous viral infections such as HBV and herpes zoster.
Pregnancy and Lactation:
- Lenalidomide is contraindicated in pregnancy and in females and males of childbearing potential who do not comply with the contraception conditions of the controlled distribution program.
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Recommended Clinical Monitoring
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CBC; baseline, weekly for first 8 weeks, then monthly
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Liver function tests; baseline and at each visit
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Renal function tests; baseline and at each visit; increased frequency in patients 65 years or older
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Pregnancy testing requirements for women of child-bearing potential; before starting and as indicated
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Thyroid function tests; baseline and ongoing
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Clinical assessments and grading of cardiac and respiratory symptoms, rash, diarrhea, fatigue, constipation, infection, bleeding, tumour lysis syndrome, arterial and venous thromboembolism, GVHD or organ transplant rejection (if applicable); at each visit
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Cancer screening for occurrence of secondary primary malignancy; assess risk prior to starting treatment, then at each visit or as clinically indicated
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Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
Suggested Clinical Monitoring
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ECG; Baseline; repeat if arrhythmia suspected
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INR in patients receiving warfarin; Baseline and as clinically indicated
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Fenaux P, Giagounidis A, Selleslag D, et al. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood 2011;118(14):3765-76.
Lenalidomide drug monograph, Cancer Care Ontario.
List A, Dewald G, Bennett J, et al. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med 2006;355:1456-65.
List A, Kurtin S, Roe DJ, et al. Efficacy of lenalidomide in myelodysplastic syndromes. N Engl J Med 2005;352:549-57.
May 2022 Updated distribution program info
Regimen Abstracts
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Regimen Monographs
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