lenalidomide

High Alert

Transfusion-dependent anemia due to specific myelodysplastic syndromes associated with deletion 5q cytogenetic abnormality.
Multiple myeloma (in combination with dexamethasone).
Maintenance therapy in patients with multiple myeloma after autologous hematopoietic stem cell transplantation.
Mantle cell lymphoma patients whose disease has relapsed or progressed after 2 prior therapies, including bortezomib.
Previously treated follicular lymphoma (in combination with rituximab).
Previously treated marginal zone lymphoma (in combination with rituximab).

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Chronic lymphocytic leukemia (↑ risk of mortality);
Concurrent use of pembrolizumab in patients with multiple myeloma (↑ risk of mortality);
OB:
Pregnancy
;
Lactation: Lactation.

Use Cautiously in:

Renal impairment (may ↑ risk of adverse reactions; dose ↓ recommended if CCr <60 mL/min);
Patients with mantle cell lymphoma with high tumor burden, high mantle cell lymphoma International Prognostic Index at diagnosis, and high white blood cell count at baseline (↑ risk of early mortality);
Rep:
Women of reproductive potential and men with female partners of reproductive potential
;
Pedi: Safety and effectiveness not established in children;
Geri: Consider age-related ↓ in renal function in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, chest pain, DEEP VEIN THROMBOSIS (DVT), MI, palpitations

Derm: pruritus, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), dry skin, STEVENS-JOHNSON SYNDROME (SJS), sweating, TOXIC EPIDERMAL NECROLYSIS (TEN)

Endo: hyperthyroidism, hypothyroidism.

F and E: hypokalemia, hypomagnesemia

GI: abdominal pain, constipation, diarrhea, nausea, vomiting, abnormal taste, anorexia, dry mouth, HEPATOTOXICITY

Hemat: neutropenia, thrombocytopenia

MS: arthralgia, myalgia

Neuro: dizziness, fatigue, headache, depression, insomnia, STROKE

Resp: cough, pharyngitis, PULMONARY EMBOLISM (PE)

Misc: fever, tumor flare reaction, chills, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), MALIGNANCY, tumor lysis syndrome

Interactions ⬆ ⬇

Drug-drug:

Risk of neutropenia and thrombocytopenia may ↑ with antineoplastics, immunosuppressants, and radiation therapy
.
May ↑ levels and risk of toxicity of digoxin.
Erythropoeitin, darbepoeitin, and estrogens may ↑ risk of thromboembolic events.

Availability ⬆ ⬇

(Generic available)

Capsules: 2.5 mg; 5 mg; 10 mg; 15 mg; 20 mg; 25 mg

Route/Dosage ⬆ ⬇

Myelodysplastic Syndromes

PO (Adults ): 10 mg once daily.

Renal Impairment

PO (Adults ): CCr 30–60 mL/min: 5 mg once daily; CCr <30 mL/min (not on dialysis): 2.5 mg once daily; CCr <30 mL/min (requiring dialysis): 2.5 mg once daily (give after dialysis on dialysis days).

Multiple Myeloma

PO (Adults ): 25 mg once daily on Days 1–21 of repeated 28-day cycles (with dexamethasone); if patients not eligible for auto-hematopoietic stem-cell transplantation (HSCT), continue treatment until disease progression or unacceptable toxicity; for patients eligible for auto-HSCT, hematopoietic stem cell mobilization should take place within 4 cycles.

Renal Impairment

PO (Adults ): CCr 30–60 mL/min: 10 mg once daily; if patient tolerates initial dose, may ↑ to 15 mg once daily after 2 cycles; CCr <30 mL/min (not on dialysis): 15 mg every 48 hr; CCr <30 mL/min (requiring dialysis): 5 mg once daily (give after dialysis on dialysis days).

Maintenance Therapy for Multiple Myeloma Following Autologous Hematopoietic Stem Cell Transplantation

PO (Adults ): After adequate hematologic recovery (ANC ≥1000/mcL and/or platelet counts ≥75,000/mcL), initiate therapy with 10 mg once daily continuously on Days 1–28 of repeated 28-day cycles; after 3 cycles, dose may be ↑ to 15 mg once daily, if tolerated; continue treatment until disease progression or unacceptable toxicity.

Renal Impairment

PO (Adults ): CCr 30–60 mL/min: 5 mg once daily; CCr <30 mL/min (not on dialysis): 2.5 mg once daily; CCr <30 mL/min (requiring dialysis): 2.5 mg once daily (give after dialysis on dialysis days).

Mantle Cell Lymphoma

PO (Adults ): 25 mg once daily on Days 1–21 of repeated 28-day cycles; continue treatment until disease relapse or unacceptable toxicity develops.

Renal Impairment

PO (Adults ): CCr 30–60 mL/min: 10 mg once daily; CCr <30 mL/min (not on dialysis): 15 mg every 48 hr; CCr <30 mL/min (requiring dialysis): 5 mg once daily (give after dialysis on dialysis days).

Follicular Lymphoma or Marginal Zone Lymphoma

PO (Adults ): 20 mg once daily on Days 1–21 of repeated 28-day cycles for up to 12 cycles.

Renal Impairment

PO (Adults ): CCr 30–60 mL/min: 10 mg once daily; if patient tolerates initial dose, may ↑ to 15 mg once daily after 2 cycles; CCr <30 mL/min (not on dialysis): 5 mg once daily; CCr <30 mL/min (requiring dialysis): 5 mg once daily (give after dialysis on dialysis days).

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Lenalidomide is a structural analog of thalidomide.
Inhibits secretion of pro-inflammatory cytokines and increases secretion of anti-inflammatory cytokines.

Therapeutic effects:

Decreased anemia in certain myelodysplastic syndromes with a decreased requirement for transfusions.
Slowed progression of multiple myeloma and mantle cell lymphoma.
Improved progression-free survival in follicular lymphoma and marginal zone lymphoma.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: immunomodulatory agents

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed following oral administration. Levels are higher in patients with multiple myeloma.

Distribution: Unknown.

Metabolism/Excretion: 66% excreted unchanged in urine, some renal excretion involves active secretion.

Half-Life: 3 hr.

Time/Action Profile ⬆ ⬇

(↓ need for transfusions)

ROUTE	ONSET	PEAK	DURATION
PO	within 3 mo	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
Instruct patient to take missed doses as soon as remembered within 12 hr. If >12 hr, omit and return to next scheduled dose; do not administer 2 doses within 12 hr.
REMS: Instruct patient to comply with all aspects of the Lenalidomide REMS program. Inform patient that they are required to participate in a telephone survey and patient registry while taking lenalidomide. Details available at www.lenalidomiderems.com.
Advise patient to notify health care provider if signs/symptoms of thromboembolism (shortness of breath, chest pain, arm or leg swelling), infection (fever, dyspnea) or bleeding occur.
Advise patient to notify health care provider if rash, signs and symptoms of liver failure (yellow skin or eyes, dark or brown urine, upper right abdominal pain, fatigue, unusual bleeding or bruising), or hypersensitivity (swelling of lips, mouth, tongue, or throat; trouble breathing or swallowing; hives; very fast heartbeat; feeling dizzy or faint) occur.
May cause dizziness. Caution patient to avoid driving and other activities requiring alertness until response to medication is known.
Inform patient that lenalidomide may ↑ risk of death in patients with mantle cell lymphoma and may ↑ risk of new cancers.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care provider before taking any new medications.
Advise patient that they cannot donate blood during and for 1 mo following therapy and male patients cannot donate sperm while taking lenalidomide.
Rep:
May cause fetal harm. Inform women of reproductive potential that they must use one highly effective method (IUD, hormonal contraceptive, tubal ligation, vasectomy) and one additional method (latex or synthetic condom, diaphragm, cervical cap) AT THE SAME TIME for ≥4 wk before, during therapy and interruptions of therapy, and for 4 wk following discontinuation of therapy, even with a history of infertility unless due to hysterectomy or patient has been postmenopausal naturally for 24 consecutive mo. Advise patient to avoid breastfeeding during therapy. Men with female partners of reproductive potential must always use a latex or synthetic condom during therapy and for up to 4 wk following last dose, even with a successful vasectomy. Men taking lenalidomide must not donate sperm during and for 4 wk after last dose. Lenalidomide must be discontinued if pregnancy is suspected or confirmed. Suspected fetal exposure must be reported to FDA via MedWatch at 1-800-FDA-1088 and to Celgene Corporation at 1-888-423-5436. Inform women who are pregnant to enroll in the Pregnancy Exposure Registry that monitors outcomes by contacting 1-888-423-5436 or visiting www.lenalidomiderems.com.

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆