Revlimid (lenalidomide)

If angioedema, anaphylaxis, grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic reaction occurs, lenalidomide therapy should be permanently discontinued. (See Hypersensitivity Reactions and also Cutaneous Reactions under Cautions.)

If grade 3 or 4 nonhematologic toxicities occur, temporarily interrupt lenalidomide therapy; when the toxicity resolves or improves to grade 2 or less, lenalidomide therapy may be resumed at the next lower dosage level.

Lenalidomide capsules should be administered orally with water, with or without food, once daily. The capsules should be swallowed intact and should not be broken, chewed, or opened.

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No dosing information is available for this tab.

Lenalidomide does not inhibit or induce cytochrome P-450 (CYP) isoenzymes in vitro.

Lenalidomide does not inhibit P-glycoprotein (P-gp), bile salt export pump (BSEP), breast cancer resistance protein (BCRP), multidrug resistance-associated protein (MRP) 2, organic anion transporter (OAT) 1 or 3, organic anion transport protein (OATP) 1B1 or 1B3, or organic cation transporter (OCT) 2.

Lenalidomide is a substrate, but not an inhibitor, of P-gp.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Lenalidomide is contraindicated in women who are pregnant. The drug should be used in women of childbearing potential only when alternative therapies are not available and adequate precautions are taken to avoid pregnancy. (See REMS under Dosage and Administration and also see Fetal/Neonatal Morbidity and Mortality under Cautions.)

*Lenalidomide is contraindicated in patients with known hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)) to the drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects reported in at least 20% of patients with multiple myeloma receiving lenalidomide include diarrhea, fatigue, anemia, constipation, neutropenia, leukopenia, peripheral edema, insomnia, muscle cramp/spasms, abdominal pain, back pain, nausea, asthenia, pyrexia, upper respiratory tract infection, bronchitis, nasopharyngitis, gastroenteritis, cough, rash, dyspnea, dizziness, decreased appetite, thrombocytopenia, and tremor.

Adverse effects reported in more than 15% of patients with MDS receiving lenalidomide include thrombocytopenia, neutropenia, diarrhea, pruritus, rash, fatigue, constipation, nausea, nasopharyngitis, arthralgia, pyrexia, back pain, peripheral edema, cough, dizziness, headache, muscle cramp, dyspnea, pharyngitis, and epistaxis.

Adverse effects reported in at least 15% of patients with mantle cell lymphoma, follicular lymphoma, or marginal-zone lymphoma receiving lenalidomide include neutropenia, thrombocytopenia, anemia, leukopenia, diarrhea, constipation, nausea, fatigue, pyrexia, cough, upper respiratory tract infection, and rash.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

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Safety and efficacy of lenalidomide have not been established in pediatric patients.

Lenalidomide is a thalidomide analog and is contraindicated for use during pregnancy. (See REMS under Dosage and Administration and also see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Not known whether lenalidomide is distributed into human milk; discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Because lenalidomide is excreted substantially by the kidneys and geriatric patients are more likely to have decreased renal function, careful dosage selection and monitoring of renal function are advised in such patients.

In clinical trials of lenalidomide in patients with newly diagnosed multiple myeloma, 94% of patients were 65 years of age or older and 35% of patients were over 75 years of age. Overall, patients over 75 years of age experienced more adverse reactions (including serious adverse reactions) than younger adults regardless of treatment arm.

In clinical trials evaluating maintenance therapy with lenalidomide in patients with multiple myeloma, 10% of patients were 65 years of age or older and no patients were over 75 years of age. Grade 3 or 4 adverse reactions occurred more frequently in patients 65 years of age or older receiving lenalidomide maintenance therapy than in younger patients. Experience in patients 65 years of age or older receiving lenalidomide maintenance therapy is insufficient to determine whether they respond differently to the drug than younger adults.

In clinical trials in patients with previously treated multiple myeloma, 45% of patients were 65 years of age or older and 12% patients were over 75 years of age. In the studies of previously treated patients, deep-vein thrombosis (DVT), pulmonary embolism (PE), atrial fibrillation, and renal failure were more common in patients over 65 years of age than younger adults treated with lenalidomide.

In clinical trials in patients with MDS or mantle cell lymphoma, 38 or 63% of patients, respectively, were 65 years of age or older. In patients with MDS or mantle cell lymphoma, 33 or 22% of patients, respectively, were 75 years of age or older. All patients with MDS experienced an adverse reaction; however, the frequency of serious adverse reactions was higher in patients over 65 years of age (54%) compared with younger adults (33%). In patients with mantle cell lymphoma, the frequency of overall adverse events was similar among patients over 65 years of age than in younger patients; however, serious adverse reactions were more common among patients over 65 years than in younger patients (55% versus 41%).

In clinical trials in patients with follicular lymphoma or marginal-zone lymphoma, 48% of patients were 65 years of age or older and 14% patients were over 75 years of age. The overall frequency of adverse reactions was 98% in both patients 65 years of age or older and younger adults. Serious adverse reactions were higher among lenalidomide-treated patients 65 years of age or older versus younger adults (37% versus 18%).