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Lenalidomide

Also known as: Lenalidomide

Thalidomide Analog

Route: Oral

6 interactions on record⛔ Black Box Warning

Lenalidomide has 6 known drug interactions based on U.S. FDA drug labeling data. 3 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Erythropoietic Agents, Estrogens, Follitropin. Patients taking Lenalidomide should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 6
Major: 3
Moderate: 2

Major (3)

Lenalidomide + Erythropoietic Agents— Concomitant use with lenalidomide may increase the risk of thrombosis. Should be used with caution after benefit-risk as…
Lenalidomide + Estrogens— Concomitant use with lenalidomide may increase the risk of thrombosis. Use with caution after benefit-risk assessment.
Lenalidomide + Follitropin— Concomitant use with lenalidomide may increase the risk of thrombosis. Use with caution after benefit-risk assessment.

Moderate (2)

Lenalidomide + Digoxin— Lenalidomide increases digoxin Cmax and AUC by 14%. Periodically monitor digoxin plasma levels during concomitant admini…
Lenalidomide + Warfarin— No effect on pharmacokinetics of lenalidomide or warfarin, but close monitoring of PT and INR is recommended in patients…

Lenalidomide + Erythropoietic Agents⚠️Major

Concomitant use with lenalidomide may increase the risk of thrombosis. Should be used with caution after benefit-risk assessment.

Lenalidomide + Estrogens⚠️Major

Concomitant use with lenalidomide may increase the risk of thrombosis. Use with caution after benefit-risk assessment.

Lenalidomide + Follitropin⚠️Major

Concomitant use with lenalidomide may increase the risk of thrombosis. Use with caution after benefit-risk assessment.

Lenalidomide + Digoxin🟡Moderate

Lenalidomide increases digoxin Cmax and AUC by 14%. Periodically monitor digoxin plasma levels during concomitant administration.

Lenalidomide + Warfarin🟡Moderate

No effect on pharmacokinetics of lenalidomide or warfarin, but close monitoring of PT and INR is recommended in patients taking concomitant warfarin.

Lenalidomide + Elotuzumabℹ️Unknown

7 DRUG INTERACTIONS 7.1 Drug Interactions For important drug interactions involving lenalidomide, pomalidomide and dexamethasone, refer to their respective prescribing information.

⛔ FDA Black Box Warning

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM Embryo-Fetal Toxicity: Do not use lenalidomide capsules during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting lenalidomide capsule treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after lenalidomide capsule treatment [see Warnings and Precautions (5.1) , and Medication Guide (17) ] . To avoid embryo-fetal exposure to lenalidomide, lenalidomide capsules are only available through a restricted distribution program, the Lenalidomide REMS program (5.2). Information about the Lenalidomide REMS program is available at www.lenalidomiderems.com or by calling the REMS Call Center 1-888-423-5436. Hematologic Toxicity (Neutropenia and Thrombocytopenia): Lenalidomide capsules can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second 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 have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors [see Error! Hyperlink reference not valid. ] . Venous and Arterial Thromboembolism: Lenalidomide capsules have demonstrated a significantly increase

Contraindications

4 CONTRAINDICATIONS • Pregnancy ( Boxed Warning , 4.1 , 5.1 , 8.1 ). • Demonstrated severe hypersensitivity to lenalidomide ( 4.2 , 5.9 , 5.15 ). 4.1 Pregnancy Lenalidomide capsules can cause fetal harm when administered to a pregnant female. Limb abnormalities were seen in the offspring of monkeys that were dosed with lenalidomide during organogenesis. This effect was seen at all doses tested. Due to the results of this developmental monkey study, and lenalidomide’s structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see Boxed Warning ] . If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus [see Warnings and Precautions (5.1 , 5.2) , Use in Special Populations (8.1 , 8.3) ] . 4.2 Severe Hypersensitivity Reactions Lenalidomide capsules are contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide [see Warnings and Precautions (5.9 , 5.15) ] .

Pregnancy & Breastfeeding

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in females exposed to lenalidomide capsules during pregnancy as well as female partners of male patients who are exposed to lenalidomide capsules. 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 REMS Call Center at 1-888-423-5436. Risk Summary Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings from animal studies [see Data ] , lenalidomide capsules can cause embryo-fetal harm when administered to a pregnant female and are contraindicated during pregnancy [see Boxed Warning , Contraindications (4.1) , and Use in Specific Populations (5.1) ] . Lenalidomide capsules are a 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), hypoplasticity of the bones, absence of bones, external ear abnormalities (including anotia, micropinna, small or absent external auditory canals), facial palsy, eye abnormalities (anophthalmos, microphthalmos), and congenital heart defects. Alimentary tract, urinary tract, and genital malformations have also been documented and mortality at or shortly after birth has been reported in about 40% of infants. Lenalidomide caused thalidomide-type limb defects in monkey offspring. Lenalidomide crossed the placenta after administration to pregnant rabbits and pregnant rats [see Data ] . If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus. If pregnancy does occur during treatment, immediately discontinue the drug. Under these conditions, refer patient to an obstetrician/gynecologist experienced in reproductive toxicity for furt

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.