Iberdomide
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM EMBRYO-FETAL TOXICITY ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans. In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment [ Contraindications (4) , see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] .
Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS treatment [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ] . Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS REMS [see Warnings and Precautions (5.2) ] . Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436.
SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS with daratumumab and hyaluronidase-fihj and dexamethasone. Anti-thrombotic prophylaxis is recommended [see Warnings and Precautions (5.3) ] . WARNING: EMBRYO-FETAL TOXICITY and SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO-FETAL TOXICITY • ZENBEXUS is contraindicated in pregnancy. ZENBEXUS is embryo-fetal toxic in animals and can cause birth defects or embryo-fetal death in humans.
In females of reproductive potential, obtain 2 negative pregnancy tests before starting ZENBEXUS treatment. (4 , 5.1 , 8.1 , 8.3) • Females of reproductive potential must use 2 effective forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after last dose of ZENBEXUS. (4 , 5.1 , 8.1 , 8.3) • Because of the risk of embryo-fetal toxicity, ZENBEXUS is only available through a restricted distribution program called ZENBEXUS Risk Evaluation and Mitigation Strategy (REMS). (5.2) Information about ZENBEXUS REMS is available at www.ZENBEXUSREMS.com or by calling the REMS Call Center at 1-888-423-5436.
SERIOUS VENOUS AND ARTERIAL THROMBOEMBOLISM • Increased risk of deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke in patients with multiple myeloma receiving ZENBEXUS. Anti-thrombotic prophylaxis is…
Dosing in kidney impairment
Recommended Dosage in Patients with Renal Impairment In patients with eGFR less than 30 mL/min/1.73 m 2 not receiving dialysis, reduce ZENBEXUS dose to 0.75 mg once daily on Days 1 to 21 of a 28-day cycle. If dose modification is needed due to adverse events, reduce ZENBEXUS dose to 1 mg every other day on Days 1 to 21 of a 28-day cycle.
In patients with eGFR greater than 30 mL/min/1.73 m 2 or eGFR less than 30 mL/min/1.73 m 2 receiving intermittent hemodialysis, no dose adjustment is recommended [see Use in Specific Populations and Clinical Pharmacology ] .
Preparation and administration
Pregnancy Testing Prior to Administration Females of reproductive potential must have negative pregnancy testing and use effective contraception methods before initiating ZENBEXUS [see Warnings and Precautions and Use in Specific Populations ] .
Administration ZENBEXUS is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Take ZENBEXUS at approximately the same time each day with or without food [see Clinical Pharmacology ] . Swallow ZENBEXUS capsules whole with water. Do not open, break, or chew the capsules. Direct contact with the capsule contents should be avoided.
In case of capsule breakage, avoid raising dust during clean-up. If contact occurs, wash thoroughly with soap and water. Delayed or Missed Doses If a dose is missed and it has been less than 12 hours since the missed dose, take the missed dose as soon as possible. If it has been more than 12 hours since the missed dose, skip the missed dose.
Do not double the next dose.
Drug interactions
Check iberdomide against a medication listLabel text (3 paragraphs)
7 DRUG INTERACTIONS • Strong or moderate CYP3A inhibitors: Avoid concomitant use with ZENBEXUS or, if concomitant use is unavoidable, reduce dose. (2.3 , 7.1) • Strong or moderate CYP3A inducers: Avoid concomitant use with ZENBEXUS. (7.1)
7.1 Effects of Other Drugs on ZENBEXUS Strong or Moderate CYP3A Inhibitors Avoid concomitant use of strong or moderate CYP3A inhibitors with ZENBEXUS. If concomitant use cannot be avoided, reduce ZENBEXUS dose [see Dosage and Administration (2.4) ] . Iberdomide is primarily metabolized by CYP3A. Concomitant use with strong or moderate CYP3A inhibitors increases iberdomide exposure [see Clinical Pharmacology (12.3) ] , which may increase the risk of adverse reactions. Strong or Moderate CYP3A Inducers Avoid concomitant use of strong or moderate CYP3A inducers with ZENBEXUS. Iberdomide is primarily metabolized by CYP3A.
Concomitant use with a strong or moderate CYP3A inducer decreases iberdomide exposure [see Clinical Pharmacology (12.3) ] , which may decrease efficacy.
Contraindications
Based on the mechanism of action [see Clinical Pharmacology (12.1) ] and findings in animal studies, ZENBEXUS can cause birth defects or embryo-fetal death in humans [see Boxed Warning , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ] . ZENBEXUS is contraindicated in females who are pregnant. Iberdomide causes adverse developmental outcomes in both rats and rabbits when administered during the period of organogenesis. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be informed of the potential hazard to a fetus. • Pregnancy (Boxed Warning , 4 , 5.1 , 8.1)
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors outcomes in patients exposed to ZENBEXUS during pregnancy. Report any suspected fetal exposure to ZENBEXUS to the FDA via the MedWatch program at 1-800-FDA-1088 and 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, ZENBEXUS can cause birth defects or embryo-fetal death in humans when administered to a pregnant female and is contraindicated during pregnancy [see Boxed Warning , Contraindications (4) , and Warnings and Precautions (5.1) ] .
ZENBEXUS has a shared mechanism of action with thalidomide. 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.
There are no available data on the use of ZENBEXUS in pregnant women to evaluate for drug associated risk. Oral administration of iberdomide in pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes including embryo-fetal mortality, alterations to growth, and structural abnormalities. Iberdomide crossed the placenta after administration to pregnant rats and rabbits (see Data) . Advise patients 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 further evaluation and counseling. Report any suspected fetal exposure to ZENBEXUS to the REMS Call Center at 1-888-423-5436. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Iberdomide caused adverse developmental outcomes in both rats and rabbits in the embryo-fetal developmental studies when administered during the period of organogenesis. Pregnant rats were administered oral doses of 0.6, 50, or 300 mg/kg/day.
At 300 mg/kg/day, adverse effects included increased post-implantation loss, fetal…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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