Deuruxolitinib
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Boxed warning
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS Increased risk of serious bacterial, fungal, viral and opportunistic infections, including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. LEQSELVI treatment is not recommended in patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death, was observed with another Janus kinase (JAK) inhibitor vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies were reported in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers was observed with another JAK inhibitor vs. TNF blockers in RA patients. ( 5.3 ) Higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke) was observed with another JAK inhibitor vs. TNF blockers in RA patients.
( 5.4 ) Thrombosis, including cerebral venous sinus thrombosis (CVT), deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with LEQSELVI. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers. ( 5.5 ) WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE) and THROMBOSIS See full prescribing information for complete boxed warning. Increased risk of serious bacterial, fungal, viral and opportunistic infections including tuberculosis (TB), that may lead to hospitalization or death.
Interrupt treatment with LEQSELVI if a serious infection occurs until the infection is controlled. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test. ( 5.1 ) Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. LEQSELVI is not approved for use in RA patients. ( 5.2 ) Malignancies have occurred in patients treated with LEQSELVI. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.
( 5.3 ) Higher rate of…
Janus Kinase Inhibitor
Dosing in kidney impairment
Renal Impairment LEQSELVI is not recommended for use in patients with severe renal impairment or end-stage renal disease (eGFR < 30 ml/min). No adjustment of dosage is required in patients with mild or moderate renal impairment. The effect of severe renal impairment on deuruxolitinib pharmacokinetics is unknown [see Clinical Pharmacology] .
Dosing in liver impairment
Hepatic Impairment LEQSELVI is not recommended for use in patients with severe hepatic impairment (Child Pugh C). No adjustment of dosage is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. The effect of severe hepatic impairment on deuruxolitinib pharmacokinetics is unknown [see Clinical Pharmacology] .
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- Deuruxolitinib
Label text (2 paragraphs)
Effect of Other Drugs on LEQSELVI Strong CYP3A and moderate or strong CYP2C9 inducers: Avoid concomitant use of LEQSELVI with strong CYP3A and moderate or strong CYP2C9 inducers. Deuruxolitinib is a CYP2C9 and CYP3A substrate. Concomitant use with a strong CYP3A and moderate or strong CYP2C9 inducer decreases deuruxolitinib exposure (C max and AUC), which may reduce LEQSELVI efficacy [see Clinical Pharmacology ( 12.3 )] . Moderate or strong CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Contraindications ( 4 )] . Deuruxolitinib is a CYP2C9 substrate.
Concomitant use with a moderate or strong CYP2C9 inhibitor is estimated to increase deuruxolitinib exposure (C max and AUC), which may increase the risk of LEQSELVI serious adverse reactions such as thrombosis [see Clinical Pharmacology ( 12.3 )] . Strong CYP3A4 and moderate or strong CYP2C9 inducers: Avoid concomitant use. ( 7 ) Moderate or strong CYP2C9 inhibitors: Contraindicated. ( 7 )
Contraindications
4 CONTRAINDICATIONS LEQSELVI is contraindicated in patients who: Are CYP2C9 poor metabolizers [see Warnings and Precautions ( 5.6 )] . Are on concomitant moderate or strong CYP2C9 inhibitors [see Warnings and Precautions ( 5.6 )] . LEQSELVI is contraindicated in patients: Who are CYP2C9 poor metabolizers. ( 4 ) Using moderate or strong CYP2C9 inhibitors. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unlikely cause of idiosyncratic clinically apparent liver injury but is a potential cause of reactivation of hepatitis B.
Deuruxolitinib is an orally available small molecule inhibitor of Janus kinases that is used to treat severe alopecia areata. Deuruxolitinib is associated with a low rate of transient and usually mild elevations in serum aminotransferase levels during therapy but has not been linked to cases of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on the findings from animal reproduction studies, deuruxolitinib may cause fetal harm during pregnancy. Available data from pregnancies reported in clinical trials with LEQSELVI are not sufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of deuruxolitinib to pregnant rats during the period of organogenesis at a dose 4.8 times the maximum recommended human dose (MRHD) resulted in reduced fetal weight and increased skeletal malformation.
Oral administration of deuruxolitinib to pregnant rabbits during the period of organogenesis at a dose 0.3 times the MRHD resulted in maternal toxicity, reduced fetal weight, and increased post-implantation loss. Oral administration of deuruxolitinib to pregnant rats during pregnancy and lactation periods at a dose 5 times the MRHD resulted in maternal toxicity, decreased pup survival, and adverse effects on postnatal development (see Data ) . Advise pregnant women of the potential risk to a fetus. The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects is 2 to 4% of the general population and miscarriage occurs in 15 to 20% of clinically recognized pregnancies. Data Animal Data In an embryo-fetal development study, deuruxolitinib was administered to pregnant rats during the period of organogenesis at oral doses of 15, 30, and 60 mg/kg/day. Reduced fetal weight and increased fetal skeletal malformation were noted at 60 mg/kg/day (4.8 times the MRHD based on AUC comparison) with no maternal toxicity. No embryo-fetal toxicity was observed at doses up to 30 mg/kg/day (equivalent to MRHD based on AUC comparison).
In another embryo-fetal development study, deuruxolitinib was administered to pregnant rabbits during the period of organogenesis at oral doses of 6, 30, and 60 mg/kg/day. Reduced fetal weight and increased post-implantation loss were noted at 60 mg/kg/day (0.3 times the MRHD based on AUC comparison), at which maternal toxicity was observed. No embryo-fetal toxicity was noted at doses up to 30 mg/kg/day (0.05 times the MRHD based on AUC comparison). In a pre- and postnatal development study in rats, deuruxolitinib was administered to pregnant rats during pregnancy and lactation periods at oral doses of 15, 30, and 75 mg/kg/day. Decreases in liveborn…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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Therapeutic equivalence (Orange Book)
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