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Deuruxolitinib Phosphate

Also known as: Leqselvi

Route: Oral

Check Deuruxolitinib Phosphate Interactions →

4 interactions on record⛔ Black Box Warning

Deuruxolitinib Phosphate has 4 known drug interactions based on U.S. FDA drug labeling data. Of these, 1 are contraindicated combinations that should be avoided entirely. Notable interactions include combinations with Mao Inhibitors, Cyp3a Inducers, Deuruxolitinib. Patients taking Deuruxolitinib Phosphate 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: 4
Contraindicated: 1
Moderate: 3

Contraindicated (1)

Deuruxolitinib Phosphate + Mao Inhibitors— LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors. Concomitant use increases deuruxoli…

Moderate (3)

Deuruxolitinib Phosphate + Cyp3a Inducers— Concomitant use decreases deuruxolitinib exposure, which may reduce LEQSELVI efficacy. Avoid concomitant use.
Deuruxolitinib Phosphate + Deuruxolitinib— Deuruxolitinib is a CYP2C9 and CYP3A substrate. Concomitant use with a strong CYP3A and moderate or strong CYP2C9 induce…
Deuruxolitinib Phosphate + Strong Or Moderate Cyp3a Inducers— Concomitant use decreases deuruxolitinib exposure, which may reduce LEQSELVI efficacy. Avoid concomitant use.

Deuruxolitinib Phosphate + Mao Inhibitors⛔Contraindicated

LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors. Concomitant use increases deuruxolitinib exposure and may increase risk of serious adverse reactions such as thrombosis.

Deuruxolitinib Phosphate + Cyp3a Inducers🟡Moderate

Concomitant use decreases deuruxolitinib exposure, which may reduce LEQSELVI efficacy. Avoid concomitant use.

Deuruxolitinib Phosphate + Deuruxolitinib🟡Moderate

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 )] . Deuruxolitinib is a CYP2C9 substrate.

Deuruxolitinib Phosphate + Strong Or Moderate Cyp3a Inducers🟡Moderate

Concomitant use decreases deuruxolitinib exposure, which may reduce LEQSELVI efficacy. Avoid concomitant use.

⛔ FDA Black Box 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

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 )

Pregnancy & Breastfeeding

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 w

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.