LEQSELVIL
Generic Name/API: deuruxolitinib
Manufacturer: Sun Pharmaceutical Industries, Inc by: Halo Pharmaceutical
Dosage Forms & Strength & Pack Size:
Tablets: 8 mg
Storage:
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and
86°F) [see USP Controlled Room Temperature].
Store in the original bottle to protect from moisture.
LEQSELVI (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with severe alopecia areata.
IMPORTANT SAFETY INFORMATION
Limitations of Use
LEQSELVI is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Contraindications
LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers or who are using moderate or strong CYP2C9 inhibitors.
Warnings
Serious Infections
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.
Mortality
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.
Malignancy
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.
Major Adverse Cardiovascular Events
Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients.
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