LEQSELVI Film-coated tablet Ref.[116129] Active ingredients: Deuruxolitinib

2.1 Recommended Evaluations and Immunizations Prior to and During Treatment

Perform the following prior to treatment with LEQSELVI:

• CYP2C9 genotype determination: Test patients for CYP2C9 variants to determine CYP2C9 genotype. LEQSELVI is contraindicated in patients who are CYP2C9 poor metabolizers (patients with decreased cytochrome P450 (CYP) 2C9 function) [see Contraindications (4)]. An FDA-cleared or -approved test for the detection of CYP2C9 variants to direct the use of LEQSELVI is not currently available.
• Evaluation for use of concomitant CYP2C9 inhibitors: LEQSELVI is contraindicated in patients taking moderate or strong CYP2C9 inhibitors [see Warnings and Precautions (5.6)].
• Active and latent tuberculosis (TB) evaluation: LEQSELVI treatment is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk of TB, start preventive therapy for TB prior to LEQSELVI treatment [see Warnings and Precautions (5.1)].
• Viral hepatitis screening in accordance with clinical guidelines: LEQSELVI treatment is not recommended in patients with active hepatitis B or hepatitis C.
• Hepatitis B infection screening: If hepatitis B infection is discovered, follow hepatitis B clinical guidelines, or refer to a liver specialist. Monitor patients for reactivation in accordance with clinical guidelines during treatment [see Warnings and Precautions (5.1)].
• Complete blood count (CBC): LEQSELVI treatment is not recommended in patients with an absolute lymphocyte count (ALC) <500 cells/mm³ absolute neutrophil count (ANC) <1,000 cells/mm³, or hemoglobin level <8 g/dl. Monitor complete blood counts periodically during treatment and modify dosage as recommended [see Dosage and Administration (2.3) and Warnings and Precautions (5.8)].
• Complete any necessary immunizations, including herpes zoster vaccinations, according to current immunization guidelines prior to LEQSELVI treatment [see Warnings and Precautions (5.9)].

2.2 Recommended Dosage

The recommended dosage of LEQSELVI for the treatment of severe alopecia areata is 8 mg orally twice daily, with or without food [see Clinical Pharmacology (12.3)].

If a dose is missed, skip the missed dose and resume dosing at the next scheduled dose.

2.3 Treatment Interruption and Resumption

Serious or Opportunistic Infections

If a patient develops a serious or opportunistic infection, interrupt LEQSELVI treatment until the infection is controlled [see Warnings and Precautions (5.1)].

Hematological Abnormalities

Recommendations for LEQSELVI treatment interruption for hematologic abnormalities are described in Table 1 [see Warnings and Precautions (5.8)].

Table 1. Recommendations for LEQSELVI Treatment Interruption for Hematologic Abnormalities and Resumption:

There is no experience regarding human overdose with LEQSELVI.

There is no specific antidote for overdose with LEQSELVI. Treatment should be symptomatic and supportive and monitor patients for signs and symptoms of adverse reactions [see Adverse Reactions (6.1)].

In case of overdose, consider contacting the Poison Center at 1-800-222-1222 for latest recommendations.

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.