Instructions for Leqselvi (Deuruxolitinib)

1. Name:Leqselvi, Deuruxolitinib, deuterated ruxolitinib

2. Indications:

Leqselvi (Deuruxolitinib) is indicated for the treatment of adult patients with severe alopecia areata (AA).

Limitations of use: It is not recommended to use Leqselvi in combination with other JAK inhibitors, biological immunomodulators, cyclosporine or other potent immunosuppressants.

3. Usage and dosage:

1. Before treatment: Before treatment with Leqselvi, according to clinical guidelines, the patient's CYP2C9 mutation should be detected to determine the CYP2C9 genotype, active and latent tuberculosis (TB) should be evaluated, and viral hepatitis screening should be performed. Complete any necessary immunizations, including shingles vaccination, according to current immunization guidelines.

2. Recommended dose:The recommended dose of Leqselvi for the treatment of severe alopecia areata is 8 mg taken orally twice a day, which can be taken with or without food. If a dose is missed, skip the missed dose and continue at the next scheduled dose.

3. Dose adjustment: LeqselviMonitor the complete blood count regularly during treatment, and adjust the dose according to recommendations. If a patient develops a serious or opportunistic infection, interrupt treatment with Leqselvi until the infection is controlled.

4. Adverse reactions:

In clinical studies of Leqselvi, common adverse reactions include headache, acne, nasopharyngitis, elevated blood creatine phosphokinase, hyperlipidemia, fatigue, weight gain, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes.

5. Supply and storage:

Leqselviis available as8 mg tablets and can be stored at 20°C to 25°C (68°F to 77°F); excursions allowed between 15°C and 30°C (59°F and 86°F). Leqselvi should be stored in the original bottle to prevent moisture.

6. Taboo:

Leqselvi is contraindicated in patients with:

1. Patients taking moderate or severeCYP2C9 inhibitors at the same time;

2. Patients with active tuberculosis;

3. Patients with active hepatitis B or hepatitis C.

7. Mechanism of action:

Deuruxolitinib, the ingredient in Leqselvi, is a Janus kinase (JAK) inhibitor. JAKs mediate signaling of many cytokines and growth factors important for hematopoiesis and immune function. JAK signaling involves the recruitment of STATs (signal transducers and activators of transcription) to cytokine receptors, activation and subsequent localization of STATs to the nucleus, resulting in the regulation of gene expression. In the in vitro kinase activity assay, Deuruxolitinib has stronger inhibitory ability against JAK1, JAK2 and TYK2 than JAK3. The correlation between JAK enzyme inhibition and therapeutic efficacy is currently unclear.

8. Overdose:

There is no experience with overdose in humansLeqselvi. There is no specific antidote for Leqselvi overdose. Treatment should be symptomatic and supportive, and patients should be monitored for signs and symptoms of adverse reactions.

9. Special groups:

1. According to animal studies, use of Leqselvi during pregnancy may cause harm to the fetus, so pregnancy planning and prevention in women of reproductive potential need to be considered. Because of the potential for serious adverse reactions in nursing infants during treatment with Leqselvi and for 1 day after the last dose (approximately 5 to 6 elimination half-lives), women are advised not to breastfeed during treatment and for 1 day after the last dose.