Instructions for Ritlecitinib

1. Generic name: Rixitinib

Product name:Litfulo

All names: Ritlecitinib, Litfulo

2. Indications:

Ritlecitinib (Ritlecitinib) is used to treat severe alopecia areata (AA) in adults and adolescents 12 years and older.

Contraindications for use: It is not recommended to use rituxitinib in combination with other JAK inhibitors, biological immunomodulators, cyclosporine or other potent immunosuppressants.

3. Usage and dosage:

1. Before treatment: Absolute lymph count (ALC) and platelet count should be measured before the start of ritixitinib treatment and 4 weeks after the start of treatment and according to routine patient management; for latent tuberculosis patients or high-risk tuberculosis patients with negative latent tuberculosis test, preventive treatment for latent tuberculosis should be started before starting ritixitinib.

2. Recommended dose: The recommended dose of ritixitinib is 50 mg once a day, with or without food. If you accidentally miss a dose, you should take the dose as soon as possible, unless it is less than 8 hours before the next dose, in which case the missed dose should be skipped. Thereafter, resume dosing at regularly scheduled times.

3. Dose adjustment: If treatment interruption of ritexitinib is required, it is expected that temporary treatment interruption of less than 6 weeks will not result in a significant reduction in regenerated scalp hair. Treatment should be discontinued if platelet count is <50,000/mm, ALC, or <500/mm. Ritexitinib is not recommended for use in patients with hepatitis B or hepatitis C. Rituxitinib is not recommended for patients with severe hepatic impairment (ChildPugh class C).

4. Adverse reactions:

Adverse reactions greater than or equal to 1% include headache, diarrhea, acne, rash, urticaria, folliculitis, fever, atopic dermatitis, dizziness, herpes zoster, stomatitis, and common laboratory abnormalities include blood creatine phosphokinase (CPK) is elevated, the number of red blood cells is reduced, the platelet count is reduced, and liver enzymes are elevated.

5. Storage:

Ritexitinib is available in capsule form and is typically stored at 20°C to 25°C (68°F to 77°F), with a tolerance of 15°C to 30°C (59°F to 86°F), and needs to be retained in the original packaging.

6. Taboo:

Ritlecitinib is contraindicated in patients with known hypersensitivityto Ritlecitinib or any of its excipients.

7. Mechanism of action:

Ritexitinib is a kinase inhibitor. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and tyrosine kinases expressed in the hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site. In a cellular context, ritixitinib inhibits cytokine-induced STAT phosphorylation mediated by JAK3-dependent receptors. In addition, ritixitinib inhibits immune receptor signaling that is dependent on members of the TEC kinase family. It is unclear how inhibition of specific JAK or TEC family enzymes correlates with therapeutic efficacy.

8. Special groups:

According to animal experimental data, ritexitinib is present in the milk of lactating rats. Due to serious adverse reactions in adults, including the risk of serious infection and malignant tumors, women are advised not to breastfeed during treatment with ritixitinib and for approximately 14 hours after the last dose (approximately 6 elimination half-lives).