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Ritlecitinib

Brand: 老挝大熊
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Rituxitinib modulates abnormal activity of the immune system by intervening in specific signaling pathways, thereby helping to restore hair growth in affected areas.

1. Drug name

1. Generic name: Ritlecitinib

2. Trade name: LITFULO™

2. Indications

Ritlecitinib is a kinase inhibitor suitable for the treatment of severe alopecia areata (Alopecia Areata) in adults and adolescents aged 12 years and above.

3. Specifications and properties

This product is a capsule, each capsule contains 50 mg of ritexitinib (80.13 mg based on ritexitinib tocetate).

IV. Main ingredients

1. Active ingredient:Ritlecitinib

2. Excipients: Crospovidone, glycerol dibehenate, lactose monohydrate, microcrystalline cellulose, hypromellose (HPMC) capsule shell, bright blue FCF, titanium dioxide, iron oxide yellow, etc.

V. Usage and Dosage

1. The recommended dose is 50mg orally taken once a day, which can be taken with food or on an empty stomach. Tablets should be swallowed whole and not crushed, broken or chewed.

2. If you miss a dose, you should take it as soon as possible. If it is less than 8 hours before the next dose, skip the dose and take the next dose according to the original plan.

VI. Dose adjustment

1. Hepatic insufficiency: Patients with mild or moderate hepatic insufficiency do not need to adjust the dose; patients with severe hepatic insufficiency (Child-Pugh C grade) are not recommended for use.

2. Renal insufficiency: No dose adjustment is required in patients with mild to moderate renal insufficiency; patients with severe renal insufficiency or end-stage renal disease have not been studied.

3. Laboratory abnormalities:

(1) If the platelet count is <50,000/mm³, the treatment should be discontinued;

(2) If the absolute lymphocyte count (ALC) is <500/mm³, the treatment should be interrupted and restarted after recovery.

7. Medication Precautions

1. Before/after meals: It can be taken with food or on an empty stomach. Food has no significant effect on absorption.

2. Missed dose: Take it as soon as possible. If it is less than 8 hours before the next dose, skip it.

3. Vomiting: If you vomit after taking the medicine, it is not recommended to take another dose. You should take the next dose as originally planned.

4. Others: Tuberculosis screening, viral hepatitis screening, routine blood tests, etc. are required before treatment.

8. Medication for special groups

1. Pregnant women: There is not enough data yet. Animal experiments show fetal toxicity. It is recommended to report pregnancy status.

2. Breastfeeding: Breastfeeding is not recommended, and breastfeeding should not be done within 14 hours after stopping the drug.

3. Children: It is safe and effective for patients 12 years old and above, but there is insufficient data for patients under 12 years old.

4. Elderly people: There is no need to adjust the dose, but the risk of infection is high and caution is required.

9. Adverse reactions

1. Common adverse reactions (incidence ≥1%) include:Headache, diarrhea, acne, rash, urticaria, folliculitis, fever, atopic dermatitis, dizziness, increased blood creatine phosphokinase, herpes zoster, decreased red blood cell count, stomatitis, etc.

2. Serious adverse reactions include: Serious infection, malignant tumors, cardiovascular events, thrombosis, allergic reactions, etc.

10. Contraindications

It is prohibited for those allergic to ritexitinib or any of its excipients.

11. Drug interactions

1. Ritexitinib can inhibit CYP3A and CYP1A2. When used together, it is necessary to monitor the plasma concentration of related substrate drugs (such as certain antiarrhythmic drugs, antidepressants, etc.) and adjust the dose if necessary.

2. Avoid co-administration with strong CYP3A inducers (such as rifampicin), which may lead to a decrease in the plasma concentration of ritixitinib.

12. Storage method

Store at 20°C to 25°C (68°F to 77°F), short-distance transport allowed between 15°C to 30°C (59°F to 86°F). Keep the original packaging to prevent children from accidentally ingesting the desiccant.