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As a selective Janus kinase (JAK) inhibitor, ritexitinib mainly regulates immune responses by inhibiting the activity of JAK1 and JAK3, providing new ideas for the treatment of various autoimmune diseases.
1. Generic name: Ritlecitinib
2. Trade name: LITFULO™
It is used to treat severe alopecia areata (including alopecia totalis and alopecia universalis) in adolescents and adults aged 12 years and above. Combination with other JAK inhibitors, biological immunomodulators, cyclosporine or other potent immunosuppressants is not recommended.
50 mg, capsules
1. Active ingredient: Ritexitinib tosylate (each capsule contains 50 mg of ritexitinib, equivalent to 80.13 mg of tosylate).
2. Excipients include: Crospovidone, glycerol dibehenate, lactose monohydrate, etc.
1. Recommended dosage: Take 50 mg orally once a day, with food or on an empty stomach.
2. Treatment of missed doses: If you miss a dose, you can take it within 8 hours. If it exceeds 8 hours, skip the dose.
3. Vomiting treatment: Take the same dose as soon as possible after vomiting.
1. Hematological abnormalities: Platelets <50,000/mm³ require permanent discontinuation of medication; lymphocytes <500/mm³ require suspension of medication until recovery.
2. Elevated liver enzymes: If ALT/AST ≥ 5 times ULN, medication needs to be suspended until drug-induced liver injury is ruled out.
3. Pancreatitis: If abdominal pain occurs, medication must be suspended and evaluated.
1. Infection monitoring: Screening for tuberculosis and hepatitis B/C is required before treatment, and vigilance for opportunistic infections such as herpes zoster during treatment.
2. Vaccination: Avoid the use of live vaccines, and complete all recommended immunizations before treatment.
3. Laboratory monitoring: Blood routine and liver function need to be monitored at baseline and after 4 weeks of treatment.
1. Pregnancy: Contraindicated. Effective contraception is required during treatment and 1 week after discontinuation of medication.
2. Lactation period: Breastfeeding is prohibited during treatment and 14 hours after the last dose.
3. Liver insufficiency: Contraindicated in patients with severe liver damage (Child-PughC).
4. The elderly (≥65 years old): No dose adjustment is required, but caution is required due to the increased risk of infection.
1. Common (≥1%) include:Headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%).
2. Serious adverse reactions include: Infection (0.66/100 person-years), malignant tumors (0.37/100 person-years), and pulmonary embolism (0.06/100 person-years).
It is prohibited for those allergic to ritexitinib or its excipients.
1. CYP3A inhibitors: May increase the exposure of ritexitinib, and adverse reactions need to be monitored.
2. Strong CYP3A inducers (such as rifampicin): Combination use is prohibited as it may reduce efficacy.
3. CYP1A2 substrate: The dosage of combined drugs needs to be adjusted.
Keep in original bottle with built-in desiccant. Store at room temperature (20-25℃), short-term storage at 15-30℃ is allowed.