All Names: ritlecitinib、Litfulo、利特昔替尼、乐复诺
Indications:Suitable for adults and adolescents aged 12 and above with severe alopecia areata
Manufacturer:LUCIUS PHARMACEUTICAL (LAOS) CO., LTD
Customs Clearance Procedure:If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
As a selective Janus kinase (JAK) inhibitor, rituximab mainly regulates immune response by inhibiting the activity of JAK1 and JAK3, providing a new approach for the treatment of various autoimmune diseases.
1、 Drug name
1. Common name: Ritlecitinib
2. Product Name: LITFULO ™
2、 Indications
Used to treat severe alopecia areata (including alopecia areata and alopecia areata) in adolescents and adults aged 12 and above. Not recommended for combination with other JAK inhibitors, biological immunomodulators, cyclosporine, or other potent immunosuppressants.
3、 Specifications and characteristics
50mg, capsule
4、 Main components
1. Active ingredient: Litaxitinib tosylate (each pill contains 50 milligrams of Litaxitinib, equivalent to 80.13 milligrams of tosylate).
2. Auxiliary materials include: cross-linked polyvinylpyrrolidone, glyceryl diester, lactose monohydrate, etc.
5、 Usage and dosage
1. Recommended dosage: Take 50 milligrams orally once a day, which can be taken with food or on an empty stomach.
2. Omission treatment: If missed, it can be supplemented within 8 hours, and if it exceeds 8 hours, the dose will be skipped.
3. Vomiting treatment: Take the same dose as soon as possible after vomiting.
6、 Dose adjustment
1. Hematological abnormalities: Platelets<50000/mm ³ require permanent discontinuation of medication; If the lymphocyte count is less than 500/mm ³, medication should be suspended until recovery is achieved.
2. Elevated liver enzymes: ALT/AST ≥ 5 times ULN, medication should be suspended until drug-induced liver injury is ruled out.
3. Pancreatitis: If abdominal pain occurs, medication should be suspended and evaluated.
7、 Medication precautions
1. Infection monitoring: tuberculosis, hepatitis B/C should be screened before treatment, and be alert to herpes zoster and other opportunistic infections during treatment.
2. Vaccination: Avoid using live vaccines and complete all recommended immunizations before treatment.
3. Laboratory monitoring: Blood routine and liver function should be monitored at baseline and after 4 weeks of treatment.
8、 Medication for special populations
1. Pregnancy: Prohibited, effective contraception is required during treatment and one week after discontinuation.
2. Breastfeeding period: Breastfeeding is prohibited during the treatment period and 14 hours after the last dose.
3. Liver dysfunction: Not recommended for patients with severe liver injury (Child Pugh C).
4. Elderly people (≥ 65 years old): No dose adjustment is required, but caution is needed to increase the risk of infection.
9、 Adverse reactions
1. Common (≥ 1%) symptoms 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).
10、 Contraindications
It is contraindicated for individuals allergic to rituximab or its excipients.
11、 Drug interactions
1. CYP3A inhibitors: may increase exposure to rituximab and require monitoring for adverse reactions.
2. Strong CYP3A inducers (such as rifampicin): Combination use is prohibited as it may reduce efficacy.
3. CYP1A2 substrate: The dosage of the combination drug needs to be adjusted.
12、 Storage method
Store in original bottle with built-in desiccant. Store at room temperature (20-25 ℃) and allow short-term storage at 15-30 ℃.
Ritlecitinibinformation