Abuxitinib is an oral small molecule Janus kinase (JAK) inhibitor and belongs to the class of immunomodulatory drugs.

1、 Drug name

1. Common name: Abrotinib

2. Product Name: CIBINQO ™

2、 Indications

Used for the treatment of adult refractory moderate to severe atopic dermatitis (eczema), and for those who have poor efficacy or are not suitable for other systemic drugs (including biologics).

3、 Specifications and characteristics

100 milligrams, tablets

4、 Main components

1. Active ingredient: Abuxitinib (50/100/200 mg/tablet).

2. Auxiliary materials include: anhydrous calcium hydrogen phosphate, hydroxypropyl methylcellulose, iron oxide red, etc.

5、 Usage and dosage

1. Recommended dosage: 100mg once daily orally. If the therapeutic effect is insufficient after 12 weeks, it can be increased to 200mg once daily.

2. Omission treatment: If missed, make up for it within 12 hours; Skip after 12 hours and take the next dose according to the original plan.

3. Diet: Can be taken with food or on an empty stomach.

6、 Dose adjustment

1. Renal insufficiency: Moderate (eGFR 30-59mL/min) reduced to 50mg once daily, severe (eGFR<30mL/min) contraindicated.

2. CYP2C19 slow metabolizers: reduce to 50 milligrams once daily.

3. Combination use of strong CYP2C19 inhibitors: reduce to 50 milligrams once daily.

4. Hematological abnormalities: Platelets<50000/mm ³ or neutrophils<1000/mm ³ require medication suspension.

7、 Medication precautions

1. Infection monitoring: tuberculosis, hepatitis B/C should be screened before treatment, and herpes zoster and other opportunistic infections should be warned during treatment.

2. Vaccination: Avoid using live vaccines and complete recommended immunization before treatment.

3. Laboratory monitoring: Blood routine, liver function, and blood lipids need to 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 one day after the last dose.

3. Elderly people (≥ 65 years old): No need to adjust dosage, but increased risk of infection and thrombosis.

9、 Adverse reactions

1. Common (≥ 1%) conditions include: nasopharyngitis (12.4%), nausea (14.5%), headache (7.8%), herpes simplex (4.2%), and thrombocytopenia (1.5%).

2. Serious adverse reactions include: severe infection (2.3/100 person years), thrombosis (0.3/100 person years), and malignant tumors (0.5/100 person years).

10、 Contraindications

1. It is contraindicated for individuals who are allergic to Abu Xitinib or its excipients.

2. Combination therapy with antiplatelet drugs is prohibited for the first 3 months of treatment (except for low-dose aspirin ≤ 81mg/day).

11、 Drug interactions

1. Strong CYP2C19 inhibitors (such as fluvoxamine): should be reduced to 50 milligrams once daily.

2. Strong CYP2C19/CYP2C9 inducers (such as rifampicin): Avoid combination therapy.

3. P-gp substrates (such as digoxin): Blood drug concentration needs to be monitored.

12、 Storage method

1. Store in original bottle, moisture-proof.

2. Store at room temperature (20-25 ℃) and allow short-term storage at 15-30 ℃.

Abrocitinibinformation