On March 27, 2023, Baricitinib tablets were officially approved by the National Medical Products Administration (NMPA) of China for the diagnosis of rheumatoid arthritis that has been diagnosed with traditional DMARDs and has decreased disease activity by less than 50% within 3-6 months.

1、 Drug name

1. Common name: Baricitinib.

Product Name: Olumiant ®。

2、 Indications

1. Used for adult patients with moderate to severe active rheumatoid arthritis who have poor efficacy or intolerance to one or more anti rheumatic drugs to improve the condition, it can be used alone or in combination with methotrexate.

2. Used for the systematic treatment of moderate to severe atopic dermatitis in children and adults aged 2 years and above.

3. Used for the treatment of severe alopecia areata in adults.

4. Used for active juvenile idiopathic arthritis, including polyarthritis, attachment associated arthritis, and juvenile psoriatic arthritis, in patients aged 2 years and older who have poor efficacy or intolerance to one or more traditional synthetic or biological anti rheumatic drugs.

3、 Specifications

Specification: Film coated tablets, specification: 1mg.

4、 Main components

1. Active ingredient: Baricitinib.

2. Auxiliary materials include: microcrystalline cellulose, cross-linked carboxymethyl cellulose sodium, magnesium stearate, mannitol, iron oxide red, soy lecithin, polyethylene glycol, polyvinyl alcohol, talcum powder, and titanium dioxide.

5、 Usage and dosage

1. Usage: Oral administration, once a day, before or after meals.

2. Recommended dose for adults: The commonly used starting dose for rheumatoid arthritis, atopic dermatitis, and alopecia areata is 4 milligrams once daily. For patients who are elderly, at risk of venous thromboembolism, at risk of major adverse cardiovascular events, at risk of malignant tumors, or have a history of chronic/recurrent infections, the recommended dose is 2 milligrams once daily.

3. Recommended dosage for children: Administer according to body weight. For those weighing 30 kilograms or more, 4 milligrams once daily; For those weighing 10 kilograms to less than 30 kilograms, take 2 milligrams once a day.

4. Children with swallowing difficulties can disperse the pills in 5-10 milliliters of room temperature water, gently stir to form a suspension, and take immediately.

6、 Dose adjustment

1. Adults with renal insufficiency: For those with a creatinine clearance rate of 30-60 milliliters per minute, the recommended dose is 2 milligrams once daily; It is not recommended to use it if the creatinine clearance rate is less than 30 milliliters per minute.

2. Children with renal insufficiency: For those with a creatinine clearance rate of 30-60 milliliters per minute, the dose should be halved.

3. Liver dysfunction: mild to moderate without adjustment; Not recommended for severe use.

4. Drug interactions: When used in combination with strong organic anion transporter 3 inhibitors (such as probenecid), the adult dose should be reduced to 2 milligrams once daily, and the pediatric dose should be halved.

5. After disease control: For patients who have achieved sustained disease control, it may be considered to reduce the dose from 4 milligrams to 2 milligrams for maintenance treatment.

7、 Medication precautions

1. It can be taken before and after meals, and taking it at a fixed time every day can help with memory.

2. If one dose is missed, it should be taken as soon as possible. If the next dose is approaching, skip the missed dose and take the next dose according to the original plan. Do not take double the dose.

3. Vomiting after taking medication should not be supplemented, wait for the next scheduled dose.

4. Children's dispersion should be taken within 4 hours after preparation.

8、 Medication for special populations

1. Pregnancy: Do not use. Women of childbearing age should take effective contraceptive measures during treatment and at least one week after discontinuing medication.

2. Breastfeeding period: It is not recommended to breastfeed.

3. Children: The safety and efficacy of patients under 2 years old have not been established. The indication for alopecia areata is not suitable for children under 18 years old.

4. Elderly individuals: Use in patients aged 65 and above may increase the risk of serious infections, cardiovascular events, and malignant tumors, and should be used when there are no other suitable treatment options available.

9、 Adverse reactions

1. Very common adverse reactions: upper respiratory tract infection, hypercholesterolemia.

2. Common adverse reactions: headache, nausea, abdominal pain, herpes simplex, urinary tract infection, shingles, rash, acne, thrombocytosis, elevated liver enzymes, elevated creatine kinase.

3. Serious risks: severe infection, venous thromboembolism, major adverse cardiovascular events, malignant tumors, gastrointestinal perforation.

10、 Contraindications

1. Do not use for individuals allergic to Baricitinib or any excipients.

2. Pregnant women are prohibited from using it.

11、 Drug interactions

1. Avoid combination use with potent immunosuppressants, other JAK inhibitors, and biological anti rheumatic drugs to improve the condition.

2. The dosage needs to be adjusted when used in combination with probenecid.

3. Avoid receiving live vaccines during use.

4. Caution should be exercised when using levamisole or teriflunomide in combination.

12、 Storage method

1. No special storage conditions are required.

2. Medicines should be stored out of reach and sight of children.

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