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On March 27, 2023, Baricitinib tablets (Baricitinib) were officially approved by the National Medical Products Administration (NMPA) of China for use in patients with clearly diagnosed rheumatoid arthritis who have received traditional DMARDs and whose disease activity has decreased by less than 50% in 3-6 months.
1. Generic name: baricitinib.
2. Trade name: Olumiant®.
1. It is used for adult patients with moderate to severe active rheumatoid arthritis who are ineffective or intolerant to one or more disease-improving anti-rheumatic drugs. It can be used alone or in combination with methotrexate.
2. For the systemic 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. For active juvenile idiopathic arthritis, including polyarticular type, enthesitis-related arthritis and juvenile psoriatic arthritis in patients 2 years and older who have had poor response to or are intolerant to one or more traditional synthetic or biological disease-modifying antirheumatic drugs.
Specifications: film-coated tablets, specifications: 1 mg.
1. Active ingredient: baricitinib.
2. Excipients include: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, mannitol, iron oxide red, soy lecithin, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.
1. Usage: Take orally, once a day, before or after a meal.
2. Recommended dose for adults: The common starting dose for rheumatoid arthritis, atopic dermatitis, and alopecia areata is 4 mg once a day. For patients who are elderly, at risk for venous thromboembolism, at risk for major adverse cardiovascular events, at risk for malignancy, or with a history of chronic/recurrent infections, the recommended dose is 2 mg once daily.
3. Recommended dosage for children: Dosage according to body weight. For those weighing 30 kg and above, 4 mg once a day; for those weighing 10 kg to less than 30 kg, 2 mg once a day.
4. Children with difficulty swallowing can disperse the tablets in 5-10 ml of room temperature water, stir gently to form a suspension and take it immediately.
1. Adults with renal insufficiency: For those with a creatinine clearance rate of 30-60 ml/min, the recommended dose is 2 mg once a day; for those with a creatinine clearance rate below 30 ml/min, it is not recommended.
2. Children with renal insufficiency: For those with a creatinine clearance rate of 30-60 ml/min, the dose should be halved.
3. Liver insufficiency: Mild to moderate, no adjustment is required; severe, not recommended.
4. Drug interactions: When combined with strong organic anion transporter 3 inhibitors (such as probenecid), the adult dose should be reduced to 2 mg once a day, and the pediatric dose should be halved.
5. After disease control: For patients who have achieved sustained disease control, the dose can be considered to be reduced from 4 mg to 2 mg for maintenance treatment.
1. It can be taken before or after meals. Taking it at a fixed time every day can help memory.
2. If you miss a dose, you should take it as soon as possible. If it is near the time of your next dose, skip the missed dose and take the next dose as originally planned. You should not take a double dose.
3. If you vomit after taking the medicine, you should not take it again and wait for the next scheduled dose.
4. Children's dispersion should be taken within 4 hours after preparation.
1. Pregnancy: use is contraindicated. Women of childbearing potential need to take effective contraceptive measures during treatment and for at least 1 week after stopping the drug.
2. Lactation period: Breastfeeding is not recommended.
3. Children: The safety and effectiveness for patients under 2 years old have not been established. Alopecia areata indications are not suitable for children under 18 years of age.
4. Elderly people: Use by 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.
1. Very common adverse reactions: upper respiratory tract infection, hypercholesterolemia.
2. Common adverse reactions: headache, nausea, abdominal pain, herpes simplex, urinary tract infection, herpes zoster, rash, acne, thrombocytosis, elevated liver enzymes, elevated creatine phosphokinase.
3. Serious risks: serious infection, venous thromboembolism, major adverse cardiovascular events, malignant tumors, gastrointestinal perforation.
1. It is prohibited for those allergic to baricitinib or any excipients.
2. It is prohibited for pregnant women.
1. Avoid combined use with powerful immunosuppressants, other JAK inhibitors, and biological disease-modifying anti-rheumatic drugs.
2. The dosage needs to be adjusted when used in combination with probenecid.
3. Avoid vaccination with live vaccines during use.
4. Caution is required when combined with levamisole or teriflunomide.
1. No special storage conditions are required.
2. Medicines should be stored out of reach and sight of children.