【藥品庫存】 本藥品為臨時採購藥品，經院長核可後，限定特定科別、病人使用。

Rheumatoid arthritis: Treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies

COVID-19: Treatment of hospitalized adult patients with supplemental oxygen need; use in combination with Remdesivir <20211203>

異位性皮膚炎：治療2 歲以上適合接受全身性治療的中度至重度異位性皮膚炎病人。
Atopic Dermatitis: Treatment for moderate to severe atopic dermatitis in patients aged 2 years and older who are suitable for systemic therapy.<20241015>

幼幼型特發性關節炎: 本品可用於單一一法或併用methotrexate，治治2 歲以上對一種或多種傳統合成型或DMARDs治療不佳或無法耐受之活動性幼幼型特發性關節炎病人。
Juvenile Idiopathic Arthritis: This product can be used as monotherapy or in combination with methotrexate to treat active juvenile idiopathic arthritis in patients aged 2 years and older who have had an inadequate response or intolerance to one or more conventional synthetic DMARDs.<20241015>

Disease Modifying Antirheumatic; Janus Kinase Inhibitor
Janus kinase (JAK) enzymes are intracellular enzymes involved in stimulating hematopoiesis and immune cell function through a signaling pathway. Inhibition of JAKs prevents the activation of STATs and reduces serum IgG, IgM, IgA, and C-reactive protein.

Distribution: Vd 76 L
Protein binding: ~50% (plasma proteins); 45% (serum proteins)
Metabolism: Hepatic, primarily via CYP3A4
Bioavailability: ~80%
Half-life elimination: ~12 hours
Time to peak: ~1 hour
Excretion: Urine: ~75% (69% as unchanged drug); feces: ~20% (15% as unchanged drug)

Hypersensitivity to baricitinib or any component of the formulation.

Rheumatoid arthritis: Use in pregnant patients with rheumatic diseases are not recommended due to lack of data.
COVID-19: Use may be considered when the potential benefits outweigh the possible risks.

Not available due to lack of data.

COVID-19:
>10%: Increased ALT and AST (≥3 x ULN)
1% to 10%:
1. Cardiovascular: Deep vein thrombosis, pulmonary embolism, venous thrombosis
2. Genitourinary: Urinary tract infection
3.Hematologic: Thrombocythemia
4. Neuromuscular & skeletal: Increased CPK in blood specimen (>5xULN)
Others: Infection
Rheumatoid arthritis:
>10%: Infection, upper respiratory tract infection
1% to 10%: Nausea, increased AST and ALT (≥3 x ULN), herpes zoster infection
Postmarketing:
1. Cardiovascular [FDA Safety Alert September 1, 2021]: Acute myocardial infarction, cerebrovascular accident, thrombosis (Thrombosis, including deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thrombosis have been observed. Promptly evaluate new-onset symptoms of DVT, PE, or arterial thrombosis).<20211203>
2. Dermatologic: Skin rash, urticaria
3. Gastrointestinal: Gastrointestinal perforation
4. Oncologic [FDA Safety Alert September 1, 2021]: Lung carcinoma, skin carcinoma
5. Hematologic: Toxicity including lymphopenia, anemia, and neutropenia, may occur and is generally reversible and managed by treatment interruption. Do not initiate therapy in patients with an absolute lymphocyte count <500 cells/mm3, absolute neutrophil count <1,000 cells/mm3, or hemoglobin <8 g/dL. Monitor complete blood counts at baseline and periodically thereafter.<20211203>
5. Hypersensitivity: Angioedema, hypersensitivity reaction
6. Infection [US Boxed Warning]: Patients receiving baricitinib are at increased risk for serious infections, infections often developed in patients receiving concomitant immunosuppressive agents (eg, methotrexate, corticosteroids). Closely monitor patients for the development of signs/symptoms of infection during and after baricitinib treatment.<20211203>
7. Tuberculosis [US Boxed Warning]: Tuberculosis (TB) (pulmonary or extrapulmonary) has been reported in patients receiving baricitinib. Patients should be evaluated for latent TB infection prior to and during therapy.<20211203>
8. Lipid abnormalities: Dose-dependent increases in lipid parameters (eg, total, low-density lipoprotein, and high-density lipoprotein cholesterol) were observed; maximum lipid increases were typically seen within 12 weeks of initiation. Assess lipids 12 weeks after baricitinib initiation and manage lipid abnormalities accordingly.<20211203>
9. Hepatic: Increased incidence of liver enzyme elevation (≥5 × ULN for ALT and ≥10 × ULN for AST) was observed. Monitor LFTs as clinically indicated; interrupt therapy if LFTs are increased and drug-induced liver injury is suspected.<20211203>

Rheumatoid arthritis:
1) 2 mg once daily, monotherapy or in combination with methotrexate or nonbiologic disease-modifying antirheumatic drugs.
2) Should not be used in combination with biologic disease-modifying antirheumatic drugs or with strong immunosuppressants such as azathioprine or cyclosporine.
3) Do not initiate therapy in patients with an absolute lymphocyte count <500 cells/mm³, absolute neutrophil count <1,000 cells/mm³, or hemoglobin <8 g/dL.
COVID-19, hospitalized patients:
1) 4 mg once daily, recommended for use in combination with corticosteroids or corticosteroids plus remdesivir. Duration of baricitinib is 14 days or until hospital discharge, whichever is first.
2) Avoid use in combination with tocilizumab.

Rheumatoid arthritis:
1. eGFR >60 mL/min/1.73 m²: No dosage adjustment necessary.
2. eGFR 30 to 60 mL/min/1.73 m²: 1 mg once daily.
3. eGFR <30 mL/min/1.73 m²: Use is not recommended.
COVID-19:
1. eGFR>60 mL/min/1.73 m²: No dosage adjustment necessary.
2. eGFR 30-60 mL/min/1.73 m²: 2 mg once daily.
3. eGFR 15-30 mL/min/1.73 m²: 1 mg once daily.
4. eGFR <15 mL/min/1.73 m²: Use is not recommended.

1. Mild to moderate impairment: No dosage adjustment necessary.
2. Severe impairment: Use is not recommended (has not been studied).
3. ALT/AST increased: If baricitinib-induced liver injury is suspected, interrupt therapy and further evaluate.