Baricitinib Application Scope

Treatment of moderate-to-severe rheumatoid arthritis in adults who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). Also approved for treatment of severe COVID-19 in hospitalized patients requiring supplemental oxygen or ventilation.

Baricitinib Characteristics

Ingredients:
- Active: Baricitinib
- Inactive (excipients): Lactose monohydrate, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, hypromellose, polyethylene glycol, titanium dioxide.
Properties: White to off-white crystalline powder; molecular formula C16H17N7O2S, molecular weight 371.4 g/mol; soluble in water
Packaging Specification: Film-coated tablets: 2 mg and 4 mg; bottles of 30 tablets or blister packs.
Storage: Store at 20–25 °C (68–77 °F); keep tightly closed in original packaging. Protect from moisture and light.
Expiry Date: See batch-specific outer packaging. Typically 24 months from manufacture.
Executive Standard: U.S. FDA-approved Full Prescribing Information (USPI) for OLUMIANT.
Approval Number: NDA 209750 (OLUMIANT tablets).
Date of Revision: Latest revision January 2024 (USPI).
Manufacturer: Eli Lilly and Company.

Guidelines for the Use of OLUMIANT

Dosage and Administration:
- Recommended Dose:
  - Rheumatoid arthritis: 2 mg orally once daily, may increase to 4 mg based on response and tolerability.
  - COVID-19: 4 mg once daily orally for up to 14 days or until hospital discharge.
- Administration: Oral tablets, swallow whole with or without food.
- Missed Dose: Take as soon as remembered unless next dose is due within 12 hours; then skip and resume schedule.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - - Upper respiratory tract infections
    - Nausea
    - Headache
    - Increased creatine phosphokinase (CPK)
    - Hypercholesterolemia
- Serious Adverse Reactions:
  - - Serious infections (e.g., tuberculosis, bacterial, viral, fungal)
    - Thrombosis (deep vein thrombosis, pulmonary embolism)
    - Hypersensitivity reactions including rash, urticaria, facial edema, bronchospasm
    - Laboratory abnormalities including decreased neutrophils and lymphocytes, elevated liver enzymes
Contraindications:
- Hypersensitivity to baricitinib or any excipients in OLUMIANT.
- Active serious infections including tuberculosis.
Precautions:
- - Monitor for signs of infection; discontinue if serious infection occurs.
  - Monitor complete blood counts regularly.
  - Use caution in patients with history of thrombosis.
  - Advise women of childbearing potential to avoid pregnancy during treatment.
  - Pregnancy and Lactation: Use only if benefits outweigh risks; breastfeeding not recommended.

Baricitinib Interactions

Avoid concomitant use with other JAK inhibitors, biologic immunomodulators, or potent immunosuppressants.
Caution when used with strong CYP3A4 inducers (e.g., rifampin) which may reduce baricitinib exposure.
No significant interactions with CYP enzymes expected as baricitinib is primarily renally excreted.
Monitor for additive immunosuppressive effects when combined with other immunomodulatory drugs.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.