Ivarmacitinib Sulfate Tablets Application Scope

Ivarmacitinib Sulfate Tablets are a selective Janus kinase 1 (JAK1) inhibitor primarily approved and indicated for the treatment of adult patients with:

Moderate to severe atopic dermatitis
Rheumatoid arthritis (RA)
Ankylosing spondylitis (AS)
Severe alopecia areata, especially in cases where patients have shown inadequate efficacy or intolerance to tumor necrosis factor (TNF) inhibitors or conventional treatments.

Ivarmacitinib Sulfate Tablets Characteristics

Ingredients: Active ingredient: Ivarmacitinib sulfate. Chemical name: (3aR,5s,6aS)-N-(3-methoxy-1,2,4-thiadiazol-5-yl)-5-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)hexahydrocyclopenta[c]pyrrole-2(1H)-carboxamide hydrogen sulfate. Molecular formula: C18H22N8O2S·H2SO4. Molecular weight: 512.56. Excipients: Lactose Tablettose 80, cellulose-lactose, low-substituted hydroxypropyl cellulose (L-HPC), colloidal silicon dioxide, stearic acid, film coating premix (containing lactose).
Properties: Film-coated tablets. Selective and potent Janus kinase 1 (JAK1) inhibitor, with greater selectivity over JAK2 (9-fold), JAK3 (77-fold), and TYK2 (420-fold).
Packaging Specification: 4 mg per tablet
Storage:Sealed storage.
Expiry Date: Typical shelf life is 1–2 years (12–24 months) depending on regulatory/packaging specifics.
Executive Standard: Class 1 chemical drug (China)
Approval Number: CXHS2400089
Date of Revision: March–April 2025
Manufacturer: Jiangsu Hengrui Medicine Co., Ltd.

Guidelines for the Use of Ivarmacitinib Sulfate Tablets

Dosage and Administration:
- Recommended Dose: 4 mg once daily. For atopic dermatitis, rheumatoid arthritis, and alopecia areata, if 4 mg once daily does not achieve adequate response, consider increasing to 8 mg once daily.
- Administration: Oral administration, with or without food (no clinically significant difference in exposure when taken with a high-fat meal).
- Missed Dose: Not specified in available sources; generally, for similar medications, take the missed dose as soon as remembered unless it is close to the next scheduled dose, in which case skip the missed dose and resume the regular schedule.
Adverse Reactions:
- Common Adverse Reactions: Upper respiratory tract infection, urinary tract infection, folliculitis, increased creatine phosphokinase (CPK), increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), decreased white blood cell count, decreased neutrophil count, decreased lymphocyte count, hyperlipidemia, hypercholesterolemia, hypertriglyceridemia, oral ulcer, toothache, hypertension, headache, cough, acne (incidence ≥2% across studies).
- Serious Adverse Reactions: Serious infections (e.g., pneumonia, herpes zoster, tuberculosis, opportunistic infections), malignancies and lymphoproliferative disorders (higher risk vs. TNF inhibitors, excluding non-melanoma skin cancer; increased in smokers), major adverse cardiovascular events (MACE: cardiovascular death, myocardial infarction, stroke; higher in patients ≥50 years with cardiovascular risk factors), thrombosis (deep vein thrombosis, pulmonary embolism, arterial thrombosis), gastrointestinal perforation, hypersensitivity reactions, severe laboratory abnormalities (e.g., severe elevations in CPK/ALT/AST, severe neutropenia/lymphopenia).
Contraindications: Known hypersensitivity to ivarmacitinib sulfate or any excipients; active severe infections or opportunistic infections; pregnancy or lactation; severe hepatic impairment; severe renal impairment or end-stage renal disease.
Precautions:
- Use with caution in patients aged 65 and above, those with cardiovascular risks, cancer risk, history of blood clots, or serious infections.
- Not recommended for use as first-line therapy if suitable alternatives are available for high-risk patients.
- Monitoring of lab values (CBC, liver and renal function) is advised during therapy.

Ivarmacitinib Sulfate Tablets Interactions

May interact with drugs metabolized by CYP450 enzymes or with immunosuppressants (e.g., corticosteroids, biologics).
Concomitant use with strong CYP inhibitors/inducers may require dose adjustment.
No major safety concerns documented, but monitor for unclassified or CYP-mediated interactions.

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.