Pack
1×30’s

Reg No
126634

Reg Date
08-05-2025

Active Ingredient
Each uncoated Tablet contains:
Upadacitinib  …………………… 30mg

(As per Innovator Specifications)

Advanced Oral Therapy for Immune-Mediated Inflammatory Diseases

NVONIB ER contains Upadacitinib, an oral Janus kinase (JAK) inhibitor designed to help manage inflammation in a range of immune-mediated inflammatory conditions.

Therapeutic Indications

INVONIB ER is indicated for the treatment of approved immune-mediated inflammatory diseases, including:

• Rheumatoid Arthritis
• Psoriatic Arthritis
• Atopic Dermatitis
• Ankylosing Spondylitis
• Axial Spondyloarthritis
• Ulcerative Colitis

Important Safety Information

Treatment with upadacitinib requires careful patient selection and clinical monitoring.

Important safety considerations associated with JAK inhibitor therapy include:

• Serious infections, including tuberculosis and opportunistic infections
• Malignancies
• Major adverse cardiovascular events
• Thrombosis
• Laboratory abnormalities
• Hypersensitivity reactions
• Gastrointestinal perforation in appropriate at-risk patients
• Embryo-fetal toxicity considerations
• Vaccination-related precautions

Healthcare professionals should evaluate individual patient risk factors before initiating treatment and monitor patients during therapy according to the approved prescribing information.

Important Precautions

Before and during treatment, appropriate clinical assessment may include evaluation for:

• Active or latent tuberculosis
• Serious or recurrent infections
• History of malignancy
• Cardiovascular risk factors
• Thrombotic risk factors
• Relevant laboratory abnormalities
• Hepatic impairment
• Renal impairment
• Potential drug interactions

Upadacitinib is not recommended in severe hepatic impairment in the referenced prescribing information. Dosage considerations may apply in certain patients with renal impairment and when concomitant medications affect CYP3A4.

important Note

This website information is intended for educational and product information purposes only. INVONIB ER should be prescribed and used strictly in accordance with the locally approved prescribing information. Please refer to the complete prescribing information for approved indications, patient eligibility, dosage and administration, contraindications, warnings, precautions, adverse reactions, and drug interactions.