Invonib ER 30mg Tablet

Active Ingredient (s)

Each uncoated Tablet contains:
Upadacitinib hemihydrate eq. to
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.

Indication (s)

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