Upanib: Each extended-release film coated tablet contains Upadacitinib Hemihydrate INN equivalent to Upadacitinib 15 mg.

Upanib: Each carton contains 1X10’s tablets in blister pack.

Upadacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which
transmit signals arising from cytokine or growth factor-receptor interactions on the
cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal
Transducers and Activators of Transcription (STATs) which modulate intracellular
activity including gene expression. Upadacitinib modulates the signaling pathway at
the point of JAKs, preventing the phosphorylation and activation of STATs.

Upanib is a Janus kinase (JAK) inhibitor indicated for the treatment of adults with
moderate to severe active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.

The recommended dose of Upanib is 15 mg once daily. Upanib may be used as
monotherapy or in combination with methotrexate or other non-biologic DMARDs.
Avoid initiation or interrupt Upanib if absolute lymphocyte count is less than 500
cells/mm3 , absolute neutrophil count is less than 1000 cells/mm3 or hemoglobin level is less than 8 g/dL.

Serious Infections: Avoid use of Upadacitinib in patients with active,serious infection, including localized infections.
Malignancy: Consider the risks and benefits of Upadacitinib treatment prior to 
 initiating therapy in patients with a known malignancy.
Thrombosis: Consider the risks and benefits prior to treating patients who may be at increased risk of thrombosis. Promptly evaluate patients with symptoms of  thrombosis and treat appropriately.
Gastrointestinal Perforations: Use with caution in patients who may be at increased risk.

Laboratory Monitoring: Recommended due to potential changes in lymphocytes,  neutrophils, hemoglobin, liver enzymes and lipids.
Embryo-Fetal Toxicity: Upadacitinib may cause fetal harm based on animal  studies. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
Vaccinations: Avoid use of Upadacitinib with live vaccines.

None

Pregnancy: The limited human data on use of Upadacitinib in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus.

Strong CYP3A4 Inhibitors
Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole). Upadacitinib should be used with caution in patients receiving chronic treatment with strong CYP3A4 inhibitors.

Strong CYP3A4 Inducers
Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of Upadacitinib. Coadministration of Upadacitinib with strong CYP3A4 inducers is not recommended.

Upadacitinib was administered in clinical trials up to doses equivalent in daily AUC to  60 mg extended-release once daily. Adverse events were comparable to those seen at  lower doses and no specific toxicities were identified. Approximately 90% of upadacitinib in the systemic circulation is eliminated within 24 hours of dosing (within the range of doses evaluated in clinical studies). In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions. Patients who develop adverse reactions should receive appropriate treatment.

Lactation: Advise not to breastfeed. Hepatic Impairment: Upadacitinib is not recommended in patients with severe hepatic impairment.

Pediatric Use: The safety and efficacy of Upadacitinib in children and adolescents aged 0 to 18 years have not yet been established. No data are available.

Do not store above 25 Deg C. Protect from light. Keep out of reach of children.