REMATIB

Upadacitinib Hemihydrate

Composition: Each Extended-Release Tablet Contains Upadacitinib 15mg as Upadacitinib Hemihydrate.

Indication: Rematib is a Janus Kinase (JAK) inhibitor indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

Dosage and administration: Do not initiate Rematib if absolute lymphocyte count <500>3, an absolute Neutrophil count (ANC) <1000>3, or haemoglobin level <8>

Rheumatoid Arthritis and Psoriatic Arthritis: The recommended dosage is 15 mg once daily.

Atopic Dermatitis: Pediatric Patients 12 years of age and older weighing at least 40 kg and adults less than 65 years of age: Initiate treatment with 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily. Adults 65 Years of Age and Older: Recommended dosage is 15 mg once daily.

Ulcerative Colitis: Adults: The recommended induction dosage is 45 mg once daily for 8 weeks. The recommended maintenance dosage is 15 mg once daily. Or, as directed by the registered physician.

Use in Pregnancy and lactation: Pregnancy-There are no adequate and well-controlled studies in pregnant women. It should be avoided during pregnancy. Lactation-It is advised to avoid Upadacitinib during lactation.

Packing: Each box contains 1x10’s tablets in blister pack.

Prescribing Description

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