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.