12-24 Hours
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Upanib 15
Ziska Pharmaceuticals Ltd.
Generic: Upadacitinib
Medicine Overview of Upanib 15mg Tablet
বাংলা
English
Indication
Rheumatoid Arthritis
Adult Dose
Rheumatoid Arthritis
Indicated for moderately to severely active rheumatoid arthritis in adults who have had an inadequate response or intolerance to methotrexate
15 mg PO qDay
May be used as monotherapy or in combination with methotrexate or other nonbiological DMARDs
Hepatic impairment
Mild or moderate (Child-Pugh A or B): No dose adjustment required
Severe (Child-Pugh C): Not recommended
Renal Dose
Renal impairment
Mild, moderate, or severe: No dose adjustment required
ESRD: Not studied
Mode of Action
Janus kinase-1 (JAK1)-selective inhibitor; JAK1 is essential for signaling for certain cytokines to elicit signals from various interleukins, cardiotrophin, neurotrophin, and interferons
These signals are essential in maintaining the inflammatory condition in rheumatoid arthritis (RA); inhibition of JAK reduces production of and modulates proinflammatory cytokines central to RA
Precaution
Malignancies reported; consider risks and benefits of treatment before initiating in patients with known malignancy, other than previously treated nonmelanoma skin cancer; screen for malignancies during treatment according to guidelines
Thrombosis reported, including DVT, PE, and arterial thrombosis
Gastrointestinal perforation reported; unknown if JAK inhibition is implicated in these events; many patients were also receiving NSAIDs
May cause neutropenia, lymphopenia, anemia, elevated lipids, or elevated liver enzymes; monitor for abnormal laboratory values and assess the need to interrupt dosing
Based on findings in animal studies, may cause fetal harm when administered to pregnant women
Side Effect
>10%
Upper respiratory tract infection (13.5%)
1-10%
Nausea (3.5%)
Neutropenia (1.1-2.4%)
Lymphopenia (0.3-2.4%)
Cough (2.2%)
Elevated ALT (0.8-2.1%)
Increased creatine phosphokinase (0.3-1.6%)
Elevated AST (1-1.5%)
Pyrexia (1.2%)
<1%
Pneumonia
Herpes zoster
Herpes simplex (includes oral herpes)
Oral candidiasis
Anemia (<0.1%)
Pregnancy Category Note
Pregnancy Limited human data on use in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage Verify pregnancy status of females of reproductive potential before starting treatment Animal data Based on animal studies, upadacitinib has the potential to adversely affect a developing fetus In animal embryofetal development studies, oral upadacitinib administration to pregnant rats and rabbits at exposures greater or equal than ~1.6 and 15 times the maximum recommended human dose (MRHD), respectively, resulted in dose-related increases in skeletal malformations (rats only), an increased incidence of cardiovascular malformations (rabbits only), increased postimplantation loss...
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