Rinvoq Tablets / Prolonged Release
Upadacitinib
15mg
ABBVIE DEUTSCHLAND GmbH & CO. KG
| Pack size | 30's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | GERMANY |
| Agent | CITY MEDICAL STORE |
| Retail Price | 6094.00 AED |
Indications
Rinvoq Tablets / Prolonged Release is used for:
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
Child Dose
Renal Dose
Renal impairment
Mild, moderate, or severe: No dose adjustment required
ESRD: Not studied
Administration
Contra Indications
Precautions
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
Pregnancy-Lactation
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 (rabbits only), and decreased fetal body weights in both rats and rabbits
Contraception
Females of reproductive potential: Use effective contraception during treatment and for 4 weeks after final dose
Clinical considerations
Published data suggest that increased disease activity is associated with risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis
Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth
Lactation
No data available on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production
Available data in animals have shown upadacitinib excreted in milk
If a drug is present in animal milk, it is likely the drug will be present in human milk
Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with upadacitinib, and for 6 days (~10 half-lives) after the last dose
Interactions
Adverse Effects
Side effects of Upadacitinib :
>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%)
Mechanism 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
Note
Rinvoq 15mg Tablets / Prolonged Release manufactured by ABBVIE DEUTSCHLAND GmbH & CO. KG. Its generic name is Upadacitinib. Rinvoq is availble in United Arab Emirates.
Farmaco UAE drug index information on Rinvoq Tablets / Prolonged Release is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.