RINVOQ (upadacitinib): A new FDA approved AbbVie medicine for treatment of rheumatoid arthritis
Rheumatoid arthritis is a complex, autoimmune disease that occurs when the immune system mistakenly attacks joints, creating inflammation that causes the tissue inside of joints to thicken, damaging the bones and associated connective tissue.
Despite the availability of multiple treatment options with varying mechanisms of action, many patients still do not achieve clinical remission or low disease activity—the primary treatment goals for rheumatoid arthritis.
AbbVie , a research-based global biopharmaceutical company, on 16 Aug 2019 announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ (containing upadacitinib for the treatment of adults with moderately to severely active rheumatoid arthritis. RINVOQ is expected to be available in the U.S. in late August 2019. RINVOQ or upadacitinib is under review by the European Medicines Agency (EMA), as well as regulatory authorities in Canada and Japan, for the treatment of adult patients with moderately to severely active rheumatoid arthritis.
Upadacitinib is a Janus kinase (JAK) inhibitor.
RINVOQ is a prescription medicine approved by FDA to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.
The recommended oral dose of RINVOQ is 15 mg once daily with or without food.
RINVOQ may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs. It is not known if RINVOQ is safe and effective in children under 18 years of age. RINVOQ is not indicated for methotrexate-naïve patients.
Use of RINVOQ in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine, is not recommended.
Adverse drug reactions:
Most common adverse drug reaction reported with RINVOQ Upper respiratory tract infection, nausea, cough and pyrexia.
RINVOQ is a medicine that can lower the ability of your immune system to fight infections. Serious and sometimes fatal infections have been reported in patients receiving RINVOQ. The most frequent serious infections reported with RINVOQ included pneumonia and cellulitis. Among opportunistic infections, tuberculosis, multidermatomal herpes zoster, oral/esophageal candidiasis, and cryptococcosis, were reported with RINVOQ.
Malignancies such as Lymphoma and other cancers, including skin cancers were observed in clinical studies of RINVOQ.
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated for inflammatory conditions with Janus kinase (JAK) inhibitors, including RINVOQ. Many of these adverse events were serious and some resulted in death.
Change in certain laboratory test parameters were also reported with Treatment with RINVOQ. These changes included neutropenia, Lymphopenia, Anemia, increased liver enzyme elevation, increases in lipid parameters, including total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Based on findings in animal studies, RINVOQ may cause fetal harm when administered to a pregnant woman.
Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors (such as ketoconazole).
Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect of RINVOQ.
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