What is RINVOQ and how is it used?
- RINVOQ is a prescription medicine that is a Janus kinase (JAK) inhibitor. RINVOQ is used to treat adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.
It is not known if RINVOQ is safe and effective in children under 18 years of age.
What are the possible side effects of RINVOQ?
RINVOQ can cause serious side effects including:
See “What is the most important information I should know about RINVOQ?”
Common side effects of RINVOQ include: upper respiratory tract infections (common cold, sinus infections), nausea, cough, and fever.
These are not all the possible side effects of RINVOQ. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS
Patients treated with RINVOQ are at increased risk for developing serious infections that may lead to hospitalization or death [see WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt RINVOQ until the infection is controlled.
Reported infections include:
- Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before RINVOQ use and during therapy. Treatment for latent infection should be considered prior to RINVOQ use.
- Invasive fungal infections, including cryptococcosis and pneumocystosis.
- Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens.
The risks and benefits of treatment with RINVOQ should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with RINVOQ, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see WARNINGS AND PRECAUTIONS].
Lymphoma and other malignancies have been observed in patients treated with RINVOQ [see WARNINGS AND PRECAUTIONS].
Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions. Many of these adverse events were serious and some resulted in death. Consider the risks and benefits prior to treating patients who may be at increased risk. Patients with symptoms of thrombosis should be promptly evaluated and treated appropriately [see WARNINGS AND PRECAUTIONS].
RINVOQ is formulated with upadacitinib, a JAK inhibitor.
Upadacitinib has the following chemical name: (3S,4R)-3-Ethyl-4-(3H-imidazo[1,2- a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide hydrate (2:1).
The strength of upadacitinib is based on anhydrous upadacitinib. The solubility of upadacitinib in water is 38 to less than 0.2 mg/mL across a pH range of 2 to 9 at 37°C.
Upadacitinib has a molecular weight of 389.38 g/mol and a molecular formula of C17H19F3N6O • ½ H2O. The chemical structure of upadacitinib is:
RINVOQ 15 mg extended-release tablets for oral administration are purple, biconvex oblong, with dimensions of 14 x 8 mm, and debossed with â€˜a15â€™ on one side.
Each tablet contains the following inactive ingredients: microcrystalline cellulose, hypromellose, mannitol, tartaric acid, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, ferrosoferric oxide, and iron oxide red.