Indications for RINVOQ:
Moderately to severely active rheumatoid arthritis (RA) in adults who have had an inadequate response or intolerance to methotrexate (MTX).
Limitations of Use:
Not recommended for use with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants (eg, azathioprine, cyclosporine).
Swallow whole. ≥18yrs: 15mg once daily. May be used as monotherapy or in combination with MTX or other nonbiologic DMARDs. Dose interruption: see full labeling.
<18yrs: not established.
Serious infections. Malignancy. Thrombosis.
Increased risk of serious infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Consider the risks/benefits in chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection. Screen for viral hepatitis before starting and during therapy. Thrombosis risk. Known malignancy. GI perforation risk (eg, history of diverticulitis). Perform periodic skin exam in those with skin cancer risk. Update immunization based on current guidelines prior to initiating therapy. Do not initiate therapy if lymphocytes <500cells/mm3, ANC <1000cells/mm3, or hemoglobin <8g/dL. Monitor lymphocytes, neutrophils, and hemoglobin at baseline, then periodically thereafter. Routinely monitor liver enzymes; interrupt therapy if ALT/AST elevated and drug-induced liver injury is suspected. Monitor lipids 12 weeks following initiation and manage hyperlipidemia. Severe hepatic impairment: not recommended. Elderly. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception during and for 4 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 6 days after the last dose).
Janus kinase (JAK) inhibitor.
Concomitant live vaccines, biologic DMARDs, or potent immunosuppressants (eg, azathioprine, cyclosporine): not recommended. Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); caution. Antagonized by strong CYP3A4 inducers (eg, rifampin); not recommended. Caution with NSAIDs.
Upper respiratory tract infections, nausea, cough, pyrexia; other serious or opportunistic infections, TB, GI perforations, malignancies (eg, lymphoma), thrombosis (evaluate and treat if occurs), cytopenias, liver enzyme or lipid elevations, non-melanoma skin cancer.