Miscellaneous immune disorders:
Indications for: TAVNEOS
As an adjunct for adults with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids.
Swallow whole. Take with food. 30mg twice daily. Concomitant strong CYP3A4 inhibitors: reduce to 30mg once daily.
Obtain LFTs prior to initiation, every 4 weeks during the 1st 6 months, then as clinically indicated. Evaluate and consider interrupting therapy if ALT/AST elevated to >3×ULN. Discontinue if ALT/AST >5×ULN, or transaminases >3×ULN with elevated bilirubin >2×ULN until Tavneos-induced liver injury is ruled out. Discontinue immediately if angioedema occurs; treat appropriately. Screen for HBV infection by measuring HBsAg and anti-HBc prior to initiation. Monitor those with evidence of HBV infection for signs of hepatitis or HBV reactivation during and for 6 months following Tavneos. If HBV reactivation occurs, immediately discontinue Tavneos and any concomitant HBV reactivation-associated therapy. Avoid in those with active, serious infection. Consider risks/benefits prior to initiation: with chronic or recurrent infection, or history of serious or opportunistic infections, exposure to TB, travel to, or residence in, areas with endemic TB or mycoses, conditions that predispose to infection. Monitor closely for infection during and after therapy; interrupt if serious or opportunistic infection develops. Active, untreated and/or uncontrolled chronic liver disease (eg, chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis), cirrhosis, or severe hepatic impairment (Child-Pugh Class C): not recommended; consider risk/benefit prior to therapy. Dialysis. Pregnancy. Nursing Mothers.
Potentiated by strong CYP3A4 inhibitors (eg, itraconazole); reduce dose (see Adult). Antagonized by strong CYP3A4 inducers (eg, rifampin). Avoid strong and moderate CYP3A4 inducers. Concomitant sensitive CYP3A4 substrates with a narrow therapeutic window (eg, midazolam); monitor closely for adverse reactions and consider dose reduction of substrates.
Nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, increased blood creatinine, paresthesia; hepatotoxicity, HBV reactivation, serious infections.
Generic Drug Availability: