RINVOQ Rx

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 therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis); monitor and evaluate promptly if new onset abdominal pain occurs. Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. 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. Medication residue in stool or ostomy output (monitor and consider alternative therapies if inadequate response). Severe hepatic impairment, ESRD (atopic dermatitis, UC): not recommended. Severe renal impairment (atopic dermatitis, UC): see Adult. 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).

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 therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis); monitor and evaluate promptly if new onset abdominal pain occurs. Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. 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. Medication residue in stool or ostomy output (monitor and consider alternative therapies if inadequate response). Severe hepatic impairment, ESRD (atopic dermatitis, UC): not recommended. Severe renal impairment (atopic dermatitis, UC): see Adult. 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).

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 therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). GI perforation risk (eg, history of diverticulitis); monitor and evaluate promptly if new onset abdominal pain occurs. Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. 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. Medication residue in stool or ostomy output (monitor and consider alternative therapies if inadequate response). Severe hepatic impairment, ESRD (atopic dermatitis, UC): not recommended. Severe renal impairment (atopic dermatitis, UC): see Adult. 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).