Lab changes (ANC, ALC, Hgb, LFT) occurred within the first 4-8 weeks, were transient, and generally returned to baseline levels within the normal range without study drug discontinuation3-5
For moderate to severe patients 12+ years not adequately controlled with other systemic drugs, including biologics.1
*USPI recommendation for CBC and liver enzymes: at baseline and periodically thereafter.
†USPI recommendation for lipids: at 12 weeks and thereafter according to hyperlipidemia guidelines.
Treatment may be restarted when blood levels return to acceptable values seen in chart above, drug-induced liver diagnosis is excluded or infection is controlled.1
RINVOQ is not recommended for use in patients with severe hepatic impairment or end-stage renal disease.1
Discontinue RINVOQ in patients that have experienced a myocardial infarction or stroke.1
Avoid RINVOQ in patients that may be at increased risk of thrombosis.1
- SERIOUS INFECTIONS1
Closely monitor patients for the development of signs and symptoms of infection during and after treatment with RINVOQ. Interrupt RINVOQ if a patient develops a serious or opportunistic infection.
Monitor patients for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
- VIRAL REACTIVATION1
Screening for viral hepatitis and monitoring for reactivation should be performed in accordance with clinical guidelines before starting and during therapy with RINVOQ.
Based on animal studies, RINVOQ may cause embryo-fetal toxicity when administered to pregnant women. Verify pregnancy status prior to starting treatment. Advise women to use effective contraception during and for 4 weeks after completion of treatment.
- VACCINATIONS 1
Avoid use of live vaccines during, or immediately prior to, RINVOQ therapy. Prior to initiating RINVOQ, it is recommended that patients be brought up to date with all immunizations, including varicella zoster or prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
Lab abnormalities: placebo-controlled period through 16 weeks1,3-5
>99% of patients did not experience a treatment interruption due to lab changes3
‡Includes subjects from M16-048, MEASURE UP 1, MEASURE UP 2, and AD UP.3
ALT=alanine aminotransferase; AST=aspartate transaminase; HDL-C=high-density lipoprotein cholesterol; LDL-C=low-density lipoprotein cholesterol; ULN=upper limit of normal.