For moderate to severe patients 12+ years not adequately controlled with other systemic drugs, including biologics.1

MONITORING

AND TREATMENT CONSIDERATIONS

Lab monitoring1,2

Perform lab tests at baseline,* at 12 weeks,† and periodically thereafter

Graph representing laboratory values and when treatment should not be initiated or continued.

*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

Baseline screening1

At baseline and periodically, screen for:

  • 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.

  • TUBERCULOSIS1

    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.

  • PREGNANCY1

    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.

  • VACCINATIONS1

    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.

~99% of patients did not experience a treatment interruption due to lab changes

Lab abnormalities: placebo-controlled period through 16 weeks1,3,4

Graph representing lab values over time in placebo-controlled trials with patients on RINVOQ 15 mg and RINVOQ 30 mg.

‡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.

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

Want to know more about treatment initiation and monitoring?