Rinvoq

Question 1

What is RINVOQ?

Accepted Answer

RINVOQ is a drug that may be used to treat certain medical conditions.

Question 2

Is RINVOQ safe to use during pregnancy?

Accepted Answer

There is not enough data available to evaluate the potential risk of major birth defects or miscarriage associated with RINVOQ use during pregnancy. However, animal studies have shown that RINVOQ has the potential to harm a developing fetus. Pregnant patients and those of reproductive potential should be advised of this potential risk.

Question 3

What risks are associated with major birth defects and miscarriage during pregnancy?

Accepted Answer

The background risks of major birth defects and miscarriage for the indicated populations are unknown. However, all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriages are 2-4% and 15-20%, respectively.

Question 4

What should I do if I become pregnant while taking RINVOQ?

Accepted Answer

Patients who become pregnant while taking RINVOQ should contact their healthcare provider immediately. Pregnancies should be reported to AbbVie Inc.'s Adverse Event reporting line at 1-888-633-9110 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Question 5

What are the risks associated with RINVOQ and lactation?

Accepted Answer

There are no data on the presence of upadacitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Available pharmacodynamic/toxicological data in animals have shown excretion of upadacitinib in milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with RINVOQ, and for 6 days (approximately 10 half-lives) after the last dose.

Question 6

What precautions should females of reproductive potential take before using RINVOQ?

Accepted Answer

Females of reproductive potential should have their pregnancy status verified before starting treatment with RINVOQ. Female patients of reproductive potential should use effective contraception during treatment with RINVOQ and for 4 weeks after the final dose, based on animal studies that suggest upadacitinib may cause embryo-fetal harm when administered to pregnant women.

Question 7

Has the safety and effectiveness of RINVOQ been established for pediatric patients?

Accepted Answer

The safety and effectiveness of RINVOQ have not been established in pediatric patients with juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. However, RINVOQ has been established as safe and effective in pediatric patients 12 years of age and older weighing at least 40 kg with atopic dermatitis. Clinical studies have shown that efficacy was consistent between the pediatric patients and adults. The adverse reaction profile in the pediatric patients was similar to the adults.

Question 8

Is RINVOQ safe for use in geriatric patients?

Accepted Answer

No significant differences in effectiveness were observed between geriatric and younger patients with rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis. However, geriatric patients had a higher rate of overall adverse events, including serious infections, in some cases. Clinical studies of RINVOQ did not include sufficient numbers of patients 65 years of age and older with ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis to determine whether they respond differently from younger adult patients.