Opzelura

Question 1

Is there a pregnancy exposure registry for OPZELURA?

Accepted Answer

Yes, there is a pregnancy registry that monitors pregnancy outcomes in pregnant persons exposed to OPZELURA during pregnancy. Pregnant persons exposed to OPZELURA and healthcare providers should report OPZELURA exposure by calling 1-855-463-3463.

Question 2

What is the risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with OPZELURA?

Accepted Answer

Available data from pregnancies reported in clinical trials with OPZELURA are not sufficient to evaluate a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ruxolitinib to pregnant rats and rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses associated with maternal toxicity. The background risks of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes.

Question 3

What is the recommended duration of not breastfeeding during treatment with OPZELURA?

Accepted Answer

Because of the serious adverse findings in adults, including risks of serious infections, thrombocytopenia, anemia, and neutropenia, advise women not to breastfeed during treatment with OPZELURA and for approximately four weeks after the last dose (approximately 5-6 elimination half-lives).

Question 4

What is the safety and effectiveness of OPZELURA in pediatric patients?

Accepted Answer

The safety and effectiveness of OPZELURA for the topical treatment of mild-to-moderate atopic dermatitis have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with atopic dermatitis have not been established. The safety and effectiveness of OPZELURA for the topical treatment of nonsegmental vitiligo have been established in pediatric patients aged 12 to 17 years of age. Use of OPZELURA in this age group is supported by evidence from clinical trials. The safety and effectiveness of OPZELURA in pediatric patients younger than 12 years of age with nonsegmental vitiligo have not been established. Oral administration of ruxolitinib to juvenile rats resulted in effects on growth and bone measures.

Question 5

Is there a difference in safety and effectiveness of OPZELURA between geriatric and younger patients?

Accepted Answer

No clinically meaningful differences in safety or effectiveness were observed between subjects less than 65 years and subjects 65 years and older.