Saphnelo

Question 1

Is SAPHNELO safe to use during pregnancy?

Accepted Answer

The limited human data with SAPHNELO use in pregnant women are insufficient to inform on drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcome. Monoclonal IgG antibodies are known to be actively transported across the placenta as pregnancy progresses; therefore, anifrolumabfnia exposure to the fetus may be greater during the third trimester of pregnancy. A pregnancy exposure registry monitors pregnancy outcomes in women exposed to SAPHNELO during pregnancy. Pregnant women with SLE are at increased risk of adverse pregnancy outcomes. If you are pregnant and taking SAPHNELO, contact AstraZeneca at 1-877-693-9268.

Question 2

What is the risk of birth defects and miscarriage with SAPHNELO use during pregnancy?

Accepted Answer

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Question 3

Can SAPHNELO be used during lactation?

Accepted Answer

No data are available regarding the presence of SAPHNELO in human milk, the effects on the breastfed child, or the effects on milk production. Anifrolumab-fnia was detected in the milk of female cynomolgus monkeys administered anifrolumab-fnia. If you are breastfeeding while taking SAPHNELO, consult with your healthcare provider to assess the potential risks and benefits.

Question 4

Is SAPHNELO safe for use in pediatric patients?

Accepted Answer

The safety and efficacy of SAPHNELO in pediatric patients less than 18 years of age have not been established.

Question 5

Is SAPHNELO safe for use in geriatric patients?

Accepted Answer

Of the 664 patients with SLE exposed to anifrolumab-fnia in clinical trials, 3% (n=20) were 65 and over. The number of patients aged 65 years of age and older was not sufficient to determine whether they respond differently from younger adult patients.