Zeposia

Question 1

What is the Pregnancy Exposure Registry for ZEPOSIA?

Accepted Answer

The pregnancy exposure registry is a program that monitors pregnancy outcomes in women exposed to ZEPOSIA during pregnancy. Pregnant women can register themselves at www.zeposiapregnancyregistry.com or by calling 1-877-301-9314.

Question 2

What is the Risk Summary for ZEPOSIA use in pregnancy?

Accepted Answer

There are no adequate data on the developmental risk associated with the use of ZEPOSIA in pregnant women. In animal studies, administration of ozanimod during pregnancy produced adverse effects on development, including embryolethality, an increase in fetal malformations, and neurobehavioral changes, in the absence of maternal toxicity.

Question 3

What are the risks of birth defects and miscarriage in women taking ZEPOSIA during pregnancy?

Accepted Answer

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

Question 4

What are the animal data regarding ZEPOSIA use in pregnancy?

Accepted Answer

In animal studies, oral administration of ozanimod during pregnancy resulted in a marked increase in embryofetal mortality, increased fetal malformations and skeletal variations, and reduced fetal body weight at the highest dose tested. Fetal blood vessel malformations occurred at clinically relevant maternal ozanimod and metabolite exposures in rabbits.

Question 5

What is the Risk Summary for ZEPOSIA use during lactation?

Accepted Answer

There are no data on the presence of ozanimod in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Following oral administration of ozanimod, ozanimod and/or metabolites were detected in the milk of lactating rat at levels higher than those in maternal plasma.

Question 6

What should women of childbearing potential know before taking ZEPOSIA?

Accepted Answer

Before initiation of ZEPOSIA treatment, women of childbearing potential should be counseled on the potential for a serious risk to the fetus and the need for contraception during treatment with ZEPOSIA. The potential risk to the fetus may persist for 3 months after stopping ZEPOSIA, so effective contraception should also be used during this time.

Question 7

Is ZEPOSIA safe and effective for pediatric use?

Accepted Answer

Safety and effectiveness of ZEPOSIA in pediatric patients have not been established.

Question 8

Were elderly patients included in clinical studies of ZEPOSIA?

Accepted Answer

No, clinical studies of ZEPOSIA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

Question 9

Are there any age-related differences in the pharmacokinetics of ZEPOSIA?

Accepted Answer

No clinically significant differences in the pharmacokinetics of ozanimod and CC112273 were observed based on age.

Question 10

Should elderly patients be monitored for any adverse reactions to ZEPOSIA?

Accepted Answer

Yes, elderly patients should be monitored for cardiac and hepatic adverse reactions, because of the greater frequency of reduced cardiac and hepatic function in the elderly population.

Question 11

Is it recommended to use ZEPOSIA in patients with hepatic impairment?

Accepted Answer

No, the use of ZEPOSIA in patients with hepatic impairment is not recommended because the effect of hepatic impairment on the pharmacokinetics of the ozanimod major active metabolites is unknown.