Pregnancy and Lactation Studies

ENROLLING PREGNANCY AND LACTATION STUDIES

BELIMUMAB (BENLYSTA™) PREGNANCY REGISTRY

If you are pregnant and have been given belimumab (BENLYSTA^™) within the four months prior to becoming pregnant and/or during pregnancy, you are eligible to participate in this global registry. The pregnant woman or one of her health care providers may contact the registry at:

• Toll-free phone number (North America): +1 877 681 6296
• Toll-free worldwide access fax number: +1 855 269 6182
• Email address: belimumab.pregnancy@ppdi.com
• Website: http://pregnancyregistry.gsk.com/belimumab.html

HEPLISAV-B^® (Hepatitis B Vaccine [Recombinant], Adjuvanted) Pregnancy Registry

Pregnant women who have been vaccinated with HEPLISAV-B^® (Hepatitis B Vaccine [Recombinant], Adjuvanted) within 28 days prior to conception or at any time during the pregnancy are eligible to participate in this U.S. registry. They may contact the registry at:

• Toll-free phone number (US): +1 844 443 7734
• Toll-free fax number (US): +1 877 202 3940
• Email address: heplisavbpregnancyregistry@ppdi.com
• Website: https://heplisavbpregnancyregistry.com

T.A.P.P. (Take Action to Prevent Pregnancy) Pregnancy Monitoring Program for Acitretin

If you think you’ve become pregnant while taking Acitretin or within three years of stopping, contact the program at:

• Toll-free phone number (US): +1 855 850 2138
• Toll-free fax number (US): +1 855 850 2137
• Website: http://www.tevagenerics.com/acitretin

CLOSED PREGNANCY AND LACTATION STUDIES

BEXSERO^® Pregnancy Registry

An observational study of the use and safety of BEXSERO® in pregnant women and their offspring.
https://clinicaltrials.gov/ct2/show/NCT02640677?term=Bexsero+Pregnancy+Registry&rank=1

CRADLE

A multicenter postmarketing study to evaluate breast milk transfer in lactating mothers receiving treatment for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis or ankylosing spondylitis.
https://clinicaltrials.gov/ct2/show/NCT02154425?term=CRADLE&rank=3

CRIB

A multicenter postmarketing study to evaluate placental transfer in women receiving treatment for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis or ankylosing spondylitis.
https://clinicaltrials.gov/ct2/show/NCT02019602?term=CRIB&rank=4

MENVEO^® Vaccine Pregnancy Registry

An observational study of the use and safety of MENVEO^® in pregnant women and their offspring.
https://www.clinicaltrials.gov/ct2/show/NCT02223637?term=Menveo+pregnancy+registry&rank=1

Oseltamivir Safety in Pregnancy

European-based, retrospective, observational, database study assessing the safety of oseltamivir exposure in pregnant women and their offspring.
Email address: Pregnancyand.InfantRegistriesSM@ppdi.com

Vedolizumab (Entyvio®) Lactation Study

A multicenter postmarketing study to evaluate breast milk transfer in women receiving vedolizumab (Entyvio^®) for ulcerative colitis or Crohn’s disease.
https://www.clinicaltrials.gov/ct2/show/NCT02559713?term=Vedolizumab+%28Entyvio%C2%AE%29+Lactation+Study&rank=1

Xolair^® Pregnancy Registry

An observational study of the use and safety of Xolair^® (Omalizumab) during pregnancy (EXPECT).
https://clinicaltrials.gov/ct2/show/NCT00373061?term=EXPECT&rank=10

Zanamivir (Relenza inhalation powder) Safety in Pregnancy

European-based, retrospective, observational, database study assessing the safety of zanamivir (Relenza inhalation powder) exposure in pregnant women and their offspring.

Email address:
Pregnancyand.InfantRegistriesSM@ppdi.com