SUMMARY  

• The company cannot recommend any practices, procedures, or usage that deviate from the approved labeling.
• Please refer to your local labeling for information regarding the use of vaccines and infant exposure in utero to ustekinumab.
• A 6-month waiting period is recommended following birth before the administration of live vaccines for infants exposed in utero to ustekinumab.¹
• Data regarding the use of vaccines in infants exposed in utero to ustekinumab are available from a prospective study, a registry, and case reports.^2-5

COMPANY CORE DATA SHEET

STELARA CLINICAL INFORMATION

Warnings and Precautions

Immunizations

Infant Exposure In Utero

For infants exposed in utero to ustekinumab, a six-month waiting period following birth is recommended before the administration of live vaccines. Administration of a live vaccine prior to 6 months of age may be considered if ustekinumab dosing was limited to the first trimester of pregnancy when placental transport is minimal, or ustekinumab serum levels are undetectable in the infant, or the benefit of the vaccination clearly outweighs the theoretical risk of administration of live vaccines to the infant.¹

CLINICAL DATA

Prospective Study

Mitrova et al (2022)² conducted a prospective, multicenter, observational study in women with inflammatory bowel disease (IBD) receiving STELARA or vedolizumab during pregnancy. Results pertinent to STELARA are summarized below.

• Women with IBD exposed to STELARA within 2 months prior to conception or during pregnancy were included.
• Maternal venous blood and umbilical cord blood were collected on the day of delivery to determine the level of ustekinumab.
• There were 20 infants exposed to ustekinumab with a median follow-up of 18 months.
• All but one infant exposed to ustekinumab entered the mandatory vaccine program (all non-live vaccines). No serious or unexpected adverse events were reported.
• Three infants exposed to ustekinumab received the rotavirus vaccination within 3 months after birth (last drug administration at gestational week 30-32, cord blood level 2.0 mg/L – available only in 1 patient). No side effects were reported.

Pregnancy in Inflammatory Bowel Disease and Neonatal Outcomes (PIANO) Registry

Beaulieu et al (2018)³ reported the use of vaccines in newborns exposed in utero to biologics through the prospective, multicenter PIANO registry. Results pertinent to STELARA are summarized below.

• Included in this substudy were infants ≥7 months of age.
• Cord blood and/or infant serum was assayed for ustekinumab concentrations and collected on the day of birth.
• Of the 43 infants born to women on biologics, 1 infant exposed to ustekinumab received the rotavirus vaccine.
  • No reaction was reported in this infant (ustekinumab level in infant, 40 mcg/mL).

Case Reports

Saito et al (2022)⁴ described the outcomes of an infant exposed in utero to ustekinumab born to a 36-year-old female patient with ulcerative colitis (UC).

• The patient was treated with STELARA (90 mg subcutaneously every 2-3 months) 2 weeks before her pregnancy was confirmed and continued until week 29 of gestation (administered at 5, 17, and 29 weeks of gestation). Oral 5-aminosalicyclic acid (4800 mg/day) was also administered during pregnancy and lactation.
• During pregnancy, her UC symptoms remained in remission.
• Her baby was delivered via cesarean section at 38 weeks and 3 days of gestation.
• The infant received Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine, combination diphtheria-pertussis-tetanus-inactivated polio vaccine (DPT-IPV), and 13-pneumococcal polysaccharide vaccine (PCV13) with no reported adverse events.
• Live vaccines, including the rotavirus and Bacillus Calmette-Guérin (BCG) vaccines, were not administered until 6 months of life.

Rocha et al (2015)⁵ reported pregnancy and fetal outcomes of a 25-year-old female patient receiving STELARA for plaque psoriasis.

• The female patient reported her pregnancy at 6 weeks (8^th month of therapy with STELARA); treatment was suspended at the time of the reported pregnancy. Her most recent dose of STELARA was about 18 days prior to conception.
• At 39 weeks, the infant was delivered and received routine vaccinations including hepatitis B and BCG. No complications were reported up to the time of this report.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 01 March 2024.