An established safety and tolerability profile

Adverse events1 Makena (n=310) Placebo (n=153)
Injection site pain 34.8% 32.7%
Injection site swelling 17.1% 7.8%
Urticaria 12.3% 11.1%
Pruritus 7.7% 5.9%
Injection site pruritus 5.8% 3.3%
Nausea 5.8% 4.6%
Injection site nodule 4.5% 2.0%
Diarrhea 2.3% 0.7%
  • Adverse reactions occurred in ≥2% of Makena-treated subjects, for auto-injector and intramuscular injection, at a higher rate than control subjects1
  • The most common adverse reactions for Makena were injection site reactions, urticaria, pruritus, nausea, and diarrhea1

Long-term safety of Makena for young children

  • A follow-up study of Makena in pregnant women assessed their children at a mean of 4 years (ages 2 to 5 years) using the Ages & Stages Questionnaire, which evaluates child development by various physical, mental, and social measures (Makena vs placebo)1,4
  • The proportion of children whose scores met the screening threshold for developmental delay in each developmental domain was similar for each treatment group4
  • There were no long-term safety implications observed in young children4