Safety
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
