Makena® is a progestin indicated to reduce the risk of preterm birth in women
with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
The effectiveness of Makena is based on improvement in the proportion of women who
delivered <37 weeks of gestation. There are no controlled trials demonstrating a
direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety
and efficacy of Makena has been demonstrated only in women with a prior spontaneous
singleton preterm birth. It is not intended for use in women with multiple gestations
or other risk factors for preterm birth.
Important safety information for Makena (hydroxyprogesterone caproate injection)
- Do not use Makena in women with any of the following conditions:
|
–
|
Current or history of thrombosis or thromboembolic disorders
|
|
–
|
Known or suspected breast cancer, other hormone-sensitive cancer or history of these
conditions
|
|
–
|
Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
|
|
–
|
Cholestatic jaundice of pregnancy
|
|
–
|
Liver tumors, benign or malignant, or active liver disease
|
|
–
|
Uncontrolled hypertension
|
- Makena should be discontinued if thrombosis or thromboembolism occurs
- Allergic reactions, including urticaria, pruritus and angioedema, have been reported
with use of Makena or with other products containing castor oil
- Women receiving Makena should be monitored if they:
|
–
|
Are prediabetic or diabetic
|
|
–
|
Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy,
cardiac or renal dysfunction
|
|
–
|
Have a history of clinical depression; Makena should be discontinued if depression
recurs
|
|
–
|
Develop jaundice; consider whether benefit of use warrants continuation
|
|
–
|
Develop hypertension
|
- Certain pregnancy-related fetal and maternal complications or events were numerically
increased in Makena-treated subjects as compared to placebo subjects, including
miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor
(16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational
diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)
- The most common adverse reactions reported in ≥2% of subjects and at a higher rate
in the Makena group than in the control group were injection site reactions (pain
[35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]),
urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea
(2% vs. 1%)