Pregnancy indications: Preterm birth (Makena): To reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Non- pregnancy indications (generic product): Treatment of advanced (stage III or IV) uterine adenocarcinoma; management of amenorrhea (primary and secondary) and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology (eg, submucous fibroids or uterine cancer); as a test for endogenous estrogen production; production of secretory endometrium and desquamation.(UTD)

Hydroxyprogesterone caproate is a synthetic progestin. The mechanism by which it decreases the risk of recurrent preterm birth is unknown.

Metabolism:
Hepatic: extensive via CYP3A4- and CYP3A5-mediated reduction, hydroxylation, and conjugation reactions.
Excretion:
Renal: 30% (free steroids and conjugated metabolites)
Elimination Half Life:
16.4 days .

Breast cancer or other estrogen or progestin-sensitive cancer, known, suspected, or history of
Diagnostic test for pregnancy
Hepatic dysfunction or disease
Hepatic tumors, benign or malignant
Hypersensitivity to hydroxyprogesterone caproate or any component of the product
Hypertension, uncontrolled
Missed abortion
Pregnancy-related cholestasis
Thrombosis or thromboembolic disorder, current or past history
Vaginal bleeding, undiagnosed, abnormal (not related to pregnancy)

B (FDA) D (AUS)

Infant risk cannot be ruled out.(MDX)

Common:
Dermatologic: Injection site pain (34.8% ), Injection site pruritus (5.8% ), Injection site reaction (4.5% ), Pruritus (7.7% ), Swelling at injection site (17.1% ), Urticaria (12.3% )
Gastrointestinal: Diarrhea (2.3% ), Nausea (5.8% )
Serious:
Hematologic: Thromboembolic disorder.(UTD)

Pregnancy indications: Preterm birth (Makena): Pregnant females ?16 years: IM: 250 mg once weekly (every 7 days). Treatment may begin between 16 weeks 0 days and 20 weeks 6 days of gestation. Continue weekly administration until 37 weeks gestation or until delivery, whichever comes first.
Non-pregnancy indications (generic product):
Amenorrhea (primary and secondary) or abnormal uterine bleeding due to hormonal imbalance: IM:
Single dose therapy: 375 mg as a single dose; begin at any time or
Cyclic therapy schedule: 250 mg on day 15 of each 28-day cycle for 4 cycles (in combination with estradiol valerate); begin cyclic therapy schedule after 4 days of desquamation. If there is no bleeding, begin cyclic therapy schedule 21 days after the 375 mg single dose schedule.
Production of secretory endometrium and desquamation: IM:
Patients not on estrogen therapy: Cyclic therapy schedule: 250 mg on day 15 of each 28-day cycle (in combination with estradiol valerate); may begin at any time; continue until cyclic therapy is no longer required.
Patients currently on estrogen therapy:
Single dose therapy: 375 mg as a single dose; begin at any time or
Cyclic therapy schedule: 250 mg on day 15 of each 28-day cycle (in combination with estradiol valerate); begin cyclic therapy schedule after 4 days of desquamation. If there is no bleeding, begin cyclic therapy schedule 21 days after the 375 mg single dose schedule. Continue until cyclic therapy is no longer required.
Test for endogenous estrogen production: IM: 250 mg as a single dose (bleeding 7 to 14 days after administration indicates endogenous estrogen); may repeat once 4 weeks after initial dose.
Uterine adenocarcinoma (advanced): IM: 1,000 mg one or more times a week (1,000 to 7,000 mg/week); discontinue upon relapse.(UTD)

Safety and effectiveness have not been demonstrated in pediatric patients younger than 16 years.(UTD)