Hydroxyprogesterone Caproate is indicated for:

Reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth

Prevention of preterm labor in a singleton pregnancy for patients aged 16 years or older who have a history of spontaneous preterm birth

Hydroxyprogesterone caproate is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid). The mechanism by which progesterone prevents preterm birth is not well understood, but many pathways are likely involved. (1) Progesterone plays a vital role in the regulation of the female reproductive system and is important for successful implantation of the embryo and maintenance of pregnancy. It acts by binding to progesterone receptors in the uterus, ovaries, breasts and in the central nervous system. These receptors exist in two isoforms, PR-A and PR-B. Progesterone binding to these receptors ultimately leads to regulation of gene transcription. (2) This results in an anti-inflammatory effect which blunts the proinflammatory state that occurs with initiation of labor, and maintains uterine quiescence by stabilizing progesterone acting on the myometrium.

Administer intramuscularly at a dose of 500 mg or 250 mg once weekly. Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Administration-

• Clean the ampoule top with an alcohol swab before use.
• Draw up 1 ml of drug into a 2 ml syringe.
• After preparing the skin, inject into the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
• Applying pressure to the injection site may minimize bruising and swelling.

• 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

Most Common: Injection site reactions (pain, swelling, pruritus, nodule), hives, itching, nausea, and diarrhea.

Call your doctor if you get any of the symptoms below:

• Blood clots symptoms: Leg swelling, redness in your leg, a spot on your leg that is warm to touch, leg pain that worsens when you bend your foot
• Allergic reactions: Hives, itching, swelling of the face

Pregnancy: Category B. No adequate and well-controlled studies in women during the first trimester of pregnancy. Teratogenic risks to infants following in utero exposure to the drug have not been demonstrated in a study of pregnant women receiving the drug during their second and third trimesters, as well as in a follow-up safety study of their infants. Not intended to stop active preterm labor; the effect of the drug for this use is unknown.

Lactation: Detectable amounts of progestins have been identified in the breast milk of women receiving progestins. No adverse effects of progestins on breastfeeding performance or on the health, growth, or development of infants have been observed. Discontinue the drug at 37 weeks of gestation or upon delivery.

• Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs.
• Allergic reactions: Consider discontinuing if allergic reactions occur.
• Decreased glucose tolerance: Monitor pre-diabetic and diabetic women receiving Hydroxyprogesterone Caproate.
• Fluid retention: Monitor women with conditions that may be affected by fluid retention, such as pre-eclampsia, epilepsy, cardiac or renal dysfunction.
• Depression: Monitor women with a history of clinical depression; discontinue Hydroxyprogesterone Caproate if depression recurs.
• Jaundice: Carefully monitor women who develop jaundice while receiving Hydroxyprogesterone Caproate and consider whether the benefit of use warrants continuation.
• Hypertension: Carefully monitor women who develop hypertension while receiving Hydroxyprogesterone Caproate and consider whether the benefit of use warrants continuation.

Pediatric Use: Not indicated for use in pediatric patients. Safety and efficacy have not been established in pediatric patients under 16 years of age. A limited number of women under 18 years of age have been studied; safety and efficacy are expected to be the same in women over 16 years of age compared with those over 18 years of age.

Geriatric Use: Not evaluated in women over 65 years of age. Not intended for use in postmenopausal women. Safety and efficacy have not been established in postmenopausal women.

Hepatic Impairment: Contraindicated in patients with liver tumors (benign or malignant) or active liver disease. The effect of hepatic impairment on the pharmacokinetics of the drug has not been evaluated.

Renal Impairment: The effect of renal impairment on the pharmacokinetics of the drug has not been evaluated.

No adverse events associated with overdosage have been reported.

Store at controlled room temperature between 15°C to 30°C. Protect from light. Keep out of the reach of children.