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American Regent, Inc.
5 Ramsey Road
Shirley, NY 11967
For Intramuscular Use Only
INDICATIONS AND USAGE
Hydroxyprogesterone caproate injection 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.
It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
IMPORTANT SAFETY INFORMATION
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.
WARNINGS AND PRECAUTIONS
Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs.
Allergic reactions: Consider discontinuing if allergic reactions occur.
Decreased glucose tolerance: Monitor prediabetic and diabetic women receiving hydroxyprogesterone caproate injection.
Fluid retention: Monitor women with conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction.
Depression: Monitor women with a history of clinical depression; discontinue hydroxyprogesterone caproate injection if depression recurs.
Jaundice: Monitor women who develop jaundice while receiving hydroxyprogesterone caproate injection and consider whether the benefit of use warrants continuation.
Hypertension: Monitor women who develop hypertension while receiving hydroxyprogesterone caproate injection and consider whether the benefit of use warrants continuation.
Most common adverse reactions reported in ≥2% of subjects and at a higher rate in the hydroxyprogesterone caproate injection group than in the control group were injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%). For the most serious adverse reactions to the use of progestins, see Warnings and Precautions.
The following adverse reactions have been identified during post approval use of hydroxyprogesterone caproate injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a whole: Local injection site reactions (including erythema, urticaria, rash, irritation, hypersensitivity, warmth); fatigue; fever; hot flashes/flushes
Digestive disorders: Vomiting
Infections: Urinary tract infection
Nervous system disorders: Headache, dizziness
Pregnancy, puerperium and perinatal conditions: Cervical incompetence, premature rupture of membranes
Reproductive system and breast disorders: Cervical dilation, shortened cervix
Respiratory disorders: Dyspnea, chest discomfort
USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary:
Data from the placebo-controlled clinical trial and the infant follow-up safety study did not show a difference in adverse developmental outcomes between children of hydroxyprogesterone caproate injection-treated women and children of control subjects. However, these data are insufficient to determine a drug-associated risk of adverse developmental outcomes as none of the hydroxyprogesterone caproate injection-treated women received the drug during the first trimester of pregnancy.
Lactation Risk Summary: Low levels of progestins are present in human milk with the use of progestin containing products, including hydroxyprogesterone caproate. Published studies have reported no adverse effects of progestins on the breastfed child or on milk production.
Pediatric Use: Hydroxyprogesterone caproate injection is not indicated for use in women under 16 years of age.
Hepatic Impairment: Hydroxyprogesterone caproate injection is extensively metabolized and hepatic impairment may reduce the elimination of hydroxyprogesterone caproate injection.
In the case of overdosage, the patient should be treated symptomatically.
For additional Safety Information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088. Reference:
1. Approved Drug Products with Therapeutic Equivalence Evaluations https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=210723. Accessed June 2018