American Regent Logo Corporate Seperator

Now Available! Hydroxyprogesterone Caproate
Injection, USP
  • The first "AP" Rated preservative free generic to Makena*1
  • Vial closure is not made with natural rubber latex




Hydroxyprogesterone Caproate Injection, USP can be ordered through the following wholesalers and distributors. [Continue to check back as additional wholesalers and distributors will be added.]



Cardinal Specialty
Item Number: 5463435
Phone: 1-866-677-4844
McKesson
Item No: 3917432
1-415-983-8300
HD Smith
Item No: 5725387
1-866-232-1222
Morris & Dickson
Item No: 363259
1-318-797-7900
Henry Schein
Item Number: 131-9522
Phone: 1-800-772-4346
McKesson Medical-Surgical
Item No: 1107840
1-855-571-2100
McGuff Medical Products
Item Number: 005165
Phone: 1-800-854-7220


**Makena is a registered trademark of AMAG Pharma USA, Inc.


verticle line seperator Medical Affairs 888-354-4855
(9am - 5pm Eastern Time, Monday - Friday)
877-845-6371
(Available outside of normal business hours)
Email: ma@luitpold.com

Customer Service 800-645-1706
(8:30am - 6pm Monday - Thursday and Friday 8:30am - 5pm Eastern time)
Email: inquiry@americanregent.com


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Frequently Asked Questions
Q. Is the American Regent’s product therapeutically equivalent to Makena?
A. Yes, it is therapeutically equivalent (AP rated) to Makena.
Q. Is the product preservative free?
A. Yes. The product is preservative free
Q. Is the vial stopper not made from natural rubber latex?
A. The vial stopper does not contain any natural rubber latex
Q. What are the storage conditions for the product?
A. The product needs to be stored between 20°C to 25°C (68°F to 77°F). Do not refrigerate or freeze product
Q. Is the product light sensitive?
A. Yes. The product needs to be protected from light. Store vial in its box. Store upright
Q. What is the dosing schedule?
A. Initiate once weekly (every 7 days) 250 mg intramuscular injections starting 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.
Q. What is the dosing schedule?
A. Initiate once weekly (every 7 days) 250 mg intramuscular injections starting 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.
Q. Can a patient self-administer injections?
A. Injections must be administered by a healthcare professional.
Q. What is the recommended administration rate?
A. Slow injection (over one minute or longer) is recommended.
Q. What is the recommended injection site?
A. Hydroxyprogesterone Caproate Injection, USP (NDC 0517-1767-01) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.
Q. Can the vial be used more than once?
A. Hydroxyprogesterone Caproate Injection, USP (NDC 0517-1767-01) is supplied as 1 mL of a sterile preservative-free clear yellow solution in a single-dose glass vial.
Q. What are the most common adverse reactions?
A. In a study where the Hydroxyprogesterone Caproate Intramuscular injection was compared with placebo, the most common adverse reactions reported with Hydroxyprogesterone Caproate intramuscular injection (reported incidence in ≥2% of subjects and higher 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%).







Hydroxyprogesterone Caproate Injection, USP 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 CONTRAINDICATIONS 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
ADVERSE REACTIONS 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. Postmarketing Experience 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
Skin: Rash
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. OVERDOSAGE 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


© 2018, American Regent, Inc., A Luitpold Pharmaceuticals, Inc. Company PP-CA-US-0001 (v7.0)     9/2018