Adult: For primary and secondary cases: As ampoule: 250 mg via slow IM inj into the upper outer quadrant of the gluteus maximus or the upper arm, usually given between days 18 and 20 of the menstrual cycle. Endometrial priming with an estrogen (e.g. for 14 days) must be carried out prior to starting treatment.
Intramuscular Reduction of premature birth risk
Adult: In women with singleton pregnancy who have a history of singleton spontaneous premature delivery: As single- or multiple-dose vials: 250 mg once weekly (every 7 days) via slow IM inj over ≥1 minute into the upper outer quadrant of the gluteus maximus. Initiate treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue once-weekly administration until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever comes first.
Intramuscular Recurrent miscarriage
Adult: For prevention of cases associated with proven progesterone deficiency: As ampoule: 250-500 mg weekly during the initial months of pregnancy, or longer if necessary.
Subcutaneous Reduction of premature birth risk
Adult: In women with singleton pregnancy who have a history of singleton spontaneous premature delivery: As auto-injector: 275 mg once weekly (every 7 days) via SC inj into the back of either upper arm. Initiate treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue once-weekly administration until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever comes first.
Contraindications
Known, suspected, or history of breast cancer or other hormone-sensitive cancer; undiagnosed abnormal vaginal bleeding not related to pregnancy; current or history of thrombosis or thromboembolic disorders; uncontrolled hypertension. Hepatic impairment, including liver tumours (benign or malignant), active liver disease, or cholestatic jaundice of pregnancy.
Special Precautions
Women with pre-diabetes or diabetes, history of clinical depression; risk factors for VTE (e.g. personal or family history, obesity, prolonged immobilisation, major trauma or surgery); existing or history of arterial and CV disease (e.g. MI, CVA, ischaemic heart disease); conditions that may be exacerbated by fluid retention (e.g. asthma, migraine, epilepsy, preeclampsia). Women who develop hypertension or jaundice during treatment. Treatment recommendations may vary among individual products or between countries (refer to detailed product guideline). Renal impairment. Pregnancy. For use in reduction of preterm birth risk: Not intended for use in women with multiple gestations or other risk factors for premature birth, or to stop active premature labour. Discontinue use at 37 weeks of gestation or upon delivery.
Adverse Reactions
Significant: Arterial thrombosis, DVT, thromboembolic events, retinal vascular thrombosis; hypersensitivity reactions (e.g. urticaria, pruritus, angioedema); certain degree of fluid retention, reduced glucose tolerance; recurrence of depression (in patients with history of clinical depression); chloasma (particularly in patients with history of chloasma gravidarum). Rarely, benign or malignant liver tumours. Gastrointestinal disorders: Nausea, diarrhoea. General disorders and administration site conditions: Inj site reactions (e.g. pain, swelling, redness, pruritus, nodules). Pregnancy, puerperium and perinatal conditions: Admission for preterm labour (other than delivery admission), preeclampsia or gestational hypertension, gestational diabetes, oligohydramnios. Skin and subcutaneous tissue disorders: Pruritus, urticaria.
Perform physical and gynaecological exam and take complete medical history before treatment initiation. Monitor blood pressure; blood glucose (in patients with pre-diabetes or diabetes). When used for primary or secondary amenorrhoea: Verify pregnancy status and screen patient for the presence of prolactin-producing pituitary tumour prior to starting therapy; perform breast and pelvic examination, and Papanicolau smear before treatment. Assess for signs or symptoms of fluid retention, jaundice, thromboembolic disorders, or depression.
Drug Interactions
May enhance clearance and lead to decreased therapeutic efficacy when given with enzyme inducers (e.g. carbamazepine, rifampicin, barbiturates, phenytoin). May interfere with the metabolism of ciclosporin, particularly tissue and plasma concentrations.
Food Interaction
May enhance clearance and lead to decreased therapeutic efficacy when given with St. John's wort.
Lab Interference
May alter the results of some laboratory tests including hepatic, thyroid, adrenal and renal function tests, plasma levels of (carrier) proteins (e.g. lipid/lipoprotein fractions, corticosteroid-binding globulin), parameters of carbohydrate metabolism, and coagulation factors.
Action
Description: Mechanism of Action: Hydroxyprogesterone caproate, a synthetic progestin, is produced by the esterification of 17α-hydroxyprogesterone (a naturally occurring progesterone) with caproic acid. It has strong progestogenic activity and appears to provide a longer and more potent progestational effect than progesterone. The mechanism of action in reducing the risk of recurrent premature birth is unknown.
Synonym: hydroxyprogesterone hexanoate. Pharmacokinetics: Distribution: Plasma protein binding: Extensive (including albumin and corticosteroid-binding globulins). Metabolism: Extensively metabolised in the liver via reduction, hydroxylation, and conjugation mainly by CYP3A4 and CYP3A5 isoenzymes into conjugated metabolites (including sulfated, glucuronidated, and acetylated products). Excretion: Via urine (IM: approx 30%) and faeces (IM: approx 50%) as conjugated metabolites (predominant) and free steroids. Elimination half-life: Approx 8 days (non-pregnant females); 16.4 ± 3.6 days (IM; pregnant females with singleton pregnancies).
Chemical Structure
Hydroxyprogesterone caproate Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 169870, Hydroxyprogesterone caproate. https://pubchem.ncbi.nlm.nih.gov/compound/Hydroxyprogesterone-caproate. Accessed Sept. 27, 2021.
Storage
Single/multi-dose vials/auto-injector: Store between 20-25°C. Do not refrigerate or freeze. Protect from light. Store vials upright; multi-dose vials must be used within 5 weeks after 1st use. Ampoules: Store below 30°C. Protect from light. Storage recommendations may vary among individual products or countries. Refer to specific product guidelines.
Anon. Hydroxyprogesterone Caproate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 04/08/2021.Anon. Hydroxyprogesterone Caproate. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 04/08/2021.Buckingham R (ed). Hydroxyprogesterone Caproate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 04/08/2021.Hydroxyprogesterone Caproate Injection (Prasco Laboratories). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/09/2021.Makena Injection (AMAG Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 04/08/2021.Makena Injection (AMAG Pharmaceuticals, Inc.). U.S. FDA. https://www.fda.gov. Accessed 04/08/2021.Proluton Depot (Bayer Co. [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 04/08/2021.
Sign Out
