ORIPRO

What it is

Oripro pessaries contain 100 mg or 200 mg of micronised progesterone in hard fat. The pessaries are opaque, bullet-shaped waxy solid masses designed for vaginal insertion. Progesterone is a naturally occurring female sex hormone secreted by the ovary, placenta and adrenal gland.

Approved indications

— Assisted reproductive technology (ART) treatment of infertile women with progesterone deficiency, requiring progesterone supplementation or replacement to support embryo implantation and maintain initial pregnancy. — Prevention of preterm birth in singleton pregnancies at risk due to shortened cervix (midtrimester sonographic cervix ≤25 mm) and/or where there is a history of spontaneous preterm birth.

Dosing overview

For ART treatment, duration is usually continued if the patient is pregnant, up to about the eleventh week of gestation. Other intravaginal therapies should not be used while progesterone pessary treatment is being undertaken.

Key safety warnings

Conditions that might be aggravated by fluid retention, such as asthma, seizure disorders, migraine, or cardiac or renal dysfunction, require use with caution and careful monitoring. A history of mental depression requires careful monitoring; discontinue if serious depression recurs during therapy. Diabetic patients require monitoring as high doses of progesterone therapy can lower glucose tolerance in some patients. Progesterone may increase low density lipoprotein (LDL) and lower high density lipoprotein (HDL) levels and aggravate problems in controlling hyperlipidemia. There is consistent evidence from several clinical trials and meta-analysis that supplementation with vaginal progesterone does not reduce risk of preterm birth or improve perinatal outcome in women with twin/multiple gestations. Efficacy and safety in pregnancies with threatened preterm labour or other risk factors for preterm birth has not been established. Use caution when driving a motor vehicle or operating machinery as dizziness or drowsiness may occur.

Contraindications

Oripro is contraindicated in sensitivity to progesterone or hard fat, undiagnosed vaginal bleeding, undiagnosed urinary tract bleeding, liver dysfunction or disease, active thrombophlebitis or thromboembolic disorder (deep vein thrombosis or pulmonary embolism) or a history of hormone associated thrombophlebitis or thromboembolic disorder, known or suspected malignancy of the breast or genital organs, and missed abortion or ectopic pregnancy. Progesterone is contraindicated in pregnancy during assisted reproductive technology treatment when normal progesterone levels are present.

PBS listing

The 200 mg pessary is listed on the PBS with 2 items, streamlined restriction, and an ex-manufacturer price of A$35.40. The 100 mg pessary is listed on the PBS with 1 item, streamlined restriction, and an ex-manufacturer price of A$47.88.

Regulatory history

Oripro was first listed on the ARTG on 8 October 1991 in both 100 mg and 200 mg jar formulations. Strip pack formulations of both strengths were first listed on 20 October 2009. In November 2020, the PBAC recommended Oripro for prevention of preterm birth. In July 2024, the PBAC recommended Oripro for luteal phase support as part of an assisted reproductive technology treatment cycle, and rescinded a previous July 2022 recommendation.