CRINONE

What it is

CRINONE contains progesterone (micronized) . It is formulated as an 8% progesterone 90 mg/1.125 g gel supplied in a single dose pre-filled applicator .

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 prevention of preterm birth, treatment can be initiated during the second trimester (16–24 weeks gestation) and is to be continued to the end of the 36th week of gestation or until delivery. For ART use, treatment duration is usually continued if the patient is pregnant, up to about the eleventh week of gestation.

Key safety warnings

Use with caution and careful monitoring in conditions that might be aggravated by fluid retention, such as asthma, seizure disorders, migraine, or cardiac or renal dysfunction. History of mental depression requires caution; discontinue if serious depression recurs during therapy. Diabetic patients require monitoring as high doses of progesterone therapy can lower glucose tolerance in some patients. 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.

Contraindications

CRINONE 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 (ART) treatment, when normal progesterone levels are present.

PBS listing

CRINONE 90 mg vaginal gel (prolonged release) in single dose pre-filled applicator is listed on the PBS as one item with streamlined restriction, with an ex-manufacturer price of A$93.82.

Regulatory history

CRINONE was first registered on the ARTG on 25 September 2002.