PROLUTEX

What it is

Prolutex is a progesterone solution for injection, with each vial containing 25 mg of progesterone. It is presented as a clear colourless solution. Progesterone is classified as a sex hormone and modulator of the genital system.

Approved indications

— Luteal support as part of an Assisted Reproductive Technology (ART) treatment program in women who are unable to use or tolerate vaginal preparations, or where there is a need or preference to use an injectable form of progesterone.

Dosing overview

Prolutex is administered once daily from the day of oocyte retrieval for up to 12 weeks where pregnancy is confirmed, at a dose of 25 mg given subcutaneously by the patient herself after instruction or intramuscularly by a doctor.

Key safety warnings

Prolutex should be discontinued if myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis, or retinal thrombosis are suspected. Patients with a history of depression need to be closely observed, and discontinuation should be considered if symptoms worsen. Because progesterone may cause some degree of fluid retention, conditions that might be influenced by this factor such as epilepsy, migraine, asthma, cardiac or renal dysfunction require careful observation. Diabetic patients should be carefully observed while receiving progesterone therapy. Sex steroid use may increase the risk of retinal vascular lesions; caution is to be taken in users over 35 years, in smokers, and in those with risk factors for atherosclerosis. Use should be terminated in case of transient ischaemic events, appearance of sudden severe headaches, or vision impairments related to papillary oedema or retinal haemorrhage. Abrupt discontinuation of progesterone dosing may cause increased anxiety, moodiness, and increased sensibility to seizures.

Contraindications

Prolutex should not be used in individuals with hypersensitivity to progesterone or to any of the excipients, undiagnosed vaginal bleeding, known missed abortion or ectopic pregnancy, severe hepatic dysfunction or disease, known or suspected breast or genital tract cancer, active arterial or venous thromboembolism or severe thrombophlebitis or a history of these events, porphyria, or a history of idiopathic jaundice, severe pruritus or pemphigoid gestationis during pregnancy.

Key safety warnings (continued — adverse effects)

The most frequently reported adverse drug reactions during treatment with Prolutex during clinical trials are administration site reactions, and breast and vulvo-vaginal disorders. Prolutex has minor or moderate influence on the ability to drive and use machines, as progesterone may cause drowsiness and/or dizziness.

Regulatory history

Prolutex progesterone 25 mg/1.112 mL solution for injection vial was first registered on the ARTG on 13 September 2023. The date of first approval was 12 December 2024.