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Shortage of PROGYNOVA estradiol valerate addressed with SSSI

12 August 2021: 

Information for Doctors

The Therapeutic Goods Administration (TGA) is advising health professionals and consumers of a current shortage for all strengths of PROGYNOVA estradiol valerate tablets. Due to manufacturing issues the shortage is expected to continue until May 2022.

PROGYNOVA tablets are used for short-term relief of symptoms associated with menopause.

The TGA has made a Serious Scarcity Substitution Instrument (SSSI) to assist patients in accessing their medicine from their pharmacist without delay, ensure treatments are not interrupted and relieve workload pressure on prescribers and pharmacists.

The SSSI is in force from 13 August 2021 until 1 May 2022. The TGA may, however, revoke the SSSI before its end date if the serious scarcity is resolved, or safety concerns are identified.

For more information see Substitution instrument to address shortage of PROGYNOVA estradiol valerate tablets (multiple strengths)

You should be alert to the current shortage of Progynova tablets when prescribing to your patients. Consider prescribing available estradiol-only tablets such as Estrofem and Zumenon tablet.

Zumenon is PBS-listed when prescribed but Estrofem is not.

Information for patients

Talk to your doctor or pharmacist if you have any questions regarding this substitution.

The pack size of estradiol-only tablets varies between brands. However, your pharmacist will supply the correct total dose that your doctor has prescribed.

If you have been prescribed Progynova 1mg or 2mg tablets and you receive a substitute medicine, your pharmacist will explain to you how to take your tablets.

If you are provided 2 mg tablets as a substitute for your usual 1 mg tablets, ask your pharmacist for advice on how to cut the tablets. If someone else is cutting the tablets for you, they may need to consider using personal protective equipment such as gloves and a mask to avoid unintended exposure to estradiol. Low dose of unintended exposure may cause harm or pose a risk of harm.

Excipients (inactive ingredients) vary between brands. Let your pharmacist know if you are allergic or intolerant to certain ingredients. You can also find information about excipients in the Consumer Medicine Information (CMI) leaflet, which is available from your pharmacist or on the TGA website.