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.

There has been a recent shortage of a number of menopausal hormone therapy (MHT) preparations and some of these have now been or soon will be resolved:

Oral MHT

Duavive – supply due to be resolved by end January 2022

Progynova 2mg – supply due to be resolved by end of April 2022

Femonston Conti – supply shortage expected between 25 June and 9 July

Transdermal MHT

Estradot 100 – supply due to be resolved by 31 August

Estradot 75 – supply due to be resolved by 31 August

Estradot 50 – supply due to be resolved by 1 July

Estradot 37.5 – supply due to be resolved by 31 August

Estradot 25 – supply due to be resolved by 1 July

Estalis Conti 50/140 – supply resolved

Estalis Conti 50/250 – supply resolved

Estalis Sequi 50/140 – supply resolved

Estalis Sequi 50/250 – supply resolved

Estraderm MX 50 – supply resolved

Estraderm MX 100 - supply resolved

Non-Hormonal Options

There is also an expected shortage of supply of non-hormonal treatment options:

Gabapentin-APOTEX 100mg – supply shortage expected between 20 August- 15 October

Gabapentin 300mg- supply shortage expected between 18 June- 16 July

APX-Gabapentin 300mg- supply shortage expected between 16 July- 6 August

Gabapentin-APOTEX 300mg – to be discontinued from 18 July

Combined oral contraceptive pill

There is also an expected shortage of combined oral contraceptive pill:

Qliara – supply due to be resolved by 1 June 2022

Please note that dates for supply have been sourced from either the pharmaceutical supplier or the TGA website and may change at any time.