About the shortage of somatropin products

Novo Nordisk notified us about a shortage of the somatropin products Norditropin FlexPro 5 mg, 10 mg and 15 mg in July 2023. The shortage, which is worldwide, is due to manufacturing issues. We published a web alert about this shortage on 27 July 2023. Updates to this information as well as details about other somatropin products affected by shortages follow.

• Novo Nordisk has extended the shortage dates of their Norditropin FlexPro somatropin products. The shortage of the 10 mg and 15 mg strengths has been extended until 31 January 2024. The shortage of the 5 mg strength has been extended until 30 June 2024. There will be limited availability of these products during this time. 
• Due to increased demand, Pfizer Australia has also reported a shortage of their Genotropin GoQuick 5 mg somatropin product. This shortage is expected to resolve on 15 April 2024.
• As the pharmaceutical company Ipsen has discontinued the somatropin product NutropinAq and has advised clinicians to transition patients to an alternative product, we are asking health professionals not to prescribe NutropinAq for patients affected by the shortage of Norditropin FlexPro or Genotropin GoQuick products.

We are working with Novo Nordisk and Pfizer, as well as the suppliers of other somatropin products and the specialist health professionals who prescribe these products, to limit the impact of these shortages on patients. We anticipate that with careful prescribing as outlined below, supplies of other available somatropin products should be adequate to cover patients’ needs.

We have developed the following advice with the Australia and New Zealand Society for Paediatric Endocrinology and Diabetes, and the Endocrine Society of Australia.

Information for patients

We understand the importance of somatropin for patients receiving it, and we appreciate the concern a shortage of this medicine may cause.

A specialist health professional may need to prescribe a different brand of somatropin (growth hormone) for you or a child in your care during the current shortages of Norditropin FlexPro and Genotropin GoQuick. They may also need to vary your treatment temporarily, which may include safe adjustment of your treatment schedule.

Please be assured that specialist doctors are experienced in managing their individual patients’ care when a medicine is in short supply or unavailable. If you have any concerns or questions about your medicine during these shortages, please speak to your prescribing doctor.

Information for clinicians

Please note the following when prescribing somatropin products during the current shortage of Norditropin FlexPro and Genotropin GoQuick 5 mg:

• Omnitrope (Sandoz), Saizen (Merck Healthcare), SciTropin A (SciGen), alternative strengths of Genotropin (Pfizer) and a limited supply of Norditropin FlexPro somatropin products are available but supply may be affected if prescribed without considering the potential for flow-on shortages.
• The long-acting growth hormone somatrogon (Ngenla) is also available for specific indications in paediatric patients.
• Stocks of Norditropin FlexPro, Genotropin GoQuick and Saizen should be conserved for adult patients, as there are limited Pharmaceutical Benefits Scheme (PBS)-subsidised alternatives.
• Genotropin GoQuick and Genotropin MiniQuick should be conserved for paediatric patients with Prader Willi syndrome, as there are no PBS-subsidised alternatives.
• Genotropin MiniQuick should also be conserved for paediatric patients who require a preservative-free formulation of somatropin.
• Do not prescribe NutropinAq for patients affected by the shortages of Norditropin FlexPro and Genotropin GoQuick products.
• Avoid prescribing under regulation 49 (formerly regulation 24) unless absolutely necessary to allow fair distribution of available products.
• Prescribers can go to the PBS website for information about PBS eligibility requirements for somatropin and somatrogon products.
• Health professionals can contact the relevant pharmaceutical company directly when prescribing somatropin for advice on availability.

Information for pharmacists

If you cannot fill a script for somatropin because the product is in shortage, reassure the patient that alternative treatment is available and either contact the prescriber directly or advise the patient to do so.

You may need to limit the number of repeats dispensed to ensure fair supply for all patients.

General information

Please note that the dates given for these shortages may change and we encourage you to check the medicine shortage reports database- external site for updates about the supply of somatropin products.

Please also keep in mind that the TGA can work with pharmaceutical companies to communicate information about medicine shortages to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the PBS.

Also, we can suggest approaches to manage the supply of medicines during shortages but we do not have the power to regulate the clinical decisions of health professionals.

We will continue to monitor the supply of somatropin and work with the suppliers and relevant health professionals to update this advice if needed.