Novo Nordisk Pharmaceuticals has notified the Therapeutic Goods Administration (TGA) about a shortage of the somatropin products Norditropin FlexPro 5mg, 10mg and 15mg. The shortage, which is worldwide, is due to manufacturing issues and is expected to continue until 31 December 2023.
The pharmaceutical company Ipsen has notified the TGA that they are discontinuing the somatropin product NutropinAq and has advised clinicians to transition patients to an alternative product. The TGA is asking health professionals not to prescribe NutropinAq for patients affected by the shortage of Norditropin FlexPro products.
The TGA is working with Novo Nordisk as well as the suppliers of other somatropin products and the specialist health professionals who prescribe these products to limit the impact of this shortage on patients. We anticipate that with careful prescribing as outlined below, supplies of other available somatropin products should be adequate to cover patients’ needs during the shortage.
The TGA has 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 shortage of Norditropin FlexPro. 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 this shortage, please speak to your prescribing doctor.
Information for clinicians
Please note the following when prescribing somatropin products during the current shortage of Norditropin FlexPro:
- Genotropin (Pfizer), Omnitrope (Sandoz), Saizen (Merck Healthcare) and SciTropin A (SciGen) somatropin products are still 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.
- A very limited emergency stock of Norditropin FlexPro can only be accessed for patients in most need and/or where alternative brands/strengths are not available. In these circumstances, contact the Novo Nordisk Customer Care Centre via email at aunrccc@novonordisk.com or by calling 1800 668 626.
- Stocks of Norditropin FlexPro and Genotropin GoQuick should be conserved for adult patients, as there are limited PBS-subsidised alternatives.
- Genotropin MiniQuick should be conserved for paediatric patients who require a preservative-free formulation of somatropin.
- Avoid prescribing under regulation 49 (formerly regulation 24) unless absolutely necessary to allow fair distribution of available products.
- Do not to prescribe NutropinAq for patients affected by the shortage of Norditropin FlexPro products.
- Health professionals can contact the relevant pharmaceutical company directly when prescribing somatropin for advice on availability.
- Prescribers can go to www.pbs.gov.au/browse/section100-gh for information about Pharmaceutical Benefits Scheme (PBS) eligibility requirements for somatropin and somatrogon products.
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 while the current shortage is expected to end by 31 December 2023, this date may change and we encourage you to check the medicine shortage reports database 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 a medicine shortage to health professionals and patients, but we cannot compel companies to increase supply or apply to have their products subsidised on the Pharmaceutical Benefits Scheme (PBS).
Also, the TGA can suggest approaches to manage the supply of medicines during shortages but does not have the power to regulate the clinical decisions of health professionals.
The TGA will continue to monitor the supply of somatropin and work with the suppliers and relevant health professionals to update this advice if needed.