Natpar - supply shortage
Ongoing
parathyroid hormone
Shortage
Human
Shortage information
Natpar is used to treat adults with hypoparathyroidism (under-active parathyroid glands). It is used as an add-on to treatment with calcium and vitamin D supplements when these treatments have not worked well enough.
Manufacturing of all strengths of Natpar will be discontinued globally at the end of 2024 and as a result Natpar will be withdrawn from the global market. This is due to manufacturing challenges which already affected the Natpar 100 micrograms/dose strength which has been unavailable since the end of June 2022. Beyond 2024, Takeda intends to supply available doses until the inventory is depleted or expired.
All EU/EEA Member States where Natpar is marketed: Austria, Belgium*, Cyprus*, Czech Republic, Finland, Germany, Greece, Hungary, Italy*, the Netherlands, Portugal*, Romania*, Spain*, Sweden and Norway.
The countries marked with an * indicate countries with a named patient program.
- Manufacturing of all strengths of Natpar will be discontinued globally at the end of 2024. This is due to manufacturing challenges which already affected the Natpar 100 micrograms/dose strength which has been unavailable since the end of June 2022 and as a result Natpar will be withdrawn from the global market. No new patients should be started on any strength of Natpar.
- For patients currently on 100 micrograms once a day, healthcare professionals can prescribe an alternative regimen while alternative strengths are available:
- two separate injections of Natpar 50 micrograms/dose (the second dose should be administered in the contralateral thigh using a new needle within 15 minutes of the first dose) or
- a reduced dose of 75 micrograms once a day, if appropriate.
- For any alternative regimen, patients should be given instructions on how to give the injection (please refer to appendix of the direct healthcare professional communication (DHPC)).
- Healthcare professionals should closely monitor serum calcium levels and monitor patients for signs and symptoms of hypocalcaemia, and adjust dosing of vitamin D and supplemental calcium as necessary. Additional advice may be available from the national competent authority.
- A direct healthcare professional communication (DHPC) has been sent to relevant healthcare professionals.
- The DHPC also contains instructions for the patients which should be given and explained to them.
- Manufacturing of all strengths of Natpar will be discontinued globally at the end of 2024 and as a result Natpar will be withdrawn from the global market. This is due to manufacturing challenges which already affected the Natpar 100 micrograms/dose strength which has been unavailable since the end of June 2022. No new patients will be started on any strength of Natpar.
- If you are currently taking 100 micrograms once a day, your doctor will prescribe an alternative dosing regimen, while alternative strengths are available. They will either prescribe:
- two separate injections of Natpar 50 micrograms or
- a reduced dose of 75 micrograms once a day, if appropriate.
- Your healthcare professional will advise you on how to give the new regimen (please refer to the patient/carer instructions published in the appendix of the of direct healthcare professional communication (DHPC)).
- Your doctor will closely monitor your blood calcium levels and may need to adjust the doses of your vitamin D and calcium supplements.
- You will receive information from your healthcare professional. A copy of this letter can be found below. If you have any questions you should speak to your doctor or pharmacist.
- Additional advice may be available from the national competent authority.
Key facts
- Medicines affected
- Natpar
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- parathyroid hormone
- Therapeutic area (MESH)
- Hypoparathyroidism
- Pharmaceutical forms affected
- Powder and solvent for solution for injection
- Strengths affected
- 100 micrograms/dose
- 75 micrograms/dose
- 50 micrograms/dose
- 25 micrograms/dose
Key dates
- First published
- Last updated