Fasturtec - supply shortage

Ongoing

rasburicase

Shortage information

Fasturtec is used to treat and prevent high levels of uric acid in the blood in order to prevent kidney failure. It is used in adults and children with blood cancers who are at risk of a sudden rise in uric acid levels when they start receiving chemotherapy (medicines to treat cancer).

Reason for shortage

A shortage in the supply of Fasturtec (7.5 mg/5 ml) is expected from 31 March 2023. This is due to a delay in transferring the manufacturing process. The duration of the shortage will vary from country to country but is expected to be resolved by June 2024.

Member States affected

Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, the Netherlands, Northern Ireland, Portugal and Sweden.

Information for healthcare professionals

• A delay in manufacturing transfer is expected to lead to a supply shortage of the 7.5 mg/5 ml presentation of Fasturtec. 
• The 1.5 mg/1 ml presentation of Fasturtec is not affected and can be used instead.
• When switching to the 1.5 mg/1 ml presentation, healthcare professionals are reminded to follow the appropriate preparation instructions. 
• A direct healthcare professional communication (DHPC) has been sent to relevant healthcare professionals and is also available on the EMA website.
• Additional advice may be available from the national competent authority.

Information for patients

• A delay in transferring the manufacturing process is expected to lead to a shortage of Fasturtec in the 7.5mg/5 ml presentation.
• The 1.5 mg/1 ml presentation of Fasturtec is not affected by the shortage and can be used instead.
• If Fasturtec 7.5 mg/5 ml is not available, your doctor or nurse will make up your dose using the 1.5 mg/1 ml presentation instead.
• Additional advice may be available from your national competent authority.

Key facts

• Medicines affected:
  Fasturtec
• Supply shortage status:
  Ongoing
• International non-proprietary name (INN) or common name:
  rasburicase
• Therapeutic area (MESH):
  Hyperuricemia
• Pharmaceutical forms affected:
  Powder and solvent for concentrate for solution for infusion
• Strengths affected:
  7.5 mg / 5 ml
• Availability of alternatives:
  Yes

Key dates

• Start of supply shortage:
  31/03/2023
• Expected resolution:
  June 2024
• First published:
  21/02/2023