Hycamtin - supply shortage
Ongoing
topotecan
Shortage
Human
Shortage information
Hycamtin is used on its own to treat patients with:
- metastatic cancer of the ovary (when the cancer has spread to other parts of the body). It is used after at least one other treatment has failed;
- small cell lung cancer, when the cancer has relapsed (come back) after treatment.
It is used when giving the original treatment again is not recommended. It is also used with cisplatin (another cancer medicine) to treat women with cervical cancer that has come back after radiotherapy or is at an advanced stage (has spread beyond the cervix).
A quality defect was found in some batches of the medicine. These batches were not released and manufacturing was suspended, causing a shortage of the medicine.
The shortage affects some of the EU/EEA Member States where the product is marketed: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Netherlands, Norway, Poland, Spain, Portugal, Romania and Sweden.
EMA’s Single Point of Contact (SPOC) working party is closely monitoring the supply situation and engaging with the marketing authorisation holder and other stakeholders to identify measures to mitigate the impact of the supply shortage.
The SPOC working party is responsible for monitoring and reporting events that could affect the supply of medicines in the EU.
- An out-of-specification assay finding in some batches of Hycamtin has led to a suspension of production, causing a shortage of the medicine.
- The company that markets the medicine is working with national authorities to remedy the shortage.
- To alleviate the supply situation, affected Member States may import the medicine from markets where the product is still available.
- In the meantime, healthcare professionals should consider switching patients to topotecan-containing intravenous formulations.
- Please consult your national shortage register for further advice, including advice on alternatives.
- A halt in production has caused a shortage of Hycamtin.
- Your doctor may change your treatment to other medicines that contain topotecan. These medicines may be given as an injection in the hospital.
- Please consult your national shortage register for further advice.
Key facts
- Medicines affected
- Hycamtin
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- topotecan
- Therapeutic area (MESH)
- Ovarian Neoplasms
- Uterine Cervical Neoplasms
- Small Cell Lung Carcinoma
- Pharmaceutical forms affected
- Capsule, hard
- Strengths affected
- 0.5 mg
- 1 mg
- Availability of alternatives
- Yes
Key dates
- First published