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Memo – shortage of supply
To:
From:
Date: 28th November 2016
Re: Hycamtin (topotecan) 0.25mg and 1 mg hard capsule
Description of product affected
Topotecan capsules are licensed as monotherapy for the treatment of adult patients with relapsed small cell lung cancer for whom re-treatment with the first-line regimen is not considered to be appropriate1.
Background
Novartis, the sole supplier of topotecan capsules, is now out of stock of both the 0.25mg and 1mg capsules due to manufacturing issues. This break in supply is a pan-European issue and is likely to last 2-4 weeks.
Alternative agents and management options
At present, the disruption in supply is limited to the oral formulation, and stock of the topotecan powder for concentrate for solution for infusion is still available (available from Novartis as the branded Hycamtin and from generic suppliers)2-3. Topotecan powder for concentrate for solution for infusion, like the oral formulation, is licensed for the treatment of patients with relapsed small cell lung cancer for whom re-treatment with the first-line regimen is not considered appropriate4. Subsequently, if topotecan is specifically required, the intravenous formulation can be used5 (dosing recommendations are available in the product information4). This decision will need to made by the patient’s individual clinician on a case-by-case basis as there will be a significant additional burden on both the patient and the NHS with use of the intravenous formulation over the oral formulation.
References
1. Novartis Pharmaceuticals UK Ltd. Hycamtin 0.25mg and 1mg hard capsule. SPC, date of revision 19 May 2015: http://www.medicines.org.uk/emc/medicine/21246
2. Personal communication: Medical Information Department, Novartis Pharmaceuticals UK Ltd, 28th November 2016
3. Personal communication: Commercial Medicines Unit, Department of Health, 28th November 2016
4. Novartis Pharmaceuticals UK Ltd. Hycamtin 1mg and 4mg powder for concentrate for solution for infusion. SPC, date of revision 19 May 2015: http://www.medicines.org.uk/emc/medicine/15277
5. Personal communication: Nisha Shaunak Lead Oncology Pharmacist, Guy’s and St Thomas’ NHS Foundation Trust, 28th November 2016
Acknowledgements
Nisha Shaunak, Lead Oncology Pharmacist, Guy’s and St Thomas’ NHS Foundation Trust
Original document prepared by:
Suhayla Dhanji, Guy’s and St Thomas’ NHS Foundation Trust Medicines Information Centre, 28th November 2016
Document modified by:
Name of individual at other centre using the product with modifications, centre, date
For all correspondence please contact:
Name of person at base hospital where memo is circulated (i.e. NOT the original author at Guy’s and St Thomas’ NHS Foundation Trust
Disclaimer: The content of some of this memo is based on clinical opinion from practitioners. Users should bear this in mind in deciding whether to base their policy on this document. Individual trusts should ensure that procedures for unlicensed medicines are followed where a foreign import drug is required in the interim.