Formulary

8.4.11 Topoisomerase I inhibitors

First Line
Second Line
Specialist
Hospital Only
Irinotecan hydrochloride
  • Solution for infusion vials 20mg/1ml
Pegylated liposomal irinotecan hydrochloride
  • Onivyde pegylated liposomal concentrate for dispersion for infusion vials 43mg/10ml

Notes

  1. NICE TA440: Pegylated liposomal irinotecan (Onivyde), in combination with 5‑fluorouracil and leucovorin, is not recommended, within its marketing authorisation, for treating metastatic adenocarcinoma of the pancreas in adults whose disease has progressed after gemcitabine-based therapy (April 2017).
  2. MHRA Drug Safety Update (March 2019): Onivyde (irinotecan, liposomal formulations): reports of serious and fatal thromboembolic events.
  3. MHRA Drug Safety Update (July 2020): Liposomal and lipid-complex formulations: name change to reduce medication errors.
Topotecan hydrochloride
  • Capsules 250micrograms, 1mg
  • Powder for solution for infusion vials 1mg, 4mg
  • Concentrate for solution for infusion 1mg/1ml

Notes

  1. NICE TA183: Topotecan in combination with cisplatin is recommended as a treatment option for women with recurrent or stage IVB cervical cancer only if they have not previously received cisplatin (October 2009).
  2. NICE TA184: Topotecan for the treatment of relapsed small-cell lung cancer (November 2009)
    1. Oral topotecan is recommended as an option only for people with relapsed small-cell lung cancer for whom:
      • re-treatment with the first-line regimen is not considered appropriate and
      • the combination of cyclophosphamide, doxorubicin and vincristine (CAV) is contraindicated (for details of the contraindications to CAV see the SmPC for each of the component drugs).
    2. Intravenous topotecan is not recommended for people with relapsed small-cell lung cancer.
  3. NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride (Caelyx), paclitaxel, trabectedin (Yondelis) and gemcitabine for treating recurrent ovarian cancer (April 2016):
    1. Topotecan is not recommended within its marketing authorisation for treating the first recurrence of platinum sensitive ovarian cancer.
    2. Topotecan is not recommended within its marketing authorisation for treating recurrent platinum‑resistant or platinum‑refractory ovarian cancer.