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topotecan

Hycamtin, Topotecan Hospira · ATC code L01CE01

Also known as: Topotekan · Brand names: Hycamtin, Topotecan Hospira, Topotecan Accord, Topotecan Ebewe, Topotecan Hikma, Topotecan Hexal, Topotecan Phares, Hycamtin IV Liyofilize, Tekan-L, Topotu, Topoxin

Key facts
Active substance
topotecan
ATC code
L01CE01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
HYCAMTIN 1 mg powder for concentrate for solution for infusion / HYCAMTIN 4 mg powder for concentrate for solution for infusion · HYCAMTIN 0.25 mg hard capsules / HYCAMTIN 1 mg hard capsules · Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion
Marketing authorisation holder
Sandoz Pharmaceuticals d.d., Pfizer Europe MA EEIG
Information as of
2026-10-28

Key facts

Topotecan (Hycamtin, Topotecan Hospira) is a topoisomerase I inhibitor cytotoxic agent used for ovarian cancer, small cell lung cancer and cervical cancer.

What it is used for

  • Infusion (Hycamtin, Topotecan Hospira): monotherapy in metastatic ovarian carcinoma after failure of first-line or subsequent therapy, and in relapsed small cell lung cancer (SCLC) when re-treatment with the first-line regimen is not appropriate.
  • Infusion: in combination with cisplatin for cervical carcinoma recurrent after radiotherapy and Stage IVB disease.
  • Hycamtin hard capsules: monotherapy in adults with relapsed SCLC when re-treatment with the first-line regimen is not appropriate.

Dosing

  • Before the first course: neutrophils 1.5 × 10⁹/l, platelets 100 × 10⁹/l and haemoglobin ≥9 g/dl.
  • Infusion, ovarian and small cell lung carcinoma: 1.5 mg/m²/day over 30 minutes for five consecutive days, three weeks between courses; after severe neutropenia or platelets below 25 × 10⁹/l reduce to 1.25 mg/m²/day, then 1.0 mg/m²/day if needed.
  • Infusion, cervical carcinoma: 0.75 mg/m²/day on days 1, 2 and 3, cisplatin 50 mg/m² on day 1; repeated every 21 days for six courses.
  • Hycamtin capsules (SCLC): 2.3 mg/m²/day for five consecutive days, three weeks between courses; swallow whole.
  • Infusion with creatinine clearance 20 to 39 ml/min (monotherapy): 0.75 mg/m²/day; not recommended below 20 ml/min.

Contraindications

  • Severe hypersensitivity to the active substance or any excipient.
  • Breast-feeding.
  • Severe bone marrow depression before the first course (neutrophils <1.5 × 10⁹/l and/or platelets 100 × 10⁹/l).

Important warnings

  • Dose-related severe myelosuppression; fatal sepsis has been reported – check blood counts regularly.
  • Neutropenic colitis, including fatal cases, should be considered with fever, neutropenia and abdominal pain.
  • Interstitial lung disease, sometimes fatal; discontinue if confirmed.
  • Clinically relevant thrombocytopenia; consider in patients at risk of tumour bleeding.

Side effects

  • Very common: infection, febrile neutropenia, neutropenia, thrombocytopenia, anaemia, leucopenia, anorexia, nausea, vomiting, diarrhoea, constipation, abdominal pain, mucositis, alopecia, pyrexia, asthenia and fatigue.
  • Common: sepsis, pancytopenia, hypersensitivity with rash, hyperbilirubinaemia; rare interstitial lung disease.

Interactions

  • With cisplatin or carboplatin on day 1, lower doses of both agents are needed than when the platinum is given on day 5.
  • Capsules: ABCB1 and ABCG2 inhibitors (e.g. ciclosporin A) increase topotecan exposure – monitor for adverse reactions.

Pregnancy and breastfeeding

  • May cause foetal harm; effective contraception during treatment and for 6 months afterwards. Breast-feeding is contraindicated.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

Source: European Medicines Agency (EMA), product information

Austria

  • Topotecan AccordAccord Healthcare B.V. · 1 register entry
  • Topotecan EbeweEbewe Pharma · 1 register entry
  • Topotecan HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • Topotecan AccordAccord Healthcare B.V. · 1 register entry
  • Topotecan HexalHexal Ag · 1 register entry
  • Topotecan HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
  • Topotecan PharesPharma Resources Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Turkey

  • Hycamtin IV LiyofilizeSANDOZ İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • Tekan-LGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 1 register entry
  • TopotuONKO İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
  • TopoxinVEM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 27 more European countries
Belgium
Topotecan Accord Healthcare
Bulgaria
Топотекан Акорд
Croatia
Topotekan Alpha-Medical
Cyprus
Topotecan Accord, Topotecan Venus, Τopotecan Accord
Czechia
Topotecan Accord
Denmark
Topotecan "ebewe", Topotecan Accord
Estonia
Topotecan Accord
Finland
Topotecan Accord, Topotecan Ebewe
France
Topotecane Accord
Greece
Topocan, Topotecan Accord
Hungary
Topotecan Accord
Iceland
Hycamtin, Potactasol, Topotecan Hospira
Ireland
Topotecan Accord
Italy
Topotecan Ahcl
Latvia
Topotecan Ahcl
Liechtenstein
Hycamtin, Potactasol, Topotecan Hospira
Lithuania
Topotecan Accord
Luxembourg
Topotecan Accord Healthcare
Netherlands
Topotecan Accord, Topotecan Hikma, Topotecan Sandoz
Norway
Hycamtin, Potactasol, Topotecan Accord, Topotecan Ebewe, Topotecan Hospira
Poland
Topotecanum Accord
Portugal
Topotecano Accord, Topotecano Azevedos, Topotecano Hikma, Topotecano Venus Pharma
Romania
Topotecan Accord
Slovakia
Topotecan Accord
Slovenia
Topotekan Accord
Spain
Topotecán Accord
Sweden
Topotecan Accord, Topotecan Ebewe

EMA – Article 57 product data (EU/EEA), 2026-10-29

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Hycamtin – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/hycamtin-epar-product-information_en.pdf
  2. European Medicines Agency. Topotecan Hospira – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/topotecan-hospira-epar-product-information_en.pdf
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  5. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.