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Cyclophosphamide

Cyclophosphamid Sandoz, Endoxan · ATC code L01AA01

Also known as: Cyclophosphamid, Siklofosfamid · Brand names: Cyclophosphamid Sandoz, Endoxan, Cyclophosphamid Accord, Cyclophosphamid Beta, Cyclophosphamid Hexal, Cyclophosphamid Seacross, Alkyloxan Inj, Sitoksan, Syklofosfamid, Frindovyx

Key facts
Active substance
Cyclophosphamide
Drug class
Nitrogen mustard
ATC code
L01AA01
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Key facts

Cyclophosphamide is an alkylating cytotoxic drug, here as oral capsules. Per the US prescribing information, it is used to treat various malignant diseases and biopsy-proven minimal change nephrotic syndrome in children.

What it is used for

  • Malignant lymphomas (including Hodgkin's disease and Burkitt's lymphoma), multiple myeloma and leukemias
  • Mycosis fungoides (advanced), neuroblastoma (disseminated), adenocarcinoma of the ovary, retinoblastoma, carcinoma of the breast; often combined with other antineoplastic drugs
  • Biopsy-proven minimal change nephrotic syndrome in pediatric patients who did not respond to or cannot tolerate corticosteroid therapy

Dosing

  • Malignant diseases (adults and children): 1 mg per kg to 5 mg per kg orally once daily, adjusted for antitumor activity, myelosuppression and other toxicity; dose reductions may be needed in combination regimens
  • Minimal change nephrotic syndrome in children: 2 mg per kg once daily for 8 to 12 weeks (maximum cumulative dose 168 mg per kg); treatment beyond 90 days increases the probability of sterility in males
  • Take in the morning with plenty of fluid to reduce urinary tract toxicity; swallow capsules whole
  • Severe renal impairment may increase toxicity; severe hepatic impairment may reduce efficacy – see the full text

Contraindications

  • History of severe hypersensitivity to cyclophosphamide, its metabolites or other components (cross-sensitivity with other alkylating agents possible)
  • Urinary outflow obstruction

Important warnings

  • Myelosuppression, immunosuppression, bone marrow failure and serious, sometimes fatal infections
  • Urinary tract and renal toxicity, including hemorrhagic cystitis
  • Cardiotoxicity (myocarditis, pericardial effusion, heart failure, arrhythmias) and pulmonary toxicity
  • Secondary malignancies and veno-occlusive liver disease
  • Embryo-fetal toxicity and infertility in both sexes
  • Impaired wound healing and hyponatremia

Side effects

  • Neutropenia, nausea and vomiting, anorexia, alopecia
  • Less often: abdominal pain, diarrhea, skin rash, pigmentation of skin and nail changes
  • Serious: infections, hemorrhagic cystitis, heart and lung toxicity, secondary cancers

Interactions

  • Protease inhibitors may increase cytotoxic metabolites, with more infections and neutropenia
  • Other agents with similar toxicities can potentiate toxicity

Pregnancy and breastfeeding

  • Can cause fetal harm; females should use effective contraception during treatment and for up to 1 year after, males with female partners for 4 months after
  • Present in breast milk

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

Patient information (US)

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.

Austria

  • Cyclophosphamid SandozSandoz Gmbh · 2 register entries
  • EndoxanBaxter Healthcare Gmbh · 2 register entries

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

Germany

  • Cyclophosphamid AccordAccord Healthcare B.V. · 1 register entry
  • Cyclophosphamid BetaBetapharm Arzneimittel Gmbh · 1 register entry
  • Cyclophosphamid HexalHexal Ag · 1 register entry
  • Cyclophosphamid SeacrossSeacross Pharma (Europe) Ltd · 1 register entry
  • EndoxanBaxter Deutschland Gmbh · 4 register entries

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

Turkey

  • Alkyloxan InjKOÇSEL İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • EndoxanBAXTER TURKEY RENAL HİZMETLER A.Ş. · 4 register entries
  • SitoksanKOÇAK FARMA İLAÇ VE KİMYA SAN. A.Ş. · 2 register entries
  • SyklofosfamidATAFARM İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry

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

USA

  • FrindovyxAVYXA Pharma, LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 27 more European countries
Belgium
Cyclofosfamide Accord, Cyclophosphamide Hikma, Endoxan
Bulgaria
Cyclophosphamide Sandoz, Ендоксан, Циклофосфамид Msn, Циклофосфамид Акорд, Циклофосфамид Сандоз
Croatia
Ciklofosfamid Accord, Endoxan
Cyprus
Cyclophosphamide Accord, Endoxan
Czechia
Cyclophosphamide Accord, Endoxan
Denmark
Cyclophosphamide Accord, Cyclophosphamide Sandoz, Sendoxan
Estonia
Cyclophosphamide Accord, Endoxan
Finland
Cyclophosphamide Accord, Sendoxan
France
Cyclophosphamide Accord, Cyclophosphamide Reddy Pharma, Cyclophosphamide Sandoz, Cyclophosphamide Seacross, Endoxan
Greece
Endoxan
Hungary
Endoxan
Iceland
Sendoxan
Ireland
Cyclophosphamide Monohydrate Seacross, Endoxana
Italy
Ciclofosfamide Accord, Cyclophosphamide Monohydrate Seacross, Endoxan
Latvia
Cyclophosphamide Accord, Endoxan
Lithuania
Cyclophosphamide Accord Healthcare, Endoxan
Luxembourg
Endoxan
Malta
Endoxana
Netherlands
Cyclofosfamide Accord, Cyclofosfamide Hikma, Cyclofosfamide Sandoz, Cyclophosphamide Seacross, Endoxan
Norway
Cyclophosphamide Accord, Sendoxan
Poland
Cyclophosphamide Accord, Cyclophosphamide Sandoz, Endoxan
Portugal
Ciclofosfamida Accord, Ciclofosfamida Hikma, Cyclophosphamide Monohydrate Seacross, Endoxan
Romania
Ciclofosfamidă Accord, Ciclofosfamidă Dr. Reddy’s, Endoxan
Slovakia
Endoxan
Slovenia
Endoxan
Spain
Ciclofosfamida Accord, Ciclofosfamida Dr. Reddy, Ciclofosfamida Hikma, Ciclofosfamida Seacross, Genoxal
Sweden
Cyclophosphamide Accord, Cyclophosphamide Sandoz, Sendoxan

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

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Sources

  1. U.S. Food and Drug Administration. Cyclophosphamide (Hikma Pharmaceuticals USA Inc.) – Prescribing Information, 2024-11-19. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=8135b917-882f-4b4c-99b7-fa8ea54af4bf
  2. 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
  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. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
  6. Wikidata (CC0): ATC L01AA.

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.