fruquintinib
Fruzaqla · ATC code L01EK
Also known as: Frukintinib
- Key facts
- Active substance
- fruquintinib
- ATC code
- L01EK
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- FRUZAQLA 1 mg hard capsules / FRUZAQLA 5 mg hard capsules
- Marketing authorisation holder
- Takeda Pharmaceuticals International AG Ireland
- Information as of
- 2026-10-28
Key facts
Fruquintinib is a VEGF receptor (VEGFR) tyrosine kinase inhibitor. It is used as monotherapy for previously treated metastatic colorectal cancer in adults.
What it is used for
- Monotherapy for adults with metastatic colorectal cancer (mCRC) previously treated with available standard therapies (fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, anti-VEGF and anti-EGFR agents) who progressed on or are intolerant to trifluridine-tipiracil or regorafenib (Fruzaqla).
Dosing
- Fruzaqla 1 mg and 5 mg hard capsules: 5 mg once daily for 21 consecutive days followed by a 7-day rest (28-day cycle), until progression or unacceptable toxicity.
- Dose reductions for adverse reactions to 4 mg and then 3 mg once daily; discontinue permanently if 3 mg is not tolerated.
- Missed dose: take it if less than 12 hours late, skip if more than 12 hours; do not repeat after vomiting on the same day.
- No dose adjustment in renal impairment or mild to moderate hepatic impairment; not recommended in severe hepatic impairment.
- See the full text for modifications for hypertension, haemorrhage, proteinuria and other adverse reactions.
Contraindications
- Hypersensitivity to the active substance or any of the excipients.
Important warnings
- Hypertension including hypertensive crisis: control blood pressure before starting and monitor; discontinue permanently for uncontrolled hypertension or crisis.
- Haemorrhagic events, including serious and fatal ones, particularly gastrointestinal; discontinue permanently for severe bleeding.
- Gastrointestinal perforation, including fatal events.
- Proteinuria, palmar-plantar erythrodysaesthesia (PPES) and PRES can occur.
- Impaired wound healing: withhold for at least 2 weeks before surgery. Avoid starting in patients with a history of thromboembolic events.
Side effects
- Most common: hypertension (49.3%), anorexia (35.6%), proteinuria (35.5%), PPES (34.6%), hypothyroidism (32.4%), dysphonia (28.6%), diarrhoea (26.3%), asthenia (24.5%).
- Most common grade ≥ 3: hypertension (19.1%) and PPES (8.3%).
- Most common serious: gastrointestinal haemorrhage (1.5%), pneumonia (1.5%), hypertension (1.5%), gastrointestinal perforation (1.3%).
Interactions
- Avoid strong and moderate CYP3A inducers (rifampicin decreased AUC by 65%).
- No dose adjustment is needed with CYP3A inhibitors or gastric acid lowering agents.
Pregnancy and breastfeeding
- May cause foetal harm; not to be used in pregnancy unless the woman's condition requires it. Highly effective contraception during treatment and for at least 2 weeks after.
- Breast-feeding: see the full text.
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.
Common questions – ask Medelix
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)
- FruzaqlaTakeda Pharmaceuticals International AG Ireland · EMEA/H/C/005979
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Fruzaqla
- Liechtenstein
- Fruzaqla
- Norway
- Fruzaqla
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
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Sources
- European Medicines Agency. Fruzaqla – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf
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.