Presentation: Fruquintinib 1mg and 5mg hard capsules. Indication: FRUZAQLA as monotherapy is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan‑based chemotherapies, anti‑VEGF agents, and anti‑EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine‑tipiracil or regorafenib. Dosage and administration: FRUZAQLA should be initiated by a physician experienced in the administration of anticancer therapy. The recommended dose is 5 mg (one 5 mg capsule) once daily at approximately the same time each day for 21 consecutive days, followed by a 7‑day rest period to comprise a complete cycle of 28 days. Treatment should be continued until disease progression or unacceptable toxicity occurs. FRUZAQLA is for oral use and the capsules can be taken with or without food and should be swallowed whole. The capsules should not be chewed, dissolved, or opened, as the potential effects of these alterations are unknown. Renal impairment: No dose adjustment is required for patients with mild, moderate, or severe renal impairment. Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. FRUZAQLA is not recommended for use in patients with severe hepatic impairment as FRUZAQLA has not been studied in this population. Elderly population: No dose adjustment is required in patients aged 65 years or above. Paediatric population: There is no relevant use of FRUZAQLA in the paediatric population for the indication of metastatic colorectal cancer. Contraindications: Hypersensitivity to the active substance or any of the excipients. Warnings and precautions: Hypertension: Hypertension, including hypertensive crisis, has been reported with FRUZAQLA. Pre‑existing hypertension should be monitored and adequately controlled in accordance with standard medical practices before starting FRUZAQLA treatment. Hypertension should be medically managed with antihypertensives and adjustment of the FRUZAQLA dose, if necessary. Permanently discontinue FRUZAQLA for hypertension that cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis. Haemorrhagic events: Haemorrhagic events have been reported with FRUZAQLA, including gastrointestinal (GI) tract events. Serious and sometimes fatal bleeding events have been reported after treatment with FRUZAQLA. Monitor haematologic and coagulation profiles more frequently in patients at risk for bleeding, including those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding. In the event of severe bleeding requiring immediate medical intervention, permanently discontinue FRUZAQLA. GI perforation: GI perforation events, including fatal events, have been reported with FRUZAQLA. Symptoms of GI perforation should be periodically monitored during treatment. Permanently discontinue FRUZAQLA in patients developing GI perforation. Proteinuria: Proteinuria events have occurred with FRUZAQLA. Proteinuria should be monitored before initiation and during treatment. If urine dipstick proteinuria ≥2 g / 24 hours is detected, dose interruptions, adjustments, or discontinuation may be necessary. FRUZAQLA should be permanently discontinued in patients developing nephrotic syndrome. Palmar-plantar erythrodysaesthesia syndrome (PPES): PPES is the most frequently reported dermatological adverse reaction. If Grade ≥2 skin reactions are detected, dose interruptions, adjustments, or discontinuation may be necessary. Posterior reversible encephalopathy syndrome (PRES): PRES has been reported in 1 patient (0.1%) with FRUZAQLA. PRES can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). In patients developing PRES, discontinuation of FRUZAQLA, along with control of hypertension and supportive medical management of other symptoms, are recommended. Impaired wound healing: Impaired wound healing has been reported in 1 patient (0.1%) treated with FRUZAQLA. Patients are recommended to withhold FRUZAQLA for at least 2 weeks prior to surgery. FRUZAQLA should not be resumed for at least 2 weeks after surgery as clinically indicated when there is evidence of adequate wound healing. Arterial and venous thromboembolic events: It is recommended to avoid starting treatment with FRUZAQLA in patients with a history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or if they have a history of stroke and/or transient ischemic attack within the last 12 months. If arterial thrombosis is suspected, FRUZAQLA should be discontinued immediately. Excipients: FRUZAQLA 1 mg capsules contain tartrazine (E102) and sunset yellow FCF (E110) and FRUZAQLA 5 mg capsules contain Allura red AC (E129), which may cause allergic reactions. Interactions: The concomitant use of FRUZAQLA with strong and moderate CYP3A inducers should be avoided. Fertility, pregnancy and lactation: Women of childbearing potential should be advised to use highly effective contraception during and for at least 2 weeks following the last dose of FRUZAQLA. There are no clinical data available on the use of FRUZAQLA in pregnant women. Based on its mechanism of action, FRUZAQLA has the potential to cause foetal harm. FRUZAQLA should not be used during pregnancy unless the woman’s clinical condition requires treatment with FRUZAQLA. The safe use of FRUZAQLA during breast‑feeding has not been established. It is not known whether FRUZAQLA or its metabolites are excreted in human milk. There are no animal data on the excretion of FRUZAQLA in animal milk. A risk to newborns/infants cannot be excluded. Breast-feeding should be discontinued during treatment with FRUZAQLA and for at least 2 weeks after the last dose. There are no data on the effects of FRUZAQLA on human fertility. Results from animal studies indicate that FRUZAQLA may impair male and female fertility. Effects on ability to drive and use machines: FRUZAQLA has minor influence on the ability to drive and use machines. Fatigue may occur following administration of FRUZAQLA. Undesirable effects (all grades): Very common (≥1/10): Thrombocytopenia, hypothyroidism, anorexia, hypertension, dysphonia, diarrhoea, stomatitis, aspartate aminotransferase increased, total bilirubin increased, alanine aminotransferase increased, palmar-plantar erythrodysaesthesia syndrome, musculoskeletal discomfort, arthralgia, proteinuria, asthenia and fatigue. Common (≥1/100 to <1/10): Pneumonia, upper respiratory tract infection, bacterial infections, leukopenia, neutropenia, hypokalaemia, epistaxis, throat pain, GI haemorrhage, GI perforation, pancreatic enzymes increased, oral pain, rash and mucosal inflammation. Other serious undesirable effects: Uncommon (≥1/1000 to <1/100): PRES, pancreatitis, cholecystitis and impaired wound healing. Refer to the SmPC for details on full side effect profile and interactions. Legal classification: POM. Marketing authorisation (MA) number(s): EU/1/24/1827/001; EU/1/24/1827/002. Name and address of MA holder: Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland. Additional information is available on request at: medinfoemea@takeda.com. PI approval code: pi-03530. Date of preparation: February 2025.