Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Takeda Pharmaceuticals International AG Ireland Branch, Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, medinfoEMEA@takeda.com
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.
FRUZAQLA should be initiated by a physician experienced in the administration of anticancer therapy.
The recommended dose of fruquintinib 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 with fruquintinib should be continued until disease progression or unacceptable toxicity occurs.
If a dose is missed by less than 12 hours, it should be taken, and the next dose should be taken as scheduled.
If a dose is missed by more than 12 hours, it should be skipped, and the next dose should be taken as scheduled.
If a patient vomits after taking a dose, the patient should not repeat the dose on the same day but resume the usual dosing as prescribed on the following day.
The dose should be modified based on safety and tolerability. Fruquintinib should be permanently discontinued in patients unable to tolerate a dose of 3 mg once daily. The recommended dose reduction schedule for adverse reactions is provided in Table 1.
Table 1. Recommended FRUZAQLA dose reduction schedule:
| Dose reduction schedule | Dose and schedule | Number and strength of capsules |
|---|---|---|
| First dose reduction | 4 mg once daily | Four 1 mg capsules once daily |
| Second dose reduction | 3 mg once daily | Three 1 mg capsules once daily |
The recommended dose modifications for adverse reactions are provided in Table 2.
Table 2. Recommended dose modification for FRUZAQLA for adverse reactions:
| Adverse reaction | Severity1 | Dose modification |
|---|---|---|
| Hypertension | Grade 3 | • Withhold if Grade 3 hypertension persists despite initiation or modification of antihypertensive treatment. • If hypertension recovers to Grade 1 or baseline, resume at a reduced dose as per Table 1. If the patient still experiences Grade 3 hypertension after taking 3 mg daily, permanently discontinue. |
| Grade 4 | Permanently discontinue. | |
| Haemorrhagic events | Grade 2 | • Withhold until bleeding fully resolves or recovers to Grade 1. • Resume at a reduced dose as per Table 1. If the patient still experiences Grade 2 haemorrhagic events after taking 3 mg daily, permanently discontinue. |
| Grade ≥ 3 | Permanently discontinue. | |
| Proteinuria | ≥ 2 g/24 hours | • Withhold until proteinuria fully resolves or is < 1 g / 24 hours (Grade 1). • Resume at a reduced dose as per Table 1. If the patient still experiences ≥ 2 g/24 hours proteinuria after taking 3 mg daily, permanently discontinue. Permanently discontinue for nephrotic syndrome. |
| Liver function test abnormalities | Grade 2 or 3 liver function test abnormalities | • Withhold until liver function test abnormality recovers to Grade 1 or baseline. • Resume at a reduced dose as per Table 1. If the patient still experiences Grade 2 or Grade 3 liver function test abnormalities after taking 3 mg daily, permanently discontinue. |
| Grade ≥ 2 elevation (> 3 x ULN) of either alanine aminotransferase (ALT) or aspartate aminotransferase (AST) with concurrent total bilirubin elevation > 2 x ULN in the absence of cholestasis; Grade 4 liver function test abnormalities | Permanently discontinue. | |
| Palmar-plantar erythrodysaesthesia syndrome (PPES) | Grade 2 | • Administer supportive treatment. • Withhold until PPES recovers to Grade 1 or baseline. • Resume at the same dose level. |
| Grade 3 | • Administer supportive treatment. • Withhold until PPES recovers to Grade 1 or baseline. • Resume at a reduced dose as per Table 1. If the patient still experiences Grade 3 PPES after taking 3 mg daily, permanently discontinue. | |
| Other adverse reactions | Grade 3 | • Withhold until the reaction recovers to Grade 1 or baseline. • Resume at a reduced dose as per Table 1. If the patient still experiences Grade 3 other adverse reactions after taking 3 mg daily, permanently discontinue. |
| Grade 4 | Discontinue. Consider resuming at a reduced dose as per Table 1 if the toxicity recovers to Grade 1 or baseline and the potential benefit outweighs the risks. |
1 Graded per national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5).
No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
No dose adjustment is required for patients with mild or moderate hepatic impairment (see section 5.2).
FRUZAQLA is not recommended for use in patients with severe hepatic impairment as FRUZAQLA has not been studied in this population.
No dose adjustment is required in patients aged 65 years or above.
There is no relevant use of FRUZAQLA in the paediatric population for the indication of metastatic colorectal cancer.
FRUZAQLA is for oral use.
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.
he highest dose of fruquintinib studied in clinical studies was 6 mg per day. The effects of fruquintinib overdose are unknown, and there is no known antidote for fruquintinib overdose. In the event of an overdose, interrupt fruquintinib, general supportive measures should be undertaken and observe until clinical stabilisation.
2 years.
This medicinal product does not require any special temperature storage conditions.
Store in the original container in order to protect from moisture.
Keep the bottle tightly closed.
High-density polyethylene (HDPE) bottle (45 mL) with polypropylene (PP) child-resistant closure and a HDPE desiccant cartridge containing silica gel. The desiccant must be kept inside the bottle.
Each bottle contains 21 hard capsules. Each bottle is packaged in a carton.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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