- Approval Id
- 6b662a257f014e38
- Drug Name
- FRUZAQLA CAPSULE 5MG
- Product Name
- FRUZAQLA CAPSULE 5MG
- Approval Number
- SIN17113P
- Approval Date
- 2024-10-17
- Registrant
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Licence Holder
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2 Posology and Method of Administration</strong><br>
<strong>Posology</strong><br>
Fruquintinib should be initiated by a physician experienced in the administration of anticancer therapy.</p>
<p>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.</p>
<p><strong><em>Duration of treatment</em></strong><br>
Treatment with fruquintinib should be continued until disease progression or unacceptable toxicity occurs.</p>
<p><em><strong>Missed doses or vomiting.</strong></em><br>
If a dose is missed by less than 12 hours, it should be taken, and the next dose should be taken as scheduled.</p>
<p>If a dose is missed by more than 12 hours, it should be skipped, and the next dose should be taken as scheduled.<br>
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 scheduled on the following day.</p>
<p><em><strong>Dose Adjustments for Adverse Reactions</strong></em><br>
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.</p>
<img src="/TGIF/Fruzaqla-Table1.png" alt="Fruzaqla Dosage Table 1" /><br><br>
<p>The recommended dose modifications for adverse reactions are provided in Table 2.</p>
<img src="/TGIF/Fruzaqla-Table2.png" alt="Fruzaqla Dosage Table 2" /><br><br>
<p><em><strong>Special Patient Populations</strong></em><br>
<strong>Elderly Patients</strong><br>
No dose adjustment is required in patients aged 65 years or above.</p>
<p><strong>Pediatric Patients</strong><br>The safety and efficacy of fruquintinib in children aged 0 to <18 years have not been established. No data are available.</p>
<p><strong>Impaired Renal Function</strong><br>No dose adjustment is required for patients with mild, moderate, or severe renal impairment <em>(see Pharmacokinetic Properties, 5.2</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>)</em>.</p>
<p><strong>Impaired Hepatic Function</strong><br>No dose adjustment is required for patients with mild hepatic impairment (total bilirubin less than or equal to the ULN with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). A dedicated PK study in a limited sample size showed no clinically meaningful differences in the dose-normalised AUC of fruquintinib between patients with moderate hepatic impairment (total bilirubin greater than 1.5 times and less than 3 times ULN and any AST) and those with normal hepatic function (see Pharmacokinetic Properties, 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). However, patients with moderate hepatic impairment were excluded from clinical studies. . Fruquintinib is not recommended for use in patients with severe hepatic impairment (total bilirubin greater than 3 times ULN and any AST) as fruquintinib has not been studied in this population.</p>
<p><strong>Method of Administration</strong><br>
Fruquintinib is for oral use.</p>
<p>Fruquintinib capsules can be taken with or without food and should be swallowed whole.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic Indications</strong><br>
Fruquintinib is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, and, if RAS wild-type, an anti-EGFR agent.</p>
- Contraindications
- <p><em><strong>4.3 Contraindications</strong></em></p>
<p>Hypersensitivity to the active substance or any of the excipients in the section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Atc Code
- L01EK04
- Pharma Manufacturer Name
- TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
