AXITINIB SANDOZ FILM COATED TABLET 5 MG

Synthon Hispania, S.L. (SPAIN)🇸🇬 Health Sciences Authority

Approval Date: Oct 23, 2025
Approval ID: 272d954adfb13dbd
Company: Synthon Hispania, S.L. (SPAIN)
Type: Therapeutic

Approval Details

Approval Id: 272d954adfb13dbd
Drug Name: AXITINIB SANDOZ FILM COATED TABLET 5 MG
Product Name: AXITINIB SANDOZ FILM COATED TABLET 5 MG
Approval Number: SIN17370P
Approval Date: 2025-10-23
Registrant: SANDOZ SINGAPORE PTE. LTD.
Licence Holder: SANDOZ SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration Posology The recommended starting oral dose of Axitinib is 5 mg twice daily. Administer Axitinib doses approximately 12 hours apart with or without food (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Axitinib Sandoz should be swallowed whole with a glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. Dose adjustments Dose increase or reduction is recommended based on individual safety and tolerability. Over the course of treatment, patients who tolerate Axitinib for at least two consecutive weeks with no adverse reactions >Grade 2 (according to the Common Toxicity Criteria for Adverse Events [CTCAE]), are normotensive, and are not receiving anti-hypertensive medication, may have their dose increased. When a dose increase from 5 mg twice daily is recommended, Axitinib dose may be increased to 7 mg twice daily, and further to 10 mg twice daily using the same criteria. Over the course of treatment, management of some adverse drug reactions may require temporary interruption or permanent discontinuation and/or dose reduction of Axitinib therapy (see Section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). If dose reduction from 5 mg twice daily is required, the recommended dose is 3 mg twice daily. If additional dose reduction is required, the recommended dose is 2 mg twice daily. Dose adjustment is not required on the basis of patient age, race, gender, or body weight. Concomitant strong CYP3A4/5 inhibitors The concomitant use of strong CYP3A4/5 inhibitors should be avoided (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole). Selection of an alternate concomitant medication with no or minimal CYP3A4/5 inhibition potential is recommended. Although Axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inhibitors, if a strong CYP3A4/5 inhibitor must be co-administered, a dose decrease of Axitinib by approximately half is recommended, as this dose reduction is predicted to adjust the Axitinib area under the plasma concentration versus time curve (AUC) to the range observed without inhibitors. The subsequent doses can be increased or decreased based on individual safety and tolerability. If co-administration of the strong inhibitor is discontinued, the Axitinib dose should be returned (after 3 – 5 half-lives of the inhibitor) to that used prior to initiation of the strong CYP3A4/5 inhibitor (see Sections 4.5 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Concomitant strong CYP3A4/5 inducers Co-administration of Axitinib with strong CYP3A4/5 inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, and Hypericum perforatum [also known as St. John’s wort]) may decrease Axitinib plasma concentrations. Selection of an alternate concomitant medication with no or minimal CYP3A4/5 induction potential is recommended. Although Axitinib dose adjustment has not been studied in patients receiving strong CYP3A4/5 inducers, if a strong CYP3A4/5 inducer must be co-administered, a gradual dose increase of Axitinib is recommended. If the dose of Axitinib is increased, the patient should be monitored carefully for toxicity. If co-administration of the strong inducer is discontinued, the Axitinib dose should be immediately returned to the dose used prior to initiation of the strong CYP3A4/5 inducer. Use in pediatrics The safety and efficacy of Axitinib in pediatric patients have not been studied. Use in the elderly No dosage adjustment is required in elderly patients (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Hepatic impairment No starting dose adjustment is required when administering Axitinib to patients with mild hepatic impairment (Child-Pugh class A). Based on the pharmacokinetic data, Axitinib starting dose should be reduced by approximately half in patients with baseline moderate hepatic impairment (Child-Pugh class B). The subsequent doses can be increased or decreased based on individual safety and tolerability. Axitinib has not been studied in patients with severe hepatic impairment (Child-Pugh class C) (see Sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Renal impairment No starting dose adjustment is needed for patients with pre-existing mild to severe renal impairment (see Section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Axitinib is indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
Contraindications: 4.3 Contraindications Hypersensitivity to axitinib or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Oct 23, 2025

Approval ID

272d954adfb13dbd

Type

Therapeutic

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