ITOVEBI FILM COATED TABLETS 9 MG

F.Hoffmann-La Roche AG (SWITZERLAND)🇸🇬 Health Sciences Authority

Approval Date: Nov 20, 2025
Approval ID: 404b42cd4f765579
Company: F.Hoffmann-La Roche AG (SWITZERLAND)
Type: Therapeutic

Approval Details

Approval Id: 404b42cd4f765579
Drug Name: ITOVEBI FILM COATED TABLETS 9 MG
Product Name: ITOVEBI FILM COATED TABLETS 9 MG
Approval Number: SIN17404P
Approval Date: 2025-11-20
Registrant: ROCHE SINGAPORE PTE. LTD.
Licence Holder: ROCHE SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: Prescription Only
Dosage Form: TABLET, FILM COATED
Dosage: 2.2 DOSAGE AND ADMINISTRATION 2.2.1 General Patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer should be selected for treatment with Itovebi based on the presence of one or more PIK3CA mutations using a validated assay. PIK3CA mutation status should be established prior to initiation of Itovebi therapy. 2.2.2 Dose Recommendation The recommended dose of is 9 mg taken orally once daily with or without food. Itovebi should be administered in combination with palbociclib and fulvestrant. The recommended dose of palbociclib is 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Refer to the prescribing information for palbociclib and fulvestrant being used for complete dosing information. Treatment of pre/perimenopausal women with Itovebi should also include a luteinizing hormone-releasing hormone (LHRH) agonist in accordance with local clinical practice. For male patients, consider treatment with an LHRH agonist according to local clinical practice. 2.2.3 Duration of Treatment It is recommended that patients are treated with Itovebi until disease progression or unacceptable toxicity. 2.2.4 Delayed or Missed Doses Patients should be encouraged to take their dose at approximately the same time each day. If a dose of Itovebi is missed, it can be taken within 9 hours after the time it is usually taken. After more than 9 hours, the dose should be skipped for that day. On the next day, Itovebi should be taken at the usual time. If the patient vomits after taking the Itovebi dose, the patient should not take an additional dose on that day and should resume the usual dosing schedule the next day at the usual time. 2.2.5 Dose Modification Management of adverse reactions may require temporary interruption, dose reduction, or discontinuation of treatment with Itovebi. The recommended dose reduction guidelines for adverse reactions are listed in Table 1. <img src="/TGIF/Itovebi-Table1.png" alt="Itovebi Dosage Table 1" /> The dose of Itovebi may be re-escalated to a maximum daily dose of 9 mg based on clinical evaluation of the patient by the treating physician. Hyperglycemia Before initiating treatment with Itovebi, fasting plasma glucose (FPG)/blood glucose (FBG) and HbA1C levels should be tested, and plasma/blood glucose levels should be optimized in all patients. Evaluate patients for renal impairment prior to treatment with Itovebi (see section 2.2.6.3 Special Dosage Instructions, Renal Impairment and section 3.2 Pharmacokinetic Properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). After initiating treatment with Itovebi, patient fasting glucose (FPG or FBG) levels should be monitored or self-monitored based on the recommended schedule (see section 2.4.1 Warnings and Precautions, General – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). <img src="/TGIF/Itovebi-Table2.png" alt="Itovebi Dosage Table 2" /> Stomatitis <img src="/TGIF/Itovebi-Table3.png" alt="Itovebi Dosage Table 3" /> Other Adverse Reactions <img src="/TGIF/Itovebi-Table4.png" alt="Itovebi Dosage Table 4" /> 2.2.6 Special Dosage Instructions 2.2.6.1 Pediatric Use The safety and efficacy of Itovebi has not been established in children and adolescents (< 18 years). 2.2.6.2 Geriatric Use No dose adjustment of Itovebi is required in patients ≥ 65 years of age. For details on geriatric data, see section 2.5.5 Geriatric Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. 2.2.6.3 Renal Impairment No dose adjustment is required in patients with mild renal impairment (eGFR ≥ 60 to < 90mL/min). The safety and efficacy of Itovebi have not been established in patients with moderate to severe renal impairment. For details on renal impairment data, see section 2.5.6 Renal Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information. 2.2.6.4 Hepatic Impairment No dose adjustment is required in patients with mild hepatic impairment (total bilirubin > ULN to ≤ 1.5 × ULN or AST > ULN and total bilirubin ≤ ULN). The safety and efficacy of Itovebi have not been studied in patients with moderate to severe hepatic impairment. For details on hepatic impairment data, see section 2.5.7 Hepatic Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Route Of Administration: ORAL
Indication Info: 2.1 THERAPEUTIC INDICATION(S) Itovebi, in combination with palbociclib and fulvestrant, is indicated for the treatment of adult patients with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine therapy.
Contraindications: 2.3 CONTRAINDICATIONS Itovebi is contraindicated in patients with a known hypersensitivity to inavolisib or any of the excipients.

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 20, 2025

Approval ID

404b42cd4f765579

Type

Therapeutic

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