Description
Indication & Scope
ITOVEBI® Inavolisib Tablets provides combined therapy with palbociclib and fulvestrant for adults with HR-positive, HER2-negative, PIK3CA-mutated locally advanced or metastatic breast cancer that progresses after adjuvant endocrine therapy.
- Mechanism: Selective PI3Kα inhibitor, which blocks the PI3K/AKT/mTOR oncogenic signaling pathway activated by mutated PIK3CA, and inhibits the proliferation of breast cancer cells.
- Drug class: Phosphatidylinositol 3-kinase alpha inhibitor, oral targeted anti-tumor prescription medicine.
- Clinical use: Third-line targeted combined therapy for endocrine-resistant advanced metastatic breast cancer with PIK3CA mutation.
| Generic Name | Inavolisib Tablets |
| Brand Name | ITOVEBI |
| Ingredient | Inavolisib Tablets |
| Dosage Form | Tablets |
| Package | 3mg*7 tablets*4 blisters/box; 9mg*7 tablets*4 blisters/box |
| Conditions Treated | Locally advanced and metastatic HR-positive, HER2-negative, PIK3CA-mutated breast cancer |
| Taboos | Patients with hypersensitivity to inavolisib; patients with uncontrolled severe hyperglycemia; pregnant women |
| Place of origin | Wurmisweg, 4303 Kaiseraugst, Switzerland |
| Prescription type | Prescription-only |
| Storage Conditions | Store at 20°C~25°C, sealed to isolate moisture |
| Manufacturer | Roche Pharma (Schweiz) AG |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250026; H20250027 |
| Approval Date | Mar 11, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 9mg taken orally once a day.
Time: Fixed daily dosing time, continuous medication until disease progression or grade 3 and above adverse toxic reactions appear.
Instructions for use: Swallow the whole tablet completely, do not crush, split or chew. It can be taken with or without food. If a dose is missed, take it within 9 hours of the scheduled time, otherwise skip the missed dose.
Interaction: CYP3A4 inhibitors will increase the exposure of inavolisib, while CYP3A4 inducers will reduce its efficacy. Strong CYP3A4 modulators are forbidden for combined use.
Side effects: Hyperglycemia, stomatitis, diarrhea, neutropenia, fatigue, decreased hemoglobin, hypocalcemia and nausea.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What patients are suitable for Inavolisib Tablets treatment?
It treats HR-positive, HER2-negative, PIK3CA-mutated advanced breast cancer after endocrine therapy failure.
What is the core pharmacological mechanism of Inavolisib Tablets?
It selectively inhibits PI3Kα to block mutated PI3K/AKT/mTOR oncogenic signaling.
What major adverse effects of Inavolisib Tablets should be monitored?
Hyperglycemia, stomatitis, diarrhea, and neutropenia are the most concerning side effects.
Which patients cannot use Inavolisib Tablets?
Hypersensitive patients, patients with uncontrolled severe hyperglycemia, and pregnant women are contraindicated.
ITOVEBI® | Inavolisib Tablets | Breast Cancer | DengYueRX
INN: Inavolisib Tablets
Indications: Breast cancer
Dosage Form: Tablets
Strength: 3mg/tablet; 9mg/tablet
