inavolisib
Itovebi · ATC code 1892
Also known as: İnavolisib
- Key facts
- Active substance
- inavolisib
- ATC code
- 1892
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Itovebi 3 mg film-coated tablets / Itovebi 9 mg film-coated tablets
- Marketing authorisation holder
- Roche Registration GmbH
- Information as of
- 2026-10-29
Key facts
Inavolisib (Itovebi) is an oral PI3Kα inhibitor used with palbociclib and fulvestrant for PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer.
What it is used for
- In combination with palbociclib and fulvestrant for adults with PIK3CA-mutated, ER-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence on or within 12 months of completing adjuvant endocrine treatment.
- Pre/perimenopausal women and men also receive an LHRH agonist.
Dosing
- 9 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.
- Combination: palbociclib 125 mg once daily for 21 days followed by 7 days off (28-day cycle); fulvestrant 500 mg intramuscularly on Days 1, 15 and 29, then monthly.
- Dose reductions for adverse reactions: 6 mg, then 3 mg daily; discontinue permanently if 3 mg is not tolerated. For hyperglycaemia, stomatitis and diarrhoea see the full text.
- Renal impairment: moderate (eGFR 30 to < 60 mL/min) starting dose 6 mg, severe (eGFR < 30 mL/min) 3 mg; mild no adjustment. Mild hepatic impairment: no adjustment.
- Missed dose: take within 9 hours, otherwise skip for that day.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Hyperglycaemia is frequent, including severe cases with ketoacidosis and fatal complications; do not start until fasting glucose is optimised. Experience in diabetes is very limited.
- Stomatitis and diarrhoea are common and may require interruption or dose reduction.
- Verify pregnancy status before starting.
Side effects
- Most common: hyperglycaemia (59.9%), stomatitis (51.2%), diarrhoea (48.1%), thrombocytopenia (48.1%), fatigue (37.7%), anaemia (37%), nausea (27.8%), decreased appetite (23.5%), rash (22.8%), headache (21%), weight decreased (17.3%), vomiting (14.8%) and urinary tract infection (13%).
- Most common serious reactions: anaemia (1.9%), diarrhoea (1.2%) and urinary tract infection (1.2%).
Interactions
- Low likelihood of clinically relevant interactions with CYP inhibitors or inducers.
- Inavolisib induces CYP3A and is a time-dependent CYP3A inhibitor in vitro – caution with sensitive narrow-therapeutic-index CYP3A4 substrates (e.g. alfentanil, ciclosporin, quinidine, sirolimus, tacrolimus).
Pregnancy and breastfeeding
- Women: effective non-hormonal contraception during treatment and for 1 week after; men with partners of childbearing potential: condom during treatment and for 1 week after.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- ItovebiRoche Registration GmbH · EMEA/H/C/006353
Source: European Medicines Agency (EMA), product information
Brand names in 3 more European countries
- Iceland
- Itovebi
- Liechtenstein
- Itovebi
- Norway
- Itovebi
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Itovebi – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/itovebi-epar-product-information_en.pdf
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.