Itovebi, inavolisib

Named-patient access overview. Itovebi is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.

About Itovebi

Itovebi (inavolisib) is manufactured by Genentech, a member of the Roche Group, and was approved by the US FDA in 2024 for use in combination with palbociclib and fulvestrant in adults with PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose disease has recurred on or after adjuvant endocrine therapy. It is an oral, selective PI3K-alpha inhibitor with degrader activity on the mutant p110-alpha subunit, which is the mechanism studied in the INAVO120 Phase 3 trial supporting the indication.

A PIK3CA mutation must be confirmed by an FDA-approved test on tumor tissue or plasma before treatment, and Itovebi is taken by mouth once daily as part of the triplet regimen set out in the prescribing information, with monitoring for hyperglycemia, stomatitis, diarrhea, and rash. For international patients, Itovebi may be coordinated through Named Patient Program or personal-import pathways with the destination country's regulator and the patient's treating oncologist handling the documentation.

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How Reserve Meds coordinates Itovebi

  1. Patient or treating physician submits a named-patient request.
  2. Clinical team verifies appropriateness of Itovebi for the patient and destination country.
  3. Treating physician issues prescription and clinical justification.
  4. Country-specific NPP / personal-import documentation is prepared.
  5. Itovebi is sourced from a DSCSA-compliant US specialty wholesaler with full serial traceability.
  6. Shipment is coordinated to the patient's physician or hospital pharmacy (cold-chain where required).

Access by country

Reserve Meds publishes a detailed country deep-dive for Itovebi in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), real costs in local currency and USD, indicative timelines, physician-credential requirements, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.

Start a request for Itovebi

Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, timeline, and a formal quote.

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Frequently asked questions

How can I get Itovebi if it is not approved or available in my country?

Reserve Meds coordinates US-sourced Itovebi for patients through a physician-led, named-patient cross-border pathway. Your treating physician provides the prescription and clinical justification; Reserve Meds prepares the named-patient documentation for your country and arranges DSCSA-compliant US sourcing and delivery to your physician or hospital pharmacy.

Can I access Itovebi through named-patient or compassionate-use import?

Yes. Named-patient access (also called compassionate use or personal import) is the core route Reserve Meds operates for Itovebi. Eligibility and paperwork depend on the regulator in your country, and Reserve Meds maps the specific pathway for each market it coordinates.

Do I need a prescription to access Itovebi through Reserve Meds?

Yes. Reserve Meds is not a pharmacy and does not prescribe. A valid prescription and clinical justification from your treating physician are required, and all clinical decisions remain with your physician.

How does Reserve Meds deliver Itovebi to a patient?

Reserve Meds sources Itovebi from a DSCSA-compliant US specialty supplier with full traceability and coordinates delivery to your treating physician or hospital pharmacy, with appropriate handling for the product.

How long does it take, and what does Itovebi cost through Reserve Meds?

After a short intake, the clinical team responds within one business day with case-specific feasibility, an indicative timeline, and a formal written quote. Cost depends on the destination, the prescribed regimen, and the duration of therapy, and is confirmed in writing before anything proceeds.

How do I start a request for Itovebi?

Submit a 60-second intake through the Reserve Meds patient portal, or message the concierge team on WhatsApp. A named coordinator follows up within 24 hours.