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Itovebi

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Itovebi

Supplied with complete CDSCO-approved import and customs documentation, including Form 12A & 12B, CDEC, GST Bill of Entry, Commercial Invoice, and Packing List.

Medicine Name: Itovebi
Generic Name (API): Inavolisib
Dosage Form & Strength: 3 mg, 9 mg
Route: Oral
Drug Class: PI3K (phosphatidylinositol 3-kinase) inhibitor

Manufacturer / Innovator:

USA

Regulatory Approval:

  • FDA-approved (October 2024)
  • in combination with palbociclib and fulvestrant
  • for adults with endocrine-resistant
  • PIK3CA-mutated
  • hormone receptor-positive
  • HER2-negative locally advanced or metastatic breast cancer whose disease recurred during or after
Family enjoying life with Named Patient Program access

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    Over a decade of trusted expertise in Named Patient Access to innovative and life-saving medicines.

  • 100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.

    100% CDSCO-compliant processes ensuring safe, ethical, and responsible medicine access.

  • Medicines sourced from authorized manufacturers with full batch traceability

    Medicines sourced from authorized manufacturers with full batch traceability.

  • EU-GDP Compliant Warehousing for secure, quality-controlled global distribution.

    EU-GDP compliant warehousing for secure, quality-controlled global distribution.

  • Temperature-Controlled Logistics for Safe and Timely Delivery

    Temperature-controlled logistics ensuring safe, reliable, and timely medicine delivery.

GDP Compliant
Licensed Wholesale distributor

Understanding Itovebi (Inavolisib) and Its Medical Uses

Itovebi (inavolisib) is a PI3K inhibitor used in combination with palbociclib and fulvestrant to treat PIK3CA-mutated breast cancer, targeting one of the most common genetic alterations in HR-positive breast cancer.

Approved Indication

Itovebi, combined with palbociclib and fulvestrant, is FDA-approved for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer whose disease recurred during or after adjuvant endocrine therapy.

How It Works

Inavolisib selectively inhibits PI3Kα, blocking abnormal signaling caused by PIK3CA mutations that drive tumor growth and contribute to resistance to standard endocrine therapy.

Dosing

The recommended dose is 9 mg orally once daily, with or without food, combined with palbociclib and fulvestrant per their respective schedules. Dose reduction is required for patients with moderate to severe renal impairment, as determined by the treating oncologist.

Warnings and Precautions for Itovebi

Itovebi requires close monitoring for several important safety considerations.

Hyperglycemia

Severe or fatal hyperglycemia, including ketoacidosis, can occur. Blood glucose should be monitored before starting treatment and periodically during treatment, with more frequent monitoring during the first 4 weeks and in patients with a history of type 2 diabetes.

Stomatitis

Mouth sores and inflammation are common. Preventive oral care measures are typically recommended from treatment initiation.

Diarrhea

Monitor for diarrhea and manage promptly to avoid dehydration.

Rash

Skin reactions can occur; monitor and manage per treating physician guidance.

Embryo-Fetal Toxicity

Itovebi can cause fetal harm. Effective contraception is required during treatment and for a defined period after the final dose.

  • Blood glucose monitoring is required, especially during the first 4 weeks of treatment.
  • Report excessive thirst, frequent urination, or unusual fatigue promptly — these may signal hyperglycemia.
  • Follow the combination-therapy monitoring schedule set by the treating oncologist.

How to Access Itovebi in India: A 6-Step Process

Step 1 – Search & request your medicine: The patient or treating doctor submits a request with basic details to initiate the access process.

Step 2 – Verification & eligibility review: The team verifies availability and reviews eligibility against regulatory and clinical requirements to ensure a compliant pathway.

Step 3 – Receive quote & delivery timeline: A transparent quotation is shared, covering medicine cost, logistics, and a clear delivery timeline.

Step 4 – Regulatory approval process: Assistance is provided to secure the approvals and documentation required for legal cross-border access.

Step 5 – Temperature-controlled import & handling: The medicine is sourced and transported under strict GDP-compliant conditions to maintain product integrity.

Step 6 – Secure delivery: The medicine is delivered to the patient or treating hospital, with updates provided at each stage.

Note: From request to delivery, every step is designed to ensure your treatment reaches you safely, compliantly, and without unnecessary delays.

Documentation and Availability of Itovebi

Itovebi (inavolisib) received FDA approval in October 2024 and is manufactured by Genentech, used in combination with palbociclib and fulvestrant for PIK3CA-mutated breast cancer.

Documentation Required

Import of Itovebi through a Named Patient Program requires a valid prescription from the treating oncologist, confirmation of PIK3CA mutation status via an FDA-approved test, and supporting clinical documentation as required by Indian regulatory authorities.

Sourcing

NPP sources Itovebi directly from Genentech's authorized supply chain to ensure product authenticity and regulatory compliance.

Sourcing and Delivery of Itovebi

Itovebi is sourced through verified, GDP-compliant channels from Genentech's authorized supply chain to ensure authenticity and quality.

Storage Requirements

Itovebi tablets should be stored at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F), in the original bottle.

Delivery Process

Once sourced, Itovebi is packed and transported under appropriate temperature-controlled conditions to preserve product integrity throughout the import process, with tracking and updates provided at each stage of delivery to the patient or treating hospital in India.

Availability of Itovebi Across Major Cities in India

Patients across India can access Itovebi through NPP's regulated import pathway, with oncology specialists in major cities supporting the treatment process.

Mumbai

Leading oncology centers in Mumbai support PIK3CA mutation testing and treatment coordination for Itovebi access.

Delhi

Delhi's major cancer hospitals assist patients with molecular testing and prescription support for Itovebi.

Bangalore

Bangalore's oncology network offers access to PIK3CA testing and treatment planning for eligible breast cancer patients.

Chennai

Chennai-based specialists coordinate Itovebi access alongside comprehensive breast cancer care.

Hyderabad

Hyderabad's cancer care institutions support patients pursuing Itovebi therapy following confirmed PIK3CA mutation status.

Kolkata

Kolkata's oncology centers help coordinate documentation and treatment access for Itovebi.

Pune

Pune-based oncologists assist with PIK3CA mutation testing and Itovebi treatment planning.

Ahmedabad

Ahmedabad's specialty hospitals support the import and treatment process for Itovebi.

Kochi

Kochi's oncology units assist patients with the documentation needed for Itovebi access.

Chandigarh

Chandigarh's cancer care centers support Itovebi treatment coordination for patients from North India.

Jaipur

Jaipur's oncology specialists help patients navigate the Itovebi access process.

Lucknow

Lucknow-based cancer centers assist patients pursuing Itovebi therapy.

Bhubaneswar

Bhubaneswar's oncology institutions support access to Itovebi for eligible patients.

Guwahati

Guwahati's specialists help coordinate Itovebi access for patients across the Northeast.

Patients in other cities across India can also access Itovebi through NPP's nationwide coordination network.

Written By:

Written By: Nitin Goswami, Senior Medical Content Writer
Last Updated: 10 September 2026
Sources: FDA • CDSCO

Medically Reviewed By:

Medically Reviewed By: Shilpi Banerjee, Registered Pharmacist (M.Pharm)
Last Updated: 10 September 2026

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