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KINASE INHIBITOR
Itovebi (inavolisib) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat some adults with certain types of breast cancer.
Itovebi is a targeted cancer medicine. It blocks a protein called phosphoinositide 3-kinase (PI3K), mainly a type called PI3K alpha. Some breast cancers have a change, or mutation, in a gene called PIK3CA.
This mutation can turn on the PI3K pathway. In lab studies, Itovebi blocked signals in this pathway and reduced tumor growth.
Doctors prescribe Itovebi to treat adults with endocrine-resistant, hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), locally advanced or metastatic breast cancer with a PIK3CA mutation. It is used with palbociclib and fulvestrant after the cancer comes back on or after completing adjuvant endocrine therapy.
Itovebi is taken as a tablet by mouth once a day, with or without food. It should be taken at about the same time each day and swallowed whole. It is used together with palbociclib and fulvestrant.
Treatment usually continues until the cancer gets worse or side effects become unacceptable or intolerable.
The recommended dose of Itovebi for breast cancer is 9 milligrams by mouth once daily. It is used with palbociclib 125 milligrams by mouth once daily for 21 days, followed by seven days off, in 28-day cycles, and with fulvestrant.
For people with moderate kidney impairment, the recommended dose is 6 milligrams once daily. For people with severe kidney impairment, the recommended dose is 3 milligrams once daily. Doctors may pause treatment, lower the dose, or stop treatment if side effects are serious or too hard to manage.
This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical trials of Itovebi used with palbociclib and fulvestrant, the most common side effects occurred in at least 20 percent of people taking Itovebi with palbociclib and fulvestrant.
These trials included adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer after recurrence on or after adjuvant endocrine therapy.
These side effects include:
Itovebi can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
Genentech, the manufacturer of Itovebi, offers the Genentech Oncology Co-Pay Assistance Program. Eligible people with commercial insurance may be able to receive copay assistance.
If you have government insurance or no insurance, the Itovebi website offers information on other ways to save on your prescription. The Genentech Oncology Co-Pay Assistance Program also offers information about financial support options through Genentech Access Solutions.
For financial support questions, contact Genentech Access Solutions at 877-436-3683. You can also visit the Genentech Oncology Co-pay Assistance Program website.
Before starting Itovebi, your doctor will test or check for:
Tell your doctor about all medications you take, including prescription drugs, over-the-counter medicines, and supplements.
If you miss a dose, take it as soon as possible within nine hours of your usual time. If more than nine hours have passed, skip that dose and take your next dose at the regular time.
If you vomit after taking a dose, do not take another dose that day. Take your next dose at the usual time the next day.
Itovebi can harm your baby if you are pregnant. Your doctor should verify pregnancy status before you start treatment. Females who can become pregnant should use effective non-hormonal birth control during treatment and for one week after the last dose.
Males with female partners who can become pregnant should use effective birth control during treatment and for one week after the last dose. Do not breastfeed during treatment with Itovebi and for one week after the last dose. Itovebi may also impair fertility in females and males of reproductive potential.
These answers are fact-checked by our editorial staff.
How effective is Itovebi?
In a study, Itovebi was used with palbociclib and fulvestrant in adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative breast cancer. The cancer was locally advanced or metastatic. The cancer had progressed during or within 12 months after completing adjuvant endocrine therapy.
People in the study had not received prior systemic therapy for locally advanced or metastatic disease. People taking Itovebi with palbociclib and fulvestrant had a median progression-free survival of 15.0 months.
This means half of the people went longer than 15.0 months before the cancer got worse or they died. People taking placebo (an inactive treatment) with palbociclib and fulvestrant had a median progression-free survival of 7.3 months.
Median overall survival was 34 months with the Itovebi combination and 27 months with the placebo combination. The objective response rate was 58 percent with the Itovebi combination and 25 percent with the placebo combination.
Can Itovebi cause stomach or digestive side effects in breast cancer treatment?
Yes. In people taking Itovebi with palbociclib and fulvestrant, diarrhea happened in 48 percent, nausea in 28 percent, vomiting in 15 percent, abdominal pain in fewer than 10 percent, and dyspepsia (indigestion) in fewer than 10 percent. Severe diarrhea can happen and may lead to dehydration and acute kidney injury.
Can Itovebi be used with other medicines for breast cancer?
Yes. Itovebi is used in combination with palbociclib and fulvestrant for this type of breast cancer, not by itself.
On MyBCTeam, people share their experiences with breast cancer, get advice, and find support from others who understand.
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