For US Healthcare Professionals

Glossary

    C
    Co-pay assistance

    Programs available to help eligible patients pay for their medicines

    E
    Endocrine therapy

    Treatment given to people with hormone receptor-positive breast cancer—it works by lowering the amount of hormones in the body or by stopping them from getting to the tumor cells. Also called hormonal therapy

    G
    Genentech

    The maker of Itovebi. Genentech is committed to helping patients get the Itovebi their healthcare provider prescribed

    Genentech Patient Foundation

    A program that gives free Genentech medicine to people who don’t have health insurance coverage or who have financial concerns and meet certain eligibility criteria

    H
    Hormone receptor

    Protein found on the surface of cells that bind hormones circulating in the blood. When hormones attach to hormone receptors, the cancer cells with these receptors grow

    Hormone receptor-positive breast cancer

    A type of cancer where the cells have a high number of hormone receptors on their surface

    M
    Metastatic breast cancer

    Cancer that started in the breast and spread to another part of the body

    Mutation

    A change in the genetic material of a cell. This may occur randomly, be inherited, or be caused by environmental changes. Most mutations are not harmful, but some can result in a genetic disorder or cancer

    P
    PI3K

    A type of protein that transmits signals in cells and is involved in cell growth

    PIK3CA

    A gene that helps make the PI3K protein. Mutations in the PIK3CA gene may cause PI3K to become overactive, which may make cancer cells grow

    PIK3CA-mutated breast cancer

    A type of breast cancer with one or more mutations in a specific gene called PIK3CA

    Placebo

    Inactive pill that may be used in studies to compare the effects of a given treatment with no treatment

    Protein

    Large, complex molecule that plays many important roles in cells

    S
    Specialty pharmacy (SP)

    An SP supplies certain medicines for patients. Some plans require you to use a certain SP to receive your medicine. SPs send your medicine to your healthcare provider's office or your home. They may also offer other services, such as referrals to financial assistance

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Important Safety Information & Use

What is Itovebi?

Itovebi (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

  • High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:

    • difficulty breathing
    • nausea and vomiting (lasting more than 2 hours)
    • stomach pain
    • excessive thirst
    • dry mouth
    • more frequent urination than usual or a higher amount of urine than normal
    • blurred vision
    • unusually increased appetite
    • weight loss
    • fruity-smelling breath
    • flushed face and dry skin
    • feeling unusually sleepy or tired
    • confusion
  • Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
    • pain
    • redness
    • swelling
    • ulcers
  • Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea.

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

  • decreased white blood cell counts, red blood cell counts, and platelet counts
  • decreased blood levels of calcium, potassium, sodium, and magnesium
  • increased creatinine blood levels
  • tiredness
  • increased blood levels of the liver enzyme alanine transaminase (ALT)
  • nausea
  • rash
  • loss of appetite
  • COVID-19 infection
  • headache

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

  • have a history of diabetes or high blood sugar
  • have kidney problems
  • are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.
    Females who are able to become pregnant:
    • Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
    • You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.
    Males with female partners who are able to become pregnant:
    • You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.
  • are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information, including Patient Information, for additional Important Safety Information.