Taking your Itovebi treatment

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How should I take Itovebi?

Take Itovebi exactly as directed by your healthcare provider.

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Once daily by mouth

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Ideally at the same time each day

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With or without food

Do not change your dose or stop taking Itovebi unless your healthcare provider tells you.

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

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

Itovebi-based treatment: Itovebi + palbociclib + fulvestrant

Itovebi is a tablet you take once per day.

Palbociclib is a tablet you take once a day for 3 weeks, followed by a week of no tablets.

Fulvestrant is given as 2 injections, one in each buttock muscle. You'll receive the injections when you first start treatment, 2 weeks after you start, 4 weeks after you start, and then once a month. You will be given these injections by your healthcare provider.

What will my treatment schedule look like?

Itovebi

Pablociclib

Fulvestrant

First month

After first month

Itovebi is usually taken as one tablet, but depending on your dose, you might need to take more than one tablet. Actual Itovebi and palbociclib tablets appear different.
Itovebi is available in 3-mg and 9-mg tablets.

Make Itovebi a part of your daily routine.
Set a daily reminder so you always remember when it’s time to take your medicine.

  • Swallow Itovebi tablet(s) whole. Do not chew, crush, or split the tablet(s)
  • If you miss your dose of Itovebi, you may still take it within 9 hours from the time you usually take it. If more than 9 hours, skip your dose for the day. The next day, take your dose at your usual time
  • If you vomit after taking Itovebi, do not take an extra dose. Take your regular dose at your usual time the next day
  • For women who have not reached menopause or are just starting menopause, your healthcare provider will prescribe a medicine called luteinizing hormone-releasing hormone (LHRH) agonist. For men, your healthcare provider may prescribe a LHRH agonist
  • Store Itovebi at room temperature (68°F to 77°F)
  • Keep Itovebi and all medicines out of reach of children

Tell your healthcare provider if you experience any side effects while taking Itovebi.

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Your Treatment Tracker

A tool to record your daily treatment experience to share with your healthcare team

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Understanding your treatment

What to expect, where to find support, and more

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Questions for Your Care Team

Ideas to help you get the conversation started

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.