Important information about high blood sugar levels

High blood sugar (hyperglycemia) is one of the possible side effects of Itovebi treatment.

A more complete overview of Itovebi side effects, including tips that may help, can be found at Side Effects & Tips.

This page can help you understand why blood sugar levels may rise with Itovebi treatment, how blood sugar levels are monitored, and what you and your healthcare provider (HCP) can do to help manage them.

What is hyperglycemia?

Hyperglycemia is a higher-than-normal amount of sugar in the blood. It is also called high blood glucose, or high blood sugar.

  • High blood sugar is common with Itovebi and may be severe or fatal 
  • Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi 
  • Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death
  • Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including excessive thirst, urinating more often, blurred vision, confusion, difficulty breathing, or increased appetite with weight loss
  • Be proactive in monitoring and managing your blood glucose levels.

Why is hyperglycemia common with Itovebi treatment?

High blood sugar is not a sign that something has gone wrong with your treatment. It happens because of how Itovebi works in your body.

Normally, a hormone called insulin helps control your blood sugar, letting it move from your bloodstream into your cells (like in your muscles and fat) to be used for energy or stored. Insulin also tells your liver not to make too much sugar.

Itovebi can block these normal insulin signals. This means sugar might not move into your cells as easily, and your liver might produce more sugar, leading to higher blood sugar levels. It's important to work with your HCP to manage high blood sugar levels to help you stay on treatment.

How is glucose monitored in patients on Itovebi?

Your HCP may monitor your fasting blood glucose in their office or clinic, or may ask you to self-monitor and report your fasting glucose levels at home.

“Fasting” means not eating or drinking anything except water for at least 8 hours (usually overnight) before your blood glucose measurement.

Monitoring will be required more frequently in the first 4 weeks of treatment. If your HCP suggests you monitor at home, ask them to recommend a glucose monitoring method for you.

Review the discussion guide for glucose monitoring to prepare for a conversation with your HCP.

Download the Blood Glucose Tracking Worksheet to keep track of your fasting blood glucose levels. Share the worksheet with your HCP at your appointments.

Monitoring schedule

Fasting glucose level

Once before starting Itovebi
Week 1 every 3 days
Weeks 2-4 once a week
Weeks 5-12 once every 2 weeks
After Week 12 once every 4 weeks and when your doctor feels it's needed

Hemoglobin A1C

Once before starting Itovebi
Once every 3 months and when your doctor feels it's needed

If you have a history of Type 2 diabetes, your blood sugar level monitoring may be more frequent.

How can you and your care team manage hyperglycemia?

  • If you experience hyperglycemia, your HCP's management options may include lowering or delaying your dose of Itovebi, prescribing medication to lower your blood sugar, suggesting lifestyle modifications (such as dietary changes) to help with the symptoms, or stopping treatment with Itovebi
  • In the Itovebi study, some patients with high blood sugar levels were treated with medication for hyperglycemia. Of the 162 adults taking Itovebi-based treatment, 1.2% stopped treatment completely because of hyperglycemia
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Consume low glycemic index (GI) foods

Foods such as leafy greens, whole grains (quinoa and oats), lentils, nuts, berries, and sweet potatoes cause slower, steadier rises in blood sugar. Avoid or limit things like white bread, white rice, white potatoes, sugary drinks, and ultraprocessed snacks.

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Balance your meals with macronutrients

Structure meals with lean protein (chicken, tofu, fish, eggs), healthy fats (avocado, olive oil, seeds), and fiber-rich carbs (veggies, legumes, whole grains). Protein and fat slow the absorption of carbs and reduce blood sugar spikes.

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Eat meals at consistent times

Consistency helps avoid blood sugar spikes and crashes. In addition to your 3 meals a day, you might also include 1–2 small snacks spaced evenly.

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Stay well-hydrated during treatment with Itovebi

Drink water regularly. Dehydration can make blood sugar more difficult to control.

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Exercise aerobically

Regular brisk walking, cycling, swimming, or even dancing can enhance insulin sensitivity and help glucose uptake by your muscles. Aim for around 150 minutes per week (30 minutes a day/5 days a week).

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Train to be stronger

Strength training builds muscle, which improves glucose metabolism. Consider bodyweight exercises, weightlifting, or resistance bands 2–3 times a week.

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Move around after meals

It reduces after-meal spikes in sugar levels. Consider a light 10–15 minute walk after your meal.

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Manage stress

Stress hormones, such as cortisol, can increase blood sugar levels. Deep breathing, meditation, yoga, hobbies, or therapy may help.

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Don’t skimp on sleep

Poor sleep hygiene can impair insulin sensitivity. Try to get 7–9 hours of consistent, quality sleep per night.

  • In a clinical study of Itovebi, among the people who developed hyperglycemia, about half experienced it within the first 7 days.

The time to first onset of hyperglycemia ranged from 2 to 955 days.

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SPEAK WITH A NURSE EDUCATOR

Receive one-on-one information sessions about Itovebi at no cost*

*Nurse Educators are representatives of Genentech and do not give medical advice. Please contact your healthcare provider if you experience side effects or need medical advice. A Nurse Educator can help with additional support and tips.

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 or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. 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 of 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.

  • PI3K

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

  • Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (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

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