Before you start Itovebi: 4 key steps to manage hyperglycemia

What you need to know to begin treatment with confidence

Before you start treatment with Itovebi, it may be helpful to learn about potential side effects. Some, such as high blood sugar levels (hyperglycemia), mouth sores (stomatitis), and diarrhea, can be serious. Be sure to tell your healthcare provider (HCP) if you experience any changes in your body or health, as they may be signs of a side effect. See Side Effects & Tips to learn more.

Here we focus on how to be prepared for hyperglycemia, if it occurs. Below you'll find key steps to help you prepare for blood sugar monitoring and possible high blood sugar levels while you are on Itovebi.

BEFORE YOUR FIRST DOSE OF ITOVEBI


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1. MONITOR YOUR BLOOD SUGAR LEVEL

Learn about glucose monitoring and make a plan with your HCP

  • Your HCP will measure your fasting blood sugar (glucose) level before you start and may continue while you are taking Itovebi, or you may monitor your glucose levels at home
  • Your fasting glucose level must be monitored regularly. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes
  • Ask your HCP to recommend a glucose monitoring method for you. Use the “Monitoring glucose” section of Questions for Your Care Team to help guide the conversation
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2. GET ONE-ON-ONE EDUCATIONAL SUPPORT

Consider sessions with an Itovebi Nurse Educator*

  • Itovebi Nurse Educators can help answer questions about starting treatment, offer tips on side effect management, and provide ongoing treatment support and education while you are on Itovebi
  • Help is available in both English and Spanish
  • There is no cost

Ask your care team how to get more information about Itovebi

*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.

AFTER STARTING ITOVEBI


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3. INFORM

Report unusual blood sugar levels and symptoms of hyperglycemia to your HCP

  • If you are self-monitoring, ask your HCP what they consider to be a normal range for fasting glucose levels and when you need to call them about your glucose level monitoring results
  • Know the symptoms of high blood sugar levels, including excessive thirst, urinating more often, blurred vision, confusion, difficulty breathing, or increased appetite with weight loss. If you experience any of these symptoms—or notice other changes that could be side effects—get in touch with your HCP as soon as possible
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4. MANAGE

Follow your HCP’s plan for managing hyperglycemia

  • If you develop high blood sugar levels, your HCP’s management options may include lowering or delaying your dose of Itovebi, prescribing medication to lower your blood sugar, or stopping treatment with Itovebi
  • Your HCP may also recommend lifestyle changes, including adjustments to your diet, exercise routine, and sleep habits
  • Your commitment to these steps is essential to experiencing the full benefit of Itovebi.

By actively following these steps and communicating with your healthcare team, you can be empowered to begin your Itovebi treatment feeling prepared.

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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.

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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 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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