Serious and common side effects
Like all medicines, Itovebi (inavolisib) can cause side effects. Be sure to tell your healthcare provider if you experience any changes in your body or health, as they may be signs of a side effect.
Itovebi may cause serious side effects, including:
High blood sugar levels (hyperglycemia)
Higher than normal amount of sugar in the blood
- 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. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including excessive thirst, urinating more often, blurred vision, mental confusion, difficulty breathing, or increased appetite with weight loss
Mouth sores (stomatitis)
Inflammation or irritation of the lining of the mouth
- Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider right away if you develop painful redness, swelling, or sores in your mouth
Diarrhea
Frequent and watery bowel movements
- Diarrhea is common with Itovebi and may be severe. 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
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, and headache.
To manage side effects, your healthcare provider may:
Tips that may help
The tips mentioned below may not work for everyone. Be sure to talk to your care team before trying any of these tips or if you experience any side effects that bother or concern you.
Higher than normal amount of sugar in the blood
- Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. If your healthcare provider asks you to self-monitor, talk to them about how and when to test and report your blood sugar levels
- Monitoring hyperglycemia is especially important in the first three months after starting Itovebi treatment
- Stay well-hydrated during treatment with Itovebi
- If you experience hyperglycemia, your healthcare provider may change or pause your dose, prescribe medication, or suggest some lifestyle modifications (such as dietary changes) to help with the symptoms
Tell your healthcare provider right away if you develop symptoms of high blood sugar, including excessive thirst, urinating more often, blurred vision, mental confusion, difficulty breathing, or increased appetite with weight loss.
Inflammation or irritation of the lining of the mouth
- Check your mouth daily and report any pain, redness, swelling, or ulcers to your healthcare team as soon as you notice them
- Practice good mouth care, such as using an extra-soft toothbrush to gently brush your teeth; ask your healthcare team if you should floss
- To lower the chances of mouth sores, your healthcare provider may recommend a medicated daily mouthwash
- Be sure to discuss dietary options with your healthcare team if you develop stomatitis
Tell your healthcare provider right away if you develop painful redness, swelling, or sores in your mouth.
Frequent and watery bowel movements
- Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea
- Food and drinks you may want to try:
- Water; drinks containing electrolytes (eg, sugar-free sports drinks); caffeine-free, sugar-free teas; and clear, fat-free broths
- Gelatin, plain yogurt, and eggs
- Toast, saltine crackers, and rice (however, if you have hyperglycemia, you may need to limit carbohydrates)
- Skinless meats that can be broiled or baked (for example: turkey, chicken, and fish)
- Foods and drinks you may want to avoid:
- Juices or foods that have a laxative effect, such as prunes or prune juice
- Drinks that contain alcohol or caffeine
- Milk and other dairy products (except for yogurt)
- Spicy, greasy, fried, and high-fiber foods
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.
An area of the skin that has changes in texture or color and may look inflamed or irritated. The skin may be red, warm, scaly, bumpy, dry, itchy, swollen, painful, cracked, or blistered
- Try to take quick showers or sponge baths instead of long, hot showers. Clean skin gently with warm water and mild, moisturizing soap; rinse and pat dry. Apply a fragrance- and alcohol-free moisturizer while skin is still damp
- Wear soft, loose-fitting clothing
- Avoid being in the sun as much as possible. If you need to be outside during the day, wear a hat and long-sleeved clothing and apply broad-spectrum sunscreen of at least SPF 30
Be sure to get skin care advice from your healthcare team if you develop a rash.
These are not all of the side effects you may experience with Itovebi-based treatment.
Your care team will help you identify and manage your side effects, so please be sure to inform them of any symptoms and concerns.
Get free Itovebi educational support from a Nurse Educator, including tips on how to manage your treatment.
Please also see pages 12-17 of the Understanding your treatment brochure and the full Prescribing Information for additional Important Safety Information.
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