Inavolisib

Inavolisib is used along with other cancer treatments to treat adults with breast cancer that has spread to other parts of the body (metastatic) and has returned after treatment with medicines.

Your doctor will conduct tests to ensure that inavolisib is the right treatment for you.

Inavolisib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Inavolisib is usually taken once per day with or without food at the same time each day.

If you vomit shortly after taking inavolisib, do not take another dose. Take your next dose as scheduled.

You may be given other medications. Keep taking these medicines for as long as your doctor has prescribed.

Do not change your dose or stop using this medicine without your doctor's advice.

Your blood may need to be tested often.

Your blood sugar will also need to be checked before and during treatment.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have other medical conditions or allergies.

You should not take inavolisib if you are allergic to it.

Tell your doctor if you have or have ever had:

• diabetes or high blood sugar; or
• kidney disease.

You may need to have a negative pregnancy test before starting this treatment.

Both men and women using inavolisib should use effective birth control to prevent pregnancy. Inavolisib can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 1 week after your last dose. Tell your doctor right away if a pregnancy occurs.

Inavolisib may affect fertility in men or women. Pregnancy may be less likely to occur while the mother or the father is using this medicine. Both men and women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Inavolisib may cause serious side effects. Call your doctor right away if you experience:

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• nausea, vomiting;
• blurred vision;
• confusion;
• weight loss, increased appetite;
• severe diarrhea, blood in your stools, stomach pain; or
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing.

Your cancer treatments may be delayed or stopped for good if you have certain side effects.

Common side effects of inavolisib may include:

• abnormal lab results;
• loss of appetite;
• rash;
• headache;
• feeling weak or tired;
• nausea; or
• new or worsening cough, fever, trouble breathing.

This is not a complete list of side effects, and others may happen. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Breast Cancer:

9 mg orally once a day, in combination with palbociclib and fulvestrantDuration of therapy: Until disease progression or unacceptable toxicity Comments:-Ensure patients meet criteria for treatment based on PIK3CA cancer mutations. -For pre- or perimenopausal women, administer a luteinizing hormone-releasing hormone (LHRH) agonist. -Consider administering a LHRH agonist in men. -Refer to the manufacturer product information for palbociclib and fulvestrant for complete dosing and administration recommendations. Use: In combination with palbociclib and fulvestrant, for the treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy

Use the medicine as soon as you can, but skip the missed dose if you are more than 9 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect inavolisib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.