Inavolisib

Inavolisib is used in combination with other medications for treatment of certain types of breast cancer that have returned after receiving other treatments. Inavolisib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Inavolisib comes as a tablet to take by mouth. It is usually taken with or without food once a day. Take inavolisib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take inavolisib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. If you vomit after taking a dose of inavolisib, do not take another dose. Just resume your usual dosing schedule.

Your doctor will tell you how long to take inavolisib.

It is important to tell your doctor how you are feeling while taking inavolisib. Your doctor may need to adjust your dose based on the presence of side effects.

Swallow the tablets whole; do not split, chew, or crush them.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking inavolisib,

• tell your doctor and pharmacist if you are allergic to inavolisib, any other medications, or any of the ingredients in inavolisib tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had kidney disease or diabetes.
• tell your doctor if you are pregnant or plan to become pregnant. You will need to take a pregnancy test before you start treatment. For females and males with female partners, use a reliable method of birth control to prevent pregnancy during your treatment and for 1 week after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking inavolisib, call your doctor immediately.Inavolisib may harm the fetus.tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking inavolisib and for at least 1 week after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

If within 9 hours of the scheduled dose time, take the missed dose as soon as you remember it. If more than 9 hours have passed, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Inavolisib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• tiredness
• nausea
• rash
• loss of appetite
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• difficulty breathing, vomiting, stomach pain, excessive thirst, frequent urinating, dry mouth, blurred vision, increased appetite, weight loss, fruity smelling breath, dry mouth or dry skin, flushing, confusion
• pain, redness, swelling, or ulcers in the mouth
• diarrhea, stomach pain, mucus or bloody stools

Inavolisib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to inavolisib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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