Sotorasib

Sotorasib is used to treat a certain type of lung cancer (non-small cell lung cancer; NSCLC) that has spread to other parts of the body or cannot be removed by surgery in adults who have received at least one other treatment. Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells.

Sotorasib comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take sotorasib 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 sotorasib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

If you cannot swallow the tablets whole, place the tablets in a glass of 4 ounces (120 mL) of non-carbonated, room temperature water. Do not use any other liquids other than water. Stir until the tablets are in small pieces. Do not crush the tablets; they will not completely dissolve. Drink the mixture right away or within 2 hours of preparing. Do not chew pieces of the tablet. Rinse the glass with an additional 4 ounces (120 mL) of water and drink to make sure that you have taken the full dose. If you do not drink the mixture right away, stir the mixture again before drinking.

If you vomit after taking sotorasib, do not take another dose. Continue your regular dosing schedule the next day.

Your doctor may temporarily or permanently stop your treatment or adjust your dose of sotorasib depending on your response to treatment and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment. Continue to take sotorasib even if you feel well. Do not stop taking sotorasib without talking to your doctor.

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 sotorasib,

• tell your doctor and pharmacist if you are allergic to sotorasib, any other medications, or any of the ingredients in sotorasib tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• The following nonprescription or herbal products may interact with sotorasib: cimetidine (Tagamet HB), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), and ranitidine. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking sotorasib. Do not start any of these medications while taking sotorasib without discussing with your healthcare provider
• if you are taking sotorasib and an antacid, take sotorasib either 4 hours before or 10 hours after the antacid.
• tell your doctor if you have or have ever had liver disease, or lung or breathing problems other than lung cancer.
• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking sotorasib, call your doctor immediately.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving sotorasib and for 1 week after your final dose.

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

Take the missed dose as soon as you remember it. However, if it has been more than 6 hours, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• diarrhea
• vomiting
• nausea
• constipation
• loss of appetite
• stomach pain
• tiredness
• muscle or bone pain
• joint pain
• rash

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

• yellowing of skin or eyes, dark-colored urine, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area
• shortness of breath, cough, or fever

Sotorasib 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 (http://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 light, 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. http://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 (http://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 will order certain lab tests to check your body's response to sotorasib. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with sotorasib.

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.

• Lumakras^®