Sotorasib is used in adults to treat non-small cell lung cancer who have already been treated with at least one other cancer medicine.

Sotorasib is given when the cancer has progressed or has spread to other parts of the body or when surgery is not an option.

Your doctor will make sure you have the correct tumor type to be treated with sotorasib.

Sotorasib may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

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

Your doctor will perform tests to make sure sotorasib is the right treatment for you.

You may take sotorasib with or without food, but take it the same way each time.

Sotorasib is usually taken once per day. You may need to take up to 8 tablets for your entire dose. Follow your doctor's instructions.

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

Read and carefully follow the instructions provided with this medicine on how to prepare and take sotorasib if you cannot swallow tablets whole. Ask your doctor or pharmacist if you don't understand these instructions.  

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

If you take an antacid (such as Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, or Tums), take your sotorasib dose 4 hours before or 10 hours after taking the antacid. Use only the type of antacid your doctor recommends.

Your blood will need to be tested often and you may need medical tests to check your liver function. Your dose or medication schedule may be changed based on the results.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Non-Small Cell Lung Cancer:

960 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity

Comments:
-This indication is approved under accelerated approval based on overall response rate and duration of response; continued approval may depend on verification and description of clinical benefit in confirmatory trial(s).

Use: For the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least 1 prior systemic therapy

Tell your doctor if you have ever had:

• liver disease; or

• lung or breathing problems other than lung cancer.

It is not known if sotorasib will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Use the medicine as soon as you can, but skip the missed dose if you are more than 6 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.

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.

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

Ask your doctor before taking an antacid and take only the type your doctor recommends.

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

Sotorasib may cause breathing problems that could lead to death. Get emergency medical help if you have new or worsening fever, cough, or shortness of breath.

Sotorasib may cause serious side effects. Call your doctor at once if you have:

• severe ongoing nausea, vomiting, or diarrhea;

• unusual bleeding--bruising, any bleeding that will not stop; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of sotorasib may include:

• nausea, diarrhea;

• cough;

• liver problems;

• muscle, joint, or bone pain;

• tiredness; or

• abnormal blood tests.

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

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Avoid taking an antacid, such as:

• cimetidine, famotidine, nizatidine, ranitidine, Pepcid, Tagamet, Zantac; or

• dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Nexium, Prevacid, Prilosec, Protonix, and others.

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

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.