Sotorasib

Brand Name(s): Lumakras®

Why is this medicine prescribed?

Sotorasib is used to treat certain types of lung cancer (non-small cell lung cancer; NSCLC) and cancer of the colon (large intestine) or rectum. 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.

Are there other uses for this medicine?

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

How should this medicine be used?

Sotorasib comes as a tablet to take by mouth. Take once daily with or without food. Take sotorasib at around the same time every day.

Take sotorasib exactly as directed. Ask your doctor or pharmacist to explain any part you do not understand. 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. Take your next dose at your regular time the next day.

Your doctor may lower your dose or stop your treatment depending on how well the medication works for you 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.

What special precautions should I follow?

Before taking sotorasib,

  • tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • 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.
  • if you are taking antacids (Maalox®, Mylanta®, Tums®); H 2 blockers such as cimetidine (Tagamet®), famotidine (Pepcid®), and nizatidine (Axid®); or proton pump inhibitors such as dexlansoprazole (Dexilant), esomeprazole (Nexium®, in Talicia®), lansoprazole (Prevaci®d), omeprazole (Prilosec®, Zegrid®), pantoprazole (Protonix®), and rabeprazole (Aciphex®), take them 10 hours before or 4 hours after sotorasib.
  • 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
  • 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.

What special dietary instructions should I follow?

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

What should I do if I forget to take a dose?

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.

What should I do in case of overdose?

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.

What side effects can this medicine cause?

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, joint, or bone pain
  • rash
  • dry skin
  • swelling of the face, arms, hands, feet, ankles, or lower legs
  • mouth sores

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, light-colored stools, unusual bleeding or bruising, loss of appetite, unusual tiredness or weakness, or pain on right side of stomach area
  • new or worsening 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 ( https://www.fda.gov/Safety/MedWatch ) or by phone (

1-800-332-1088).

What should I know about storage and disposal of this medication?

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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What other information should I know?

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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