Sotorasib (soe-toe-RAS-ib)

Treats non-small cell lung cancer (NSCLC).

Brand Name(s):

Lumakras

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. Take the medicine at the same time each day.
• Swallow the tablet whole. Do not crush, break, or chew it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• If you cannot swallow the tablets:
  • Put the tablets in a glass with 120 milliliters (mL) of non-carbonated, room temperature water without crushing the tablets. Do not use any other liquids.
  • Stir until the tablets are in small pieces. The tablets will not completely dissolve. The color of the mixture may be pale to bright yellow.
  • Drink the mixture right away or within 2 hours of preparing. Do not chew the small pieces of tablets.
  • Add another 120 mL of water to the same glass and drink to make sure get the full dose.
  • Stir the mixture again before drinking, if you do not drink the mixture right away.
• Missed dose: If a dose is missed by more than 6 hours, do not take an extra dose. Take the next dose at the regular scheduled time. Do not take extra medicine to make up for the missed dose. If you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular scheduled time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how sotorasib works. Tell your doctor if you are using digoxin, midazolam, rifampin, or rosuvastatin.
• Tell your doctor if you are also taking a stomach medicine (including famotidine, omeprazole, or other H2 blockers or PPIs). Take Lumakras™ at least 4 hours before of 10 hours after taking an antacid.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant, or if you have kidney disease, liver disease, or other lung or breathing problems.
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• This medicine may cause the following problems:
  • Liver problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Chest pain, cough, fever, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rapid weight gain, swelling in your hands, ankles, or feet

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea
• Joint, muscle, or bone pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088