Lumakras

Lumakras is used to treat KRAS G12C-mutated non-small cell lung cancer (NSCLC) or colorectal cancer (CRC) in adults. It is an oral tablet that is taken once a day.

Lumakras’ mechanism involves targeting a specific cancer mutation called KRAS G12C that drives tumor growth. It works by permanently attaching to this mutated protein, locking it in an "off" position so it can't signal cancer cells to multiply. This stops tumor growth and causes cancer cell death, but only in cells with this specific mutation, sparing healthy cells. In some colorectal cancers, combining Lumakras with drugs that block EGFR (another cancer pathway) works better than either treatment alone. Lumakras is an inhibitor of the RAS GTPase family.

Lumakras (sotorasib) gained FDA approval on May 28, 2021. There is no generic

Lumakras is FDA approved to treat:

• KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) as a single agent in adults who have received at least one prior systemic therapy This indication is approved under accelerated approval designation based on overall response rate (ORR) and duration of response (DOR). Continued approval may be contingent upon a continued clinical benefit being shown in confirmatory clinical trials.
• KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) in combination with panitumumab, in adults who have previously received certain chemotherapy medicines (fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy).

Your healthcare provider will perform a test to make sure that Lumakras is right for you.

It is not known if Lumakras is safe and effective in children.

Take Lumakras exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking this medicine unless your healthcare provider tells you to.

• Take your dose of Lumakras 1 time each day, at the same time each day.
• Take Lumakras with or without food.
• Swallow the tablets whole. Do not chew, crush, or split tablets.

For colon or rectal cancer, you will also receive panitumumab through a vein in your arm (intravenously), given by your healthcare provider. You will first take Lumakras before you receive your first dose of panitumumab. Your healthcare provider will temporarily or permanently stop your treatment with panitumumab if your treatment with Lumakras is temporarily or permanently stopped.

If you cannot swallow Lumakras tablets whole:

• Place your prescribed dose of Lumakras in a glass of 4 ounces (120 mL) of non-carbonated, room temperature water without crushing the tablets. Do not use any other liquids. Stir or swirl the cup for about 3 minutes until the tablets are in small pieces (the tablets will not completely dissolve). The color of the mixture may be pale yellow to bright yellow.
• Drink the Lumakras and water 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 of Lumakras.
• If you do not drink the mixture right away, stir or swirl the mixture again before drinking.

If you take an antacid medicine, take Lumakras either 4 hours before or 10 hours after the antacid.

If you vomit after taking a dose of Lumakras, do not take an extra dose. Take your next dose at your regularly scheduled time the next day.

Before taking Lumakras, tell your healthcare provider about all your medical conditions, including if you:

• have liver problems.
• have lung or breathing problems other than lung cancer.
• are pregnant or plan to become pregnant. It is not known if Lumakras will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Lumakras passes into your breast milk. Do not breastfeed during treatment with Lumakras and for 1 week after the last dose.

The most common side effects of Lumakras when used alone for NSCLC are:

• diarrhea
• muscle or bone pain
• nausea
• tiredness
• cough
• changes in certain blood tests.

The most common side effects of Lumakras when used in combination with panitumumab for CRC are:

• skin rash
• dry skin
• diarrhea
• mouth sores
• tiredness
• muscle and bone pain
• changes in certain blood tests.

Serious side effects and warnings

Lumakras may cause serious side effects, including:

• Liver problems. Abnormal liver blood tests are common with Lumakras and can sometimes be severe. Your healthcare provider should do blood tests before starting and during treatment with Lumakras to check your liver function. Tell your healthcare provider right away if you develop any signs or symptoms of liver problems, including: your skin or the white part of your eyes turns yellow (jaundice) dark or “tea-colored” urine light-colored stools (bowel movements) tiredness or weakness nausea or vomiting bleeding or bruising loss of appetite pain, aching, or tenderness on the right side of your stomach area (abdomen).
• Lung or breathing problems. Lumakras may cause inflammation of the lungs that can lead to death. Tell your healthcare provider or get emergency medical help right away if you have new or worsening shortness of breath, cough, or fever.

Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Lumakras if you develop side effects.

These are not all the possible side effects of Lumakras. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Amgen at 1-800-772-6436 (1-800-77-AMGEN).

If you miss a dose of Lumakras, take the dose as soon as you remember. If it has been more than 6 hours, do not take the dose. Take your next dose at your regularly scheduled time the next day. Do not take 2 doses at the same time to make up for a missed dose.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary, and herbal supplements. Lumakras can affect the way some other medicines work, and some other medicines can affect the way Lumakras works.

Especially tell your healthcare provider if you take antacid medicines, including Proton Pump Inhibitor (PPI) medicines or H2 blockers during treatment with Lumakras. Ask your healthcare provider if you are not sure.

Store Lumakras at room temperature between 68°F to 77°F (20°C to 25°C).

• The bottle has a child-resistant closure.
• Keep out of the reach of children.

Active Ingredient: sotorasib

Inactive Ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate. Tablet film coating material contains polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, iron oxide yellow and iron oxide red (320 mg tablet only).

Lumakras is made by Amgen Inc., located in Thousand Oaks, CA 91320-1799 U.S.A.