Sotorasib

What is Sotorasib?

• Sotorasib (Lumakras) is an inhibitor of the RAS GTPase family used to treat adults with non-small cell lung cancer (NSCLC).

AMG 510

What are the uses of this medicine?

This medicine is used to treat adults with non-small cell lung cancer (NSCLC):

• that has spread to other parts of the body or cannot be removed by surgery, and
• whose tumor has an abnormal KRAS G12C gene, and
• who have received at least one prior treatment for their cancer.

How does this medicine work?

• An orally available agent that targets the specific KRAS mutation, p.G12C, with potential antineoplastic activity.
• Upon oral administration, sotorasib selectively targets the KRAS p.G12C mutant, at either the DNA, RNA or protein level, and prevents, through an as of yet not elucidated manner, expression of and/or tumor cell signaling through the KRAS p.G12C mutant.
• This may inhibit growth in KRAS p.G12C-expressing tumor cells.
• The KRAS p.G12C mutation is seen in some tumor cell types and plays a key role in tumor cell proliferation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid coadministration of Lumakras with proton pump inhibitors (PPIs), H2 receptor antagonists, and locally acting antacids. If coadministration with an acid-reducing agent cannot be avoided, administer Lumakras 4 hours before or 10 hours after administration of a locally acting antacid.
• Avoid coadministration of Lumakras with strong CYP3A4 inducers.
• Avoid coadministration of Lumakras with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate.
• Avoid coadministration of Lumakras with P-gp substrates, for which minimal concentration changes may lead to serious toxicities.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Select patients for treatment of locally advanced or metastatic NSCLC with Lumakras based on the presence of KRAS G12C mutation in tumor or plasma specimens.

Recommended dosage The recommended dosage of Lumakras is 960 mg (eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity.

Administration

• Take Lumakras exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Lumakras unless your healthcare provider tells you to.
• Take Lumakras 1 time each day, at about the same time each day.
• Take Lumakras with or without food.
• Swallow Lumakras tablets whole. Do not chew, crush, or split tablets.
• If you cannot swallow Lumakras tablets whole:
• Place your daily 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 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 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 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.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Tablets: 120 mg

This medicine is available in fallowing brand namesː

• Lumakras

What side effects can this medication cause?

The most common side effects of this medicine include:

• diarrhea
• muscle or bone pain
• nausea
• tiredness
• liver problems
• cough
• changes in liver function tests
• changes in certain other blood tests

Lumakras may cause serious side effects, including: Liver problems which may include:

• 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

What special precautions should I follow?

• Lumakras can cause hepatotoxicity. Monitor liver function tests every 3 weeks for the first 3 months of treatment then once monthly as clinically indicated. Withhold, reduce dose, or permanently discontinue Lumakras based on the severity.
• Lumakras can cause ILD/pneumonitis that can be fatal. Monitor for new or worsening pulmonary symptoms. Immediately withhold Lumakras for suspected ILD/pneumonitis and permanently discontinue if no other potential causes of ILD/pneumonitis are identified.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no available data on Lumakras use in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Lumakras have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

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, and iron oxide yellow.

Who manufactures and distributes this medicine?

Distributed by: Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA 91320-1799 U.S.A

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

• Store Lumakras at room temperature between 68°F to 77°F (20°C to 25°C).
• The bottle has a child-resistant closure.

• Dailymed label info on Sotorasib
• FDA Sotorasib

Sotorasib Resources
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