Sotorasib

Sotorasib is a prescription medication used for the treatment of non-small cell lung cancer. 

• Sotorasib is available under the following different brand names: Lumakras

Adult dosage

Tablet

• 120 mg

Non-Small Cell Lung Cancer

Adult dosage

• 960 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Sotorasib include:

diarrhea,

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

Serious side effects of Sotorasib include:

• jaundice
• bleeding or bruising
• dark or “tea-colored” urine
• loss of appetite
• light-colored stools (bowel movements)
• pain, aching, or tenderness on the right side of the stomach area (abdomen)
• tiredness or weakness in the stomach area (abdomen)
• Rare side effects of Sotorasib include:

none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sotorasib has severe interactions with the following drugs:
  • mavacamten
  • pacritinib
• Sotorasib has serious interactions with at least 186 other drugs.
• Sotorasib has moderate interactions with the following drugs:
  • belumosudil
  • isavuconazonium sulfate
  • ripretinib
  • warfarin
• Sotorasib has minor interactions with the following drug:
  • atogepant

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sotorasib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sotorasib?”

Cautions

• Hepatotoxicity reported, which may lead to drug-induced liver injury and hepatitis; monitor liver function tests (ALT, AST, and TB) before initiation, every 3 weeks for the first 3 months, then monthly or as clinically indicated, and more frequently in patients who develop transaminase and/or bilirubin elevations
• May cause ILD/pneumonitis that can be fatal; median time to the first onset was 2 weeks; monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever)
• Drug interaction overview
  • CYP3A4 substrate and inducer
  • May induce CYP2C8, CYP2C9, and CYP2B6
  • P-glycoprotein (P-gp) and BCRP inhibitor
  • Acid-reducing agents
    • Avoid coadministration
    • Coadministration with PPIs, H2-receptor antagonists, and locally acting antacids decreased sotorasib concentrations and its efficacy
    • If unavoidable, administer sotorasib 4 hr before or 10 hr after administration of locally acting antacids
  • Strong CYP3A4 inducers
    • Avoid coadministration
    • Coadministration with a strong CYP3A4 inducer decreased sotorasib concentrations and its efficacy
  • CYP3A4 substrates
    • Avoid coadministration with CYP3A4 sensitive substrates, for which minimal concentration changes may lead to therapeutic failures of the substrate
    • Coadministration with CYP3A4 substrates decreased its plasma concentrations and its efficacy
    • If unavoidable, increase sensitive CYP3A4 substrate dosage in accordance with its prescribing information
  • P-gp substrates
    • Avoid coadministration with P-gp substrates for which minimal concentration changes may lead to serious toxicities
    • Coadministration with a P-gp substrate (digoxin) increased digoxin plasma concentrations and adverse reactions
    • If unavoidable, decrease P-gp substrate dosage in accordance with its prescribing information

Pregnancy and Lactation

• No data are available on use in pregnant females
• Lactation
  • There are no data on drug presence or its metabolites in human milk, effects on the breastfed children, or effects on milk production
  • Advise women not to breastfeed during treatment and for 1 week after the final dose