Sotorasib
Sotorasib is a targeted cancer medicine for adults whose tumors carry a KRAS G12C mutation, used for non-small cell lung cancer and metastatic colorectal cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Sotorasib (Lumakras) is a targeted cancer tablet that binds permanently to KRAS G12C, a mutated growth-signal protein, and locks it “off.” On the U.S. market since about 2021, it is a specialist drug for KRAS G12C-positive non-small cell lung cancer after earlier treatment, and for metastatic colorectal cancer alongside panitumumab, an infused antibody. It is usually more manageable than traditional chemotherapy, but diarrhea, nausea, tiredness and muscle or joint aches are common. Its serious risks are liver injury, caught with regular liver blood tests, and lung inflammation (pneumonitis), which can be fatal, so report new or worsening cough, shortness of breath or fever right away.
Clinical pearls
- Avoid acid reducers like omeprazole and famotidine; if you need an antacid, take Lumakras 4 hours before or 10 hours after it.
- Swallow the tablets whole, at the same time each day, with or without food; never chew, crush or split them.
- It can raise digoxin and rosuvastatin levels and weaken some other drugs, while rifampin weakens sotorasib itself.
- Expect liver tests every 3 weeks for the first 3 months, then about monthly; report yellow eyes or dark urine sooner.
Patient information guide A plain-language walkthrough of Sotorasib, written from its FDA label.
What Sotorasib is used for
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Sotorasib is used for adults with KRAS G12C-mutated cancers, confirmed by an FDA-approved test.
- Lumakras alone: locally advanced or metastatic non-small cell lung cancer (NSCLC) after at least one prior systemic therapy. This use has accelerated approval based on response rate and duration of response. Continued approval may depend on confirmatory trials.
- Lumakras with panitumumab: metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.
How Sotorasib works
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Sotorasib blocks KRAS G12C, a mutant protein found in certain tumors. It binds permanently to the protein and locks it in an inactive state. This stops the signals that drive tumor growth, without affecting normal KRAS.
In colorectal cancer, activation of EGFR can make tumors resist KRAS G12C blockers. Panitumumab blocks EGFR, and in a lab model the combination worked better than either drug alone.
Sotorasib dosage
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Lumakras is a tablet taken by mouth once a day at the same time each day. You can take it with or without food. Follow your prescriber's directions and the label.
- Swallow tablets whole. Do not chew, crush or split them.
- If swallowing is hard, the tablets can be dispersed in room-temperature, non-carbonated water. Drink it right away or within 2 hours, then rinse the cup with more water and drink that too.
- If you miss a dose by more than 6 hours, skip it and take the next dose the next day. Never double up.
- If you vomit after a dose, do not take an extra one.
- For colorectal cancer, the first Lumakras dose is taken before the first panitumumab infusion.
Dosing details from the FDA-approved label
From the Sotorasib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- KRAS G12C-mutated locally advanced or metastatic NSCLC (single agent)
- 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity
- Take at the same time each day with or without food; swallow tablets whole; if adverse reactions occur, first dose reduction 480 mg once daily, second dose reduction 240 mg once daily
- KRAS G12C-mutated mCRC (in combination with panitumumab)
- 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily in combination with panitumumab until disease progression or unacceptable toxicity
- Administer first dose of LUMAKRAS prior to first panitumumab infusion; take with or without food
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Recommended dosage as a single agent for NSCLC and in combination with panitumumab for mCRC: 960 mg orally once daily. ( 2.2 ) Swallow tablets whole with or without food. ( 2.2 ) 2.1 Patient Selection KRAS G12C-mutated Locally Advanced or Metastatic NSCLC 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. If no mutation is detected in a plasma specimen, test tumor tissue [see Clinical Studies (14.1) ]. KRAS G12C-mutated mCRC Select patients for treatment of mCRC based on the presence of KRAS G12C mutation in tumor specimens [see Clinical Studies (14.2) ]. Information on FDA-approved tests for the detection of KRAS G12C mutations is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage and Administration LUMAKRAS as a Single Agent for KRAS G12C-mutated Locally Advanced or Metastatic NSCLC The recommended dosage of LUMAKRAS is 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily until disease progression or unacceptable toxicity. LUMAKRAS in Combination with Panitumumab for KRAS G12C-mutated mCRC The recommended dosage of LUMAKRAS is 960 mg (three 320 mg tablets or four 240 mg tablets or eight 120 mg tablets) orally once daily in combination with panitumumab until disease progression or unacceptable toxicity. Administer the first dose of LUMAKRAS prior to first panitumumab infusion. Refer to the panitumumab full prescribing information for recommended panitumumab dosage information. Take the daily dose of LUMAKRAS at the same time each day with or without food [see Clinical Pharmacology (12.3) ] . Swallow tablets whole. Do not chew, crush or split tablets . If a dose of LUMAKRAS is missed by more than 6 hours, take the next dose as prescribed the next day. Do not take 2 doses at the same time to make up for the missed dose. If vomiting occurs after taking LUMAKRAS, do not take an additional dose. Take the next dose as prescribed the next day. Administration to Patients Who Have Difficulty Swallowing Solids Disperse tablets in 120 mL (4 ounces) of non-carbonated, room-temperature water without crushing. No other liquids should be used.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Sotorasib side effects
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Common side effects in lung cancer include:
Common side effects
- Diarrhea
- Nausea
- Muscle and joint pain
- Tiredness
- Liver problems (abnormal liver tests)
- Cough
- Rash and dry skin (with panitumumab)
- Mouth sores (with panitumumab)
When to get medical help
- Call your doctor if you have yellowing of the skin or eyes, dark urine, belly pain or unusual tiredness. These can be signs of liver problems.
- Get medical help right away for new or worsening shortness of breath, cough or fever. These can be signs of lung inflammation (ILD/pneumonitis), which can be fatal.
- Tell your doctor about severe or ongoing nausea, vomiting or diarrhea, even with supportive medicines.
- Call your doctor about any severe side effect, since the dose may need to be paused or lowered.
With panitumumab in colorectal cancer, the most common ones are rash, dry skin, diarrhea, mouth sores (stomatitis), tiredness and musculoskeletal pain. Report liver symptoms or new breathing problems promptly.
Sotorasib warnings and precautions
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- Liver injury: Lumakras can raise liver enzymes and cause hepatitis or drug-induced liver injury. Liver tests are done before treatment, every 3 weeks for 3 months, then about monthly. In lung cancer studies, liver problems were more common (40%) in people who had recent immunotherapy.
- Lung inflammation (ILD/pneumonitis): This can be fatal. Watch for shortness of breath, cough or fever. Treatment is stopped right away if it is suspected.
- Severe nausea, vomiting or diarrhea may require pausing the medicine and then using a lower dose.
Sotorasib interactions
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Several medicines change how Lumakras works or are changed by it.
- Proton pump inhibitors and H2 blockers: they lower Lumakras levels and may reduce its effect.
- Local antacids: if needed, take Lumakras 4 hours before or 10 hours after.
- Strong CYP3A4 inducers (for example rifampin): they lower Lumakras levels.
- CYP3A4 substrates (for example midazolam): their levels drop and they may work less well.
- P-gp substrates (for example digoxin): their levels rise and side effects may increase.
- BCRP substrates (for example rosuvastatin): their levels rise, so you may be monitored and the dose lowered.
Interactions listed in the FDA-approved label
From the Sotorasib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Acid-reducing agents (proton pump inhibitors, H2 receptor antagonists, locally acting antacids): Coadministration with gastric acid-reducing agents decreased sotorasib concentrations, which may reduce the efficacy of sotorasib. Avoid coadministration. If it cannot be avoided, administer LUMAKRAS 4 hours before or 10 hours after a locally acting antacid.
- Strong CYP3A4 inducers: Coadministration with a strong CYP3A4 inducer decreased sotorasib concentrations, which may reduce the efficacy of sotorasib. Avoid coadministration of LUMAKRAS with strong CYP3A4 inducers.
- CYP3A4 substrates: Sotorasib is a CYP3A4 inducer; coadministration decreased the substrate's plasma concentrations, which may reduce the efficacy of the substrate. Avoid coadministration with CYP3A4 sensitive substrates for which minimal concentration changes may lead to therapeutic failures. If it cannot be avoided, increase the sensitive CYP3A4 substrate dosage in accordance with its Prescribing Information.
- P-glycoprotein (P-gp) substrates: Sotorasib is a P-gp inhibitor; coadministration increased the substrate's plasma concentrations, which may increase the adverse reactions of the substrate. Avoid coadministration with P-gp substrates for which minimal concentration changes may lead to serious toxicities. If it cannot be avoided, decrease the P-gp substrate dosage in accordance with its Prescribing Information.
- Breast cancer resistance protein (BCRP) substrates: Sotorasib is a BCRP inhibitor; coadministration increased the substrate's plasma concentrations, which may increase the risk of adverse reactions of the substrate. Monitor for adverse reactions of the BCRP substrate and decrease the BCRP substrate dosage in accordance with its Prescribing Information.
Read the label’s full interactions text
7 DRUG INTERACTIONS Acid-Reducing Agents: Avoid coadministration with proton pump inhibitors (PPIs) and H 2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer LUMAKRAS 4 hours before or 10 hours after a local antacid. ( 2.4 , 7.1 ) Strong CYP3A4 Inducers: Avoid coadministration with strong CYP3A4 inducers. ( 7.1 ) CYP3A4 Substrates: Avoid coadministration with CYP3A4 substrates for which minimal concentration changes may lead to therapeutic failures of the substrate. If coadministration cannot be avoided, adjust the substrate dosage in accordance to its Prescribing Information. ( 7.2 ) P-gp substrates: Avoid coadministration with P-gp substrates for which minimal concentration changes may lead to serious toxicities. If coadministration cannot be avoided, decrease the substrate dosage in accordance to its Prescribing Information. ( 7.2 ) 7.1 Effects of Other Drugs on LUMAKRAS Acid-Reducing Agents The solubility of sotorasib is pH-dependent. Coadministration of LUMAKRAS with gastric acid-reducing agents decreased sotorasib concentrations [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of sotorasib. Avoid coadministration of LUMAKRAS with proton pump inhibitors (PPIs), H 2 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 [see Dosage and Administration (2.4) ] . Strong CYP3A4 Inducers Sotorasib is a CYP3A4 substrate. Coadministration of LUMAKRAS with a strong CYP3A4 inducer decreased sotorasib concentrations [see Clinical Pharmacology (12.3) ] , which may reduce the efficacy of sotorasib. Avoid coadministration of LUMAKRAS with strong CYP3A4 inducers . 7.2 Effects of LUMAKRAS on Other Drugs CYP3A4 Substrates Sotorasib is a CYP3A4 inducer.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Sotorasib
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- There are no contraindications listed.
- Tell your doctor about liver or lung problems. Severe liver impairment has not been studied, and you may be monitored more often.
- Do not breastfeed during treatment and for 1 week after the last dose.
- There are no data in pregnant women. Ask your doctor about pregnancy risks.
- Safety in children has not been established.
- Older adults had no overall differences in safety or effectiveness.
- Review all your medicines, especially acid reducers.
What Sotorasib does in the body
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Sotorasib blocks KRAS signaling and slows growth in KRAS G12C tumor cells. At the recommended dose it does not cause large increases in the QTc interval, a heart rhythm measurement. The relationship between dose and effect over time is not known.
How your body processes Sotorasib
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Sotorasib reaches peak blood levels in about 1 hour. A high-fat meal raised exposure by 25%, which is why it can be taken with or without food. Its half-life is about 5 hours, and steady levels are reached within 22 days. It is broken down mainly by non-enzymatic conjugation and by CYP3A enzymes. Most of it leaves in the stool (74%), and little leaves in urine (6%).
How to store Sotorasib
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Store at 20°C to 25°C (68°F to 77°F).
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Sotorasib
180 supplements and herbal products have documented interactions with Sotorasib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 6
- Moderate · 137
- Minor · 37
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Sotorasib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Sotorasib — the kind of thing our pharmacy team would talk through with you at the counter.
What is Lumakras for?
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How do I take it?
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What if I miss a dose?
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What side effects should I expect?
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Can I take my heartburn medicine with it?
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Is it safe if I'm pregnant or breastfeeding?
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Is Sotorasib available over the counter?
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When was Sotorasib first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Sotorasib on HelloPharmacist
Sotorasib forms and strengths (how it comes)
Sotorasib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Sotorasib inactive ingredients by manufacturer.
Tablet
How this form is used
- Lumakras is used alone for KRAS G12C-mutated locally advanced or metastatic NSCLC after at least one prior systemic therapy.
- Lumakras is used with panitumumab for KRAS G12C-mutated metastatic colorectal cancer after prior chemotherapy.
- Lumakras tablets are taken once daily at the same time each day, with or without food.
- Swallow Lumakras tablets whole. Do not chew, crush or split them.
- If you have trouble swallowing, Lumakras tablets can be mixed in room-temperature non-carbonated water without crushing. Drink it right away or within 2 hours.
- If you vomit after a dose of Lumakras, do not take an extra dose.
Sotorasib on the U.S. market: products, makers and brands
How Sotorasib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Sotorasib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2021. Brand names on the directory include Lumakras; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
How widely Sotorasib is used (Medicaid data)
A general measure of how commonly Sotorasib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Sotorasib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Sotorasib prescribed? Of the 1,601 medications we measure, Sotorasib ranks #1,434 by Medicaid prescriptions — more than 10% of them.
Utilization by Sotorasib product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
sotorasib 320 MG Oral Tablet Most dispensed
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2628240
sotorasib 120 MG Oral Tablet
Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2550719
sotorasib 240 MG Oral Tablet
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2687205
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Sotorasib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 7 listed Sotorasib NDCs with Medicaid activity.
Compare Sotorasib products
A representative set of FDA-listed product records for Sotorasib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 120 mg | Oral | Amgen Inc | NDA | View NDC → |
| 240 mg | Oral | Amgen Inc | NDA | View NDC → |
| 320 mg | Oral | Amgen Inc | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Sotorasib NDCs →
Sotorasib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Sotorasib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Sotorasib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Sotorasib FDA approval history
How Sotorasib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Sotorasib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Sotorasib recalls since July 2021.
✅No Sotorasib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2550714 1 dose form · 3 strengths
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Dose form (SCDF) Oral Tablet RxCUI 2550718In current FDA listings
Look up RxCUI 2550714 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Sotorasib supply and shortage status
Whether Sotorasib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Sotorasib brand names
Sotorasib is sold under one brand name in the FDA directory — Lumakras. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Sotorasib: manufacturers and labelers
One company lists Sotorasib products with the FDA. By number of product records, the largest are Amgen Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Sotorasib drug class (RxNorm)
Sotorasib belongs to the Other antineoplastic agents class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Sotorasib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amgen Inc is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →