Lumakras is a brand-name prescription drug. It’s FDA-approved to treat a specific type of non-small cell lung cancer (NSCLC) in adults.

A doctor can prescribe Lumakras if all of the following apply:

  • The NSCLC is either locally advanced or metastatic. “Locally advanced” means the cancer has spread to at least one other part of the body near the lungs. “Metastatic” means the cancer has spread to many other areas of the body outside the lungs.
  • The NSCLC has already been treated with at least one systemic therapy. Systemic therapy is a type of treatment that affects your whole body.
  • The NSCLC is caused by certain abnormal changes to a gene called KRAS.

For more information about what uses Lumakras is prescribed for, see the “Lumakras for non-small cell lung cancer” section below.

Drug details

Lumakras contains the active drug sotorasib. It belongs to a class of drugs called RAS GTPase inhibitors.

Lumakras comes as an oral tablet in one strength: 120 milligrams.

FDA approval

The Food and Drug Administration (FDA) approved Lumakras in 2021. The drug is approved to treat a specific type of NSCLC caused by abnormal changes to the KRAS gene.

For this use, Lumakras received accelerated approval from the FDA. This means the drug was approved for use based on the results of early clinical trials.

Usually, the FDA approves drugs after in-depth clinical trials are completed. However, for some medications, such as Lumakras, the FDA may give early approval before the in-depth trials are finished. Accelerated approval is generally reserved for drugs that treat conditions without many treatment options, such as cancer.

The FDA will decide whether to give Lumakras full approval after more trials of the drug have been completed.

Effectiveness

For information about the effectiveness of Lumakras, see the “Lumakras for non-small cell lung cancer” section below.

Lumakras contains the active drug sotorasib. Lumakras is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics usually cost less than brand-name drugs.

As with all medications, the cost of Lumakras can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Keep in mind that you may be able to get a 90-day supply of Lumakras. If approved by your insurance company, getting a 90-day supply of the drug could reduce your number of trips to the pharmacy and help lower the cost. If you’re interested in this option, check with your doctor, pharmacist, or insurance company.

It’s important to note that you may have to get Lumakras at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

Before approving coverage for Lumakras, your insurance company may require you to get prior authorization. This means your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure if you’ll need to get prior authorization for Lumakras, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Lumakras, or if you need help understanding your insurance coverage, help is available.

Amgen, Inc., the manufacturer of Lumakras, offers a program called Amgen Assist 360. This program provides information on cost assistance for Lumakras. For more information and to find out if you’re eligible for support, call 888-4ASSIST (888-427-7478) or visit the manufacturer’s website.

To learn more about saving money on prescriptions, check out this article.

Mail-order pharmacies

Lumakras may be available through a mail-order pharmacy. Using this service may help lower the drug’s cost and allow you to get your medication without leaving home.

If recommended by your doctor, you may be able to receive a 90-day supply of Lumakras, so there’s less concern about running out of the medication. If you’re interested in this option, check with your doctor, pharmacist, or insurance company. Some Medicare plans may help cover the cost of mail-order medications.

If you don’t have insurance, you can ask your doctor or pharmacist about online pharmacy options.

Generic version

Lumakras contains the active drug sotorasib. Lumakras is available only as a brand-name medication. It’s not available in a generic form.

A generic drug is an exact copy of the active drug in a brand-name medication. Generics tend to cost less than brand-name drugs.

Lumakras can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Lumakras. These lists do not include all possible side effects.

For more information about the possible side effects of Lumakras, talk with your doctor or pharmacist. They can give you tips on managing any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Lumakras, you can do so through MedWatch.

Mild side effects

Mild side effects* of Lumakras can include:

Most of these side effects may go away within a few days or a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

* This is a partial list of mild side effects of Lumakras. To learn about other mild side effects, talk with your doctor or pharmacist or view Lumakras’ prescribing information.

Serious side effects

Serious side effects from Lumakras are less likely, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

* These conditions may not cause any symptoms, but they can be identified with certain lab tests. To learn more about lab tests with Lumakras treatment, see “Why do I need to have certain lab tests before taking Lumakras?” in the “Common questions about Lumakras” section below.
† For more information about this side effect, see “Side effect details” below.

Side effect details

Here’s some detail on certain side effects this drug may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Lumakras.

Liver damage

Taking Lumakras may lead to liver damage as a side effect.

Your doctor will use liver function tests to detect liver damage. Abnormal results from these tests can suggest your liver isn’t working correctly. This is a common side effect of Lumakras. However, serious liver problems, such as hepatitis, are rare.

Symptoms of liver damage can include:

Before you start taking Lumakras, your doctor will check your liver function with a blood test. They’ll continue checking your liver during treatment. If your liver function tests are abnormal at any point during your Lumakras treatment, your doctor may have you stop taking the drug temporarily. They’ll let you know if it’s safe for you to start taking Lumakras again.

If you have symptoms of liver damage while taking Lumakras, tell your doctor right away. They’ll advise if it’s safe for you to continue treatment.

Lung disease

Certain lung diseases are rare but serious side effects of Lumakras. Lung diseases with Lumakras are usually caused by swelling and damage to lung tissue. In rare cases, these conditions can be life threatening.

Specific examples of serious lung diseases that may occur with Lumakras include pneumonitis and interstitial lung disease (ILD). Pneumonitis is inflammation (irritation and swelling) in the air sacs of your lungs. ILD is inflammation that forms scar tissue in your lungs.

Symptoms of these lung conditions include:

Tell your doctor right away if you have any symptoms of lung disease while taking Lumakras. They may have you stop taking the drug if you develop these conditions.

Diarrhea

Both mild and serious cases of diarrhea were reported in clinical trials of Lumakras. Mild diarrhea was more common than serious diarrhea.

If you have diarrhea while taking Lumakras, it’s important to stay hydrated. You can do so by drinking water or sports drinks that contain electrolytes, such as Gatorade. You can also increase your water intake by eating hydrating foods, such as cucumbers, watermelon, or carrots.

Your doctor can also recommend medications that can help relieve diarrhea. For example, they may suggest you take bismuth subsalicylate (Pepto-Bismol) or loperamide (Imodium).

In rare cases, taking Lumakras can lead to severe diarrhea that doesn’t get better. This can occur even after taking drugs to treat it. Be sure to tell your doctor if this happens. They may have you stop taking the drug temporarily. Or they may prescribe a lower dosage of Lumakras for you. (To learn more about dosage, see the “Lumakras dosage” section below.)

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Lumakras. However, it isn’t known how often this side effect happened in clinical trials of Lumakras.

Symptoms of a mild allergic reaction can include:

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing

Call your doctor right away if you have an allergic reaction to Lumakras, as the reaction could become severe. Call 911 or your local emergency number if your symptoms feel life threatening or if you think you’re having a medical emergency.

The Lumakras dosage your doctor prescribes will depend on specific factors. This includes any side effects you may have. (For more information about possible side effects, see the “Lumakras side effects” section above.)

Typically, your doctor will start you on the dosage that’s recommended to treat your condition. Then they’ll monitor your condition over time to decide if you need to continue the drug.

Your doctor will ultimately prescribe Lumakras for the shortest amount of time needed to treat your condition. They’ll do this while trying to keep your risk of side effects low.

The following information describes the dosage that’s commonly taken or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Lumakras comes as an oral tablet in one strength: 120 milligrams (mg).

Dosage for non-small cell lung cancer

Lumakras is approved to treat a specific type of non-small cell lung cancer (NSCLC) in adults. (For more information, see the “Lumakras for non-small cell lung cancer” section below.)

The recommended dosage of Lumakras for NSCLC is 960 mg once per day. This means you’ll take eight tablets per dose.

What if I miss a dose?

If you miss a dose of Lumakras, take your missed dose as soon as you remember. However, if it’s been more than 6 hours since your missed dose, skip it. You can take your next dose again on your regular schedule. If you aren’t sure whether to take or skip a missed dose, talk with your doctor or pharmacist.

Do not take any extra doses of Lumakras to make up for a missed dose. Doing so could increase your risk of side effects with the drug. (For more information about possible side effects, see the “Lumakras side effects” section above.)

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Will I need to take this drug long term?

Lumakras is meant to be taken as a long-term treatment. If you and your doctor determine that Lumakras is safe and effective for you, you’ll likely take it long term.

The Food and Drug Administration (FDA) has approved Lumakras to treat a certain type of non-small cell lung cancer (NSCLC)* in adults. For this use, NSCLC must be caused by certain abnormal changes to a gene called KRAS.

Your doctor will only prescribe you Lumakras under certain conditions. (For more information about these conditions, see the “Lumakras for non-small cell lung cancer” section below.)

* For this use, Lumakras received accelerated approval from the FDA. To learn more, see “FDA approval” in the “What is Lumakras?” section above.

What the KRAS gene does

KRAS is a gene that typically helps with cell growth in your body. KRAS is found naturally throughout your body. However, it’s also found in some lung cancer cells.

In some cases, people with lung cancer may have a certain mutation (abnormal change) in the KRAS gene. This change is called KRAS G12C, and it creates an abnormal protein that helps cancer cells grow quickly.

What Lumakras does

Lumakras is taken to treat NSCLC that has the KRAS G12C mutation. The drug works by targeting cancerous proteins made from the mutated KRAS gene in cancer cells. This stops cancer cells from growing. (The way a drug works in the body is called its “mechanism of action.”)

For more information about how Lumakras works, visit the drug manufacturer’s website.

How long does it take to work?

Lumakras starts working right away to slow the growth of your lung cancer. However, it may take several weeks for your tumors to stop growing or become smaller.

You likely won’t notice Lumakras working in your body. Your doctor will order tests during your treatment to make sure the drug is working for you.

The Food and Drug Administration (FDA) approves prescription drugs such as Lumakras to treat certain conditions.

Lumakras for NSCLC

Lumakras is FDA-approved to treat a specific type of non-small cell lung cancer (NSCLC)* in adults.

A doctor can prescribe Lumakras if all of the following apply:

  • The NSCLC is either locally advanced or metastatic. “Locally advanced” means the cancer has spread to at least one other part of the body near the lungs. “Metastatic” means the cancer has spread to many other areas of the body outside the lungs.
  • The NSCLC has already been treated with at least one systemic therapy. Systemic therapy is a type of treatment that affects your whole body.
  • The NSCLC is caused by certain abnormal changes to a gene called KRAS. For details about these changes, see “About KRAS gene changes” below.

* For this use, Lumakras received accelerated approval from the FDA. To learn more, see “FDA approval” in the “What is Lumakras?” section above.

About NSCLC

NSCLC refers to a group of lung cancers. With lung cancer, cells in your lungs grow quickly and multiply (create more cells). These cancerous cells can eventually form tumors, damage the lungs, or spread to other parts of the body.

At first, you may not have any symptoms of NSCLC. However, over time you may develop symptoms such as:

To find out more about your condition, talk with your doctor. You can also learn more about lung cancer by visiting our MNT lung cancer hub.

About KRAS gene changes

KRAS is a gene that typically helps with cell growth in your body. KRAS is found naturally throughout your body. However, it’s also found in some lung cancer cells.

In some cases, people with lung cancer may have a certain mutation (abnormal change) in this gene. This change is called KRAS G12C, and it creates an abnormal protein that helps cancer cells grow quickly.

Lumakras is taken to treat NSCLC that has the KRAS G12C mutation. Before you start Lumakras treatment, your doctor will order a blood test or a biopsy (removal of a small portion of your tumor for testing). They’ll use these tests to check your lung cancer for the KRAS G12C mutation. If your cancer has this mutation, your doctor may recommend Lumakras as a treatment option.

Effectiveness for non-small cell lung cancer

Lumakras has been found to be an effective treatment for NSCLC with the KRAS G12C mutation.

The National Comprehensive Cancer Network’s NSCLC current treatment guidelines include Lumakras as a recommended treatment option.

For information about how the drug performed in clinical trials, see Lumakras’ prescribing information.

Lumakras and children

Lumakras is not approved for use in children. Clinical trials of Lumakras only included adults. So, it isn’t known for sure if Lumakras is safe or effective for use in children.

Here are answers to some frequently asked questions about Lumakras.

Does Lumakras treat colon cancer?

Lumakras isn’t approved by the Food and Drug Administration (FDA) to treat colon cancer. It’s only approved to treat a certain type of non-small cell lung cancer.* However, in some cases, your doctor may prescribe Lumakras off-label to treat colon cancer. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

More clinical trials are needed to know whether Lumakras is safe and effective for treating colon cancer. One trial is currently looking at Lumakras in combination with the cancer drug panitumumab (Vectibix) for this use.

If you have questions about taking Lumakras to treat colon cancer, talk with your doctor.

* For this use, Lumakras received accelerated approval from the FDA. To learn more, see “FDA approval” in the “What is Lumakras?” section above. For more information about what uses Lumakras is prescribed for, see the “Lumakras for non-small cell lung cancer” section above.

Will Lumakras cure my cancer?

No, Lumakras won’t cure your lung cancer. There’s currently no known cure for lung cancer.

Lumakras is approved to treat a specific type of non-small cell lung cancer (NSCLC) in adults. Whether or not Lumakras can be taken for NSCLC depends on several factors. For more information, see “Lumakras for non-small cell lung cancer” above.

To learn more about how Lumakras works to treat lung cancer, see the “How Lumakras works” section above. You can also talk with your doctor or pharmacist.

Why do I need to have certain lab tests before taking Lumakras?

You’ll need to have a few lab tests done before starting Lumakras treatment. These tests are used to check whether Lumakras is the right medication for your cancer. They’re also used to check for certain possible side effects of the drug. (For more information on side effects, see “Lumakras side effects” above.)

Before you start Lumakras, your doctor will order a blood test or biopsy (removal of a small portion of your tumor for testing). They’ll use these tests to check your lung cancer for certain changes to a gene called KRAS.* If your cancer has these changes, your doctor may recommend Lumakras as a treatment option.

Lumakras may also cause side effects that can be identified with certain blood tests. Your doctor will likely order these tests to check for certain conditions before you begin taking the drug. And they may continue these tests from time to time to watch for side effects of the drug.

Below are other lab tests your doctor may give you:

If you have questions about lab tests you’ll need before or during treatment with Lumakras, talk with your doctor.

* To learn more about the KRAS gene, see “About KRAS gene changes” in the “Lumakras for non-small cell lung cancer” section above.

There aren’t any known interactions between Lumakras and alcohol. If you drink alcohol, talk with your doctor about how much, if any, you can safely drink while taking Lumakras.

Lumakras can interact with several other medications. High fat or high protein meals may also interact with the drug.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe. (For more information on side effects, see “Lumakras side effects” above.)

Lumakras and other medications

Below is a list of medications that can interact with Lumakras. This list does not contain all drugs that may interact with Lumakras.

Before taking Lumakras, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you take. Sharing this information can help you avoid potential interactions.

Due to the risk of interactions, doctors typically will not prescribe Lumakras with the following drugs:

  • Antacids. Antacids are taken to relieve indigestion or heartburn. Taking Lumakras with these drugs can make Lumakras less effective. If you need to take these drugs, your doctor will recommend taking your Lumakras dose at least 4 hours before or 10 hours after taking the antacid. Examples include:
    • aluminum hydroxide/magnesium carbonate (Gaviscon)
    • aluminum hydroxide/magnesium hydroxide/simethicone (Mylanta)
  • Histamine-2 (H2) blockers. H2 blockers are taken to treat conditions such as acid reflux. Taking Lumakras with these medications can make Lumakras less effective. Examples include:
  • Proton pump inhibitors (PPIs). PPIs are taken to treat conditions such as gastroesophageal reflux disease (GERD) or heartburn. Taking Lumakras with these drugs can make Lumakras less effective. Examples include:
  • Certain benzodiazepines. Benzodiazepines are taken to treat conditions such as anxiety and seizures. Taking Lumakras with these medications can make either of them less effective. An example is midazolam (Nayzilam, Seizalam).
  • Certain antibiotics. Antibiotics are taken to treat infections caused by bacteria. Taking Lumakras with these drugs can make Lumakras less effective. An example of an antibiotic is rifampin (Rifadin, Rimactane).
  • Certain cardiac glycosides. These drugs are taken to treat heart conditions, such as heart failure. Taking Lumakras with these medications can increase the risk of side effects with cardiac glycosides. An example is digoxin (Lanoxin).

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Lumakras and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Lumakras. However, you should still check with your doctor or pharmacist before taking any of these products with Lumakras.

Lumakras and foods

There aren’t any foods that have been specifically reported to interact with Lumakras. However, high fat and high protein meals may increase the risk of side effects during Lumakras treatment.

If you have any questions about eating certain foods with Lumakras, talk with your doctor.

You should take Lumakras according to the instructions your doctor gives you.

Lumakras comes as a tablet that you swallow. For more information about how to take Lumakras, visit the drug manufacturer’s website.

When to take

You’ll likely take Lumakras once per day. You can take the drug at any time. However, try to take your dose around the same time each day.

To help make sure you don’t miss a dose, try using a medication reminder. This can include setting an alarm or using a timer. You could also download a reminder app on your phone.

Accessible labels and containers

If your prescription label is hard to read, talk with your doctor or pharmacist. Some pharmacies offer labels that have large print, braille, or a code you scan with a smartphone to convert text to speech. If your local pharmacy doesn’t have these options, your doctor or pharmacist may be able to direct you to one that does.

If you have trouble opening medication bottles, ask your pharmacist if they can put Lumakras in an easy-open container. They also may be able to recommend tools that can make it simpler to open lids.

Taking Lumakras with food

You can take Lumakras with or without food. However, eating high fat or high protein meals may increase the risk of side effects during Lumakras treatment. For more information, see the “Lumakras interactions” section above.

Can Lumakras be crushed, split, or chewed?

No, Lumakras should not be crushed, split, or chewed. You should swallow the tablets whole.

If you have trouble swallowing Lumakras tablets, talk with your doctor or pharmacist. You can also see this article.

It’s not known if Lumakras is safe to take while pregnant. This drug hasn’t been studied during human pregnancy. Animal studies didn’t show any harm to offspring born to animals that were given the drug during pregnancy. However, animal studies don’t always predict what will happen in humans.

If you’re pregnant or planning a pregnancy, tell your doctor before starting Lumakras treatment. They can discuss the risks and benefits of taking Lumakras during pregnancy.

It’s not known if Lumakras is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re taking Lumakras.

For more information about taking Lumakras during pregnancy, see the “Lumakras and pregnancy” section above.

It may not be safe to breastfeed while taking Lumakras. It isn’t known if Lumakras can pass into breast milk. However, due to the potential for side effects in a breastfed child, your doctor will likely recommend that you do not take Lumakras while breastfeeding.

Your doctor may also advise you to wait until at least 1 week after your last dose of Lumakras before breastfeeding.

If you’re breastfeeding or planning to breastfeed, talk with your doctor. They can recommend ways to feed your child while you take Lumakras.

Before taking Lumakras, talk with your doctor about your health history. Lumakras may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

  • Liver problems. Lumakras may cause liver problems as a side effect. If you have liver problems, such as hepatitis, talk with your doctor before starting treatment with Lumakras. They can advise if it’s safe to take the drug.
  • Lung problems. Before starting Lumakras treatment, tell your doctor about any lung problems you have (other than lung cancer). And tell your doctor if you have severe lung problems, such as interstitial lung disease or pneumonitis. This is because Lumakras can cause certain lung problems as a side effect. If you already have lung problems, your doctor can advise if it’s safe to take Lumakras.
  • Allergic reaction. If you’ve had an allergic reaction to Lumakras or any of its ingredients, your doctor will likely not prescribe Lumakras. Ask your doctor what other medications are better options for you.
  • Pregnancy. It isn’t known for sure if Lumakras is safe to take during pregnancy. For more information, see the “Lumakras and pregnancy” section above.
  • Breastfeeding. It may not be safe to breastfeed while taking Lumakras. For more information, see the “Lumakras and breastfeeding” section above.

Note: For more information about the potential negative effects of Lumakras, see the “Lumakras side effects” section above.

Do not take more Lumakras than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Lumakras

If you think you’ve taken too much of this drug, call your doctor. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. However, if your symptoms are severe, call 911 or your local emergency number, or go to the nearest emergency room right away.

When you get Lumakras from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid taking expired medications. If you have unused medication that has gone past the expiration date, talk with your pharmacist about whether you might still be able to take it.

Storage

How long a medication remains good to take can depend on many factors, including how and where you store the medication.

You should store Lumakras tablets at room temperature of 68°F to 77°F (20°C to 25°C) in a tightly sealed container away from light. However, you can store the tablets between 59°F and 86°F (15°C and 30°C) for a short time, such as while traveling. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Lumakras and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

This article provides several useful tips on medication disposal. You can also ask your pharmacist for information about how to dispose of your medication.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.