Augtyro (repotrectinib)

Augtyro generic

Augtyro 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 ingredient in a brand-name medication. Generics typically cost less than brand-name drugs.

Augtyro dosage

The Augtyro dosage your doctor prescribes will depend on several factors. These include:

• other medical conditions you may have
• any side effects you may have with Augtyro

The following information describes dosages that are commonly prescribed or recommended. However, be sure to follow the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Augtyro comes as an oral capsule that you swallow. It’s available in one strength: 40 milligrams (mg).

Dosage for non-small cell lung cancer

Augtyro is prescribed for non-small cell lung cancer in certain situations. The starting dosage is 160 mg once daily for the first 14 days. Then your doctor will likely increase the dosage to 160 mg twice daily.

If you develop certain side effects with Augtyro, your doctor may pause or stop your treatment. Then, if they restart your treatment, they may prescribe a lower dosage of Augtyro. This may help prevent the side effects from coming back. If you have questions about the dosage that’s right for you, talk with your doctor.

About taking Augtyro

Below you’ll find information about key dosage issues.

• When to take: You’ll take Augtyro once or twice per day. You should take it on a consistent schedule. Taking the medication around the same time or times each day helps keep a steady level of the drug in your body. This helps Augtyro work effectively.
• If you miss a dose: If you miss a dose of Augtyro, skip it and take your regular dose at the next scheduled time. To help you remember your doses, consider setting an alarm or using a reminder app.
• If you vomit after taking Augtyro: If you vomit at any time after taking a dose of Augtyro, you do not need to take another dose to “make up for it.” Just take your regular dose at the next scheduled time.
• Taking Augtyro with food:You can take Augtyro with or without food. This medication isn’t affected by the timing of meals.
• Crushing, splitting, or chewing Augtyro: Augtyro capsules should be swallowed whole. They should not be crushed, split, chewed, or opened. Do not take any Augtyro capsules that are cracked or damaged in any way. Talk with your doctor or pharmacist if you have difficulty swallowing pills.
• Length of treatment: Augtyro is meant to be a long-term treatment. If you and your doctor determine that Augtyro is safe and effective for you, you’ll likely take it long term.

Overdose

Do not take more Augtyro 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 Augtyro

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

Augtyro side effects

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

For more information about the possible side effects of Augtyro, talk with your doctor or pharmacist. They can give you tips on how to manage 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 Augtyro, you can do so through MedWatch.

Mild side effects

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

Mild side effects of Augtyro can include:

• dizziness
• changes in your sense of taste
• peripheral neuropathy (numbness in your hands, arms, legs, or feet)
• constipation
• fatigue
• shortness of breath
• problems with attention and memory
• difficulty with balance or walking
• sleepiness or difficulty sleeping
• headache
• nausea
• muscle pain or weakness
• weight gain
• mild allergic reaction*

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

* For more information about allergic reaction and Augtyro, see “Allergic reaction” below.

Serious side effects

Serious side effects from Augtyro aren’t common, 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:

• Serious lung problems. These may include interstitial lung disease (inflammation and scarring in the lungs), pneumonitis (inflammation and irritation in the lungs), pneumonia, or pleural effusion (fluid buildup in the space around the lungs). Symptoms can include new or worsening:
  • chest pain
  • dry or productive cough
  • difficulty breathing
  • hypoxia (low oxygen level in the blood)
• Cognitive (brain-related) side effects or mental health changes that may be severe, such as:
  • confusion
  • hallucinations (seeing or hearing things that are not real)
  • mood disorders, such as depression, anxiety, or mania
  • vertigo (spinning sensation)
• Liver problems. Signs and symptoms may include:
  • blood tests showing increased liver enzymes or high bilirubin
  • pain in the upper-right area of your abdomen
  • nausea or vomiting
  • jaundice
• Hyperuricemia (high level of uric acid in the blood). This may not directly cause symptoms, but without treatment, high uric acid can lead to problems such as:
  • gouty arthritis, which may cause pain and swelling in your big toe or other joints
  • kidney stones, which may cause decreased urination and abdominal pain
• Other blood disorders, such as low lymphocytes (a type of white blood cell) or high creatine kinase (a type of protein that, if elevated in the blood, may be a sign of muscle damage).
• Increased risk of bone fractures.
• Severe allergic reaction.*

* For details about allergic reaction and Augtyro, see “Allergic reaction” below.

ALLERGIC REACTION

As with most drugs, some people can have an allergic reaction after taking Augtyro. This side effect wasn’t reported in clinical trials of this drug but can still occur.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing

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
• difficulty breathing

Call your doctor right away if you have an allergic reaction to Augtyro, 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.

Augtyro uses

The Food and Drug Administration (FDA) approves prescription drugs such as Augtyro to treat certain conditions. Augtyro may also be prescribed off-label for other conditions. Off-label drug use is when an FDA-approved drug is prescribed for a purpose other than what it’s approved for.

Augtyro for non-small cell lung cancer

Augtyro is FDA-approved for use in adults to treat non-small cell lung cancer (NSCLC) that is:

• locally advanced (has spread within the chest) or metastatic (has spread to other parts of the body)
• ROS1-positive (ROS1+), which means the cancer cells have a mutation (abnormal change) in a gene called ROS1

The ROS1+ mutation is known as ROS1 fusion (also called ROS1 rearrangement).

NSCLC is the most common type of lung cancer. Symptoms of NSCLC may include cough, shortness of breath, chest discomfort, difficulty breathing, and fatigue.

Your doctor will order testing to determine the type of lung cancer you have. This includes checking for certain gene mutations.

Genes are pieces of DNA that encode instructions so that your body can make certain proteins. Typically, the ROS1 gene encodes proteins that help cells grow. However, if an abnormal mutation occurs, the resulting proteins cause cells in the lung to grow rapidly and excessively, leading to cancerous tumors. These proteins help the cancer grow and spread.

Augtyro is a ROS1 kinase inhibitor. It works by inhibiting (blocking) the ROS1 protein and other proteins that help cancer cells grow. In ROS1+ NSCLC cells, Augtyro prevents these proteins from helping cancer cells grow. This helps prevent the cancer from continuing to grow and spread, which may also help limit or reduce the size of tumors.

You can learn more about this condition by visiting our lung cancer hub.

Augtyro and children

Augtyro is FDA-approved for use in adults. This medication isn’t approved for use in children.

Augtyro interactions

Augtyro can interact with several other medications. It can also interact with certain supplements as well as certain foods.

Before taking Augtyro, 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 use. Sharing this information can help you avoid potential interactions.

Interactions with medications, foods, and supplements

Below is a list of medications, supplements, and foods that can interact with Augtyro. This list does not contain all drugs that may interact with Augtyro. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Alcohol interaction

Alcohol is not known to interact with Augtyro.

If you have questions about how much alcohol is safe to drink while taking Augtyro, talk with your doctor or pharmacist.

Augtyro cost and coupons

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

Financial and insurance assistance:If you need financial support to pay for Augtyro, or if you need help understanding your insurance coverage, help is available.

A program called BMS Access Support is available for Augtyro. For more information and to find out whether you’re eligible for support, call 800-861-0048 or visit the program website.

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

Generic version:Augtyro is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

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

Similar drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Augtyro, talk with your doctor. They can tell you about other medications that may work well for you.

Similar to Augtyro, the following drugs are ROS1 kinase inhibitors:

• entrectinib (Rozlytrek)
• crizotinib (Xalkori)
• ceritinib (Zykadia)

Things to consider when taking Augtyro

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Augtyro and pregnancy

Augtyro should not be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication. Your doctor may suggest certain birth control options to use during treatment with Augtyro and for 2 months after your last dose.

Augtyro and birth control

It’s not known whether Augtyro 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 Augtyro.

Note: Sex and gender exist on spectrums. Use of the terms “female” and “male” in this article refers to sex assigned at birth.

For females taking Augtyro

For females who can become pregnant, a nonhormonal birth control method is recommended to help prevent pregnancy during Augtyro treatment. This is because Augtyro can interact with hormonal birth control, making it less effective at helping prevent pregnancy. Continue using a nonhormonal birth control method for 2 months after your last dose of Augtyro.

For males taking Augtyro

For males with sexual partners who can become pregnant, a birth control method (such as condoms) is recommended to help prevent pregnancy. Continue using birth control for 4 months after your last dose of Augtyro.

Augtyro and breastfeeding

It’s not known whether Augtyro is safe to take while breastfeeding. Augtyro’s manufacturer recommends not breastfeeding during Augtyro treatment and for 10 days after your last dose.

If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication. They’ll likely recommend other ways to feed your child.

Common questions about Augtyro

Here are answers to some frequently asked questions about Augtyro.

How does Augtyro work?

Genes are pieces of DNA that encode instructions so that your body can make certain proteins. Typically, the ROS1 gene encodes proteins that help cells grow. However, if an abnormal mutation occurs, the resulting proteins cause cells in the lung to grow rapidly and excessively, leading to cancerous tumors. These proteins help the cancer grow and spread.

Augtyro is a ROS1 kinase inhibitor. It works by inhibiting (blocking) the ROS1 protein and other proteins that help cancer cells grow. In ROS1-positive non-small cell lung cancer (NSCLC) cells, Augtyro prevents these proteins from helping cancer cells grow. This helps prevent the cancer from continuing to grow and spread, which may also help limit or reduce the size of tumors.

If you have questions about how Augtyro works, talk with your doctor or pharmacist.

Can Augtyro cause long-term side effects?

Augtyro isn’t known to cause long-term side effects. Augtyro’s side effects should go away shortly after you stop taking the drug. In some cases, doctors can recommend treatments to help manage or treat the side effects of medications.

If you develop certain side effects with Augtyro, your doctor may pause or stop your treatment. Then, if they restart your treatment, they may prescribe a lower dosage of Augtyro. This may help prevent the side effects from coming back.

Talk with your doctor if you have questions about the possible risks of Augtyro treatment.

Is Augtyro similar to Xalkori?

Both Augtyro and Xalkori belong to the same general drug class, called kinase inhibitors. They’re both approved by the Food and Drug Administration (FDA) to treat a specific type of NSCLC in certain situations. Xalkori is approved for other uses as well.

Augtyro is a newer drug than Xalkori. The FDA first approved Xalkori (crizotinib) in 2011. Augtyro (repotrectinib) was approved in 2023.

In some cases, NSCLC can become resistant to Xalkori treatment. This means the drug may work at first, but eventually it can stop working, possibly leading to the cancer returning or worsening.

In clinical trials of Augtyro, many of the participants had tried Xalkori in the past. In some participants, their cancer had a response to Augtyro. This means that Augtyro may work for NSCLC that has become resistant to other kinase inhibitors, including Xalkori.

Talk with your doctor or pharmacist to learn more about the similarities and differences between Augtyro and Xalkori.