Gavreto (pralsetinib)

What is Gavreto?

Gavreto is a brand-name prescription medication. It’s FDA-approved to treat certain cancers caused by specific gene changes.

Specifically, Gavreto is approved for use in:

• Adults with a type of metastatic non-small cell lung cancer (NSCLC). (Metastatic lung cancer has spread to other parts of your body beyond your lungs.)
• Adults and children ages 12 years and older with a type of thyroid cancer called medullary thyroid cancer (MTC) that’s either advanced or metastatic. For this use, Gavreto is prescribed for people who need to take systemic therapy (medication that affects your whole body).
• Adults and children ages 12 years and older with a type of either advanced or metastatic thyroid cancer that was already treated with radioactive iodine therapy. However, that therapy either didn’t work for their cancer or stopped working. For this use, Gavreto is prescribed for people who need to take systemic therapy.

For more information on the types of cancer that Gavreto is used to treat, see the “Gavreto uses” section below.

Drug details

Gavreto contains the active drug pralsetinib. It belongs to a class of drugs called RET inhibitors. (A drug class describes a group of medications that work in a similar way.)

Gavreto comes ascapsules that are taken by mouth. And it’s available in one strength: 100 milligrams (mg).

FDA approval

In 2020, Gavreto was approved by the Food and Drug Administration (FDA) to treat certain cancers caused by specific gene mutations. This drug received accelerated approved from the FDA for its approved uses.

Accelerated approval

The FDA approved Gavreto under its accelerated approval regulations. Accelerated approval is based on information the FDA reviews from early clinical trials of a medication.

Usually, medications receive approval from the FDA after extensive studies on a drug have been done. For some drugs, approval may be granted before all of its studies have been finished. This is the case with accelerated approval. And it’s reserved for certain drugs, such as Gavreto, that are made to treat conditions that don’t have a lot of successful treatment options available.

For example, Gavreto is the first once-daily targeted therapy that’s approved for treating certain types of lung and thyroid cancer that have specific genetic changes.

More trials are still being done to confirm Gavreto’s approval for these conditions. The FDA won’t make a decision for full approval of Gavreto until additional clinical trials have been completed.

Effectiveness

For information about the effectiveness of Gavreto, see the “Gavreto uses” section below.

Gavreto generic

Gavreto 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 typically cost less than brand-name drugs.

Gavreto dosage

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

• other medical conditions you may have
• other medications you may be taking
• side effects that you may have with Gavreto

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. They’ll determine the best dosage to fit your needs.

Drug forms and strengths

Gavreto comes as capsules that you’ll swallow. It’s only available in one strength: 100 milligrams (mg).

Dosage for non-small cell lung cancer

For metastatic non-small cell lung cancer (NSCLC) that has mutated or rearranged RET genes,* the recommended Gavreto dosage is 400 mg once daily. (You’ll take four 100-mg capsules to get this dose.)

Gavreto should be taken on an empty stomach. Specifically, you’ll need to avoid food for at least 2 hours before and at least 1 hour after your dose of the drug.

* With metastatic lung cancer, the cancer has spread to other parts of your body beyond your lungs. Rearrangements and mutations (abnormal changes) in a gene can cause the gene to not work properly. For more information about this type of cancer, see the “Gavreto uses” section below.

Dosage for thyroid cancers

For certain thyroid cancers with mutated or rearranged RET genes,* the recommended dosage of Gavreto is 400 mg once daily. (You’ll take four 100-mg capsules to get this dose.)

Gavreto should be taken on an empty stomach. Specifically, you’ll need to avoid food for at least 2 hours before and at least 1 hour after your dose of the drug.

* Rearrangements and mutations (abnormal changes) in a gene can cause the gene to not work properly. For more information about these types of thyroid cancer, see the “Gavreto uses” section below.

Children’s dosage

Gavreto is used in children ages 12 years and older with certain types of thyroid cancer. For this use, the dosage prescribed for children is the same as that for adults. See the “Dosage for thyroid cancers” section above for details.

What if I miss a dose?

If you miss a dose of Gavreto, take it as soon as possible on the same day. If you don’t remember by the time you need to take your next dose, just skip the missed dose. Don’t take two doses of Gavreto to make up for the missed dose. Doing so can increase your risk for side effects from Gavreto.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can also work.

What if I vomit after taking a dose?

If you throw up after taking a dose of Gavreto, don’t take another dose of the drug. Instead, just take your regularly scheduled dose of Gavreto the next day.

Will I need to use this drug long term?

Gavreto is meant to be used as a long-term treatment. If you and your doctor determine that Gavreto is safe and effective for you, you’ll likely take it until either:

• your cancer gets worse, or
• you have side effects from the drug that aren’t tolerable

Gavreto side effects

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

For more information about the possible side effects of Gavreto, 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’d like to notify the FDA about a side effect you’ve had with Gavreto, you can do so through MedWatch.

Mild side effects

Mild side effects* of Gavreto can include:

• constipation
• diarrhea
• fatigue
• increased liver enzyme level
• mild high blood pressure
• muscle and joint pain
• changes in electrolyte levels, such as increased potassium level, decreased sodium level, or decreased calcium level

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 from Gavreto. To learn about other mild side effects, talk with your doctor or pharmacist or view Gavreto’s patient information.

Serious side effects

Serious side effects from Gavreto 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 you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Decreased levels of certain blood cells, which can be serious in rare cases. Examples include:
  • low red blood cell level, which can cause cold hands or feet, weakness, and shortness of breath
  • low white blood cell level, which can increase your risk for infection
• Liver problems, including liver damage. Symptoms can include:
  • dark colored urine
  • loss of appetite
  • nausea and vomiting
  • pain in the upper right area of your belly
  • unusual bleeding or bruising
  • yellowing of your skin or the whites of your eyes
• Bleeding problems. Symptoms can include:
  • blood in your stool or stool that’s black and looks like tar
  • frequent nosebleeds
  • unusual bleeding or bruising
  • vomiting blood or having vomit that looks like coffee grounds
  • changes in speech, confusion, or headache, if you’re bleeding in your head
• Problems with wound healing. Symptoms can include:
  • wounds that don’t heal or that take longer than usual to heal
• Lung problems, such as interstitial lung disease (ILD) and pneumonitis.*
• Severe increase in blood pressure.*
• Tumor lysis syndrome (TLS), which occurs when substances from cancer cells are released into your body.*
• Allergic reaction.*

* For more information about this side effect, see “Side effect details” below.

Side effects in children

Side effects of Gavreto in children weren’t specifically reported in clinical trials of the drug.

It’s important to note that Gavreto has been tested in certain children. And it was safe and effective in children ages 12 years and older with certain types of thyroid cancer.*

However, Gavreto hasn’t been tested in children with a type of non-small cell lung cancer. So, it’s not approved for this use in children.

* Gavreto is used for certain types of cancer with a mutated or rearranged RET gene. Rearrangements and mutations (abnormal changes) in a gene can cause the gene to not work properly. For more information about these types of cancer, see the “Gavreto uses” section below.

Side effect details

Here’s some detail on certain side effects this drug may cause.

Lung problems

Although it was rare during clinical trials, Gavreto did cause severe inflammation in some people’s lungs.

For example, the drug can cause interstitial lung disease (ILD) and pneumonitis. In rare cases, lung inflammation caused by Gavreto can be fatal.

Symptoms of ILD and pneumonitis can include:

• cough
• fever
• shortness of breath

Your doctor will monitor you for ILD and pneumonitis while you’re taking Gavreto. If you have any symptoms of lung problems, let your doctor know right away.

If you develop any symptoms of these conditions, your doctor may change the way you take Gavreto. And based on how severe your lung inflammation is, your doctor may decide to:

• lower your Gavreto dosage
• have you stop taking Gavreto and try a different medication instead

If you have concerns about developing lung problems with Gavreto, talk with your doctor.

High blood pressure

Gavreto can cause both mild and serious high blood pressure.

Mild high blood pressure was one of the most common side effects in people taking Gavreto during clinical trials. Most people don’t have symptoms from mildly elevated blood pressure. So, you may only notice this side effect if you check your blood pressure.

Rarely, Gavreto can cause severely elevated blood pressure. Severe high blood pressure can cause symptoms such as:

• chest pain
• confusion
• dizziness
• headache
• shortness of breath

If you have symptoms of severe high blood pressure, call your doctor right away. However, if your symptoms feel life threatening, call 911 or your local emergency number.

Before taking Gavreto, your doctor will check your blood pressure. If they find that you have high blood pressure that isn’t managed, they’ll treat it before you can safely take Gavreto.

In any case, 1 week after you’ve started taking Gavreto, your doctor will check your blood pressure. Then, they’ll recommend that you check your blood pressure at least monthly while you’re taking Gavreto. You may need to visit your doctor’s office for this check, or they may let you do it at home.

Most people taking Gavreto who have mild increases in blood pressure are able to manage this side effect using medications. Or, their doctor may adjust their dosage of Gavreto.

If you have severe increases in your blood pressure, your doctor will likely have you stop taking Gavreto until your blood pressure returns to a safe level. In some cases of severe high blood pressure, your doctor may have you stop taking Gavreto and try another medication instead.

Tumor lysis syndrome

Tumor lysis syndrome (TLS) is very rare side effect of Gavreto. If it occurs, it can be life threatening.

TLS happens when substances from cancer cells are released into your body as the cancer cells die. During cancer treatment, cancer cells can sometimes break down quickly, releasing a lot of substances into your body. Then, your kidneys can be overworked trying to clear these substances from your body. When your kidneys can’t keep up and the tumor substances build up, you may develop TLS.

Early on, TLS can cause symptoms such as:

• cloudy urine
• making less urine than usual or needing to urinate less often than usual
• fatigue (lack of energy)
• muscle cramps
• nausea and vomiting
• weakness

Left untreated, TLS can lead to more severe symptoms, including:

• abnormal heart rhythm
• delirium (a change in mental function)
• hallucinations (seeing or hearing things that aren’t really there)
• kidney failure
• loss of muscle control
• seizures

In some cases, TLS may need to be treated with dialysis. And sometimes, you’ll need to stay in the hospital if you have TLS.

While you’re taking Gavreto, try to stay well hydrated. Doing so may help prevent TLS. Talk with your doctor about how much water intake is right for you.

If you have mild TLS symptoms, call your doctor right away. If you’re having severe TLS symptoms, call 911 or your local emergency number. Or, have someone take you to the nearest emergency room.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Gavreto. However, allergic reaction wasn’t reported in clinical trials of Gavreto.

Symptoms of a mild allergic reaction can include:

• 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
• trouble breathing

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

Gavreto uses

The Food and Drug Administration (FDA) approves prescription drugs such as Gavreto to treat certain conditions. Gavreto may also be used off-label for other conditions. Off-label drug use means using a drug for a purpose other than what it’s been approved for by the FDA.

Gavreto for non-small cell lung cancer

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

NSCLC is the most common form of lung cancer. Gavreto treats NSCLC in adults that’s both:

• metastatic, which means that it has spread to other parts of your body beyond your lungs
• RET fusion-positive, which means the RET genes are rearranged from their normal order

Rearrangements and mutations (abnormal changes) in a gene can cause the gene to not work properly. Your doctor will order a test to see if your cancer has a RET gene mutation or rearrangement. If it does, it may respond to treatment with Gavreto.

Gavreto is a targeted treatment. It’s designed to find cancer cells with the RET gene mutation or rearrangement. And it works by stopping the cells from growing or spreading in your body.

Effectiveness for NSCLC

Gavreto has been found effective for NSCLC that’s metastatic and RET fusion-positive. For information about the drug’s effectiveness during clinical trials, see Gavreto’s prescribing information.

In addition, National Comprehensive Cancer Network (NCCN) guidelines recommend Gavreto as a first-choice treatment option for adults with this form of cancer.

Gavreto for thyroid cancers

Gavreto is FDA-approved to treat certain thyroid cancers in adults and children ages 12 and older.

Specifically, Gavreto is approved for use in:

• Adults and children ages 12 years and older with a type of thyroid cancer called medullary thyroid cancer (MTC) that’s either advanced or metastatic. For this use, Gavreto is prescribed for people who need to take systemic therapy (medication that affects your whole body).
• Adults and children ages 12 years and older with a type of either advanced or metastatic thyroid cancer that was already treated with radioactive iodine therapy. However, that therapy either didn’t work for their cancer or stopped working. For this use, Gavreto is prescribed for people who need to take systemic therapy.

Gavreto is used for certain types of thyroid cancer with a RET gene mutation (abnormal change) or rearrangement. Rearrangements and mutations in a gene can cause the gene to not work properly.

Your doctor will order a test to see if your cancer has a RET gene mutation or rearrangement. If it does, it may respond to treatment with Gavreto.

Gavreto is a targeted treatment. It’s designed to find cancer cells with the RET gene mutation or rearrangement. And it works by stopping the cells from growing or spreading in your body.

Effectiveness for thyroid cancers

Gavreto has been found effective for treating certain types of thyroid cancer. For information about Gavreto’s effectiveness during clinical trials, see the drug’s prescribing information.

In addition, NCCN guidelines recommend Gavreto as a first-choice treatment option for adults with this form of cancer.

Gavreto and children

Gavreto is FDA-approved to treat certain thyroid cancers in children ages 12 and older. To learn about the specific type of thyroid cancer that Gavreto can be used for, see the “Gavreto for thyroid cancers” section above.

And for information about how well this drug worked in children during clinical trials, see Gavreto’s prescribing information.

Gavreto vs. Retevmo

You may wonder how Gavreto and Retevmo compare. The table below summarizes some similarities and differences of these medications.

Gavreto and Retevmo are approved by the Food and Drug Administration (FDA) to treat certain cancers caused by specific gene changes. Specifically, they’re approved for use in:

• Adults with a type of metastatic non-small cell lung cancer. (Metastatic lung cancer has spread to other parts of your body beyond your lungs.)
• Adults and children ages 12 years and older with a type of thyroid cancer called medullary thyroid cancer that’s either advanced or metastatic.
• Adults and children ages 12 years and older with a type of either advanced or metastatic thyroid cancer.

Doctors can prescribe these medications in certain situations for the cancers listed above. While these drugs have similar uses and forms, they have some differences too. For example, their side effects may vary.

Talk with your doctor to learn more about these drugs and decide whether one is best for your condition.

Gavreto and alcohol

There aren’t any known interactions between Gavreto and alcohol.

However, certain side effects of Gavreto can be worsened if you drink alcohol. These side effects include:

• diarrhea
• headache
• tiredness

Additionally, both Gavreto and alcohol can cause liver damage. So, drinking alcohol while taking Gavreto may increase your risk for serious liver damage.

If you drink alcohol, talk with your doctor about it before you begin taking Gavreto. They’ll help determine how much, if any, alcohol is safe for you to drink while you’re taking Gavreto.

Gavreto interactions

Gavreto can interact with several other medications. It might also interact with certain supplements and foods.

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.

Gavreto and other medications

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

Before taking Gavreto, 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.

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

Types of drugs that could interact with Gavreto include:

• Strong CYP3A4 inhibitors, which block the CYP3A4 enzyme (a type of protein) from breaking down and clearing Gavreto from your body. These drugs can raise your risk for side effects from Gavreto. You shouldn’t take strong CYP3A4 inhibitors with Gavreto. Examples of strong CYP3A4 inhibitors include:
  • cimetidine
  • itraconazole
  • ketoconazole
• Strong CYP3A4 inducers, which speed up the activity of the CYP3A4 enzyme, lowering the amount of Gavreto in your body. These drugs can make Gavreto less effective and stop it from working. You shouldn’t take strong CYP3A4 inducers with Gavreto. If using taking these medications together can’t be avoided, your doctor may increase your dosage of Gavreto.
  • rifampin
  • carbamazepine (Tegretol)
  • phenytoin (Dilantin)
• P-gp inhibitors that are also strong CYP3A4 inhibitors. Taking these drugs with Gavreto can raise your risk for side effects from Gavreto. You shouldn’t take medications that are both P-gp and CYP3A4 inhibitors, unless your doctor recommends it. If this is the case, your doctor will lower your dosage of Gavreto. Examples of combined P-gp and strong CYP3A4 inhibitors include:
  • itraconazole (Sporanox)
  • ritonavir (Norvir)
  • clarithromycin (Biaxin XL)

Gavreto and herbs and supplements

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

Gavreto and foods

There aren’t any foods that have been specifically reported to interact with Gavreto. If you have any questions about eating certain foods with Gavreto, talk with your doctor.

However, keep in mind that Gavreto should be taken on an empty stomach. You shouldn’t take Gavreto with food. In fact, you should avoid eating for at least 2 hours before and at least 1 hour after you take a dose of Gavreto.

Gavreto cost

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

It’s important to note that you’ll have to get Gavreto 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 Gavreto, your insurance company may require you to get prior authorization. This means that 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 Gavreto, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Gavreto, or if you need help understanding your insurance coverage, help may be available.

A program called YourBlueprint is available for Gavreto. This program may offer ways to help lower the cost of Gavreto. Talk with your doctor about getting enrolled in this program.

For more information and to find out if you’re eligible for support, call 888-BLUPRNT (888-258-7768). Or, ask your doctor to visit the program website to learn about enrollment.

Generic version

Gavreto is available only as a brand-name medication. It’s not currently 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.

How to take Gavreto

You should take Gavreto according to your doctor’s or another healthcare professional’s instructions.

When to take

Gavreto should be taken once daily.

To help make sure that you don’t miss a dose, try using a medication reminder. This can include setting an alarm or timer on your phone or downloading a reminder app. A kitchen timer can also work.

Taking Gavreto with food

Gavreto should be taken on an empty stomach. Don’t take it with food. In fact, you should avoid eating for at least 2 hours before and at least 1 hour after you take a dose of Gavreto.

What if I vomit after taking my Gavreto dose?

If you throw up after taking a dose of Gavreto, don’t take another dose of the drug. Instead, just take your regularly scheduled dose of Gavreto the next day.

Can Gavreto be crushed, split, or chewed?

No, you shouldn’t crush, split, or chew Gavreto capsules. If you have trouble swallowing capsules, talk with your doctor or pharmacist. They can help you find an alternative.

How Gavreto works

Gavreto is approved by the Food and Drug Administration (FDA) for treating certain cancers caused by particular gene changes.

Specifically, Gavreto is used for a certain type of lung cancer and certain types of thyroid cancer. For information about these approved uses, see the “Gavreto uses” section above.

What happens in lung and thyroid cancer

Cancer occurs when cells in your body develop a genetic change that makes them start to grow and multiply uncontrollably. (Cells that multiply are making more cells.)

Usually, your immune system notices these abnormal cells and quickly attacks and destroys them. However, some cancer cells develop certain genetic changes that make them better able to survive.

Often, cancer cells develop genetic changes that enable them to grow and spread quickly. These cells develop what are known as oncogenes. Oncogenes are formed when normal genes develop mutations (abnormal genetic changes).

Some lung and thyroid cancer cells have a mutated or rearranged RET gene that’s an oncogene.

What Gavreto does

Gavreto works by inhibiting (blocking) the activity of the RET oncogenes in certain lung and thyroid cancers. When the RET oncogene can’t work, the cancer can’t spread or grow like it typically would.

How long does it take to work?

Gavreto begins working as soon as you take your first dose. However, you aren’t likely to feel the drug working right away.

While you’re taking Gavreto, your doctor may order tests to check how well the drug is working for your cancer.

If you have questions about how soon the drug will begin working for your cancer, talk with your doctor. They can evaluate how well your cancer is responding to this therapy.

Gavreto and pregnancy

You shouldn’t use Gavreto during pregnancy. This is because as the drug could harm a developing fetus.

The active drug in Gavreto, called pralsetinib, hasn’t been studied in pregnant people. Studies in pregnant rats showed that Gavreto caused harm. This included congenital anomalies (commonly known as birth defects) and loss of pregnancy. That said, it’s important to remember that animal studies don’t always predict what will happen in people.

If you’re able to become pregnant, your doctor will order a pregnancy test for you before you take Gavreto. You’ll need to test negative for pregnancy in order to be prescribed this medication.

While you’re taking Gavreto, you’ll need to use effective, non-hormonal birth control to help prevent pregnancy. (See the “Gavreto and birth control” section below for more details.) If you become pregnant while taking Gavreto, call your doctor right away to let them know.

Gavreto and fertility

Gavreto may affect fertility (the ability to reproduce) in both males and females.*

If this is a concern for you, talk with your doctor before you start taking Gavreto. They can see if alternative treatments that won’t impact your fertility are available for your condition.

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

Gavreto and birth control

Gavreto isn’t 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 using Gavreto.

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

For females using Gavreto

If you’re a female* who can become pregnant, you’ll need to use an effective, non-hormonal birth control while you’re taking Gavreto. And you’ll need to continue using birth control for at least 2 weeks after you take your last dose of Gavreto.

* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.

For males using Gavreto

If you’re a male* with a sexual partner who can become pregnant, you’ll need to use birth control while you’re taking Gavreto. And you should continue using birth control for at least 1 week following your last dose of the drug.

* Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Gavreto and breastfeeding

Breastfeeding while taking Gavreto isn’t recommended.

It isn’t known whether the active drug in Gavreto, called pralsetinib, passes into breast milk. Pralsetinib could cause serious side effects to a child who’s breastfed. So, you should avoid breastfeeding while you’re taking Gavreto. And you should avoid breastfeeding for at least 1 week after your last dose of the drug.

If you have additional questions about breastfeeding and treatment options for your condition, talk with your doctor.

Common questions about Gavreto

Here are answers to some frequently asked questions about Gavreto.

Is Gavreto chemotherapy?

No, Gavreto isn’t chemotherapy.

Chemotherapy treatments work by attacking all cells in your body that are multiplying rapidly. (Cells that are multiplying are making more cells.) This includes healthy cells as well as cancer cells. So, chemotherapy can cause many side effects.

Instead, Gavreto is a targeted therapy for cancer. It targets (works on) a specific receptor (attachment site) inside cancer cells that help the cancer cells spread and grow in your body.

Gavreto can still affect some of your healthy cells, and it can cause some serious side effects. However, targeted therapies, such as Gavreto, tend to have fewer side effects than chemotherapy drugs.

If you have additional questions about how Gavreto differs from chemotherapy, talk with your doctor or pharmacist.

Can I take Gavreto if I’m having surgery?

It depends. If you need to have surgery while you’re taking Gavreto, your doctor will help determine the best actions for you to take. This will vary based on:

• the type of surgery you’re having
• how long your wounds will take to heal after surgery
• how comfortable you and your doctor are with starting Gavreto again after the surgery

Certain cancer drugs, including Gavreto, can slow down or interfere with your body’s ability to heal wounds. That’s why your doctor will have to evaluate whether it’s safe for you to take the drug if you’re having surgery.

If you’re having an elective surgery, you shouldn’t take Gavreto for at least 5 days before your procedure. (Elective surgery is surgery that may be needed, but it doesn’t have to be done right away).

If you’re having major surgery, you shouldn’t take Gavreto for at least 2 weeks after the surgery, or until your wounds have properly healed. Your doctor or surgeon will monitor how well your wounds are healing. (Major surgery is surgery that requires a large incision and is an invasive operation. An example would be having your appendix removed.)

If you have additional questions about taking Gavreto and having surgery, talk with your doctor or surgeon. And be sure to tell all of your doctors, including surgeons and specialists, that you’re taking Gavreto. They can determine the best course of action to take regarding your medications and recommended surgeries.

Has Gavreto been studied in older adults?

Yes, Gavreto has been studied in older adults.

One study had over 400 participants. Of the people involved, 30% were 65 years of age or older. This study included people with lung cancers or thyroid cancers that could be treated with Gavreto. (For more information on the specific cancer types that Gavreto treats, see the “Gavreto uses” section above).

In this study, researchers didn’t find any differences in older adults compared with other people in:

• how well Gavreto worked, or
• how safe Gavreto was

If you have additional questions about taking Gavreto given your age, talk with your doctor or pharmacist.

Gavreto precautions

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

• Breathing problems or lung problems, other than cancer. Rarely, Gavreto can cause severe lung inflammation. People who already have breathing problems or lung problems (other than cancer) may be at higher risk for this side effect. Be sure to talk with your doctor about any lung or breathing problems you have before you take Gavreto. If they decide that Gavreto is safe for you to take, your doctor will monitor you for lung inflammation while you’re taking Gavreto. If you develop symptoms of lung inflammation, your doctor will have you stop taking Gavreto. Based on the severity of your lung inflammation, they may decide to lower your Gavreto dose or have you stop taking Gavreto altogether and try a different medication.
• High blood pressure. Gavreto can cause mild increases in blood pressure. And rarely, it can cause serious increases in blood pressure. Before taking Gavreto, your doctor will check your blood pressure. If they find that you have high blood pressure that isn’t controlled, they’ll need to treat it before you can safely take Gavreto. Your doctor will also recommend monthly blood pressure checks while you’re taking Gavreto.
• Bleeding problems. Rarely, Gavreto can cause bleeding problems. If you already have bleeding problems, you may be at higher risk for this side effect. Talk with your doctor about any bleeding problems you may have before you start treatment with Gavreto. They’ll determine whether Gavreto is safe for you or if you should try a different medication for your condition.
• Planned surgery. Certain cancer drugs, including Gavreto, can slow down or interfere with your body’s ability to heal wounds. If you’re having elective surgery, you shouldn’t take Gavreto for at least 5 days before your procedure. If you’re having major surgery, you shouldn’t take Gavreto for at least 2 weeks after it, or until your wounds have properly healed. Your doctor or surgeon will monitor how well your wounds are healing. Be sure to tell your doctor about any planned surgeries you have before you start taking Gavreto. They may decide to have you wait until after your surgery to start taking this drug. Or, they may decide to have you take a medication other than Gavreto.
• Allergic reaction. If you’ve had an allergic reaction to Gavreto or any of its ingredients, you shouldn’t take this drug. Ask your doctor about which other medications are better options for you.
• Pregnancy. You shouldn’t use Gavreto while pregnant. For more information, see the “Gavreto and pregnancy” section above.
• Breastfeeding. You shouldn’t breastfeed while taking Gavreto. For more information, see the “Gavreto and breastfeeding” section above.

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

Gavreto overdose

Don’t use more Gavreto 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 Gavreto

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. But if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.