Gavreto Side Effects What They Are and How to Manage Them
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† An allergic reaction is possible after taking Gavreto. But this side effect wasn’t reported in studies. If you develop serious side effects while taking Gavreto, contact your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
accessdata.fda.gov/drugsatfda_docs/label/2022/213721s005lbl.pdfOur experts continually monitor the health and wellness space, and we update our articles when new information becomes available. Current Version Sep 16, 2022 By Rosanna Sutherby, PharmD Edited By Ami Knox Medically Reviewed By Tanya Kertsman, PharmD Share this articleMedically reviewed by Tanya Kertsman, PharmD — By Rosanna Sutherby, PharmD on September 16, 2022
Side Effects of Gavreto What You Need to Know
Medically reviewed by Tanya Kertsman, PharmD — By Rosanna Sutherby, PharmD on September 16, 2022Introduction
If you have a certain kind of cancer, your doctor might suggest Gavreto as a treatment option for you. Gavreto is a prescription drug used to treat:a certain kind of metastatic non-small cell lung cancer (NSCLC) in adultsa certain kind of advanced or metastatic thyroid cancer in adults and some children who:require systemic therapy (medication affecting the whole body), andhave had radioactive iodine therapy that didn’t work or stopped workinga certain kind of advanced or metastatic medullary thyroid cancer (MTC) in adults and some children who require systemic therapy With metastatic cancer, the cancer has spread to areas of the body outside of where it started. With advanced cancer, the cancer has spread near the location where it started. The active ingredient in Gavreto is pralsetinib. An active ingredient is what makes a drug work. This medication is a biologic, which means it’s made from living cells. Gavreto comes as a capsule that you swallow. If you and your doctor decide Gavreto is safe and effective for you, you’ll likely take it long term. For more information about Gavreto, including details about its uses, see this in-depth article on the drug. Like other drugs, Gavreto can cause mild to serious side effects. Keep reading to learn more.What are the more common side effects of Gavreto
Some people may experience mild to serious side effects during their Gavreto treatment. Examples of Gavreto’s commonly reported side effects include:constipationfatigue (low energy)muscle paindiarrheahigh blood pressure* * To learn more about this side effect, see the “Side effects explained” section below.What are the mild side effects of Gavreto
Gavreto can cause mild side effects. The list below includes some mild side effects that have been reported with Gavreto. But these are not all the possible mild side effects this drug may cause. To learn more about Gavreto’s side effects, view the drug’s prescribing information. Gavreto’s mild side effects include:belly painmild coughdecreased appetiteconstipationdizzinessfatigue (low energy)nauseamouth soresmuscle paindiarrheamild high blood pressure*increased liver enzyme levels*mild allergic reaction* * To learn more about this side effect, see the “Side effects explained” section below. In many cases, these side effects should be temporary. And some may be easily managed. But if you have any symptoms that are ongoing or bother you, talk with your doctor or pharmacist. And do not stop taking Gavreto unless your doctor recommends it. Gavreto may cause mild side effects other than the ones listed above. See the drug’s prescribing information for details. Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Gavreto, visit MedWatch.What are the serious side effects of Gavreto
Taking Gavreto can cause serious side effects. Serious side effects that have been reported with Gavreto include:lung problems, such as pneumonia and lung inflammationsepsis (strong immune response to an infection)feverproblems with wound healingurinary tract infection (UTI)low level of red blood cells* or white blood cellsshortness of breathtumor lysis syndrome (TLS)*liver problems*bleeding problems*severe high blood pressure*severe allergic reaction*† * To learn more about this side effect, see the “Side effects explained” section below.† An allergic reaction is possible after taking Gavreto. But this side effect wasn’t reported in studies. If you develop serious side effects while taking Gavreto, contact your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Side effects explained
Learn more about some of the side effects Gavreto may cause.High blood pressure
In studies, Gavreto caused both mild and serious high blood pressure. Mild high blood pressure was one of the more common side effects reported in these studies. If your blood pressure is mildly elevated, you may not have symptoms. Most people only notice this side effect if they check their blood pressure. In some cases, Gavreto can cause severely high blood pressure, symptoms of which include:headacheshortness of breathdizzinessvisual changeschest painconfusionWhat might help
Before you start Gavreto treatment, your doctor will likely check your blood pressure. If you have high blood pressure that’s not treated, they’ll likely prescribe medication to lower your blood pressure before you start Gavreto. Regardless of whether you have high blood pressure before starting Gavreto treatment, your doctor will monitor your blood pressure regularly while you’re receiving the drug. Depending on your blood pressure readings, they may prescribe medication to treat high blood pressure. They may also adjust your Gavreto dosage if needed. If you have severely high blood pressure while taking Gavreto, your doctor may have you pause your Gavreto treatment. Or they may have you permanently stop taking this medication and recommend a different treatment for your cancer.Bleeding problems
Gavreto can cause bleeding problems, but this side effect was rare in studies of the drug. In some cases, this side effect may be serious or life threatening. Taking Gavreto can decrease your platelet levels. Platelets are cells that help your blood clot. So having low platelet levels increases your risk of bleeding or may make it difficult for your blood to clot. Symptoms of bleeding problems include:frequent nosebleedsbleeding gumsbleeding that takes longer than usual to stopbloody urine or stoolsbruising more easily than usualheavier bleeding than usualvomiting bloodconfusionheadacheWhat might help
Let your doctor know right away if you have symptoms of bleeding problems. But if you have serious or life threatening bleeding, immediately call 911 or your local emergency number. In cases of severe bleeding, your doctor will have you permanently stop Gavreto treatment. They may recommend a different treatment option for you.Increased liver enzyme levels and liver problems
In studies of Gavreto, increased liver enzyme levels was a commonly reported side effect. Liver enzyme levels help doctors know how your liver is working. Elevated liver enzyme levels may be a sign of liver problems. These problems can sometimes be serious or life threatening. Symptoms of liver problems include:loss of appetiteyellowing of your skin or white part of your eyesdark urinefatigue (low energy)bloody, black, or pale stoolspain in the upper right part of your bellynauseavomitingdiarrheaconfusionbleeding or bruisingWhat might help
Your doctor will order blood tests to check your liver enzyme levels before you start Gavreto treatment. You’ll also have these tests every 2 weeks during your first 3 months of treatment, then once per month afterward. Based on your test results, your doctor may adjust your Gavreto dosage, pause your treatment, or have you permanently stop this medication. It’s important to let your doctor know immediately if you have symptoms of liver problems. They’ll determine the cause of your symptoms and adjust your Gavreto treatment if necessary.Low level of red blood cells
Gavreto can cause red blood cells to decrease to a low level, a condition called anemia. (Red blood cells help carry oxygen to organs throughout your body.) This side effect was common in studies of Gavreto. Symptoms of anemia can include:fatigue (low energy)shortness of breathweaknesslightheadedness or dizzinesspale gums, skin, or nailsheadachecold hands or feetfast heart ratefaintingWhat might help
If you have any of the symptoms listed above, tell your doctor right away. They can order blood tests to check your red blood cell level. If your level is low, your doctor may recommend treatment with supplements or vitamins that help your body make more red blood cells. Examples include:vitamin B12 or B complexfolic acidiron To reduce your risk of anemia or increase your red blood cell level, you can also consume foods rich in these nutrients. Examples include lentils, fish, meat, and dairy products. If you have concerns about your risk of anemia during Gavreto treatment, talk with your doctor.Tumor lysis syndrome
Tumor lysis syndrome (TLS) is a rare side effect reported in Gavreto studies. TLS happens when parts of cancer cells are released into your body as the cancer cells break down and die. If TLS occurs, it can be life threatening. Your risk of TLS is higher if you’re dehydrated, have rapidly growing tumors, or have kidney problems. Symptoms of TLS include:fatigue (low energy)muscle crampsweaknessnausea and vomitingcloudy urinedecreased urine outputswellingshortness of breath More severe symptoms include:kidney failureloss of muscle controlhallucinationsseizuresWhat might help
Staying hydrated while taking Gavreto may reduce your risk of TLS. If you have symptoms of TLS, contact your doctor or get emergency help right away.Allergic reaction
Like most drugs, Gavreto can cause an allergic reaction in some people. But this side effect wasn’t reported in studies. Symptoms can be mild to serious and can include:skin rashitchinessflushing (temporary warmth, redness, or deepening of skin color)swelling under your skin, usually in your eyelids, lips, hands, or feetswelling of your mouth, tongue, or throat, which can make it hard to breatheWhat might help
If you have mild symptoms of an allergic reaction, such as a mild rash, contact your doctor right away. They may suggest a treatment to manage your symptoms. Examples include:an antihistamine you take by mouth, such as Benadryl (diphenhydramine)a product you apply to your skin, such as hydrocortisone cream If your doctor confirms you’ve had a mild allergic reaction to Gavreto, they’ll decide if you should continue taking it. If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care. If your doctor confirms you’ve had a serious allergic reaction to Gavreto, they may have you switch to a different treatment.Keeping track of side effects During your Gavreto treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start taking new drugs or using a combination of treatments. Your side effect notes can include things such as:what dose of the drug you were taking when you had the side effecthow soon you had the side effect after starting that dosewhat your symptoms werehow it affected your daily activitieswhat other medications you were takingany other information you feel is important Keeping notes and sharing them with your doctor will help them learn more about how Gavreto affects you. They can then use this information to adjust your treatment plan if needed.Warnings for Gavreto
Gavreto may not be right for you if you have certain medical conditions. These are known as drug-condition interactions. Other factors may also affect whether Gavreto is a good treatment option for you. Talk with your doctor about your health history before starting Gavreto. They can discuss with you the risks and benefits of taking Gavreto. The list below includes factors to consider. High blood pressure. Gavreto can increase your blood pressure. It can even cause severe high blood pressure. If you already have high blood pressure, your doctor will make sure it’s managed before prescribing Gavreto. They’ll also check your blood pressure 1 week after starting Gavreto treatment and then once per month during your treatment. If your blood pressure is high, your doctor may prescribe medication to manage it. Allergic reaction. If you’ve had an allergic reaction to Gavreto or any of its ingredients, your doctor will likely not prescribe Gavreto. Ask them what other medications are better options for you. Lung problems other than cancer. Gavreto may cause lung or breathing problems, including interstitial lung disease and severe lung inflammation. If you have lung problems other than cancer, you may have an increased risk of this side effect. Before starting Gavreto, be sure to discuss any lung or breathing problems with your doctor. This will help them determine whether Gavreto is safe for you to take. Liver problems. Gavreto can cause serious liver problems, including liver damage. People who already have liver problems may have a higher risk of this side effect. Before starting Gavreto and regularly after you start treatment, your doctor will check your liver function. If you develop liver problems during your treatment, they’ll reduce your Gavreto dosage or have you pause or stop your treatment. Bleeding problems. Gavreto can increase your risk of bleeding. If you already have bleeding problems, this medication may worsen your condition. Before you start taking Gavreto, be sure to talk with your doctor about your health history. This will help them determine whether the drug is a safe treatment option for you. Planned or recent surgery. Gavreto and certain other cancer drugs can slow down wound healing or make it more difficult for wounds to heal. Before you start taking Gavreto, tell your doctor if you’ve recently had major surgery. They’ll likely wait at least 2 weeks after your surgery to prescribe this drug. Or they may wait until your wounds have healed. If you’re planning to have surgery during Gavreto treatment, your doctor will likely have you stop taking it at least 5 days before surgery. Then you’ll resume taking the drug 2 weeks after surgery or when your wounds have healed.Alcohol and Gavreto
There are no known interactions between alcohol and Gavreto. But alcohol can worsen some of Gavreto’s side effects, such as diarrhea, dizziness, and nausea. Also, both Gavreto and alcohol can cause liver problems. Drinking alcohol during your Gavreto treatment may increase your risk of liver damage. Talk with your doctor to learn how much alcohol, if any, is safe to consume while taking Gavreto.Pregnancy and breastfeeding while taking Gavreto
Gavreto is not safe to take during pregnancy. This is because it can cause harm to a developing fetus. If you can become pregnant, your doctor will have you take a pregnancy test before starting Gavreto treatment. They’ll only prescribe this medication if your pregnancy test is negative. Your doctor will also recommend that you use an effective method of nonhormonal birth control during treatment. You’ll need to continue using this birth control for at least 2 weeks after your last Gavreto dose. If you’re male* and have a partner who can become pregnant, your doctor will recommend that you use an effective method of birth control during treatment. You’ll need to continue using birth control for at least 1 week after your last Gavreto dose. It’s not known whether Gavreto passes into breast milk. But due to the risk of serious side effects in a child who is breastfed, breastfeeding is not recommended during Gavreto treatment. You should also avoid breastfeeding for 1 week after your last Gavreto dose. If you’re breastfeeding or planning to do so, talk with your doctor. They’ll discuss safe ways for you to feed your child during Gavreto treatment. * In this article, we use the term “male” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.What to ask your doctor
As with other medications, some people taking Gavreto may experience side effects. Knowing what side effects you may have from this medication can help you manage them. Talk with your doctor before starting Gavreto treatment and if you develop any side effects. They can answer your questions about side effects. Here are examples of questions to ask your doctor:Does my risk of high blood pressure depend on the dosage I take?Can Gavreto cause hair loss?Will my current medications increase my risk of side effects with Gavreto?Is my risk of diarrhea higher when I first start treatment?Ask a pharmacist
Q
Can Gavreto cause side effects after stopping treatment with the drug?AnonymousA
A It’s unlikely. In studies, side effects occurring after Gavreto treatment weren’t reported. But the drug can cause long term side effects that may start during Gavreto treatment and continue even after stopping the medication. For example, taking Gavreto can affect a person’s ability to reproduce. This side effect may not be reversed even after stopping Gavreto treatment. It’s not clear whether this side effect is rare or common. But if you’re planning a pregnancy, talk with your doctor before you start taking Gavreto. They’ll recommend a safe treatment option for you. If you have questions about long-term side effects of Gavreto, talk with your doctor.The Healthline Pharmacist TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice. Disclaimer: Healthline 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. Last medically reviewed on September 16, 2022How we vetted this article
SourcesHistoryHealthline has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. We avoid using tertiary references. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.Gavreto (pralsetinib) capsules, for oral use. (2022).accessdata.fda.gov/drugsatfda_docs/label/2022/213721s005lbl.pdfOur experts continually monitor the health and wellness space, and we update our articles when new information becomes available. Current Version Sep 16, 2022 By Rosanna Sutherby, PharmD Edited By Ami Knox Medically Reviewed By Tanya Kertsman, PharmD Share this articleMedically reviewed by Tanya Kertsman, PharmD — By Rosanna Sutherby, PharmD on September 16, 2022