Gavreto
Gavreto (pralsetinib) is a targeted therapy for advanced or metastatic non-small cell lung cancer (NSCLC) and thyroid cancers with RET gene changes (mutations). Gavreto (pralsetinib) is a recommended option for those cancers, and it’s conveniently available as pills you take by mouth once a day. But it often causes troublesome fatigue, constipation, and high blood pressure.
What is Gavreto (pralsetinib)?
What is Gavreto (pralsetinib) used for?
Metastatic NSCLC with RET gene fusion in adults
Advanced or metastatic thyroid cancers with RET mutations, in adults and children 12 years of age or older
How Gavreto (pralsetinib) works
Some cancers form when normal cells in the body have changes (mutations) in their genetic material. These mutations can lead to abnormal proteins, which causes the tumors to grow and spread.
Specifically, certain cancers have changes in the RET gene. These changes can result in abnormal RET proteins that send signals for tumors to grow. Gavreto (pralsetinib) interrupts tumor growth by blocking these abnormal RET proteins from sending the growth signal.
Drug Facts
What are the side effects of Gavreto (pralsetinib)?
Common Side Effects
- Lower electrolyte levels (calcium, sodium, magnesium, phosphate) (up to 70%)
- Labs suggesting liver or kidney problems (up to 69%)
- Muscle, bone, or joint pain (up to 42%)
- Constipation (up to 41%)
- High blood pressure (40%)
- Feeling very tired (38%)
- Diarrhea (34%)
Other Side Effects
- Swelling
- Cough
- Headache or migraine
- Rash
- Feeling short of breath
- Fever
- Feeling numbness or tingling in the fingers or toes
Serious Side Effects
- Lung inflammation: cough, shortness of breath, fever
- Liver injury: pain in the right side of the stomach, yellowing of the eyes or skin, dark or brown urine
- High blood pressure: headache, dizziness, confusion, chest pain
- Severe bleeding: sudden or painful headache, changes in vision, severe stomach pain, coughing or spitting up blood
- Tumor lysis syndrome: muscle cramps, dark or brown urine, fluttering or pounding heart beat
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
- Dry cough, shortness of breath or trouble breathing
- Increase in blood pressure
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Bone, joint, or muscle pain
- Constipation
- Diarrhea
- Dry mouth
- Fever
- Swelling of the ankles, hands, or feet
- Unusual weakness or fatigue
Pros and cons of Gavreto (pralsetinib)
Pros
Taken by mouth once a day
Okay to take with heartburn medications, such as omeprazole (Prilosec) and famotidine (Pepcid AC)
Recommended option for NSCLC and thyroid cancers with RET mutations
Cons
Must take on an empty stomach
Interacts with many other medications and herbals, such as itraconazole (Sporanox) and St. John’s wort
Not safe to take during pregnancy
Pharmacist tips for Gavreto (pralsetinib)
Gavreto (pralsetinib) is available as 100 mg capsules, so you’ll need 4 capsules to make your daily dose. Take your entire dose at around the same time each day.
Gavreto (pralsetinib) works best when you take it on an empty stomach, so you should avoid eating 2 hours before or 1 hour after your dose. If you vomit after taking Gavreto (pralsetinib), don’t make up the dose.
If you miss a dose of this medication and it’s the same day, take it as soon as you remember. If you realize you forgot a dose and it’s almost time for your next dose, don’t double up and take your normal dose at the regular time.
Gavreto (pralsetinib) interacts with many medications, supplements, and herbals. For instance, you should avoid using the antifungal medication itraconazole (Sporanox) while taking this medication, because it can raise Gavreto (pralsetinib) levels in the body and raise your risk for side effects. On the other hand, taking the herbal supplement St. John’s wort could lower Gavreto (pralsetinib) levels in the body and make Gavreto (pralsetinib) not work as well against cancer. Be sure to share a complete list of the medications, supplements, and herbals you take with your healthcare team. That way, they can make sure what you’re taking is safe to use with Gavreto (pralsetinib).
Before you start taking Gavreto (pralsetinib), talk to your provider if you are pregnant or are planning to become pregnant. Gavreto (pralsetinib) can harm the unborn baby and might affect fertility. If you’re able to become pregnant, use an effective non-hormonal birth control method (e.g. condoms, copper intrauterine device or IUD) while taking Gavreto (pralsetinib) and for 2 weeks after stopping. Birth control that contains hormones (e.g. the pill) might not work as well while using Gavreto (pralsetinib).
If you’re taking Gavreto (pralsetinib) and your partner is pregnant or is able to become pregnant, use effective birth control during treatment and for 1 week after stopping.
Since Gavreto (pralsetinib) hasn’t been studied in people who are breastfeeding, avoid breastfeeding while taking this medication and for 1 week after stopping.
Gavreto (pralsetinib) caused changes in bone growth in studies done in animals. If your child is starting treatment with Gavreto (pralsetinib), your provider will periodically check up on your child’s growth pattern by taking measurements and doing scans.
Frequently asked questions about Gavreto (pralsetinib)
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What are the risks and warnings for Gavreto (pralsetinib)?
Gavreto (pralsetinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Lung inflammation
Gavreto (pralsetinib) can cause damage to the lungs. In rare cases, this can be life-threatening. Let your healthcare team know if you have a new or worsening cough, trouble catching your breath, or fevers. You’ll probably need to stop the medication while your provider checks your lungs for problems.
High blood pressure
Let your provider know if have high blood pressure. If your blood pressure isn't under control, you won't be able to start Gavreto (pralsetinib) because this medication can also cause high blood pressure. Your provider will check your blood pressure before you start Gavreto (pralsetinib) and regularly while you’re receiving treatment. If needed, they’ll prescribe you blood pressure lowering medications. If your blood pressure isn’t well-controlled by medications, your provider might have you temporarily take a break from Gavreto (pralsetinib) while working on getting your blood pressure back down to a safe range. Once your blood pressure is back to a safe range, they’ll have you start Gavreto (pralsetinib) again, but at a lower dose. In rare cases, if your blood pressure is still dangerously high even with blood pressure medication, your provider might have you stop taking Gavreto (pralsetinib). If you notice symptoms of dangerously high blood pressure like dizziness or headache, let your provider know.
Liver injury
Gavreto (pralsetinib) might damage your liver. Let your healthcare team know if you notice signs of liver damage, such as pain in the right side of the stomach, yellowing of the eyes or skin, or dark or brown urine. But many people don’t feel any physical symptoms from liver problems. Your provider will order blood tests regularly to track how well your liver is working (every 2 weeks for the first 3 months, then monthly afterward). In studies, some people had higher levels of liver enzymes on their blood tests (a sign of potential liver injury) within the first 3 weeks of starting Gavreto (pralsetinib). If your provider suspects that you have liver damage, your provider might have you take a break from Gavreto (pralsetinib). Once your liver test results return to normal, you might be able to restart the medication at a lower dose.
Severe bleeding
In rare cases, Gavreto (pralsetinib) contributed to serious bleeding, which could be fatal. Bleeding can happen anywhere in the body, including in the lungs, stomach, and brain.
If you experience any serious or unusual bleeding, especially bleeding that’s hard to stop, seek medical attention immediately. Get medical help right away if you feel nauseous, have a sudden or painful headache, notice a change in your vision, have stomach pain, or are coughing or spitting up blood.
Surgery and wound healing problems
Gavreto (pralsetinib) can slow down the wound healing process. If you're going to have surgery or any other procedures, let your provider know. They’ll ask you to stop taking this medication at least 5 days before a planned surgery. After major surgery, you should wait for at least 2 weeks before starting this medication again, checking with your healthcare team to make sure your wound is fully healed before restarting treatment. If you have an injury and notice the wound’s taking a long time to heal, make sure to tell your care team.
Tumor lysis syndrome
Risk factors: Rapidly growing tumors | Large amount of tumor in the body | History of kidney problems | Dehydration
In clinical studies, a few people taking Gavreto (pralsetinib) for thyroid cancer experienced a serious reaction called tumor lysis syndrome (TLS). TLS happens when many cancer cells die and suddenly break down in your body, all at the same time. When this happens, the cells release their inner contents, like uric acid, potassium, and phosphorus, into your blood. High levels of uric acid and electrolytes in your body can cause serious problems, such as kidney damage and abnormal heart rhythms.
When you start treatment with Gavreto (pralsetinib), your provider will order labs for you to check for signs of TLS. Tell your provider right away if you’re having signs of TLS, such as urinating less than usual or having dark urine, muscle cramps, or a racing heartbeat. To prevent TLS, it’s a good idea to drink enough fluids daily to keep hydrated. If needed, your provider might give you intravenous (IV) fluids and prescribe you medications to lower your uric acid levels.
Harm to the unborn baby
Let your provider know if you are pregnant or plan to become pregnant. Gavreto (pralsetinib) might affect fertility and is likely to harm unborn babies. If you’re able to become pregnant, your provider will have you do a pregnancy test before starting treatment. They’ll also ask you to use effective non-hormonal birth control while taking this medication and for at least 2 weeks after your last dose. If you’re male and have a partner who’s able to become pregnant, continue using effective birth control while taking Gavreto (pralsetinib) and for at least a week after the last dose.
Gavreto (pralsetinib) dosage forms
Typical dosing for Gavreto (pralsetinib)
The typical dose is 400 mg by mouth daily on an empty stomach.
What are alternatives to Gavreto (pralsetinib)?
Metastatic NSCLC with RET gene fusion in adults
Advanced or metastatic thyroid cancers with RET mutations, in adults and children 12 years of age or older
Advanced or metastatic NSCLC with RET gene fusion in adults
Advanced or metastatic thyroid cancers with RET mutations in adults and children age 12 years and older
Advanced or metastatic tumors with RET mutations in adults, when other treatments haven’t worked or aren’t available
Gavreto (pralsetinib) images
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References
Best studies we foundAmerican Cancer Society. (n.d.). Thyroid cancer.
American Cancer Society. (2019). What is thyroid cancer?
American Cancer Society. (2022). Targeted drug therapy for non-small cell lung cancer.
American Heart Association. (2023). Changes you can make to manage high blood pressure.
American Lung Association. (2021). RET and lung cancer.
Andrini, E., et al. (2022). Non-small-cell lung cancer: How to manage RET-positive disease. Drugs in Context.
Blueprint Medicines Corporation and Genentech, Inc. (2021). Understanding biomarker testing.
Genentech, Inc. (2023). Gavreto- pralsetinib capsule [package insert]. DailyMed.
Gupta, A., et al. (2018). Tumor lysis syndrome. Journal of the American Medical Association Oncology.
MedlinePlus. (2018). RET gene.
National Cancer Institute. (2023). Non-small cell lung cancer treatment (PDQ®)–Patient version.
National Comprehensive Cancer Network. (2022). Thyroid cancer.
National Comprehensive Cancer Network. (2023). Metastatic non-small cell lung cancer.
Vodopivec, D. M., et al. (2022). RET kinase inhibitors for RET-altered thyroid cancers. Therapeutic Advances in Medical Oncology.
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