Balversa
Balversa (erdafitinib) is an oral medication used to treat adults with bladder cancer. It’s specifically for those with genetic changes in the fibroblast growth factor receptor (FGFR) genes, after they have already been treated with platinum-based chemotherapy. It’s conveniently taken by mouth once a day. Side effects include high phosphate levels in the body and certain eye problems. Because of these risks, you should follow up with your provider closely for routine lab monitoring and eye exams while taking the medication.
What is Balversa (erdafitinib)?
What is Balversa (erdafitinib) used for?
Bladder cancer with FGFR3 or FGFR2 genetic changes, previously treated with platinum-based chemotherapy
How Balversa (erdafitinib) works
Balversa (erdafitinib) is a targeted therapy that works by blocking a protein called fibroblast growth factor receptor (FGFR). In normal cells, FGFR helps to control how cells grow. But if there is a change (mutation) in the FGFR gene, it can lead to the development of cancer cells that grow and spread too quickly. So by blocking FGFR from working, Balversa (erdafitinib) slows down or stops the cancer cells from growing.
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What are the side effects of Balversa (erdafitinib)?
Common Side Effects
- Mouth irritation or sores (56%)
- Feeling tired or weak (54%)
- Diarrhea (47%)
- Dry mouth (45%)
- Nail changes (45)
- Poor appetite (38%)
- Changes in taste (37%)
- Dry skin (34%)
- Constipation (28%)
- Dry eyes (28%)
- Hair loss (26%)
- Redness or irritation to the palms of hands or soles of feet (26%)
- Stomach pain (23%)
- Nausea (21%)
Other Side Effects
- Muscle or joint pain
- Increased tears
- Weight loss
- Urinary tract infections (UTI)
- Shortness of breath
- Fever
- Low red blood cells (anemia)
- Low salt levels
Serious Side Effects
- Eye problems: blurred vision, vision changes, vision loss, dry eyes
- High phosphate levels: painful skin lesions, muscle cramps, numbness around the mouth
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
- Blurry vision, vision loss, seeing wavy or bent objects or blind spots with dark, light, or flashing spots
- High phosphorus level—muscle pain or cramps, bone or joint pain, numbness and tingling around the mouth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
- Change in nail shape, thickness, or color
- Diarrhea
- Dryness or irritation of the eyes, lips, mouth, or nose
- Hair loss
- Loss of appetite with weight loss
- Pain, redness, or swelling with sores inside the mouth or throat
- Unusual weakness or fatigue
Pros and cons of Balversa (erdafitinib)
Pros
Taken by mouth once a day
Taken with or without food
Recommended treatment option for FGFR gene changes in bladder cancer
Cons
Not safe during pregnancy or breastfeeding
Might need to limit the amount of phosphorus in your diet
Need frequent eye exams
Pharmacist tips for Balversa (erdafitinib)
Balversa (erdafitinib) can be taken with or without food at the same time every day. Make sure you swallow tablets whole. Don’t cut or crush them since it might not make them work as well.
Your dose of Balversa (erdafitinib) might change depending on phosphate level, eye exams, and if you’re experiencing serious side effects. Pay close attention to the dose and tablet strengths. Tablet strengths are different colors.
If you miss a dose of Balversa (erdafitinib), take a dose as soon as possible on the same day. Take your regular daily dose the next day. Don’t take extra tablets to make up for a missed dose to avoid additional side effects. And if you vomit at any time after taking Balversa (erdafitinib), wait until the next day to take the next dose.
Balversa (erdafitinib) can commonly cause mouth sores. Practice good mouth care to help you deal with this potential side effect. Rinse your mouth frequently, brush your teeth with a soft toothbrush, and avoid alcohol and mouthwashes with alcohol.
Balversa (erdafitinib) can cause dry eyes. Using artificial tears, or other hydrating eye gels or ointments, every 2 hours while awake can help prevent this side effect.
Balversa (erdafitinib) can lead to changes in the nail or the skin around the nail. Avoid biting, picking, or chewing your nails to avoid making this worse or getting an infection.
Balversa (erdafitinib) might cause a bitter or metallic taste change. You can change your utensils to plastic to help. Mints or chewing gum can also help with taste changes.
When taking Balversa (erdafitinib), you’ll need regular appointments to watch for certain side effects]. Your phosphate levels will be checked 2-3 weeks after you start, and then monthly. Also expect to have eye exams before treatment, monthly for the first 4 months, and then every 3 months as needed to look for any changes in vision.
Frequently asked questions about Balversa (erdafitinib)
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What are the risks and warnings for Balversa (erdafitinib)?
Balversa (erdafitinib) 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.
High phosphorus levels
Risk factors: Taking medications that raise phosphate levels | Diet high in phosphorus
Balversa (erdafitinib) can cause high phosphate levels, which can happen anywhere from a week to 4 months after starting the medication. High levels of phosphorus cause minerals to build up in your body, which can lead to complications. It can also lead to weak bones and raise the risk of fractures. Balversa (erdafitinib).
To make sure your phosphate levels stay normal, you’ll need your phosphate level checked before starting Balversa (erdafitinib), 2 to 3 weeks after, and then monthly as needed. You might need to change your diet and limit how much phosphate you eat to 600-800 mg daily and avoid medications that raise your phosphate, such as vitamin D supplements and bisphosphonates. Your provider might also prescribe medications that lower phosphate if needed. Tell your provider right away if you have any symptoms of high phosphate levels including painful skin lesions, muscle cramps, or numbness around the mouth.
Eye problems
Risk factors: History of vision or eye problems
Balversa (erdafitinib) can cause changes in vision, dry or irritated eyes, or problems of the retina. You’ll need to see an eye specialist and get eye exams monthly for the first 4 months of treatment and then every 3 months. Tell your provider right away if you have any blurred vision or visual changes. Using artificial tears, or other hydrating eye gel or ointment, every 2 hours while awake can help prevent dry eyes.
Harm to unborn baby
Balversa (erdafitinib) can cause harm to unborn babies. So it’s important to avoid becoming pregnant. If you're able to get pregnant, or have a partner that can become pregnant, use birth control during treatment and for at least 1 month after the last dose of Balversa (erdafitinib). Discuss with your provider right away if you become pregnant or are planning to become pregnant.
Balversa (erdafitinib) dosage forms
Typical dosing for Balversa (erdafitinib)
The typical starting dose for Balversa (erdafitinib) is 8 mg by mouth once a day. After 2 to 3 weeks, your provider might raise your dose to 9 mg by mouth once a day if your phosphate lab levels are normal and you don't experience any serious side effects.
How much does Balversa (erdafitinib) cost?
What are alternatives to Balversa (erdafitinib)?
Bladder cancer with FGFR3 or FGFR2 genetic changes, previously treated with platinum-based chemotherapy
Non-small cell lung cancer (NSCLC)
Renal cell carcinoma (kidney cancer)
Endometrial carcinoma (uterine cancer)
Cancers with high tumor mutation burden (TMB-H), high microsatellite instability (MSI-H), or deficient mismatch repair (dMMR)
Balversa (erdafitinib) images
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References
Best studies we foundAmerican Cancer Society. (2020). Nail changes.
American Cancer Society. (2020). Taste and smell changes.
American Cancer Society. (2021). How targeted therapies are used to treat cancer.
American Kidney Fund. (2023). High phosphorus (hyperphosphatemia).
Dai, S., et al. (2019). Fibroblast growth factor receptors (FGFRs): Structures and small molecule inhibitors. Cells.
Goyal, R., et al. (2023). Hyperphosphatemia. StatPearls.
Janssen Products LP. (2023). Balversa- erdafitinib tablet, film coated [package insert]. DailyMed.
Loriot, Y., et al. (2023). Erdafitinib or chemotherapy in advanced or metastatic urothelial carcinoma. The New England Journal of Medicine.
Lyou, Y. (2021). Screening for targetable FGFR mutations from a community practice perspective. American Society of Clinical Oncology Daily News.
MedlinePlus. (2020). FGFR2 gene.
MedlinePlus. (2023). FGFR3 gene.
National Cancer Institute. (2023). What is bladder cancer?
National Comprehensive Cancer Network. (2023). Bladder cancer.
National Kidney Foundation. (2019). Phosphorus and your diet.
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