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.
Drug facts
Side effects of Balversa (erdafitinib)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
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%)
Less Common 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
Balversa (erdafitinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Eye problems: blurred vision, vision changes, vision loss, dry eyes
- High phosphate levels: painful skin lesions, muscle cramps, numbness around the mouth
The following Balversa (erdafitinib) 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
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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.
Common questions about Balversa
Balversa can raise phosphate levels so it’s important to limit how much phosphate you eat to 600-800 mg daily. You may need to avoid foods high in phosphorus while taking Balversa. Having high levels of phosphate or hyperphosphatemia can be dangerous and cause muscle cramps, bone pain, weak bones, or rash. Talk with your provider about possible diet changes while taking this medication.
In a clinical trial, people with bladder cancer who took Balversa survived about 4 months longer compared to those who had chemotherapy. And the tumor shrank for about 45% of people who took Balversa .
Balversa works against bladder cancer that have mutations in FGFR3 or FGFR2 genes. Your provider will take a tissue sample (biopsy) to test if you have these mutations. If the tests show abnormal FGFR genes, and you have already received platinum-based chemotherapy in the past Balversa might be an option for you.
Balversa should be taken until the bladder cancer worsens or if there are significant side effects that you can’t tolerate. Speak with your healthcare provider about how long you should take this medication and ways to help manage side effects you might experience.
Balversa can cause harm to an unborn baby. Your healthcare provider may give you a pregnancy test before you start taking the medication. If you’re able to get pregnant or have a partner who can become pregnant, you should use birth control while taking Balversa and for at least 1 month after the last dose. Let your provider know right away if you or your partner become pregnant while on this medication.
It isn’t recommended to breastfeed while taking Balversa. There are no studies to show how Balversa affects breastfed children, but because of the possibility of serious side effects, don’t breastfeed while taking this medication and for at least 1 month after the last dose.
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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
Tablet| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 3mg of | 56 tablets | $20,912.84 | $373.44 |
| 4mg of | 56 tablets | $27,881.71 | $497.89 |
| 5mg of | 28 tablets | $17,428.43 | $622.44 |
Typical dosage 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?
$17,428.43
What are alternatives to Balversa (erdafitinib)?
Balversa (erdafitinib) images
