Pronunciation: bal-VER-sah
Generic name: erdafitinib
Dosage form: oral tablet
Drug class: Multikinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Jan 23, 2024.

What is Balversa?

Balversa (erdafitinib) is an oral kinase inhibitor that may be used to treat adults with locally advanced or metastatic urothelial cancer (bladder cancer) that has spread or cannot be removed by surgery. Balversa is used only if:

• Your cancer carries a certain type of abnormal FGFR gene, and
• You have tried at least one other medicine by mouth or injection (systemic therapy) that did not work or is no longer working.

Balversa works by inhibiting the activity of FGFR, which is a type of protein called a kinase, responsible for cell signaling and viability. FGFR is present in bladder cancer tumor cells as well as healthy cells throughout the body. Because Balversa can affect all cells with this protein, it may affect normal cells and cause serious side effects but research has demonstrated a 36% reduction in the risk of death compared to standard chemotherapy.

Urothelial carcinoma, also known as transitional cell carcinoma, originates in urothelial cells lining the urethra, bladder, ureters, renal pelvis, and certain other organs. Almost all bladder cancers are urothelial carcinomas.

Balversa was initially FDA-approved on an accelerated approval basis on April 12, 2019. It was granted full approval on January 19, 2024. Balversa was the first medicine of its kind approved to treat people with advanced bladder cancer where the tumor carries a certain abnormal FGFR gene.

Warnings

Not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.

May cause central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Your healthcare provider will perform monthly eye examinations during the first four months of treatment, every 3 months afterward, and at any time for visual symptoms.

Increases in phosphate levels are an effect of Balversa. Your healthcare provider will monitor your laboratory results.

Can cause fetal harm. Both men and women using this medicine should use effective birth control to prevent pregnancy.

It is not known if Balversa is safe and effective in children.

Before taking this medicine

Tell your healthcare provider about all of your medical conditions, including if you:

• have vision or eye problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

It may be harder for you to get pregnant while you are using Balversa. You should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

Your healthcare provider will test your cancer for certain types of abnormal FGFR genes and make sure that Balversa is right for you.

Pregnancy

Balversa can harm your unborn baby. You should not become pregnant during treatment. If you are a female who can become pregnant your healthcare provider may do a pregnancy test before you start treatment. You should use effective birth control during treatment and for 1 month after the last dose of Balversa. Talk to your healthcare provider about birth control methods that may be right for you.

Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

Males with female partners who can become pregnant should use effective birth control when sexually active during treatment with Balversa and for 1 month after the last dose.

Breastfeeding

Do not breastfeed during treatment and for 1 month after the last dose of Balversa.

How should I take Balversa?

Take Balversa exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Swallow the Balversa tablets whole, once daily.

• May be taken with or without food.
• The recommended initial dosage is 8 mg once daily with a dose increase to 9 mg daily if certain criteria are met.

Your doctor may want you to use artificial tears or other lubricating eye medication every 2 hours while you are awake. Keep using these medicines for as long as your doctor has prescribed.

Your blood will need to be tested often. Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

You will need frequent vision tests.

What happens if I miss a dose?

Take the missed dose on the same day you remember it. Take your next dose at the regular time the next day. Do not use two doses in one day.

If you vomit shortly after taking Balversa, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the side effects of Balversa?

Get emergency medical help if you have signs of an allergic reaction to Balversa, such as hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.

Balversa may cause serious side effects, including:

• Eye problems- these are common but can be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye), and disorders of the retina, an internal part of the eye. Tell your healthcare provider right away if you develop blurred vision, loss of vision, or other visual changes. You should use artificial tear substitutes, hydrating or lubricating eye gels, or ointments at least every 2 hours during waking hours to help prevent dry eyes. During treatment with Balversa, your healthcare provider will send you to see an eye specialist
• High phosphate levels in the blood (hyperphosphatemia). This is common but can also be serious and may lead to a build-up of minerals such as calcium in different tissues in your body. Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with Balversa, and then monthly.

Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change or stop treatment if needed.

Tell your healthcare provider right away if you develop painful skin lesions, any muscle cramps, or numbness or tingling around your mouth.

Tell your healthcare provider right away if you develop any nail or skin problems including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, color or texture changes in your nails, infected skin around the nail, an itchy skin rash, dry skin, or cracks in the skin.

You may have high phosphate levels, and your blood will need to be tested often. Tell your doctor if you have symptoms such as numbness or tingling around your mouth, muscle stiffness, body aches, itching or rash, tiredness, trouble sleeping, nausea, vomiting, loss of appetite, or feeling short of breath.

Call your doctor at once if you have:

• vision problems, vision loss
• eye pain or redness or
• problems with your fingernails or toenails - pain, bleeding, separation of the nails from the skin (nail bed), unusual breakage, changes in nail color or texture, cracks, or infection in your cuticles.

Common Balversa side effects may include:

• nails separating from the nail bed or poor formation of the nail
• dry skin
• decreased phosphate in the blood
• mouth sores
• diarrhea or constipation
• dry mouth, mouth sores, or change in sense of taste
• increased level of creatinine, calcium, potassium, or alkaline phosphatase in the blood
• dry eye or fluid buildup behind the retina in your eye
• change in liver function
• redness, swelling, peeling, or tenderness, mainly on the hands or feet (hand-foot syndrome)
• decreased red blood cells (anemia)
• decreased salt (sodium) levels in the blood
• tiredness
• hair loss
• muscle pain
• nausea, stomach pain, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

What other drugs will affect Balversa?

Other drugs may interact with Balversa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Tell your doctor about all your other medicines, especially:

medicines that may change phosphate levels - potassium phosphate supplements, vitamin D supplements, antacids, enemas or laxatives that contain phosphate, and other medicines known to contain phosphate.

This is not a full list of interactions. See the prescribing information for more information.

Storage

Store Balversa tablets at room temperature between 68°F to 77°F (20°C to 25°C).

Keep all medicines out of the reach of children.

Ingredients

Active ingredient: erdafitinib

Inactive ingredients:

• Tablet Core: croscarmellose sodium, magnesium stearate (from vegetable source), mannitol, meglumine, and microcrystalline Cellulose.
• Film Coating (Opadry amb II): glycerol monocaprylocaprate type I, polyvinyl alcohol-partially hydrolyzed, sodium lauryl sulfate, talc, titanium dioxide, iron oxide yellow, iron oxide red (for the orange and brown tablets only), ferrosoferric oxide/iron oxide black (for the brown tablets only).

Manufacturer

Janssen Pharmaceutical Companies.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer