Balversa is used in adults to treat bladder cancer that has spread to other parts of the body (metastatic), or cannot be removed with surgery.

Balversa is used only if your cancer has a specific genetic marker (an abnormal "FGFR" gene), and if you were treated with at least one other platinum cancer medicine that did not work or has stopped working. Your doctor will test you for this gene.

Balversa is usually given after other treatments have failed.

Balversa was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

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.

You may need to have a negative pregnancy test before starting Balversa.

Tell your doctor if you have ever had problems with your eyes or vision.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Erdafitinib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Balversa.

Do not breastfeed while using this medicine, and for at least 1 month after your last dose.

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, 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.

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

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.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Urothelial Carcinoma:

8 mg orally once daily; increase to 9 mg orally once daily based on serum phosphate levels and tolerability at 14 to 21 days until disease progression or unacceptable toxicity

Comments
-Select patients for therapy based on the presence of susceptible FGFR genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic.

Use: For the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has susceptible FGFR3 or FGFR2 genetic alterations, and progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

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.

You may need to have a negative pregnancy test before starting Balversa.

Tell your doctor if you have ever had problems with your eyes or vision.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Erdafitinib can harm an unborn baby or cause birth defects if the mother or father is using this medicine.

Keep using birth control for at least 1 month after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Balversa.

Do not breastfeed while using this medicine, and for at least 1 month after your last 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.

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

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

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

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.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Balversa side effects may include:

• dry eyes;

• dry mouth, mouth sores;

• hair loss;

• dry skin, problems with your fingernails or toenails;

• redness, swelling, pain, or blisters on the palms of your hands or the soles of your feet;

• muscle pain;

• feeling tired;

• abnormal liver or kidney function tests;

• low sodium levels, low red blood cell count;

• nausea, stomach pain, loss of appetite;

• diarrhea, constipation; or

• changes in your sense of taste.

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 FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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.

Other drugs may interact with erdafitinib, 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.