erdafitinib (Balversa)

Brand Names: Balversa

Generic Name: erdafitinib

• What is erdafitinib (Balversa)?
• What are the possible side effects of erdafitinib (Balversa)?
• What is the most important information I should know about erdafitinib (Balversa)?
• What should I discuss with my healthcare provider before taking erdafitinib (Balversa)?
• How should I take erdafitinib (Balversa)?
• What happens if I miss a dose (Balversa)?
• What happens if I overdose (Balversa)?
• What should I avoid while taking erdafitinib (Balversa)?
• What other drugs will affect erdafitinib (Balversa)?
• Where can I get more information (Balversa)?

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

Erdafitinib is used only if your cancer has a specific genetic marker (an abnormal "FGFR" gene). Your doctor will test you for this gene.

Erdafitinib is usually given after other treatments have failed.

Erdafitinib 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.

Erdafitinib may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: 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;
• painful or irritated eyelids;
• feeling like something is in your eye;
• watery eyes, your eyes may be more sensitive to light; 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 side effects may include:

• dry eyes;
• puffy eyelids;
• dry mouth, mouth sores;
• hair loss;
• dry skin, problems with your fingernails or toenails;
• pain, redness, numbness, and peeling skin on your hands or 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.

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.

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

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

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 erdafitinib.

This medicine may affect fertility (ability to have children) in women. However, it is important to use birth control to prevent pregnancy because erdafitinib can harm an unborn baby.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you vomit shortly after taking erdafitinib, 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 based on the results.

You will need frequent vision tests.

Store at room temperature away from moisture and heat.

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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 2 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.

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.

Other drugs may affect 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.

Your pharmacist can provide more information about erdafitinib.

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