Erdafitinib

Generic name: erdafitinib [ ER-da-FI-ti-nib ]
Brand name: Balversa
Dosage form: oral tablet (3 mg; 4 mg; 5 mg)
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com on Feb 13, 2024. Written by Cerner Multum.

What is erdafitinib?

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

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

Erdafitinib is not recommended to treat adults who have not received previous PD-1 or PD-L1 inhibitor treatment.

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

Erdafitinib side effects

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

Erdafitinib may cause serious side effects. Call your doctor at once if you have:

• vision problems, vision loss;

• eye pain or redness;

• itchy rash, dry skin, or cracks in the skin;

• symptoms of high phosphate levels--numbness or tingling around your mouth, painful skin lesions, or cramps; 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 around the nails.

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

Common side effects of erdafitinib may include:

• dry eyes, vision problems;

• 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;

• tiredness;

• abnormal lab results;

• nausea, 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.

Related/similar drugs

Keytruda, pembrolizumab, doxorubicin, cisplatin, nivolumab, Opdivo, Trodelvy

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

Tell your doctor if you have or 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 erdafitinib 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.

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

It may be harder for you to get pregnant while you are using this medicine.

How should I take erdafitinib?

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.

You may take erdafitinib once per day with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

If you vomit shortly after taking erdafitinib, do not take another dose. Take your next dose as scheduled.

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.

You may need frequent vision exams.

Erdafitinib may lead to high phosphate levels and you may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods you should eat or avoid.

Store at room temperature away from moisture and heat.

Erdafitinib dosing information

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.

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 and stay on your once-daily schedule. Do not take two doses in one day.

What happens if I overdose?

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

What should I avoid while taking erdafitinib?

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

What other drugs will affect erdafitinib?

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

This list is not complete. Other drugs may affect erdafitinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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

Medical Disclaimer

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