How should I take erdafitinib (Balversa)?

Erdafitinib tablet to take orally once a day with or without food. Take erdafitinib at around the same time every day and as advised by your Doctor. Do not take more or less of it or more often than your doctor prescribes it.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking erdafitinib, do not take another dose. Continue your regular dosing schedule.

What are the side effects of erdafitinib (Balversa)?

Erdafitinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• diarrhea (loose stools)
• vomiting (Emesis)
• constipation
• sores on lips, mouth, or throat
• dry mouth (xerostomia)
• abnormal taste (dysgeusia)
• abdominal pain (bellyache)
• appetite loss (anorexia)
• abnormal weight loss
• unusual hair thinning or hair loss
• fever
• muscle or joint pain (arthralgia)
• burning sensation during urination
• fatigue (tiredness) or tiredness
• shortness of breath (dyspnea)

Serious side effects

If you experience any of these symptoms, stop taking erdafitinib and call your doctor immediately:

• blurred vision, loss of vision, or other visual changes
• nail problems or changes
• itchy, dry, or cracked skin
• rash
• swelling, pain, redness, or peeling of skin on the palms and soles of the feet

Erdafitinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to FDA at http://www.fda.gov/Safety/MedWatch or by phone (1-800-332-1088).

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you have side effects. Use the free Ankr platform or Ankr app to track your symptoms.

What special precautions should I follow?

Before starting erdafitinib (Balversa), tell your doctor:

• about your allergies.
• about other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. These may interact with erdafitinib (Baalversa) and cause you to have more side effects or make your treatment(s) less effective.
• if you have high blood levels of phosphorus, have ever had eye or vision problems, or have kidney or liver disease.
• if you are pregnant, plan to become pregnant, or if you plan on fathering a child. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while taking erdafitinib, call your doctor immediately. Erdafitinib may harm the fetus.
• if you are breastfeeding.

While you are on erdafitinib (Balversa):

• You may have dry eyes and other eye problems, which may be serious. Your doctor may tell you to use artificial tears or lubricant eye drops while on erdafitinib.
• You may have a decrease in fertility if you are a woman. Talk to your doctor about the risks of taking erdafitinib.
• You should not breastfeed while taking erdafitinib and for one month after the final dose.
• You should know that this medication may cause dry eyes and other eye problems, which may be serious. Your doctor may tell you to use artificial tears or lubricant eye drops during your treatment with erdafitinib.

I forgot a dose. What should I do?

Take the dose as soon as you remember it on that day. However, if you do not remember the missed dose until the next day, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of an emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

How should I store and safely dispose erdafitinib (Balversa)?

Keep the medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Do not flush unneeded medication down the toilet. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Brand names

• Balversa^®