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Erdafitinib Oral Tablet (ERDAFITINIB - ORAL)

Instructions

Swallow the medicine without crushing or chewing it.

This medicine may be taken with or without food.

To prevent or treat dry eyes while taking this medicine, you may need to use a lubricating eye medicine every 2 hours while you are awake.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal schedule. Do not take 2 doses at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Do not take the medicine more than once during 24 hours.

Brand Name(s): Balversa

Generic Name: Erdafitinib

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

To avoid a serious skin reaction, avoid heat and hot water. Also avoid pressure on elbows, knees, and feet. For example, avoid tight clothing, kneeling, or long walks.

This medicine can damage the eyes and cause severe vision loss. Stop taking this medicine and call your doctor immediately if you notice any changes in vision. These changes may be blurred vision, double vision, vision loss, light sensitivity, or eye pain.

Do not use the medication any more than instructed.

Do not breastfeed while on this medicine. You may safely start breastfeeding 1 month after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women of childbearing age should have a negative pregnancy test before starting this medicine.

Women must use reliable forms of birth control while taking this medicine and for 1 month after stopping to prevent pregnancy.

Men with a pregnant partner must wear a condom during sexual activity while taking this medicine and for 1 month after stopping to prevent harm to the developing baby.

Do not take St. John's wort while on this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Do not share this medicine with anyone who has not been prescribed this medicine.

Always refill this medicine before it runs out.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • decreased appetite
  • constipation or diarrhea
  • dry mouth
  • dry eyes
  • hair loss
  • mouth sores or irritation
  • joint or muscle pain
  • nausea and vomiting
  • dry skin
  • stomach pain
  • changes in taste or unpleasant taste
  • weight loss

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • pain, redness, swelling or blistering on hands, feet or elbows
  • nail color changes
  • pain or bleeding in a nail
  • blurring or changes of vision

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.