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Generic Name: erdafitinib

Trade Name: Balversa™

For which conditions Balversa drug approved? Balversa is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma with a certain type of abnormal “FGFR” gene and who have progressed following treatment with at least one prior platinum-based chemotherapy. Balversa was approved under accelerated approval and efficacy will continue to be monitored in ongoing clinical trials.

What is the mechanism of action? Balversa is a kinase inhibitor affecting cancer cells that express FGFR. A kinase is a type of protein in the body that helps control cell division. Cancer cells grow in an uncontrolled fashion, and Balversa works by interfering with the kinase to stop cancer cells from dividing and growing.

How is Balversa typically given (administered)? Balversa is taken orally with or without food once daily. You should take Balversa at approximately the same times every day and swallow whole. If you miss a dose, take the missed dose as soon as possible on the same day and take your regular dose the next day. Do not take more Balversa than prescribed to make up for a missed dose. If you vomit following a dose, do not take another dose; take the next prescribed dose at the usual time.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Balversa. Typically, blood will be drawn before and after treatment to check levels of blood cells and to monitor for low white blood cell counts and infections. In addition, patients may undergo physical examinations, scans, or other measures to assess side effects and response to therapy. Patients will also be monitored by an eye specialist. Balversa can harm an unborn baby, so women should not become pregnant while taking this drug. Do not breastfeed during treatment with Balversa and for 1 month following the last dose of Balversa.

What are the most common (occur in 10% or more of patients) side effects of treatment with Balversa?

  • Mouth sores
  • Fatigue
  • Change in kidney function
  • Diarrhea
  • Dry mouth
  • Nail separation
  • Change in liver function
  • Low sodium levels
  • Decrease in appetite
  • Changes in taste
  • Anemia
  • Dry skin
  • Dry eyes
  • Hair loss
  • Hand-foot syndrome
  • Constipation
  • Abdominal pain
  • Nausea
  • Muscle pain

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

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Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

Notify your healthcare provider if you develop blurred vision, loss of vision or other visual changes, nail or skin problems, itchy skin rash, dry skin or cracks in the skin. During treatment with Balversa, your healthcare provider will send you to see an eye specialist and you should use hydrating or lubricating eye gels as recommended every 2 hours during waking hours to help prevent dry eyes. Tell your healthcare provider about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements.

Are there any special precautions patients should be aware of before starting treatment?

Tell your healthcare provider if you have vision or eye problems. and symptoms of low white blood cell counts or infections. Discuss drug interactions with your doctor and pharmacist before starting Balversa; avoid concomitant use as advised.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Contact your healthcare professional right away if you experience any of the following:

  • Fever
  • Chills
  • Dizziness
  • Feeling very tired
  • Bleeding or bruising more easily than normal
  • Shortness of breath
  • Chest pain
  • Rapid breathing
  • Rapid heart rate
  • You become pregnant.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.