Balversa (Erdafitinib): Uses, Side Effects and Dosage

What is BALVERSA?

BALVERSA is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery:

• which has a certain type of abnormal FGFR gene, and
• who have tried at least one other medicine by mouth or injection (systemic therapy) that did not work or is no longer working.

Your healthcare provider will test your cancer for certain types of abnormal FGFR genes and make sure that BALVERSA is right for you.

BALVERSA is not recommended for the treatment of people who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.

It is not known if BALVERSA is safe and effective in children.

Before taking BALVERSA tell your healthcare provider about all of your medical conditions, including if you:

• have vision or eye problems.

• are pregnant or plan to become pregnant. BALVERSA can harm your unborn baby. You should not become pregnant during treatment with BALVERSA.

  Females who can become pregnant:

  • Your healthcare provider may do a pregnancy test before you start treatment with BALVERSA.
  • You should use effective birth control during treatment and for 1 month after the last dose of BALVERSA. Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant.

  Males with female partners who can become pregnant:

  • You should use effective birth control when sexually active during treatment with BALVERSA and for 1 month after the last dose.
• are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 1 month after the last dose of BALVERSA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I take BALVERSA?

• Take BALVERSA exactly as your healthcare provider tells you.
• Take BALVERSA 1 time each day.

• Swallow BALVERSA tablets whole with or without food.

• Your healthcare provider may change your dose of BALVERSA, temporarily stop or completely stop treatment if you get certain side effects.
• If you miss a dose of BALVERSA, take the missed dose as soon as possible on the same day. Take your regular dose of BALVERSA the next day. Do not take more BALVERSA than prescribed to make up for the missed dose.
• If you vomit after taking BALVERSA, do not take another BALVERSA tablet. Take your regular dose of BALVERSA the next day.

What are the possible side effects of BALVERSA?

BALVERSA may cause serious side effects, including:

• Eye problems.Eye problems are common with BALVERSA but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye. Tell your healthcare provider right away if you develop blurred vision, loss of vision or other visual changes. You should use artificial tear substitutes, hydrating or lubricating eye gels or ointments at least every 2 hours during waking hours to help prevent dry eyes. During treatment with BALVERSA, your healthcare provider will send you to see an eye specialist.

• High phosphate levels in the blood (hyperphosphatemia).Hyperphosphatemia is common with BALVERSA but can also be serious. High levels of phosphate in your blood may lead to build-up of minerals such as calcium in different tissues in your body. Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with BALVERSA, and then monthly.

  • Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change or stop treatment with BALVERSA if needed.
  • Tell your healthcare provider right away if you develop painful skin lesions, any muscle cramps, or numbness or tingling around your mouth.

The most common side effects of BALVERSA include:

• nails separate from the bed or poor formation of the nail
• mouth sores
• diarrhea
• increased level of creatinine in the blood
• increased level of the enzyme alkaline phosphatase in the blood
• change in liver function
• decreased red blood cells (anemia)
• decreased salt (sodium) levels in the blood
• tiredness
• dry mouth

• dry skin
• decreased phosphate in the blood
• decreased appetite
• change in sense of taste
• constipation
• increased level of calcium in the blood
• dry eye
• redness, swelling, peeling or tenderness, mainly on the hands or feet (hand-foot syndrome)
• increased level of potassium in the blood
• hair loss
• fluid buildup behind the retina in your eye

Tell your healthcare provider right away if you develop any nail or skin problems including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, color or texture changes in your nails, infected skin around the nail, an itchy skin rash, dry skin, or cracks in the skin.

BALVERSA may affect fertility in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of BALVERSA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store BALVERSA?

• Store BALVERSA tablets at room temperature between 68 °F to 77 °F (20 °C to 25 °C).

Keep BALVERSA and all medicines out of the reach of children.

General information about the safe and effective use of BALVERSA.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use BALVERSA for a condition for which it was not prescribed. Do not give BALVERSA to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BALVERSA that is written for healthcare professionals.

What are the ingredients in BALVERSA?

Active ingredient:erdafitinib

Inactive ingredients:

Tablet Core: Croscarmellose sodium, Magnesium stearate (from vegetable source), Mannitol, Meglumine, and Microcrystalline Cellulose.

Film Coating (Opadry amb II): Glycerol monocaprylocaprate Type I, Polyvinyl alcohol-partially hydrolyzed, Sodium lauryl sulfate, Talc, Titanium dioxide, Iron oxide yellow, Iron oxide red (for the orange and brown tablets only), Ferrosoferric oxide/iron oxide black (for the brown tablets only).

Manufactured for:Janssen Products, LP, Horsham, PA 19044, USA

For patent information: www.janssenpatents.com

© 2019 Janssen Pharmaceutical Companies

For more information call Janssen Products, LP at 1-800-526-7736 (1-800-JANSSEN) or go to www.BALVERSA.com.