BALVERSA (erdafitinib) Tablets for Bladder Cancer

BALVERSA is a once-daily pill available as a prescription 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 Fibroblast growth factor receptor (FGFR) gene, and
• who have at least tried one other chemotherapy medicine that contains platinum, and it did not work.

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

It is not known if BALVERSA is safe to use in children.

BALVERSA was studied in 87 adults with advanced bladder cancer. It was done with the help of an objective response rate, or ORR.

• 32.2% of patients (28 out of 87) experienced a certain amount of tumor shrinkage. 2.3% (2 out of 87) had a complete response and 29.9% (26 out of 87) had a partial response.

• Patients who had an objective response rate (ORR) had their tumor shrinkage last for a median of 5.4 months. This means that for 50% of the patients, the response lasted for 5.4 months or longer, and for the other 50% of the patients, it was shorter than 5.4 months

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

• have a vision or eye problems.

• are pregnant or planning to become pregnant. BALVERSA can harm your unborn baby.
  • Females who can become pregnant: Your doctor may do a pregnancy test before you start treatment with BALVERSA. You should use birth control during treatment and for 1 month after the last dose of BALVERSA. Talk to your doctor about birth control methods that may be right for you. Tell your doctor 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 planning to breastfeed. Do not breastfeed during treatment and for 1 month after the last dose of BALVERSA.

• Tell your doctor about all the medicines you take, including prescriptions, herbal supplements, over-the-counter medicines, and vitamins.

• Take BALVERSA exactly as your doctor tells you.

• Take BALVERSA 1 time each day.

• Swallow the BALVERSA tablets whole with or without food.

• Your doctor may change your dose of BALVERSA, and temporarily stop or completely stop treatment if you get certain side effects.

• If you miss a dose of BALVERSA, take the dose you missed 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 a BALVERSA tablet, do not take another BALVERSA tablet. Take your regular dose of BALVERSA the next day.

• Your doctor should confirm the presence of FGFR genetic alterations in tumor specimens before starting treatment with BALVERSA.

• Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met.

• Swallow whole with or without food.

It is available in tablets: 3 mg, 4 mg, and 5 mg.

None.

The most common side effects of BALVERSA include:

• mouth sores

• feeling tired

• change in kidney function

• diarrhea

• dry mouth

• nails separate from the bed or poor formation of the nail

• change in liver function

• low salt (sodium) levels

• decreased appetite

• change in sense of taste

• low red blood cells (anemia)

• dry skin and eyes

• hair loss

• redness, swelling, peeling, or tenderness, mainly on the hands or feet (‘hand-foot syndrome’)

• constipation

• stomach (abdominal) pain

• nausea

• muscle pain

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

BALVERSA may cause serious side effects, including:

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

• High phosphate levels in the blood (hyperphosphatemia): Hyperphosphatemia can happen with BALVERSA but can also be serious. High levels of phosphate in your blood may lead to a build-up of minerals such as calcium in different tissues in your body. Your doctor will check your blood phosphate level between 14 and 21 days after starting treatment with BALVERSA, and then monthly.
  • Your doctor may prescribe changes in your diet or phosphate lowering therapy, or change or stop treatment with BALVERSA if needed.
  • Tell your doctor right away if you develop any muscle cramps, painful skin lesions, numbness or tingling around your mouth.

Moderate CYP2C9 or strong CYP3A4 inhibitors, Strong CYP2C9 or CYP3A4 inducers, Moderate CYP2C9 or CYP3A4 inducers, Serum phosphate level-altering agents, CYP3A4 substrates, OCT2 substrates, and P-gp substrates can interact with BALVERSA.

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

Active ingredient: erdafitinib
Inactive ingredients: Tablet Core: Croscarmellose sodium, Microcrystalline Cellulose, Magnesium stearate (from vegetable source), Mannitol, and Meglumine. Film Coating (Opadry amb II): Sodium lauryl sulfate, Glycerol monocaprylocaprate Type I, Polyvinyl alcohol-partially hydrolyzed, 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).