Balversa: Uses, Side Effects and Dosage

What BALVERSA is used for:

BALVERSA is used to treat a type of bladder cancer called urothelial carcinoma (cancer in the bladder and urinary tract organs). It is used in adults whose cancer:

• has spread to other parts of the body or cannot be removed by surgery; and
• has worsened after treatment with at least one other therapy; and
• has changes in certain genes called FGFR3 (known as fibroblast growth factor receptors).

Your healthcare professional will determine if you are eligible for treatment with BALVERSA.

How BALVERSA works:

Fibroblast growth factor receptors (FGFRs) are proteins found on cells that help them grow and divide. Some people with bladder cancer have FGFRs that are abnormally active. BALVERSA works by blocking the activity of FGFRs to slow down the growth and spread of bladder cancer cells.

The ingredients in BALVERSA are:

Medicinal ingredients: erdafitinib

Non-medicinal ingredients: croscarmellose sodium, ferrosoferric oxide/iron oxide black (for the brown tablets only), glycerol monocaprylocaprate Type I, iron oxide red (for the orange and brown tablets only), iron oxide yellow, magnesium stearate (from vegetable source), mannitol, meglumine, microcrystalline cellulose, polyvinyl alcohol partially hydrolyzed, sodium lauryl sulfate, talc, titanium dioxide

BALVERSA comes in the following dosage form(s):

Tablets (film-coated): 3 mg (yellow), 4 mg (orange) and 5 mg (brown)

Do not use BALVERSA if:

• you are allergic to erdafitinib or to any other ingredient in the medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BALVERSA. Talk about any health conditions or problems you may have, including if you:

• have vision or eye problems.
• have or have had kidney problems.
• have or have had liver problems.

Other warnings you should know about:

• General:

  • Only a healthcare professional who has experience treating cancer should treat you with this drug.
  • Before prescribing you BALVERSA, your healthcare professional will do a test. This test will confirm that your disease is suitable for treatment with this drug.

• BALVERSA may cause:

  • Eye problems, which are common and can be serious.

    • Eye problems include dry eyes, disorders of the cornea (front part of eye) and disorders of the retina (an internal part of the eye).
    • Tell your healthcare professional right away if you develop any eye problem or if your vision changes while taking BALVERSA.
    • Use a lubricating eye ointment or a tear replacement therapy at least every 2 hours while awake to prevent and treat dry eyes.

  • High phosphate levels in the blood (hyperphosphatemia), which are common and can be serious.

    • Adhere to a low phosphate diet. Ask your healthcare professional for dietary advice. Avoid the use of medicines that can increase the levels of phosphate in your blood. This includes potassium phosphate supplements, vitamin D supplements, antacids, and phosphate-containing enemas and laxatives.
    • If you develop increased levels of phosphate in your blood, you may be prescribed another medicine to manage this side effect.
• Stomatitis (mouth sores, inflammation of the mouth): Stomatitis is common with BALVERSA.

• Female patients:

  • Pregnancy and birth control

    • If you are able to become pregnant:

      • A pregnancy test should be done before you start to take BALVERSA.
      • Avoid becoming pregnant while taking BALVERSA. It may harm your unborn child or make you lose the pregnancy.
      • Use an effective method of birth control while taking BALVERSA. Talk to your healthcare professional about birth control methods that may be right for you.
      • Keep using birth control for 1 month after stopping BALVERSA.
    • Tell your healthcare professional right away if you become pregnant or you think you may be pregnant while taking BALVERSA, including up to 1 month after your last dose.

    • If you plan to get pregnant after taking your last dose of BALVERSA, ask your healthcare professional for advice. This is because BALVERSA may remain in your

      • body after the last dose.

  • Breastfeeding

    • BALVERSA may pass into breast milk. Do NOT breast-feed while you are taking it and for 1 month after taking your last dose of BALVERSA.
    • Talk to your healthcare professional about the best way to feed your baby.

• Male patients:

  • Pregnancy and birth control

    • Avoid fathering a child while taking BALVERSA. It may harm your unborn child.
    • If your partner becomes pregnant while you are taking BALVERSA, tell your partner’s healthcare professional right away.
    • Use an effective method of birth control while taking BALVERSA. Talk to your healthcare professional about birth control methods that may be right for you.
    • Men taking BALVERSA must use a condom. Do NOT donate or store semen while taking it. This is because the drug may pass into the sperm.
    • Keep using birth control and do NOT donate or store semen for 1 month after stopping BALVERSA.
• Fertility – information for women and men: BALVERSA may affect your fertility. Talk to your healthcare professional if this is a concern for you.

• Children and adolescents: BALVERSA is NOT recommended for use in patients under the age of 18 years.

• Adults (65 years and older):

  You may be at a higher risk of side effects if you are 65 years of age and older.

• Check-ups and testing:

  You will have regular visits with your healthcare professional during treatment with BALVERSA. They will:

  • Do blood tests to monitor your phosphate levels, and check your liver and kidney health. The tests will be done:

    • before you start on BALVERSA,
    • about 2 weeks after starting treatment, and
    • once a month thereafter during treatment with BALVERSA.

Your healthcare professional will tell you if your blood test results are abnormal.

• Check your eyes.

  • You will be sent to see an eye specialist to examine and monitor your eyes. This will be done before you start on BALVERSA and if you develop eyes or vision problems while taking BALVERSA.
  • Your healthcare professional will also check your eyes once a month during treatment using an Amsler grid test. They may give you instructions on using the grid so you can monitor your vision at home between visits.

• Driving and using machines:

  Eye problems are common in patients taking BALVERSA. You may also feel weak and tired. Give yourself time after taking BALVERSA to see how you feel before driving a vehicle or using machinery. If you develop any of these symptoms, do NOT drive or use machines as long as these last.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with BALVERSA:

• clarithromycin, ciprofloxacin, rifampin – used to treat bacterial infections
• itraconazole, fluconazole, miconazole – used to treat fungal infections
• atazanavir, darunavir/ritonavir, cobicistat – used to treat viral infections, primarily HIV
• enzalutamide, apalutamide – used to treat prostate cancer
• mitotane – used to treat adrenal cancer
• carbamazepine and phenytoin – used to prevent seizures or to treat epilepsy or to treat a painful condition of the face called trigeminal neuralgia
• St. John’s Wort (Hypericum perforatum) – an herbal medicine used for depression
• digoxin – used for heart problems

How to take BALVERSA:

• Take BALVERSA exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
• Your healthcare professional will tell you how much BALVERSA to take. It is important that you take the recommended daily dose.
• Do NOT change your dose or stop taking BALVERSA without first talking with your healthcare professional.

• Take BALVERSA with or without food at about the same time each day.

• If you take digoxin, your healthcare professional may adjust the time that you take your medications.
• Swallow BALVERSA tablets whole.
• If you vomit after taking your dose, do NOT take another one. Take your next dose the next day at the normal time.

Usual dose:

Usual adult starting dose:

8 mg: Take two 4 mg tablets by mouth once a day.

Your healthcare professional may adjust your dose, temporarily stop or completely stop your treatment. This may happen:

• based on your blood test and eye exam results.
• if you are taking medicines that may interact with BALVERSA.
• if you have certain side effects while taking BALVERSA.

Increased adult dose:

9 mg: Take three 3 mg tablets by mouth once a day.

Reduced adult dose:

6 mg: Take two 3 mg tablets by mouth once a day.

5 mg: Take one 5 mg tablet by mouth once a day.

4 mg: Take one 4 mg tablet by mouth once a day.

Overdose:

If you think you, or a person you are caring for, have taken too much BALVERSA, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

• If you forget to take your dose of BALVERSA, take it as soon as you remember if it is on the same day. Continue with taking the next scheduled dose the next day at the normal time.
• If you miss a day’s dose, do NOT take a double dose to make up for the missed dose. Instead, wait until it is time and take your regular dose at the normal time.

Possible side effects from using BALVERSA:

These are not all the possible side effects you may feel when taking BALVERSA. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• decreased appetite
• mouth sores
• diarrhea
• constipation
• nausea
• vomiting
• stomach (abdominal) pain
• dry mouth
• dry skin
• hair loss
• nasal dryness
• vagina dryness
• feeling tired
• feeling weak
• fever
• muscle pain
• change in sense of taste
• weight loss
• sore throat
• rash
• nose bleeds
• indigestion

BALVERSA can cause abnormal blood test results. Your healthcare professional will decide when to perform the tests and interpret the results

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store BALVERSA at room temperature between 15ºC - 30ºC.
• Keep out of reach and sight of children.
• Do NOT throw away any medicines via wastewater or household waste. Ask your healthcare provider or pharmacist about the right way to throw away outdated or unused BALVERSA. These measures will help protect the environment.

If you want more information about BALVERSA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (innovativemedicine.jnj.com/canada); or by calling 1-800-567-3331 or 1-800-387-8781.

Janssen Inc., a Johnson & Johnson company

Toronto, Ontario M3C 1L9

Date of Authorization: 2025-12-18

All trademarks used under license.

Under license from Astex Therapeutics Limited.