Balversa

Patient Information Leaflet

Balversa 3 mg film-coated tablets, 4 mg film-coated tablets, 5 mg film-coated tablets

erdafitinib

This medicinal product is under additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any adverse reactions you experience while taking this medicine. See the end of section 4 for information on how to report adverse reactions.
Please read all of this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful to them.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Balversa is and what it is used for
2. What you need to know before taking Balversa
3. How to take Balversa
4. Possible side effects
5. How to store Balversa
6. Contents of the pack and other information

1. What Balversa is and what it is used for

Balversa is an anticancer medicine containing the active substance “erdafitinib”. It belongs to a
group of medicines called “fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors”.
Balversa is used in adults to treat locally advanced (spread to nearby areas) and unresectable (cannot be
removed by surgery) or metastatic (spread to other parts of the body) urothelial carcinoma (a cancer of the
bladder and urinary tract).
It is used when the cancer:

• has alterations in the “fibroblast growth factor receptor 3” (FGFR3) gene, and
• has worsened after treatment with immunotherapy.

Balversa should only be used if tumour cells have FGFR3 gene alterations.
Before starting treatment, your doctor will perform a test to check whether you have such FGFR3 gene
alterations, to ensure this medicine is appropriate for you.
The active substance in Balversa, erdafitinib, works by blocking proteins in the body called FGFR
tyrosine kinases. This helps slow down or stop the growth of tumour cells that have abnormal FGFR3
receptors due to alterations in the FGFR3 gene.

2. What you need to know before taking Balversa

Do not take Balversa if

• you are allergic to erdafitinib or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before using Balversa if:

• you have increased levels of phosphate in your blood
• you have eye or vision problems
• you are pregnant
• you are a woman who could become pregnant

Eye (vision) problems
Balversa increases the risk of central serous retinopathy (CSR: a condition in which fluid accumulates under the macula, the central part of the retina at the back of the eye, causing blurred and distorted vision). The risk of CSR is higher in people aged 65 years or older.

• Before starting treatment with Balversa, you will undergo a complete eye examination, including tests to assess vision, the retina, and eye structure.
• Your doctor will closely monitor your eyes by performing eye examinations every month for the first 4 months of treatment and every 3 months thereafter.
• If you experience any symptoms of vision changes, your doctor will arrange for an urgent eye examination.
• Inform your doctor immediately if you experience any symptoms of CSR, including blurred vision or reduced peripheral (side) vision, a dark spot in your central vision, distorted central vision where lines appear wavy or bent, objects appearing smaller or farther away than they actually are, faded colors, floating particles or spots moving across your field of vision, flashes of light, or the sensation of looking through a curtain. See also section 4, “The most important side effects”.
• If you develop CSR during treatment with Balversa, your doctor may need to temporarily interrupt treatment. Treatment will be permanently discontinued if symptoms do not resolve within 4 weeks or are severe.

During treatment with Balversa, you will need to use eye drops or gels regularly to prevent and treat dry eyes.
High levels of phosphate in the blood (hyperphosphatemia)
Balversa can cause an increase in phosphate levels in the blood (hyperphosphatemia). This is a known side effect of Balversa that usually occurs within the first few weeks of starting treatment. This may lead to mineral accumulation such as calcium in soft tissues, cutaneous calcinosis (calcium buildup in the skin causing hard lumps or nodules), and non-uremic calcinosis (a rare skin condition causing painful ulcers due to calcium accumulation in blood vessels).

• Your doctor will monitor your blood phosphate levels during treatment. You may be advised to limit intake of foods high in phosphates and avoid other medicines that could increase phosphate levels.
• Vitamin D supplements are not recommended during treatment with Balversa, as they may also contribute to increased levels of phosphate and calcium.
• If your blood phosphate levels become too high, your doctor may recommend taking medications to help control them.
• If you develop very high phosphate levels in your blood, your doctor may need to adjust your dose of Balversa or stop treatment completely.
• Inform your healthcare provider immediately if you develop the following symptoms, which could be signs of hyperphosphatemia: painful skin lesions, muscle cramps, numbness, or tingling around the mouth.

Skin disorders
When taking Balversa, you may experience itching, dry or red skin, swelling, peeling, or sensitivity, particularly on the hands or feet (hand-foot syndrome). You should monitor your skin condition and avoid unnecessary exposure to sunlight as well as excessive use of soap and bathing. You should use moisturizers regularly and avoid scented products.
Photosensitivity
During treatment with Balversa, you may become more sensitive to sunlight. This can cause skin damage. Be cautious and take precautions when spending time outdoors in the sun. Precautions include wearing clothing that covers the skin and using sunscreen to protect against harmful UV rays.
Nail disorders
During treatment with Balversa, you may experience nail separation from the nail bed, infection of the skin around the nails, or changes in nail color. You should monitor the appearance of your nails for any signs of infection and perform preventive nail care, such as good hygiene and using over-the-counter nail-strengthening products.
Mucosal disorders
During treatment with Balversa, you may experience dry mouth and/or mouth ulcers. You should maintain good oral hygiene during treatment and avoid spicy or acidic foods.
Children and adolescents
This medicine is not intended for use in children and adolescents, as there is no experience with the use of Balversa in this age group.
Other medicines and Balversa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Taking Balversa with certain other medicines may affect how Balversa works and cause side effects.
The following medicines may reduce the effectiveness of Balversa by decreasing the amount of Balversa in your blood:

• carbamazepine (used to treat epilepsy)
• rifampicin (used to treat tuberculosis)
• phenytoin (used to treat epilepsy)
• St John’s wort (used to treat depression)

The following medicines may increase the risk of side effects of Balversa by increasing the amount of Balversa in your blood:

• fluconazole (used to treat fungal infections)
• itraconazole (used to treat fungal infections)
• ketoconazole (used to treat fungal infections)
• posaconazole (used to treat fungal infections)
• voriconazole (used to treat fungal infections)
• miconazole (used to treat fungal infections)
• ceritinib (used to treat lung cancer)
• clarithromycin (used to treat infections)
• telithromycin (used to treat infections)
• elvitegravir (used to treat HIV)
• ritonavir (used to treat HIV)
• paritaprevir (used to treat hepatitis)
• saquinavir (used to treat HIV)
• nefazodone (used to treat depression)
• nelfinavir (used to treat HIV)
• tipranavir (used to treat HIV)
• lopinavir (used to treat HIV)
• amiodarone (used to treat arrhythmias)
• piperine (used as a supplement)

Balversa may increase the risk of side effects of other medicines by increasing the amount of these medicines in your blood. These include:

• midazolam (used to treat seizures)
• hormonal contraceptives
• colchicine (used to treat gout)
• digoxin (used to treat certain arrhythmias or heart failure)
• dabigatran (used as an anticoagulant)
• apixaban (used as an anticoagulant)

Balversa with food
Do not take Balversa with grapefruit or Seville oranges (bitter oranges); do not eat them, drink their juice, or take supplements containing them, as they may increase the amount of Balversa in your blood.
Pregnancy, contraception, and breastfeeding
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
Information for women

• Pregnancy o Balversa may harm the unborn baby. o You must not use Balversa during pregnancy unless otherwise directed by your doctor. o You must not become pregnant during treatment with Balversa and for 1 month after the last dose of Balversa. o Inform your doctor immediately if you become pregnant.
• Pregnancy test o Your doctor will ask you to take a pregnancy test before starting treatment with Balversa.
• Contraception o Balversa may reduce the effectiveness of certain contraceptive methods. Speak to your doctor about appropriate contraceptive measures during treatment with Balversa. Women who could become pregnant must use effective contraception during treatment and for 1 month after the last dose of Balversa.
• Breastfeeding o Balversa must not be used during breastfeeding and for 1 month after the last dose of this medicine.

Information for men
Men must use effective contraception (condom) during treatment with Balversa and for 1 month after the last dose. They should also refrain from donating or storing sperm during treatment and for 1 month after the last dose.
Driving and using machines
Eye problems have been reported in patients receiving Balversa. If you experience vision problems, do not drive or operate tools or machinery until your vision returns to normal.
Balversa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to take Balversa

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
How much Balversa to take
Your doctor will determine the dose and how often you should take this medicine.

• The recommended starting dose of Balversa is 8 mg taken orally once daily. To achieve this dose, you will need to take one 5 mg tablet and one 3 mg tablet, or two 4 mg tablets.

Approximately 2 weeks after starting treatment with Balversa, your doctor will perform a blood test to
check your blood phosphate levels.

• Based on the results of this blood test and the presence or absence of side effects, the dose may be increased to 9 mg daily.
• Your doctor may also decide to reduce the dose if you experience certain adverse effects such as mouth ulcers, redness, swelling, peeling or tenderness, mainly on the hands or feet, nail separation from the nail bed, or elevated blood phosphate levels.

Taking the medicine

• Swallow the Balversa tablets whole.
• The medicine can be taken with or without food.
• Try to take this medicine at the same time every day. This will help you remember to take it.
• If you vomit, do not take another tablet. Take the next dose the following day at your usual time.

If you take more Balversa than you should
If you take too much Balversa, call your doctor immediately or go to the nearest emergency department.
If you forget to take Balversa

• If you miss a dose, take it as soon as possible on the same day. The next day, take your normal dose of Balversa.
• Do not take a double dose to make up for a forgotten dose.

If you stop taking Balversa
Do not stop taking this medicine unless instructed by your doctor.
If you have any questions about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most important side effects
Contact your doctor immediately if you notice any of the following serious symptoms:
Central serous retinopathy (very common: may affect more than 1 in 10 people)
The following symptoms may be signs of CSR:

• blurred vision or reduced peripheral (side) vision
• a dark spot in the central vision
• distorted central vision, where lines appear wavy or bent
• objects appearing smaller or further away than they are
• colours appearing faded
• floating particles or spots moving across the visual field, flashes of light, or a sensation of looking through a curtain.

Hyperphosphataemia (very common: may affect more than 1 in 10 people)
The following symptoms may be signs of hyperphosphataemia:

• high level of phosphate in the blood

Nail disorders (very common: may affect more than 1 in 10 people)
The following symptoms may be signs of nail disorders:

• separation of the nail from the nail bed (onycholysis)
• skin infection around the nails (paronychia)
• poor nail growth (nail disorder)
• discoloured nails (nail colour change)

Skin disorders (very common: may affect more than 1 in 10 people)
The following symptoms may be signs of skin disorders:

• redness, swelling, peeling, or tenderness, mainly on hands or feet (“hand-foot syndrome”)
• hair loss (alopecia)
• dry skin

Mucosal disorders (very common: may affect more than 1 in 10 people)
The following symptoms may be signs of mucosal disorders:

• mouth ulcers (stomatitis)
• dry mouth

Contact your doctor immediately if you notice any of the above signs of “central serous
retinopathy”, “hyperphosphataemia”, “nail disorders”, “skin disorders” or “mucosal disorders”.
Your doctor may ask you to stop treatment with Balversa or refer you to a specialist if you have
eye or vision problems.
Other side effects may occur with the following frequencies:
Very common (may affect more than 1 in 10 people):

• diarrhoea
• decreased appetite
• altered taste sensation, with foods tasting metallic, sour, or bitter (dysgeusia)
• weight loss
• constipation
• nausea
• vomiting
• stomach ache
• dry eyes
• feeling weak and extremely tired
• low levels of sodium in the blood (hyponatraemia)
• increased levels of “creatinine” in the blood (increased creatinine)
• increased blood levels of the liver enzyme “alanine aminotransferase” (increased ALT)
• increased blood levels of the liver enzyme “aspartate aminotransferase” (increased AST)
• low red blood cell count (anaemia)
• nosebleeds (epistaxis)

Common (may affect up to 1 in 10 people):

• nail pain
• development of grooves on the nails or breaking of one or more nails
• very dry skin
• cracked, thickened, or scaly skin
• itching or itchy skin rash (eczema)
• abnormalities in skin growth or appearance
• erythema
• dryness or inflammation of the eyes (conjunctivitis)
• ulcers or inflammation of the front part of the eye (“cornea”)
• clouding of the lens in the eye (cataract)
• redness and swelling of the eyelids
• watery eyes
• high levels of calcium in the blood
• low levels of phosphate in the blood
• dry nose
• indigestion (dyspepsia)
• sudden reduction in kidney function
• high level of parathyroid hormone (PTH) (hyperparathyroidism)
• kidney failure
• kidney problems (renal impairment)
• liver damage (hepatic cytolysis)
• abnormalities in liver function
• high level of “bilirubin” in the blood

Uncommon (may affect up to 1 in 100 people):

• bleeding under the nail
• discomfort or pain in the nails
• skin reaction
• thinning of the skin
• redness of the palms of the hands
• dryness of mucous membranes (including nose, mouth, eyes, vagina)
• calcium deposits in blood vessels, which may lead to blood clots, skin ulcers, and serious infections

If you experience any of the above side effects, consult your doctor.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, consult your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Balversa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and bottle after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Balversa contains

• The active substance is erdafitinib.
• Each film-coated tablet contains 3 mg, 4 mg, or 5 mg of erdafitinib.
• The other components are:
  Tablet core: croscarmellose sodium, magnesium stearate (E572), mannitol (E421), meglumine, and microcrystalline cellulose (E460).
  Film coating (Opadry amb II): glycerol monocaprylocaprate type I, partially hydrolyzed polyvinyl alcohol, sodium lauryl sulfate, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172) (only in 4 mg and 5 mg tablets), black iron oxide (E172) (only in 5 mg tablets).

Description of the appearance of Balversa and contents of the pack
The film-coated tablets of Balversa 3 mg are yellow, round, biconvex, with “3” engraved on one side and “EF” on the other side.
The film-coated tablets of Balversa 4 mg are orange, round, biconvex, with “4” engraved on one side and “EF” on the other side.
The film-coated tablets of Balversa 5 mg are brown, round, biconvex, with “5” engraved on one side and “EF” on the other side.
Balversa film-coated tablets are supplied in child-resistant bottles.
Not all pack sizes may be marketed.

Bottle:
The tablets are supplied in a plastic bottle with a child-resistant closure. Each bottle contains 28, 56, or 84 film-coated tablets. Each carton contains one bottle.

3 mg tablet:

• each carton of 56 film-coated tablets contains one bottle of 56 tablets
• each carton of 84 film-coated tablets contains one bottle of 84 tablets.

4 mg tablet:

• each carton of 28 film-coated tablets contains one bottle of 28 tablets
• each carton of 56 film-coated tablets contains one bottle of 56 tablets.

5 mg tablet:

• each carton of 28 film-coated tablets contains one bottle of 28 tablets.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Cilag SpA
Via C. Janssen
Borgo San Michele
Latina 04100
Italy

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Janssen-Cilag NV UAB "JOHNSON & JOHNSON"
Tel/Tél: +32 14 64 94 11 Tel: +370 5 278 68 88
[email protected] [email protected]

България Luxembourg/Luxemburg
„Джонсън & Джонсън България” ЕООД Janssen-Cilag NV
Тел.: +359 2 489 94 00 Tél/Tel: +32 14 64 94 11
[email protected] [email protected]

Česká republika Magyarország
Janssen-Cilag s.r.o. Janssen-Cilag Kft.
Tel: +420 227 012 227 Tel.: +36 1 884 2858
[email protected]

Danmark Malta
Janssen-Cilag A/S AM MANGION LTD
Tlf: +45 4594 8282 Tel: +356 2397 6000
[email protected]

Deutschland Nederland
Janssen-Cilag GmbH Janssen-Cilag B.V.
Tel: 0800 086 9247 / +49 2137 955 6955 Tel: +31 76 711 1111
[email protected] [email protected]

Eesti Norge
UAB "JOHNSON & JOHNSON" Eesti filiaal Janssen-Cilag AS
Tel: +372 617 7410 Tlf: +47 24 12 65 00
[email protected] [email protected]

Ελλάδα Österreich
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη Janssen-Cilag Pharma GmbH
Α.Ε.Β.Ε. Tel: +43 1 610 300
Tηλ: +30 210 80 90 000

España Polska
Janssen-Cilag, S.A. Janssen-Cilag Polska Sp. z o.o.
Tel: +34 91 722 81 00 Tel.: +48 22 237 60 00
[email protected]

France Portugal
Janssen-Cilag Janssen-Cilag Farmacêutica, Lda.
Tél: 0 800 25 50 75 / +33 1 55 00 40 03 Tel: +351 214 368 600
[email protected]

Hrvatska România
Johnson & Johnson S.E. d.o.o. Johnson & Johnson România SRL
Tel: +385 1 6610 700 Tel: +40 21 207 1800
[email protected]

Ireland Slovenija
Janssen Sciences Ireland UC Johnson & Johnson d.o.o.
Tel: 1 800 709 122 Tel: +386 1 401 18 00
[email protected] [email protected]

Ísland Slovenská republika
Janssen-Cilag AB Johnson & Johnson, s.r.o.
c/o Vistor hf. Tel: +421 232 408 400
Sími: +354 535 7000
[email protected]

Italia Suomi/Finland
Janssen-Cilag SpA Janssen-Cilag Oy
Tel: 800.688.777 / +39 02 2510 1 Puh/Tel: +358 207 531 300
[email protected] [email protected]

Κύπρος Sverige
Βαρνάβας Χατζηπαναγής Λτδ Janssen-Cilag AB
Τηλ: +357 22 207 700 Tfn: +46 8 626 50 00
[email protected]

Latvija
UAB "JOHNSON & JOHNSON" filiāle Latvijā
Tel: +371 678 93561
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu