BALVERSA 3 mg Film-Coated Tablets

Зміст інструкції

1. Balversa 3 mg film-coated tablets, 4 mg film-coated tablets, 5 mg film-coated tablets
   1. What is Balversa and what is it 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

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

erdafitinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

Read this leaflet carefully before 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 their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 you take 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 is Balversa and what is it used for

Balversa is an anti-cancer medicinal product containing the active substance “erdafitinib”. It belongs to a
group of medicines called “tyrosine kinase inhibitors”.
Balversa is used in adults for the treatment of locally advanced (spread to the nearby area) and unresectable (i.e. cannot be
removed surgically) or metastatic (i.e. spread to other parts of the body) urothelial carcinoma (bladder and urinary tract
cancer).
It is used if the tumor:

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

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

2. What you need to know before taking Balversa

Do not take Balversa if

• you are allergic to erdafitinib or 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 problems with your eyes or vision
• you are pregnant
• you are a woman who could become pregnant

Eye problems (vision)
Balversa increases the risk of central serous retinopathy (CSR: a condition in which fluid accumulates that isolates the macula, the central part of the retina in 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 have a complete eye exam, including tests to check your vision, retina, and eye structure.
• Your doctor will carefully monitor your eyes by performing eye exams every month for the first 4 months of treatment and every 3 months thereafter.
• If you experience any symptoms of altered vision, your doctor will refer you for an urgent eye exam.
• Tell your doctor immediately if you have any symptoms of CSR, including blurred vision or reduced peripheral (side) vision, a dark spot in central vision, distorted central vision where lines appear crooked or bent, objects appearing smaller or farther away than they actually are, colors appearing faded, floating particles or spots crossing your field of vision, flashes of light, or a feeling of looking through a curtain. See also section 4 under “Most important side effects”
• If you develop CSR during treatment with Balversa, your doctor may need to temporarily stop treatment. Treatment will be stopped permanently if the symptoms do not resolve within 4 weeks or are very severe.

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

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

Skin conditions
When taking Balversa you may experience itching, dry or red skin, swelling,
scaling or sensitivity, especially on your hands or feet (hand-foot syndrome). You should monitor the
condition of your skin and avoid unnecessary exposure to sunlight as well as excessive
use of soap and baths. 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. Take care and take precautions when spending time outdoors in the sun. Precautions include wearing clothing that covers the skin and using sunscreens to protect yourself
from harmful sun rays.
Nail conditions
During treatment with Balversa, you may experience nail separation from the nail bed,
skin infection around the nails, or changes in nail color. You should monitor
the appearance of your nails for any signs of infection and perform preventative treatments
for your nails, such as good hygiene and the use of over-the-counter nail strengthening products.
Mucous membrane conditions
During treatment with Balversa you may experience dry mouth and/or mouth ulcers.
During treatment with Balversa, you should practice good oral hygiene 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 some other medicines may affect the
functioning of Balversa and cause unwanted side effects.
The following medicines can decrease the effectiveness of Balversa by reducing the amount of Balversa in
the 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 can increase the risk of side effects of Balversa by increasing the
amount of Balversa in the 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 can increase the risk of side effects of other medicines by increasing the amount of
such medicines in the 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 a blood thinner)
• apixaban (used as a blood thinner)

Balversa with food
Do not take Balversa with grapefruit or Seville oranges (bitter oranges), that is, do not eat them,
drink their juice or take supplements that may contain them, as they may increase the
amount of Balversa in your blood.

Pregnancy, contraception and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor beforetaking this medicine.

Information for women

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

Information for men
Men should use effective contraceptive measures (condom) during treatment with
Balversa and for 1 month after the last dose. They should also refrain from donating or
preserving sperm during treatment and for 1 month after the last dose.

Driving and operating machinery
Eye problems have been reported in patients taking Balversa. If you experience vision problems, do not drive
or use 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, that is to say essentially “sodium-free”.

3. How to take Balversa

follow the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much Balversa to take
The doctor will establish the dose and frequency with which you will need to take this medicine.

• The recommended initial dose of Balversa is 8 mg by mouth once a day. or To obtain this dose you will need to take one 5 mg tablet and one 3 mg tablet or two 4 mg tablets.

After approximately 2 weeks of treatment with Balversa, the doctor will perform a blood test to
check your phosphate level in your blood.

• Based on the result of this blood test and the presence or absence of side effects, the dose may be increased to 9 mg per day.
• The doctor may also decide to reduce the dose if you experience certain undesirable effects such as mouth ulcers, redness, swelling, scaling or sensitivity mainly on the hands or feet, separation of the nails from the nail bed, high phosphate level in the blood.

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 each day. This will help you remember to take it.
• If you vomit, do not take another tablet. Take the next dose the next day, at the usual time.

If you take more Balversa than you should
If you take an excessive amount of Balversa, call your doctor immediately or go to the nearest emergency
room.

If you forget to take Balversa

• If you forget 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 missed dose.

If you stop taking Balversa
Do not stop taking this medicine unless instructed by your doctor.
If you have any doubts about the use of 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
Tell 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 crooked or bent
• objects appear smaller or further away than they are
• colours appear faded
• floating particles or spots across the field of vision, flashes of light or a feeling of looking through a curtain.

Hyperphosphatemia (very common:may affect more than 1 in 10 people)
The following symptoms may be a sign of hyperphosphatemia:

• high phosphate levels 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 nails from the nail bed (onycholysis)
• skin infection around the nails (paronychia)
• poor nail growth (nail disorder)
• discolored nails (nail color change)

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

• redness, swelling, scaling or sensitivity, mainly on the 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

Tell your doctor immediately if you notice any of the above signs of “central serous retinopathy”, “hyperphosphatemia”, “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 sense of taste, with a metallic, acidic or bitter taste in foods (dysgeusia)
• weight loss
• constipation
• nausea
• vomiting
• stomach pain
• dry eyes
• feeling weak and extremely tired
• low levels of sodium in the blood (hyponatremia)
• increased levels of “creatinine” in the blood (increased creatinine)
• increased levels in the blood of the liver enzyme “alanine aminotransferase” (increased ALT)
• increased levels in the blood of the liver enzyme “aspartate aminotransferase” (increased AST)
• low number of red blood cells (anaemia)
• nosebleeds (epistaxis)

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

• nail pain
• formation of ridges on the nails or breaking of one or more nails
• very dry skin
• cracked, thickened or scaly skin
• itching or itchy rash (eczema)
• abnormalities in skin growth or appearance
• erythema
• dry or inflamed eyes (conjunctivitis)
• ulcers or inflammation of the front part of the eye (“cornea”)
• 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 decrease in kidney function
• high level of parathyroid hormone (PTH) (hyperparathyroidism)
• kidney failure
• kidney problems (renal impairment)
• liver damage (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 the membranes (including nose, mouth, eyes, vagina)

If you get any of these side effects, speak to your doctor.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help to 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 which is stated on the blister, the carton and the
vial after “Exp.”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not use this medicine if the packaging is damaged or shows signs of tampering.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Balversa contains

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

Description of the appearance of Balversa and contents of the pack
Balversa 3 mg film-coated tablets are yellow, round, biconvex, with
“3” imprinted on one side; and “EF” on the other side.
Balversa 4 mg film-coated tablets are orange, round, biconvex, with
“4” imprinted on one side; and “EF” on the other side.
Balversa 5 mg film-coated tablets are brown, round, biconvex, with
“5” imprinted on one side; and “EF” on the other side.
Balversa film-coated tablets may be supplied in child-resistant blister packs or 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 a bottle of 56 tablets
• each carton of 84 film-coated tablets contains a bottle of 84 tablets.

4 mg tablet:

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

5 mg tablet:

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

Blister:
Balversa is supplied in a carton. Each carton contains 14, 28, 56 or 84 film-coated tablets in
one or two blister packs.

3 mg tablet:

• each 28-day carton of 56 film-coated tablets contains 2 blister packs of 28 tablets each
• each 28-day carton of 84 film-coated tablets contains 2 blister packs of 42 tablets each.

4 mg tablet:

• starter pack: carton of 7 days containing 1 blister pack with a total of 14 film-coated tablets of 4 mg for 1 week of treatment; to be used for the initial dose before the doctor increases the dose or decides to reduce it
• each 28-day carton of 28 film-coated tablets contains 1 blister pack of 28 tablets
• each 28-day carton of 56 film-coated tablets contains 2 blister packs of 28 tablets each.

5 mg tablet:

• each 28-day carton of 28 film-coated tablets contains 1 blister pack 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, contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11
[email protected]

Lietuva
UAB "JOHNSON & JOHNSON"
Tel: +370 5 278 68 88
[email protected]

България
„Джонсън & Джонсън България” ЕООД
Тел.: +359 2 489 94 00
[email protected]

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11
[email protected]

Česká republika
Janssen-Cilag s.r.o.
Tel: +420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.: +36 1 884 2858
[email protected]

Danmark
Janssen-Cilag A/S
Tlf: +45 4594 8282
[email protected]

Malta
AM MANGION LTD
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: 0800 086 9247 / +49 2137 955 6955
[email protected]

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111
[email protected]

Eesti
UAB "JOHNSON & JOHNSON" Eesti filiaal
Tel: +372 617 7410
[email protected]

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00
[email protected]

Ελλάδα
Janssen-Cilag Φαρμακευτική Μονοπρόσωπη
Α.Ε.Β.Ε.
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00
[email protected]

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tél: 0 800 25 50 75 / +33 1 55 00 40 03
[email protected]

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700
[email protected]

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: +1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00
[email protected]

Ísland
Janssen-Cilag AB
c/o Vistor hf.
Sími: 354 535 7000
[email protected]

Slovenská republika
Johnson & Johnson, s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1
[email protected]

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300
[email protected]

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Τηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tfn: +46 8 626 50 00
[email protected]

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

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]
More detailed information on this medicine is available on the website of the European Medicines Agency, https://www.ema.europa.eu