BALVERSA 3 MG

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
ERDAFITINIB
Available from:
J-C HEALTH CARE LTD
ATC code:
L01EX16
Pharmaceutical form:
FILM COATED TABLETS
Composition:
ERDAFITINIB 3 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
JANSSEN CILAG S.P.A., ITALY
Therapeutic area:
ERDAFITINIB
Therapeutic indications:
BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has:- Susceptible FGFR3 or FGFR2 genetiic alterations, and- Progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Authorization number:
165 77 36132 00
Authorization date:
2020-11-10

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

29-03-2021

Patient Information leaflet Patient Information leaflet - Hebrew

29-03-2021

Read the complete document

PATIENT

PACKAGE

INSERT

IN

ACCORDANCE WITH THE PHARMACISTS’

REGULATIONS )PREPARATIONS( – 1986

The medicine is dispensed

with a doctor’s prescription only

Balversa

®

3 mg

Film-Coated Tablets

Balversa

®

4 mg

Film-Coated Tablets

Balversa

®

5 mg

Film-Coated Tablets

Active ingredient and its quantity

Each tablet of Balversa 3 mg contains:

Erdafitinib 3 mg

Each tablet of Balversa 4 mg contains:

Erdafitinib 4 mg

Each tablet of Balversa 5 mg contains:

Erdafitinib 5 mg

Inactive

allergenic

ingredients

the preparation – see Section 6 “Further

Information”.

Read the leaflet carefully in its entirety

before using the medicine. This leaflet

contains concise information about the

medicine. If you have further questions, refer

to the doctor or pharmacist.

This medicine has been prescribed for the

treatment of your ailment. Do not pass it on

to others. It may harm them, even if it seems

to you that their ailment is similar.

1. WHAT IS THE MEDICINE INTENDED

FOR?

Balversa is used to treat adults with locally

advanced or metastatic bladder cancer

)urothelial carcinoma( and is characterized by:

Abnormal changes in the FGFR2 or FGFR3

genes

Disease that has progressed during

or following at least one line of therapy

that

includes

platinum-containing

chemotherapeutic drugs, including within 12

months of pre-operative adjunctive therapy

)neoadjuvant( that includes platinum-

containing chemotherapeutic drugs, or after

surgery )adjuvant( that includes platinum-

containing chemotherapeutic drugs.

Therapeutic group

Kinase inhibitors

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

You are sensitive )allergic( to the active

ingredient )erdafitinib( or to any of the

additional ingredients contained in the

medicine. For a list of additional ingredients,

see Section 6 “Further Information”.

Special warnings regarding use of the

medicine

Before treatment with Balversa, tell the

doctor about your medical condition,

especially if:

You have eye problems or vision problems.

You are pregnant or plan to become

pregnant. Balversa can harm your unborn

baby. You should not become pregnant while

using Balversa.

You have high phosphate levels in the blood

)hyperphosphatemia(.

Children and adolescents

The medicine is not intended for children and

adolescents below the age of 18.

There is no information regarding the safety

and efficacy of use of the preparation in

children and adolescents under the age of 18.

Tests and follow-up

The doctor will perform tests to monitor your

blood phosphate levels.

In women – your doctor will request that you

perform a pregnancy test before beginning

treatment with Balversa.

Drug interactions

If you are taking, or have recently

taken, other medicines including non-

prescription medicines and nutritional

supplements, tell the doctor or pharmacist.

Taking Balversa at the same time as other

medicines may affect the activity of Balversa

and may affect the activity of other medicines.

In particular, if you are taking:

Medicines for the treatment of fungal

infections )e.g., itraconazole, fluconazole(

Medicines to treat bacterial infections )e.g.,

rifampicin(

Medicines to treat heart problems and lower

blood pressure )e.g., digoxin(

Potassium phosphate supplements

Vitamin D supplements

Acid-reducing

medicines

)antacids,

histamine H2 blockers, proton pump

inhibitors(

Enema or laxatives containing phosphate

Medicines containing phosphate as an

inactive substance

Metformin )for the treatment of diabetes(

Use of the medicine and food

Balversa can be taken with or without food.

Pregnancy, breastfeeding and fertility

Tell your doctor right away if you are pregnant

or think you may be pregnant.

If you are pregnant, think you may be

pregnant or are planning to have a baby, do

not use Balversa as the medicine may harm

your unborn baby and even pose a risk of

pregnancy loss.

You should use effective birth control during

treatment and for 1 month after taking the last

dose. Consult the doctor about birth control

methods that are right for you.

Based on findings from animal experiments,

Balversa may impair fertility in women of

childbearing age.

If you are breastfeeding, talk to your doctor or

pharmacist before taking the medicine.

It is unknown whether Balversa passes into

breast milk, has on effect on milk production

or on the breastfed child. However, due to the

potential for side effects in the breastfed child,

your doctor will advise you not to breastfeed

during treatment and up to a month after

taking the last dose of Balversa.

If your female partner is of childbearing age, is

pregnant or may be pregnant, you should use

effective birth control during treatment with

Balversa and for 1 month after the last dose.

3. HOW SHOULD THE MEDICINE BE

USED?

Always use according to the doctor’s

instructions.

Check with the doctor or pharmacist if you are

uncertain regarding the dosage and treatment

regimen of the preparation.

The dosage and treatment regimen will be

determined by the doctor only.

Take Balversa treatment once a day.

Swallow the tablet whole with or without food.

Your doctor may change your dose of

Balversa, or temporarily stop or completely

stop treatment if you get certain side effects.

Do not exceed the recommended dose.

There is no information regarding halving or

crushing the tablet.

If

you

took

a

higher

dose

than

recommended, or if a child has accidentally

swallowed the medicine, refer to a doctor or

proceed to a hospital emergency room and

bring the package of the medicine with you.

If you forgot to take the medicine, take the

regular dose as soon as possible on the same

day. Return to your normal dosing regimen on

the following day. Do not take more tablets than

the daily dose to make up for the forgotten

dose.

If you vomit after taking Balversa, do not take

another tablet. Take your regular dose the next

day.

Do not stop taking the medicine without

consulting the doctor.

Adhere to the treatment as recommended by

the doctor.

Do not take medicines in the dark! Check

the label and the dose each time you take

medicine. Wear glasses if you need them.

If you have further questions regarding

use of the medicine, consult the doctor

or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Balversa may

cause side effects in some users. Do not be

alarmed by reading the list of side effects. You

may not suffer from any of them.

Balversa may cause serious side effects,

including:

Eye problems – Eye problems are common

during treatment with Balversa but can be

serious. Eye problems include dry or inflamed

eyes, inflamed cornea )front part of the eye(

and disorders of the retina )the internal part

of the eye(. Tell your doctor 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 doctor will send

you to see an eye specialist.

High phosphate levels in the blood

)hyperphosphatemia( – Hyperphosphatemia

is common with treatment with Balversa but

can be serious. Your doctor will check your

blood phosphate level between 14 and 21

days after starting treatment with Balversa,

and then monthly, and may change your dose

if needed.

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 sodium levels

poor appetite

change in sense of taste

low red blood cells )anemia(

dry skin

dry eyes

hair loss

redness, swelling, peeling or tenderness,

mainly on the hands or feet )‘hand-foot

syndrome’(

constipation

abdominal pain

nausea

muscle pain

Tell your doctor right away if you develop

any skin or nail problems including nails

separating from the nail bed, nail pain, nail

bleeding, breaking of the nails, color or texture

changes in your nails, inflamed skin around

the nail, an itchy skin rash, dry skin, or cracks

in the skin.

Balversa may affect fertility in women of

childbearing age. Consult with your doctor if

this is a concern for you.

The table below shows side effects by body

systems:

Body System

Side effect

Gastrointestinal

disorders

Stomatitis

Vomiting

General

disorders and

administration

site conditions

Pyrexia

Skin and

subcutaneous

disorders

Onycholysis

Alopecia

Nail discoloration

Eye disorders

Blurred vision

Lacrimation increased

Nervous system

disorders

Dysgeusia

Infections and

infestations

Paronychia

Urinary tract infection

Conjunctivitis

Respiratory and

thoracic disorders

Lower pharyngeal pain

Dyspnea

Renal and urinary

tract disorders

Hematuria )blood in the

urine(

Musculoskeletal

and connective

tissue disorders

Musculoskeletal pain

Joint pain

Investigations

Weight decreased

Laboratory

abnormalities

Hematology:

Hemoglobin decreased

Platelets decreased

Leukocytes decreased

Neutrophils decreased

Chemistry:

Phosphate level

increased/decreased

Creatinine increased

Sodium decreased

Increase in an

enzyme called alanine

aminotransferase

Increase in an enzyme

called alkaline

phosphatase

Albumin decreased

Increase in an enzyme

called aspartate

aminotransferase

Magnesium decreased

Calcium increased

Potassium increased

Fasting glucose levels

increased

If a side effect occurs, or if one of the side

effects worsens, or if you suffer from a side

effect not mentioned in the leaflet, consult

with the doctor.

Side effects can be reported to the Ministry

of Health by clicking on the link “Report Side

Effects of Drug Treatment” found on the Ministry

of Health homepage )www.health.gov.il(

that directs you to the online form for reporting

side effects, or by entering the link:

https://sideeffects.health.gov.il

5. HOW SHOULD THE MEDICINE BE

STORED?

Avoid poisoning! This medicine, and any other

medicine, should be kept in a safe place out of

the reach and sight of children and/or infants

in order to avoid poisoning. Do not induce

vomiting unless explicitly instructed to do so

by the doctor.

Do not use the medicine after the expiry date

)exp. Date( appearing on the package. The

expiry date refers to the last day of that month.

Do not store above 25°C.

After first opening the package, use within 12

months and no later than the expiry date of

the preparation.

Store the tablets in their original package.

6. FURTHER INFORMATION

In addition to the active ingredient, the

medicine also contains:

Microcrystalline cellulose

Mannitol

Croscarmellose sodium

Magnesium stearate

Meglumine

Opadry amb II 88A120003 Yellow )3 mg(:

Polyvinyl alcohol-partially hydrolyzed

Talc

Titanium dioxide

Iron oxide yellow

Glycerol monocaprylocaprate Type 1

Sodium lauryl sulfate

Opadry amb II 88A130001 Orange )4 mg(:

Polyvinyl alcohol-partially hydrolyzed

Talc

Titanium dioxide

Iron oxide yellow

Glycerol monocaprylocaprate Type 1

Sodium lauryl sulfate

Iron oxide red

Opadry amb II 88A165000 Brown )5 mg(:

Polyvinyl alcohol-partially hydrolyzed

Talc

Titanium dioxide

Iron oxide red

Glycerol monocaprylocaprate Type 1

Sodium lauryl sulfate

Iron oxide yellow

Iron oxide black/ferrosoferric oxide

What does the medicine look like and what

are the contents of the package:

Balversa 3 mg is a yellow, round, biconvex,

film-coated tablet, debossed with “3” on one

side and “EF” on the other side.

Balversa 4 mg is an orange, round, biconvex,

film-coated tablet, debossed with “4” on one

side and “EF” on the other side.

Balversa 5 mg is a brown, round, biconvex,

film-coated tablet, debossed with “5” on one

side and “EF” on the other side.

Balversa 3 mg is supplied in a plastic bottle

containing 56 or 84 tablets.

Balversa 4 mg is supplied in a plastic bottle

containing 28 or 56 tablets.

Balversa 5 mg is supplied in a plastic bottle

containing 28 tablets.

Importer and Registration Holder and

Address: J-C Health Care Ltd., Kibbutz

Shefayim 6099000, Israel.

Registration number of the medicine in the

National Drug Registry of the Ministry of

Health:

Balversa 3 mg: 165-77-36132-00

Balversa 4 mg: 165-78-36133-00

Balversa 5 mg: 165-79-36134-00

Approved in 11/20

BALV CTAB PL SH 171220

Similar products

Search alerts related to this product

View documents history

Share this information