BALVERSA 3 MG

Country: Israel

Language: English

Source: Ministry of Health

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 date:

2020-11-10

Patient Information leaflet

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
and
allergenic
ingredients
in
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 b

Summary of Product characteristics

PAGE 1 OF 21
Balversa_Film_Coated_Tablets_PI_Sep_2022_sub_USPI_Sep2022
1
NAME OF THE MEDICINAL PRODUCT
Balversa 3mg film coated tablets
Balversa 4mg film coated tablets
Balversa 5mg film coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains either 3, 4 or 5mg of erdafitinib
3
PHARMACEUTICAL FORM
Film coated tablet.
3mg: Yellow, round biconvex, film-coated, debossed with “3” on one
side and “EF” on the
other side.
4mg: Orange, round biconvex, film-coated, debossed with “4” on one
side and “EF” on the
other side.
5mg: Brown, round biconvex, film-coated, debossed with “5” on one
side and “EF” on the
other side.
4
INDICATIONS AND USAGE
BALVERSA is a kinase inhibitor indicated for the treatment of adult
patients with locally
advanced or metastatic urothelial carcinoma (mUC) that has
•
susceptible FGFR3 or FGFR2 genetic 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.
5
DOSAGE AND ADMINISTRATION
5.1
Select patients for treatment of locally advanced or metastatic
urothelial carcinoma with
BALVERSA based on the presence of susceptible FGFR genetic alterations
in tumor
specimens
_[see Clinical Studies (14.1)]_
.
5.2
RECOMMENDED DOSAGE AND SCHEDULE
The recommended starting dose of BALVERSA is 8 mg (two 4 mg tablets)
orally once
daily, with a dose increase to 9 mg (three 3 mg tablets) once daily
based on serum
phosphate (PO
4
) levels and tolerability at 14 to 21 days
_[see Dosage and Administration _
_(_
5
_.3)]._
PAGE 2 OF 21
Balversa_Film_Coated_Tablets_PI_Sep_2022_sub_USPI_Sep2022
Swallow tablets whole with or without food. If vomiting occurs any
time after taking
BALVERSA, the next dose should be taken the next day. Treatment should
continue until
disease progression or unacceptable toxicity occurs.
If a dose of BALVERSA is missed, it can be taken as soon as possible
on the same day.
Resume the regular daily