TALZENNA 0.25 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

TALAZOPARIB AS TOSYLATE

Tilgjengelig fra:

PFIZER PHARMACEUTICALS ISRAEL LTD

ATC-kode:

L01XX60

Legemiddelform:

HARD CAPSULE

Sammensetning:

TALAZOPARIB AS TOSYLATE 0.25 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

EXCELLA GMBH & CO.KG., GERMANY

Terapeutisk område:

TALAZOPARIB

Indikasjoner:

TALZENNA is indicated for the treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (BRCA) mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer.

Autorisasjon dato:

2020-03-24

Informasjon til brukeren

Talzenna 0.25 mg and 1 mg, Israel, PIL, CC TC 030124
2024-0089961
1
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Talzenna
®
0.25 mg
Talzenna
®
1 mg
Hard capsules
Each capsule contains:
talazoparib (as tosylate) 0.25 mg or 1 mg
Inactive ingredients and allergens: see section 6 'Further
information'.
Read the entire leaflet carefully before using this medicine. This
leaflet contains concise
information about the medicine. If you have any further questions,
consult your doctor or
pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is similar to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Talzenna is intended for the treatment of patients with HER2-negative,
locally advanced or
metastatic breast cancer with a deleterious or suspected deleterious
germline mutation in the
BRCA gene (gBRCAm - Germline BRCA mutation).
Therapeutic group: inhibitor of poly (ADP-ribose) polymerase (PARP)
enzymes.
2.
BEFORE USING THIS MEDICINE
Do not use this medicine if:
•
You are sensitive (allergic) to the active ingredient or to any of the
other
ingredients in this medicine (listed in section 6).
Special warnings regarding use of the medicine
Before treatment with Talzenna, tell your doctor if:
•
You have kidney problems - in these patients, there is need for dosage
adjustment that will
be determined by the attending doctor.
•
You are pregnant or planning to get pregnant.
•
You are breastfeeding or planning to breastfeed.
Children and adolescents
This medicine is not intended for children and adolescents under 18
years of age.
There is no information regarding the safety and efficacy of using
this preparation in children and
adolescents.
Tests and follow-up
•
The doctor will perform a test for BRCA mutation carrier status
•
Your doctor will perform blood tests to check blood cell count:
o
Every month during treatment w

Preparatomtale

Talzenna 0.25 mg and 1 mg, Israel, LPD, CC 301023
2023-0088880
1
FULL PRESCRIBING INFORMATION
NAME OF THE MEDICINAL PRODUCT
Talzenna
®
0.25 mg
Talzenna
®
1 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION
Talzenna 0.25 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 0.25 mg
talazoparib.
Talzenna 1 mg hard capsules
Each hard capsule contains talazoparib tosylate equivalent to 1 mg
talazoparib.
For the full list of excipients, see section 11.
PHARMACEUTICAL FORM
Hard capsule.
1
INDICATIONS AND USAGE
TALZENNA is indicated for the treatment of adult patients with
deleterious or suspected deleterious germline
breast cancer susceptibility gene (BRCA)-mutated (gBRCAm) human
epidermal growth factor receptor 2
(HER2)-negative locally advanced or metastatic breast cancer.
2
DOSAGE AND ADMINISTRATION
2.1
PATIENT SELECTION
Select patients for the treatment of advanced breast cancer with
TALZENNA based on the presence of germline
BRCA mutations _[see Indications and Usage (1), Clinical Studies
(14)]_.
2.2
RECOMMENDED DOSING
The recommended dose of TALZENNA is 1 mg taken orally once daily, with
or without food.
The 0.25 mg capsule is available for dose reduction.
Patients should be treated until disease progression or unacceptable
toxicity occurs.
To avoid contact with the capsule content, TALZENNA capsules should be
swallowed whole, and must not be
opened or dissolved.
If the patient vomits or misses a dose, an additional dose should not
be taken. The next prescribed dose should
be taken at the usual time.
Talzenna 0.25 mg and 1 mg, Israel, LPD, CC 301023
2023-0088880
2
2.3
DOSE MODIFICATIONS FOR ADVERSE REACTIONS
To manage adverse reactions, consider interruption of treatment with
or without dose reduction based on
severity and clinical presentation. Recommended dose reductions are
indicated in Table 1 and Table 2.
Treatment with TALZENNA should be discontinued if more than three dose
reductions are required.
TABLE 1.
DOSE REDUCTION LEVELS FOR ADVERSE REACTIONS
DOSE LEVEL
DOSE
Recommended starting