TRODELVY

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

SACITUZUMAB GOVITECAN

Commercializzato da:

GILEAD SCIENCES ISRAEL LTD

Forma farmaceutica:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Composizione:

SACITUZUMAB GOVITECAN 200 MG

Via di somministrazione:

I.V

Tipo di ricetta:

Required

Prodotto da:

GILEAD SCIENCES IRELAND UC, IRELAND

Indicazioni terapeutiche:

Trodelvy as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease.Trodelvy is indicated for the treatment of adult patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Data dell'autorizzazione:

2022-09-29

Foglio illustrativo

1
TRODELVY
®
(SACITUZUMAB GOVITECAN 200 MG)
POWDER FOR CONCENTRATE FOR SOLUTION
FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Trodelvy
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 200 mg sacituzumab govitecan.
After reconstitution, one mL of solution contains 10 mg sacituzumab
govitecan.
Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate
(ADC). Sacituzumab is a
humanised monoclonal antibody (hRS7
IgG1κ)
that recognises Trop-2. The small molecule, SN-38, is
a topoisomerase I inhibitor, which is covalently attached to the
antibody by a hydrolysable linker.
Approximately 7-8 molecules of SN-38 are attached to each antibody
molecule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
Off-white to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trodelvy as monotherapy is indicated for the treatment of adult
patients with unresectable or
metastatic triple-negative breast cancer (mTNBC) who have received two
or more prior systemic
therapies, including at least one of them for advanced disease (see
section 5.1).
Trodelvy is indicated for the treatment of adult patients with
unresectable locally advanced or
metastatic hormone receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-
negative (IHC 0, IHC 1+ or IHC 2+/ISH
–
) breast cancer who have received endocrine-based therapy
and at least two additional systemic therapies in the metastatic
setting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Trodelvy must only be prescribed and administered to patients by
healthcare professionals experienced
in the use of anti-cancer therapies and administered in an environment
where full resuscitation
facilities are available.
2
Posology
The recommended dose of sacituzumab govitecan is 10 mg/kg body weight
administered as an
intravenous infusion once weekly on Day 1 and Day 8 of 21-day
treatment cycles. Treatment should
be continued until disease progression or unacceptable toxicit

Scheda tecnica

1
TRODELVY
®
(SACITUZUMAB GOVITECAN 200 MG)
POWDER FOR CONCENTRATE FOR SOLUTION
FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Trodelvy
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 200 mg sacituzumab govitecan.
After reconstitution, one mL of solution contains 10 mg sacituzumab
govitecan.
Sacituzumab govitecan is a Trop-2-directed antibody-drug conjugate
(ADC). Sacituzumab is a
humanised monoclonal antibody (hRS7
IgG1κ)
that recognises Trop-2. The small molecule, SN-38, is
a topoisomerase I inhibitor, which is covalently attached to the
antibody by a hydrolysable linker.
Approximately 7-8 molecules of SN-38 are attached to each antibody
molecule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion
Off-white to yellowish powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trodelvy as monotherapy is indicated for the treatment of adult
patients with unresectable or
metastatic triple-negative breast cancer (mTNBC) who have received two
or more prior systemic
therapies, including at least one of them for advanced disease (see
section 5.1).
Trodelvy is indicated for the treatment of adult patients with
unresectable locally advanced or
metastatic hormone receptor (HR)-positive, human epidermal growth
factor receptor 2 (HER2)-
negative (IHC 0, IHC 1+ or IHC 2+/ISH
–
) breast cancer who have received endocrine-based therapy
and at least two additional systemic therapies in the metastatic
setting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Trodelvy must only be prescribed and administered to patients by
healthcare professionals experienced
in the use of anti-cancer therapies and administered in an environment
where full resuscitation
facilities are available.
2
Posology
The recommended dose of sacituzumab govitecan is 10 mg/kg body weight
administered as an
intravenous infusion once weekly on Day 1 and Day 8 of 21-day
treatment cycles. Treatment should
be continued until disease progression or unacceptable toxicit