PADCEV 20 MG

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

ENFORTUMAB VEDOTIN

Prieinama:

ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL

ATC kodas:

L01XC36

Vaisto forma:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Sudėtis:

ENFORTUMAB VEDOTIN 20 MG/VIAL

Vartojimo būdas:

I.V

Recepto tipas:

Required

Pagaminta:

ASTELLAS PHARMA US, INC, USA

Gydymo sritis:

ENFORTUMAB VEDOTIN

Terapinės indikacijos:

PADCEV is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who: - have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting or:- are ineligible for cisplatin-containing chemotherapy and have previously received a PD-1/PD-L1 inhibitor.

Leidimo data:

2021-05-27

Pakuotės lapelis

1
INDICATION
Padcev™ is indicated for the treatment of adult patients with
locally advanced or metastatic urothelial
cancer (mUC) who:
• have previously received a programmed death receptor-1 (PD-1) or
programmed death-ligand 1
(PD-L1) inhibitor and platinum-containing chemotherapy in the
neoadjuvant/adjuvant, locally
advanced or metastatic setting, or
• are ineligible for cisplatin-containing chemotherapy and have
previously received a PD-1/PD-L1
inhibitor.
LA – LOCALLY ADVANCED; MUC – METASTATIC UROTHELIAL CARCINOMA;
PD-1 – PROGRAMMED DEATH-1; PD-L1 – PROGRAMMED DEATH-LIGAND
1
PADCEV
®
(ENFORTUMAB VEDOTIN)
DOSING & ADMINISTRATION
GUIDE
The following content does not constitute medical advice.
It should not replace professional judgment or clinical experience
WARNING: SERIOUS SKIN REACTIONS
• PADCEV can cause severe and fatal cutaneous adverse reactions
including Stevens-Johnson syndrome
(SJS) and Toxic Epidermal Necrolysis (TEN), which occurred
predominantly during the first cycle of
treatment, but may occur later.
• Closely monitor patients for skin reactions.
• Immediately withhold PADCEV and consider referral for specialized
care for suspected SJS or TEN or
severe skin reactions.
• Permanently discontinue PADCEV in patients with confirmed SJS or
TEN; or Grade 4 or recurrent Grade
3 skin reactions
For more information, please refer to physician leaflet
2
WHICH OF YOUR PATIENTS COULD
BE ELIGIBLE FOR PADCEV?
1
LA – LOCALLY ADVANCED; PD-1 – PROGRAMMED DEATH-1; PD-L1 –
PROGRAMMED DEATH-LIGAND
1
PADCEV IS AN ADC TARGETED AGAINST NECTIN-4
1
• Nectin-4 is an adhesion protein located on the surface of cells
1
• Nectin-4 is highly expressed in bladder tumour specimens
3
• Nonclinical data suggest that the main anticancer activity of
PADCEV is a result of the following:
1
A NECTIN-4–TARGETED TREATMENT APPROVED FOR LA/MUC IN THE
POST-PLATINUM, POST–PD-1/PD-L1 SETTING
1
Binding of the ADC to
Nectin-4–expressing cells
1
Internalisation of the
ADC–Nectin-4 complex
2
Release of MMA

Prekės savybės

Page 1 of 24
1 NAME OF THE MEDICINAL PRODUCT
PADCEV
TM
20 mg
Each single dose vial contains 20 mg enfortumab vedotin as lyophilized
powder for reconstitution and
dilution for intravenous infusion only.
PADCEV
TM
30 mg
Each single dose vial contains 30 mg enfortumab vedotin as lyophilized
powder for reconstitution and
dilution for intravenous infusion only.
WARNING: SERIOUS SKIN REACTIONS
•
PADCEV CAN CAUSE SEVERE AND FATAL CUTANEOUS ADVERSE REACTIONS
INCLUDING STEVENS-JOHNSON
SYNDROME (SJS) AND TOXIC EPIDERMAL NECROLYSIS (TEN), WHICH OCCURRED
PREDOMINANTLY
DURING THE FIRST CYCLE OF TREATMENT, BUT MAY OCCUR LATER.
•
CLOSELY MONITOR PATIENTS FOR SKIN REACTIONS.
•
IMMEDIATELY WITHHOLD PADCEV AND CONSIDER REFERRAL FOR SPECIALIZED CARE
FOR SUSPECTED SJS
OR TEN OR SEVERE SKIN REACTIONS.
•
PERMANENTLY DISCONTINUE PADCEV IN PATIENTS WITH CONFIRMED SJS OR TEN;
OR GRADE 4 OR
RECURRENT GRADE 3 SKIN REACTIONS _[SEE DOSAGE AND ADMINISTRATION
(3.2), WARNINGS AND _
_PRECAUTIONS (5.1) AND ADVERSE REACTIONS (6.1)]._
2 THERAPEUTIC INDICATION
PADCEV
TM
is indicated for the treatment of adult patients with locally advanced
or metastatic urothelial
cancer (mUC) who:
•
have previously received a programmed death receptor-1 (PD-1) or
programmed death-ligand 1
(PD-L1) inhibitor, and a platinum-containing chemotherapy in the
neoadjuvant/adjuvant, locally
advanced or metastatic setting
•
are ineligible for cisplatin-containing chemotherapy and have
previously received one or more
prior lines of therapy.
3 DOSAGE AND ADMINISTRATION
3.1 RECOMMENDED DOSAGE
The recommended dose of PADCEV
TM
is 1.25 mg/kg (up to a maximum of 125 mg for patients ≥ 100 kg)
administered as an intravenous infusion over 30 minutes on Days 1, 8
and 15 of a 28-day cycle until disease
progression or unacceptable toxicity.
Page 2 of 24
3.2 DOSE MODIFICATIONS
TABLE 1. DOSE MODIFICATIONS
ADVERSE REACTION
SEVERITY*
DOSE MODIFICATION*
SKIN REACTIONS
_[see Boxed _
_Warning, Warnings _
_and Precautions _
_(5.1)]_
Suspected SJS or
TEN
Immediately withhold, consu