PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MGVIAL

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Enfortumab vedotin

Available from:

ASTELLAS PHARMA SINGAPORE PTE. LTD.

ATC code:

L01XC36

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Composition:

Enfortumab vedotin 20.0 mg/vial

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Baxter Oncology GmbH (DP manufacturer & Primary packager)

Authorization status:

ACTIVE

Authorization date:

2022-05-30

Patient Information leaflet

1
PATIENT INFORMATION LEAFLET
PADCEV
® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MG
PADCEV
® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG
enfortumab vedotin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor.

If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What PADCEV is and what it is used for
2.
What you need to know before you are given PADCEV
3.
How to use PADCEV
4.
Possible side effects
5.
Contents of the pack and other information
1.
WHAT PADCEV IS AND WHAT IT IS USED FOR
PADCEV contains the active substance enfortumab vedotin which is made
up of a monoclonal antibody
linked to a substance intended to kill cancer cells. The monoclonal
antibody recognises certain cancer cells
and delivers the substance to the cancer cells.
This medicine is used in adults to treat a kind of cancer called
bladder cancer (urothelial carcinoma). People
get PADCEV when their cancer has spread or cannot be taken out by
surgery.
PADCEV is given to people that have received an immunotherapy medicine
and also received a
chemotherapy-containing platinum medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PADCEV
YOU MUST NOT BE GIVEN PADCEV

if you are allergic to enfortumab vedotin or any of the other
ingredients of this medicine (listed in
section 5).
WARNINGS AND PRECAUTIONS
Talk to your doctor immediately if you:

have any of the following skin reaction symptoms:

rash or itching that continues to get worse or comes back after
treatment,

skin blistering or peeling,

painful sores or ulcers in mouth or nose, throat, or genital area,

fever or flu-like symptoms,

or swollen lymph nodes.
These may be signs of a severe skin reaction that can happen while
receiving this medicine, particularly
during th

Summary of Product characteristics

1
1.
NAME OF THE MEDICINAL PRODUCT
PADCEV
®
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MG
PADCEV
®
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for concentrate for infusion contains either 20 mg
or 30 mg enfortumab vedotin.
After reconstitution, each mL contains 10 mg of enfortumab vedotin.
Enfortumab vedotin is a Nectin-4 targeted antibody drug conjugate
(ADC) comprised of a fully human
IgG1 kappa antibody, conjugated to the microtubule-disrupting agent
monomethyl auristatin E
(MMAE) via a protease-cleavable maleimidocaproyl valine-citrulline
linker.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Padcev is indicated for the treatment of adult patients with locally
advanced (LA) 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Padcev should be initiated and supervised by a
physician experienced in the use of
anti-cancer therapies.
Posology
The recommended dose of Padcev 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.
TABLE 1. RECOMMENDED DOSE REDUCTION SCHEDULE FOR ADVERSE EVENTS
DOSE LEVEL
Starting dose
1.25 mg/kg up to 125 mg
First dose reduction
1.0 mg/kg up to 100 mg
Second dose reduction
0.75 mg/kg up to 75 mg
Third dose reduction
0.5 mg/kg up to 50 mg
2
_Dose Modifications _
TABLE 2. PADCEV DOSE INTERRUPTION, REDUCTION AND DISCONTINUATION
RECOMMENDATIONS IN PATIENTS
WITH LA OR MUC
ADVERSE
REACTION
SEVERITY*
DOSE MODIFICATION*
SKIN REACTION