PADCEV enfortumab vedotin 30 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

enfortumab vedotin, Quantity: 30 mg

Available from:

Astellas Pharma Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: polysorbate 20; histidine hydrochloride monohydrate; histidine; trehalose dihydrate

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

PADCEV as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand-1 inhibitor.

Product summary:

Visual Identification: Powder for injection vial. White to off-white lyophilized powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-07-07

Patient Information leaflet

PADCEV
®
P
A
D
C
E
V
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about being given this medicine, speak to your doctor or
pharmacist.
▼
This medicine is new. Please report side effects. See the full CMI for
further details.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I BEING GIVEN PADCEV?
PADCEV contains the active ingredient enfortumab vedotin. PADCEV is
used in adults to treat a kind of cancer called urothelial
cancer (urothelial carcinoma). People get PADCEV when their cancer has
spread or cannot be taken out by surgery.
For more information, see Section 1. Why am I being given PADCEV? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN PADCEV?
PADCEV should not be given if you have ever had an allergic reaction
to enfortumab vedotin or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. PADCEV should not be given to children
and adolescents below 18 years of age.
For more information, see Section 2. What should I know before I am
given PADCEV? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with PADCEV and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN PADCEV?
•
Your doctor will give you PADCEV through an infusion (a drip) into a
vein (intravenously) over 30 minutes.
•
You will get PADCEV once a week for 3 weeks in each 28 day period of
treatment. Your doctor will decide how many treatments
you need.
More instructions can be found in Section 4. How am I given PADCEV? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN PADCEV?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are being
given PADCEV.
•
Tell your doctor if you have

Summary of Product characteristics

1
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION - PADCEV
TM (ENFORTUMAB
VEDOTIN)
WARNING
_SERIOUS SKIN REACTIONS_
• PADCEV can cause severe and fatal cutaneous adverse reactions,
including Stevens-Johnson
syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
• 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; Grade 4 or recurrent
Grade 3 skin reactions.
(See sections 4.2 Dose and method of administration, and 4.4 Special
warnings and precautions
for use.)
1
NAME OF THE MEDICINE
Enfortumab vedotin
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 vc maleimidocaproyl
linker.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Powder for injection vial. White to off-white lyophilized powder.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
PADCEV as monotherapy is indicated for the treatment of adult patients
with locally advanced
or metastatic urothelial cancer who have previously received a
platinum-containing
chemotherapy and a programmed death receptor-1 or programmed
death-ligand-1 inhibitor.
▼


2
4.2
D
OSE AND METHOD OF ADMINISTRATION
GENERAL
Prior to administration, the PADCEV vial is reconstituted with Sterile
Water for Injection (SWFI).
The reconstituted solution is transferred to an intravenous infusion
bag containi