PADCEV for I.V. infusion 30mg (パドセブ点滴静注用30mg)

Country: Japan

Language: English

Source: すりの適正使用協議会 RAD-AR Council, Japan

Active ingredient:

Enfortumab vedotin(genetical recombination)

Available from:

Astellas Pharama Inc.

INN (International Name):

Enfortumab vedotin(genetical recombination)

Pharmaceutical form:

injection

Patient Information leaflet

Drug Information Sheet("Kusuri-no-Shiori")
Injection
Revised: 06/2023
The information on this sheet is based on approvals granted by the
Japanese regulatory authority. Approval
details may vary by country. Medicines have adverse reactions (risks)
as well as efficacies (benefits). It is
important to minimize adverse reactions and maximize efficacy. To
obtain a better therapeutic response,
patients should understand their medication and cooperate with the
treatment.
BRAND NAME:
PADCEV FOR I.V. INFUSION 30MG
ACTIVE INGREDIENT:
Enfortumab vedotin(genetical recombination)
DOSAGE FORM:
injection
IMPRINT OR PRINT ON WRAPPING:
EFFECTS OF THIS MEDICINE
This medicine is incorporated into the cancer cells by binding to a
protein Nectin-4 in cancer
cells, and suppresses cancer cell proliferation.
It is usually used to treat radically unresectable urothelial
carcinoma that has progressed after
cancer chemotherapy.
THE FOLLOWING PATIENTS MAY NEED TO BE CAREFUL WHEN USING THIS
MEDICINE.BE SURE TO TELL YOUR DOCTOR
AND PHARMACIST.
・If you have previously experienced any allergic reactions (itch,
rash, etc.) to any medicines
or foods.
If you have or have a history of hyperglycemia or diabetes mellitus.
If you have any risk factor (obesity, etc.) for diabetes mellitus.
If you have peripheral neuropathy (peripheral nerve disorder).
If you have or have a history of interstitial lung disease.
If you have liver dysfunction.
・If you are pregnant or breastfeeding.
・If you are taking any other medicinal products. (Some medicines may
interact to enhance or
diminish medicinal effects. Beware of over-the-counter medicines and
dietary supplements
as well as other prescription medicines.)
DOSING SCHEDULE (HOW TO TAKE THIS MEDICINE)
・
Your dosing schedule prescribed by your doctor is((         

to be written by a healthcare
professional
))
・In general, for adults, administer by intravenous infusion for at
least 30 minutes at a time,
once a week for 3 consecutive weeks and the fourth week is a medicine