País: Austràlia
Idioma: anglès
Font: Department of Health (Therapeutic Goods Administration)
enfortumab vedotin, Quantity: 20 mg
Astellas Pharma Australia Pty Ltd
Injection, powder for
Excipient Ingredients: polysorbate 20; trehalose dihydrate; histidine; histidine hydrochloride monohydrate
Intravenous Infusion
1 vial
(S4) Prescription Only Medicine
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.
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
Registered
2022-07-07
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 Llegiu el document complet
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 Llegiu el document complet