Страна: Сінгапур
мова: англійська
Джерело: HSA (Health Sciences Authority)
Enfortumab vedotin
ASTELLAS PHARMA SINGAPORE PTE. LTD.
L01XC36
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Enfortumab vedotin 20.0 mg/vial
INTRAVENOUS
Prescription Only
Baxter Oncology GmbH (DP manufacturer & Primary packager)
ACTIVE
2022-05-30
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 Прочитайте повний документ
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 Прочитайте повний документ