Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Romania
Nguồn: EMA (European Medicines Agency)
Pembrolizumab
Merck Sharp & Dohme B.V.
L01FF02
pembrolizumab
Agenți antineoplazici
Melanoma; Hodgkin Disease; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Carcinoma, Transitional Cell; Squamous Cell Carcinoma of Head and Neck; Urologic Neoplasms; Endometrial Neoplasms
MelanomaKeytruda as monotherapy is indicated for the treatment of adults and adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Keytruda as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC, or with Stage III melanoma and lymph node involvement who have undergone complete resection. Non small cell lung carcinoma (NSCLC)Keytruda as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum based chemotherapy (for selection criteria, see section 5. Keytruda as monotherapy is indicated for the first line treatment of metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. Keytruda, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of metastatic non squamous non small cell lung carcinoma in adults whose tumours have no EGFR or ALK positive mutations. Keytruda, in combination with carboplatin and either paclitaxel or nab paclitaxel, is indicated for the first line treatment of metastatic squamous non small cell lung carcinoma in adults. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic non small cell lung carcinoma in adults whose tumours express PD L1 with a ≥ 1% TPS and who have received at least one prior chemotherapy regimen. Pacienții cu EGFR sau ALK pozitiv de tumoră mutații ar trebui să, de asemenea, au primit terapie vizate înainte de a primi KEYTRUDA. Classical Hodgkin lymphoma (cHL)Keytruda as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. Urothelial carcinomaKeytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum containing chemotherapy. Keytruda as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin containing chemotherapy and whose tumours express PD L1 with a combined positive score (CPS) ≥ 10. Head and neck squamous cell carcinoma (HNSCC)Keytruda, as monotherapy or in combination with platinum and 5 fluorouracil (5 FU) chemotherapy, is indicated for the first line treatment of metastatic or unresectable recurrent head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a CPS ≥ 1. Keytruda as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD L1 with a ≥ 50% TPS and progressing on or after platinum containing chemotherapy. Renal cell carcinoma (RCC)Keytruda, in combination with axitinib, is indicated for the first line treatment of advanced renal cell carcinoma in adults. Keytruda as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, please see section 5. Microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancersColorectal cancer (CRC)Keytruda as monotherapy is indicated for theadults with MSI-H or dMMR colorectal cancer in the following settings:first line treatment of metastatic microsatellite instability high (MSI H) or mismatch repair deficient (dMMR) colorectal cancer in adults;treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine based combination therapy. Non-colorectal cancersKeytruda as monotherapy is indicated for the treatment of the following MSI H or dMMR tumours in adults with:advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation;unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. Oesophageal carcinomaKeytruda, in combination with platinum and fluoropyrimidine based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD L1 with a CPS ≥ 10. Triple negative breast cancer (TNBC)Keytruda, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence. Keytruda, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Endometrial carcinoma (EC)Keytruda, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum containing therapy in any setting and who are not candidates for curative surgery or radiation. Cervical cancerKeytruda, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD L1 with a CPS ≥ 1. Gastric or gastro-oesophageal junction (GEJ) adenocarcinomaKEYTRUDA, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
Revision: 54
Autorizat
2015-07-17
141 B. PROSPECTUL 142 PROSPECT: INFORM aţii PENTRU PACIENT KEYTRUDA 25 MG/ML CONCENTRAT PENTRU SOL uţ IE PERFUZABIL ă pembrolizumab CITI ţ I CU A tenţi E ş I ÎN ÎNTREGIME ACEST PROSPECT ÎNAINTE DE A VI SE ADMINISTRA ACEST MEDICAMENT DEOARECE CO nţ INE INFORMA ţ II IMPORTANTE PENTRU DUMNEAVOAST ră . - Pă stra ţ i acest prospect. S-ar putea s ă fie necesar să -l reciti ţ i. - Este import ant să p ăs tra ț i la dumneavoastr ă cardul în timpul tratamentului. - Dac ă a veţ i orice întreb ă ri suplimentare, adres aţ i- vă medicului dumneavoastr ă. - Dac ă manifes taţ i orice reac ţ ii adverse, adre saţ i-v ă medicului dumneavoast ră . Acestea includ orice posibile rea cţ ii adverse nemen ţi onate în acest prospect. Vezi pct. 4. CE G ă SI ţi ÎN ACEST PROSPECT 1. Ce este KEYTRUD A şi pentru ce se utilizea ză 2. Ce trebuie să ştiţi înai nte să vi se administreze KEYTRUDA 3. Cum vi se administreaz ă K EYTRUDA 4. Reac ţi i adverse posibile 5. Cum se p ă strea ză KE YTRUDA 6. Con ţin utul ambalajul ui şi alte inform aţi i 1. CE ESTE KEYTRUDA ş I PENTRU CE SE UTILIZE ază KEYTRUDA c onține substanța activ ă pembrolizumab, care este un anticorp monoclonal. KEYTRUDA a cți onea ză aj utând sistemul dumneavoastr ă imunitar s ă lupte împotriva cancerului. KEYTRUDA se utili zează la ad ulț i pentru a trata: • un tip de cancer de piele denumit melanom • un tip de cancer de pl ăm ân denumit cancer pulmonar altul decât cel cu celule mici • un tip de cancer denumit limfom Hodgkin clasic • un tip de cancer denumit cancer de v ezică urin ară (c arcinom urotelial) • un tip de cancer de cap ș i gât denumit carcinom cu celul e scuamoas e al capului ş i gâtului • un tip ce cancer de rinichi denumit carcinom renal • un tip de cancer care s-a demonstrat a fi cu instabilitate microsatelit ă d e grad înalt (MSI-H) sau cu defici ență de reparare a nepotrivirii ADN-ului (dMMR) la nivelul colonul ui sau rectului (denumit cancer colorectal) , uterului (denu Đọc toàn bộ tài liệu
1 ANEXA I REZUMATUL CARACTERISTICILOR PRODUSULUI 2 1. DENUMIREA COMERCIAL Ă A ME DICAMENTULUI KEYTRUDA 25 mg/ml concentrat pentru s oluţie perf uzabi lă. 2. COMPOZI ŢI A CALITAT IVĂ ŞI CANTITA TIVĂ Un flacon cu 4 ml d e concentrat co nține pembrolizumab 100 mg. Fiecare ml de concentrat con ține pe mbrolizumab 25 mg. Pembrolizumab este un anticorp monoclonal umanizat cu acț iune împotriva receptorului 1 cu rol în controlul mo rții celulare programate (PD-1 – programmed cell death-1) (izotipul IgG4/kappa cu o modificare a secven ţei de stabilizare în regiunea Fc) produs în celule ovariene de hamster chinezesc prin tehnologia ADN recombinat. Pentru lista tuturor excipien ţ ilor, vezi pct. 6.1. 3. FORMA FARMACEUTIC Ă Conce ntrat pentru soluţ ie perfuzabil ă. Solu ţie limpede pâ nă l a u şor opalescent ă, incolor ă până la ușo r g ălbuie , cu pH-ul 5,2-5,8. 4. DATE CLINICE 4.1 Indicaţii terapeutice Melanom KEYTRUDA este indicat în monoterapie pentru t ratamentul adulților și adolescenți lor cu vârsta de 12 ani ș i peste, cu melanom avansat (nerezecabil sau metastatic) . KEYTRUDA este indicat în monoterapie pentru tratamentul adjuvant al adulților și adolescenți lor cu vârsta de 12 ani și peste, cu melanom stadiul IIB, IIC sau III și la care s- a efectuat rezec ți e co mpletă (vezi pct. 5.1). Carcinom pulmonar, altul decâ t cel cu celule mici (NSCLC, non- small cell lung carcinoma ) KEYTRUDA este indicat în monoterapie pentru tratamentul adjuvant al adulților cu carcinom pulmonar, altul decât cel cu celule mici , care prezint ă risc crescut de recu rență în urma rezecției complete și administrării chimioterapie i pe bază de săruri de platină ( pentru criteriile de selec ție, vezi pct. 5.1). KEYTRUDA este indicat în monoterapie pentru tratamentul de primă linie al carcinomului pulmonar, altul decât cel cu celule mici , metastatic, l a adulţi ale căror tumori exprimă PD -L1 cu un scor tumoral prop orţional (STP) ≥ 50%, fără mutații tumorale EGFR s Đọc toàn bộ tài liệu