Keytruda

Šalis: Europos Sąjunga

kalba: bulgarų

Šaltinis: EMA (European Medicines Agency)

Veiklioji medžiaga:

Пембролизумаб

Prieinama:

Merck Sharp & Dohme B.V.

ATC kodas:

L01FF02

INN (Tarptautinis Pavadinimas):

pembrolizumab

Farmakoterapinė grupė:

Антинеопластични средства

Gydymo sritis:

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

Terapinės indikacijos:

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. Пациенти с EGFR или АЛК положителни тумори мутации също трябва да получават таргетную терапия до получаване на Кейтруда. 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.

Produkto santrauka:

Revision: 54

Autorizacija statusas:

упълномощен

Leidimo data:

2015-07-17

Pakuotės lapelis

144
Б. ЛИСТОВКА
145
Листовка: информация за пациента
KEYTRUDA
25 MG/ML
концентрат за инфузионен разтвор
пембролизумаб (рembrolizumab)
Прочетете внимателно цялата листовка
,
преди да Ви бъде приложено това
лекарство, тъй
като тя съдържа важна за Вас
информация.
-
Запазете тази листовка.
Може да се наложи
да я прочетете отново.
-
Важно е да носите картата
със себе си по време на лечението.
-
Ако имате някакви допълнителни
въпроси, попитайте Вашия лекар.
-
Ако получите някакви нежелани реакции
,
уведомете Вашия лекар
.
Това включва и всички
възможни нежелани реакции, неописани
в тази листовка. Вижте точка
4.
Какво съдържа
тази листовка
1.
Какво представлява
KEYTRUDA
и за какво се използва
2.
Какво трябва да знаете, преди да Ви
бъде приложен
KEYTRUDA
3.
Как се прилага
KEYTRUDA
4.
Възможни нежелани реакции
5.
Как да съхранявате
KEYTRUDA
6.
Съдържание на опаковката и
допълнителна
информация
1.
Какво представлява
KEYTRUDA
и за какво
се използва
KEYTRUDA
съдържа активното вещество
пембролизумаб, което е моноклонално
антитяло
.
KEYTRUDA действа, като помага на имунната
Ви система да се бори с рака
.
KEYTRUDA се използва при възрастни за
лечение на:
•
вид рак на кожата, наречен �

Prekės savybės

1
ПРИЛОЖЕНИЕ I
КРАТКА ХАРАКТЕРИСТИКА НА ПРОДУКТА
2
1.
ИМЕ НА ЛЕКАРСТВЕНИЯ ПРОДУКТ
KEYTRUDA
25 mg/ml
концентрат за инфузионен разтвор
2.
КАЧЕСТВЕН И КОЛИЧЕСТВЕН СЪСТАВ
Един флакон с
4 ml
концентрат съдържа 100
mg
пембролизумаб
(
pembrolizumab)
.
Всеки
ml
концентрат
съдържа
25
mg пембролизумаб.
Пембролизумаб е хуманизирано
моноклонално, анти
-
програмирана клетъчна смърт
-1 (PD-1),
антитяло (IgG4/kappa изотип със
стабилизираща промяна в секвенция
в Fc
региона),
произведено в клетки от яйчник на
китайски хамстер по рекомбинантна ДНК
технология.
За пълния списък на помощните
вещества вижте точка 6.1.
3.
ЛЕКАРСТВЕНА ФОРМА
Концентрат за инфузионен разтвор
Бистър
до слабо опалесциращ, безцветен до
бледожълт разтвор
, pH 5,2
–
5,8
4.
КЛИНИЧНИ ДАННИ
4.1
Терапевтични показания
Меланом
KEYTRUDA като монотерапия е показан за
лечение на възрастни и юноши на 12
години и
по
-
големи с авансирал (неоперабилен или
метастатичен) меланом.
KEYTRUDA като монотерапия е показан за
адювантно лечение на
възрастни и юноши на
12
години и по
-
големи с меланом стадий
IIB, IIC
или
III
и при които е извършена пълна
резекция (вж. точка
5.1).
Недребноклетъчен карцином на белия
дроб
(NSCLC)
KEYTRUDA
като мон