LYNPARZA- olaparib tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

OLAPARIB (UNII: WOH1JD9AR8) (OLAPARIB - UNII:WOH1JD9AR8)

Доступна с:

AstraZeneca Pharmaceuticals LP

ИНН (Международная Имя):

OLAPARIB

состав:

OLAPARIB 100 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Lynparza is indicated for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1) ] . Lynparza is indicated in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza [see Dosage and Administration (2.1)]. Lynparza is indicated for the maintenance treatment of adult patients with deleterious or su

Обзор продуктов:

Lynparza is available as 150 mg and 100 mg tablets. Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Store in original bottle to protect from moisture.

Статус Авторизация:

New Drug Application

тонкая брошюра

AstraZeneca Pharmaceuticals LP
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Medication Guide
Lynparza® (Lin-par-zah)
(olaparib)
tablets
What is the most important information I should know about Lynparza?
Lynparza may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute
Myeloid Leukemia (AML).
Some people who have received previous treatment with chemotherapy,
radiotherapy or certain other
medicines for their cancer have developed MDS or AML during treatment
with Lynparza. MDS or AML
may lead to death. If you develop MDS or AML, your healthcare provider
will stop treatment with
Lynparza.
Symptoms of low blood cell counts are common during treatment with
Lynparza, but can be a sign of
serious bone marrow problems, including MDS or AML. Symptoms may
include:
•
weakness
•
weight loss
•
fever
•
frequent infections
•
blood in urine or stool
•
shortness of breath
•
feeling very tired
•
bruising or bleeding more easily
Your healthcare provider will do blood tests to check your blood cell
counts:
•
before treatment with Lynparza
•
every month during treatment with Lynparza
•
weekly if you have low blood cell counts that last a long time. Your
healthcare provider may stop
treatment with Lynparza until your blood cell counts improve.
Lung problems (pneumonitis). Tell your healthcare provider if you have
any new or worsening
symptoms of lung problems, including shortness of breath, fever,
cough, or wheezing. Your healthcare
provider may do a chest x-ray if you have any of these symptoms. Your
healthcare provider may
temporarily or completely stop treatment if you develop pneumonitis.
Pneumonitis may lead to death.
Blood clots (Venous Thromboembolism). Some people may develop a blood
clot in a deep vein, usually
in the leg (venous thrombosis), or a clot in the lungs (pulmonary
embolism) which may be severe or lead
to death. Tell your healthcare provider right away if you have any
symptoms such as pain or swelling in
an extremity, shortness of breath, chest pain, breathing that is mo

Характеристики продукта

LYNPARZA- OLAPARIB TABLET, FILM COATED
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LYNPARZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LYNPARZA.
LYNPARZA (OLAPARIB) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Indications and Usage (1.3) 9/2023
Dosage and Administration (2.1) 9/2023
Indications and Usage (1.8) 5/2023
Dosage and Administration (2) 5/2023
Warnings and Precautions, Myelodysplastic Syndrome/Acute Myeloid
Leukemia
(5.1) 11/2023
INDICATIONS AND USAGE
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
Ovarian cancer
•
•
•
Breast cancer
•
•
Pancreatic cancer
•
Prostate cancer
•
®
for the maintenance treatment of adult patients with deleterious or
suspected deleterious germline or
somatic _BRCA_-mutated advanced epithelial ovarian, fallopian tube or
primary peritoneal cancer who
are in complete or partial response to first-line platinum-based
chemotherapy. Select patients for
therapy based on an FDA-approved companion diagnostic for Lynparza.
(1.1, 2.1)
in combination with bevacizumab for the maintenance treatment of adult
patients with advanced
epithelial ovarian, fallopian tube or primary peritoneal cancer who
are in complete or partial response
to first-line platinum-based chemotherapy and whose cancer is
associated with homologous
recombination deficiency (HRD)-positive status defined by either:
•
•
a deleterious or suspected deleterious _BRCA_ mutation, and/or
genomic instability.
Select patients for therapy based on an FDA-approved companion
diagnostic for Lynparza. (1.2, 2.1)
for the maintenance treatment of adult patients with deleterious or
suspected deleterious germline or
somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube or
primary peritoneal cancer, who
are in complete or partial response to platinum-based chemotherapy.
Select patients for therapy
based on an FDA-approved companion diagnostic for