LYNPARZA- olaparib capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

AstraZeneca Pharmaceuticals LP

Designación común internacional (DCI):

OLAPARIB

Composición:

OLAPARIB 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Lynparza is indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (gBRCAm ) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. None. Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology (12.1)] , Lynparza can cause fetal harm when administered to a pregnant woman. There are no available data on Lynparza use in pregnant women to inform the drug associated risk. In an animal reproduction study, the administration of olaparib to pregnant rats during the period of organogenesis caused teratogenicity and embryo-fetal toxicity at exposures below those in patients receiving the recommended human dose of 400 mg twice daily [see Data] . Apprise pregnant women of the potential hazard to the fetus and the potential risk for loss of the pregnancy. The estimated background risk of major birth d

Resumen del producto:

Lynparza 50 mg is a white, opaque, hard capsule, marked in black ink with: “OLAPARIB 50 mg” on the cap and AstraZeneca logo on the body; available in: Bottles of 112 capsules                    NDC 0310-0657-58 Refrigerate at 2ºC to 8ºC (36ºF to 46ºF). Protect from freezing. If needed, Lynparza may be kept at room temperature not to exceed 30ºC (86ºF) for no more than 3 months. Lynparza should not be exposed to temperatures greater than 40ºC (104ºF). Do not take Lynparza if it is suspected of having been exposed to temperatures greater than 40ºC (104ºF) or has been frozen. Refer to full prescribing information for storage conditions for Lynparza tablets.

Estado de Autorización:

New Drug Application

Información para el usuario

AstraZeneca Pharmaceuticals LP
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Medication Guide
Lynparza® (Lin-par-zah)
(olaparib)
capsules
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 ovarian cancer or 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 stop treatment or completely stop treatment
if you develop pneumonitis.
Pneumonitis may lead to death.
What is Lynparza?
Lynparza is a prescription medicine used alone to treat women who have
a certain type of abnormal
inherited BRCA gene, advanced ovarian cancer, and:
•
have received treatment with 3 or more prior types of chemotherapy.
Your healthcare provider will perform a test to make sure that
Lynparza is right for you.
It

Ficha técnica

LYNPARZA- OLAPARIB CAPSULE
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) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Indications and Usage (1.1) 10/2017
Warnings and Precautions (5.1, 5.2) 10/2017
INDICATIONS AND USAGE
Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated
for the treatment of adult patients with deleterious
or suspected deleterious germline _BRCA-_mutated advanced ovarian
cancer who have been treated with three or more
prior lines of chemotherapy. Select patients for therapy based on an
FDA-approved companion diagnostic for Lynparza.
(1.1, 2.2)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
•
•
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
•
®
To avoid substitution errors and overdose, DO NOT SUBSTITUTE LYNPARZA
CAPSULES WITH LYNPARZA TABLETS on a
milligram-to-milligram basis due to differences in the dosing and
bioavailability of each formulation. (2.1)
Recommended capsule dose is 400 mg taken orally twice daily with or
without food. (2.3)
Continue treatment until disease progression or unacceptable toxicity.
(2.3)
For adverse reactions, consider dose interruption or dose reduction.
(2.4)
For moderate renal impairment (CLcr 31-50 mL/min), reduce dose to 300
mg twice daily. (2.6)
Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML): Occurred in
<1.5% of patients exposed to
Lynparza monotherapy and the majority of events had a fatal outcome.
Monitor patients for hematological toxicity at
baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.
(5.1)
Pneumonitis: Occurred in <1% of patients exposed to Lyn