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PBS Information:
This product is not listed on the PBS
BEFORE PRESCRIBING, PLEASE REVIEW FULL PRODUCT INFORMATION AVAILABLE ON
REQUEST FROM ASTRAZENECA ON 1800 805 342 OR
www.astrazeneca.com.au/PILYNPARZA
®
(olaparib) Minimum Product Information:
INDICATIONS:
Monotherapy for the maintenance treatment of patients with platinum- sensitive relapsed
BRCA
-mutated
(germline or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum- based
chemotherapy. Prior treatment must have included at least 2 courses of platinum- based regimens.
CONTRAINDICATIONS:
Hypersensitivity to the active substance (olaparib) or to any
of the excipients.
PRECAUTIONS:
Haematological toxicity
is common in patients treated with olaparib and usually mild -moderate. Patients should not start treatment with LYNPARZA
until they have recovered from haematological toxicity caused by previous anti - cancer therapy. A baseline complete blood count followed by monthly monitoring is recommended for
the first 12 months of treatment and periodically after this.
Myelodysplastic syndrome/Acute Myeloid Leukaemia
(MDS/AML) have been reported in a small number of patients (<1%)
and the majority of reports have been fatal.
Pneumonitis
has been reported in a small number of patients receiving olaparib, and some reports have been fatal.
Use in pregnancy:
Category D. LYNPARZA may cause foetal harm when administered to a pregnant woman. Women of child bearing potential must use effective contraception during treatment and
for 1 month after receiving the last dose.
Use during lactation:
Breast feeding should be avoided in women receiving LYNPARZA and for 1 month after the last dose.
Use in Men:
Not
indicated Children or adolescents: Not indicated.
Interactions with other medicines.
INTERACTIONS:
LYNPARZA co administration with strong CYP3A inducers or inhibitors should
be avoided. Addition of LYNPARZA and cytotoxic agents has been shown to potentiate and prolong myelosuppressive side effects.
ADVERSE REACTIONS
:
Very common (≥10%):
decreased appetite, headache, dysgeusia, dizziness, nausea, vomiting, diarrhoea, dyspepsia, fatigue, anaemia, neutropenia, lymphopenia, mean corpuscular volume elevation,
increased creatinine;
Common (≥1% to <10%):
stomatitis, upper abdominal pain, thromboyctopenia; for other listed adverse reactions, see full PI.
DOSAGE AND ADMINISTRATION:
400 mg (eight 50 mg capsules) taken twice daily, equivalent to a total daily dose of 800 mg. LYNPARZA should be taken on an empty stomach and patients should refrain from eating
for 2 hours.
Date of first inclusion in the ARTG:
7th January 2016
Reference 1.
Lynparza Approved Product Information 10 October 2016.
Lynparza
TM
is a trademark of the AstraZeneca group of companies. AstraZeneca Pty. Ltd. ABN 54 009 682 311. 66 Talavera Road, Macquarie Park,
NSW 2113. AstraZeneca Medical Information: 1800 805 342.
www.astrazeneca.com.au. WL293061. AU-1404. Date of preparation November 2016.
I have high grade serous ovarian cancer
for BRCAm
If I am positive
with Lynparza
TM
*
TEST ME
TREAT ME
*as maintenance therapy for PSR disease,
in response after platinum-based
chemotherapy (must have
≥
2 courses)
1