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NOW PBS LISTED
2
FROM 1
ST
FEBRUARY 2017
PBS Information:
Lynparza. Authority Required. For maintenance treatment of germline BRCA mutated platinum-sensitive
relapsed high-grade serous ovarian, fallopian tube or primary peritoneal cancer for patients who have responded to prior
platinum based chemotherapy. Refer to PBS schedule for full authority information.
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.
References 1.
Lynparza Approved Product Information 10 October 2016.
2.
PBS Website
http://www.pbs.gov.au/pbs/home[Accessed 1 February, 2017]. 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. AU-1960, WL294703, January 2017.
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
Explanatory note:
Patients who are found to have a germline BRCA1 or
BRCA2 mutation should be referred for post-test genetic counselling, as
there may be implications for other family members. Appropriate genetic
counselling should be provided to the patient either by the specialist treating
practitioner, a genetic counselling service or a clinical geneticist on referral.
MBS item 73295:
Detection of germline BRCA1 or BRCA2 gene mutations, in a patient with platinum-sensitive
relapsed ovarian, fallopian tube or primary peritoneal cancer with high grade serous features or a high grade serous
component, and who has responded to subsequent platinum-based chemotherapy, requested by a specialist or
consultant physician, to determine whether the eligibility criteria for olaparib under the Pharmaceutical Benefits
Scheme (PBS) are fulfilled.