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Lynparza Dosage

Generic name: OLAPARIB 100mg
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on Dec 7, 2020.

2.1 Patient Selection

Information on FDA-approved tests for the detection of genetic mutations is available at http://www.fda.gov/companiondiagnostics.

Select patients for treatment with Lynparza based on the presence of deleterious or suspected deleterious HRR gene mutations, including BRCA mutations, or genomic instability based on the indication, biomarker, and sample type (Table 1).

Table 1 Biomarker Testing for Patient Selection*
*
Where testing fails or tissue sample is unavailable/insufficient, or when germline testing is negative, consider using an alternative test if available.

Indication

Biomarker

Sample type

Tumor

Blood

Plasma

(ctDNA)

First-line maintenance treatment of germline or somatic BRCAm advanced ovarian cancer

BRCA1m, BRCA2m

X

X

First-line maintenance treatment of HRD-positive advanced ovarian cancer in combination with bevacizumab

BRCA1m, BRCA2m and/or genomic instability

X

Maintenance treatment of recurrent ovarian cancer

No requirement for biomarker testing

Advanced gBRCAm ovarian cancer

gBRCA1m, gBRCA2m

X

gBRCAm HER2-negative metastatic breast cancer

gBRCA1m, gBRCA2m

X

First-line maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma

gBRCA1m, gBRCA2m

X

Germline or somatic HRR gene-mutated metastatic castration-resistant prostate cancer

ATMm, BRCA1m, BRCA2m, BARD1m, BRIP1m, CDK12m, CHEK1m, CHEK2m, FANCLm, PALB2m, RAD51Bm, RAD51Cm, RAD51Dm, RAD54Lm

X

gBRCA1m, gBRCA2m

X

ATMm, BRCA1m, BRCA2m

X

Recommended Dosage

The recommended dosage of Lynparza is 300 mg taken orally twice daily, with or without food.

If a patient misses a dose of Lynparza, instruct patient to take their next dose at its scheduled time.

Instruct patients to swallow tablets whole. Do not chew, crush, dissolve, or divide tablet.

First-Line Maintenance Treatment of BRCA-mutated Advanced Ovarian Cancer

Continue treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous treatment, can be treated beyond 2 years.

First-Line Maintenance Treatment of HRD-positive Advanced Ovarian Cancer in Combination with Bevacizumab

Continue Lynparza treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients with a complete response (no radiological evidence of disease) at 2 years should stop treatment. Patients with evidence of disease at 2 years, who in the opinion of the treating healthcare provider can derive further benefit from continuous Lynparza treatment, can be treated beyond 2 years.

When used with Lynparza, the recommended dose of bevacizumab is 15 mg/kg every three weeks. Bevacizumab should be given for a total of 15 months including the period given with chemotherapy and given as maintenance. Refer to the Prescribing Information for bevacizumab when used in combination with Lynparza for more information.

Recurrent Ovarian Cancer, Germline BRCAm Advanced Ovarian Cancer, HER2-negative Metastatic Breast Cancer, Metastatic Pancreatic Adenocarcinoma, and HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer

Continue treatment until disease progression or unacceptable toxicity for:

Maintenance treatment of recurrent ovarian cancer
Advanced germline BRCA-mutated ovarian cancer
Germline BRCA-mutated HER-2 negative metastatic breast cancer
First-line maintenance treatment of germline BRCA-mutated metastatic pancreatic adenocarcinoma.
HRR gene-mutated metastatic castration-resistant prostate cancer

Patients receiving Lynparza for mCRPC should also receive a gonadotropin-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.

Dosage Modifications for Adverse Reactions

To manage adverse reactions, consider interruption of treatment or dose reduction. The recommended dose reduction is 250 mg taken twice daily.

If a further dose reduction is required, then reduce to 200 mg taken twice daily.

Dosage Modifications for Concomitant Use with Strong or Moderate CYP3A Inhibitors

Avoid concomitant use of strong or moderate CYP3A inhibitors with Lynparza.

If concomitant use cannot be avoided, reduce Lynparza dosage to:

100 mg twice daily when used concomitantly with a strong CYP3A inhibitor.
150 mg twice daily when used concomitantly with a moderate CYP3A inhibitor.

After the inhibitor has been discontinued for 3 to 5 elimination half-lives, resume the Lynparza dose taken prior to initiating the CYP3A inhibitor [see Drug Interactions (7.2) and Clinical Pharmacology (12.3)].

Dosage Modifications for Renal Impairment

Moderate Renal Impairment

In patients with moderate renal impairment (CLcr 31-50 mL/min), reduce the Lynparza dosage to 200 mg orally twice daily [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.