Dosing and adverse reaction (AR) management strategies for LYNPARZA1

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Dosing and administration of LYNPARZA

LYNPARZA is recommended for 1 year of treatment* in the adjuvant setting

In the metastatic setting, continue LYNPARZA until disease progression or unacceptable toxicity

Recommended daily dose1

The recommended daily dose of LYNPARZA is:

300 mg (two 150-mg tablets) taken orally twice daily, with or without food (total 600 mg daily)

The recommended daily dose of LYNPARZA is 300 mg taken twice daily, with or without food

Dose interruption1 OR

Consider dose interruption if a patient experiences an AR.

See the complete Prescribing Information for detailed dose interruption instructions for select ARs

Pause doses if patient experiences an AR

OR

Dose reduction1

Consider dose reduction if a patient experiences an AR.

INITIAL REDUCTION

Initial reduction to 250 mg (one 150-mg tablet and one 100-mg tablet) taken twice daily (total 500 mg daily)

Initial dose reduction

FURTHER REDUCTION

Further reduction to 200 mg (two 100-mg tablets) taken twice daily (total 400 mg daily)

Further dose reduction

*In the adjuvant setting: Continue LYNPARZA for a total of 1 year or until disease recurrence or unacceptable toxicity, whichever occurs first.

In the metastatic setting: Continue LYNPARZA until disease progression or unacceptable toxicity.

For those patients with gBRCAm, HR-positive, HER2-negative early breast cancer

Endocrine therapy should be continued in patients taking LYNPARZA, consistent with current clinical practice guidelines1

This is not all the dosage and administration information necessary to dose LYNPARZA.

Please refer to the dosage and administration section of the Prescribing Information for LYNPARZA.

LYNPARZA dose modifications due to adverse reactions in pivotal trials1

    Discontinuations Reductions* Interruptions†
OlympiAEarly Breast Cancer LYNPARZA (n=911) 10% 23% 31%

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    Discontinuations Reductions‡ Interruptions§
OlympiADMetastatic Breast Cancer LYNPARZA (n=205) 5% 25% 35%
Chemotherapy (n=91) 8% 31% 28%

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~9 out of 10 patients remained on LYNPARZA without an AR-related discontinuation1

In OlympiA

The most frequent ARs leading to dose interruption of LYNPARZA were anemia (11%), neutropenia (6%), nausea (5%), leukopenia (3.5%), fatigue (3%), and vomiting (2.9%) and the most frequent ARs leading to dose reduction of LYNPARZA were anemia (8%), nausea (4.7%), neutropenia (4.2%), fatigue (3.3%), leukopenia (1.8%), and vomiting (1.5%). The ARs that most frequently led to discontinuation of LYNPARZA were nausea (2%), anemia (1.8%), and fatigue (1.3%).1

In OlympiAD

The most frequent ARs leading to dose interruption of LYNPARZA were neutropenia (17.6%), palmar-plantar erythrodysesthesia (5.5%), anemia (2.2%), increased ALT (2.2%), increased AST (2.2%), leukopenia (2.2%), fatigue (1.1%), diarrhea (1.1%) decreased WBC (1.1%), pyrexia (1.1%).1

ARs were usually managed by dose interruption or dose reduction, rather than by discontinuation.1

  • *In OlympiA, the LYNPARZA dose was reduced to 250 mg BID. If further reduction was needed, then the dose could be reduced to 200 mg BID. If the reduced dose was not tolerated, no further dose reduction was allowed and LYNPARZA was discontinued.1,2
  • †For LYNPARZA, dose interruptions in OlympiA were allowed for a maximum of 4 weeks. If the AR causing the dose interruption was not resolved at 4 weeks, LYNPARZA was discontinued.2
  • ‡In OlympiAD, the LYNPARZA dose was reduced to 250 mg BID. If further reduction was needed, then the dose could be reduced to 200 mg BID. If the reduced dose of 200 mg BID was not tolerated, no further dose reduction was allowed and LYNPARZA was discontinued.3
  • §For LYNPARZA, repeated dose interruptions in OlympiAD were allowed as required, for a maximum of 4 weeks on each occasion.3
  • ALT=alanine aminotransferase; AST=aspartate aminotransferase; WBC=white blood cell.

Explore related content:

OlympiAEfficacy

Review the long-term efficacy data of LYNPARZA for patients with gBRCAm, HER2-negative, high-risk eBC. The OlympiA trial enrolled patients with HR+ or triple-negative breast cancer.

Explore the OlympiA data

LYNPARZA Adverse Reaction (AR) Management Guidance Website

Explore adverse reaction data from clinical trials, including median onset and duration of ARs, and view AR management strategies for certain ARs based on established medical protocols.

Learn more about AR data from clinical trials

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