Lynparza 150 mg (Olaparib)

Adult dose

Take 300 mg (2 tablets of 150 mg) orally twice daily (total daily dose of 600 mg). Duration of treatment Monotherapy maintenance treatment for advanced BRCA-mutated high-grade epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer): Treatment may be continued for 2 years or until disease progression or unacceptable toxicity occurs. Patients who achieve a complete response (no radiologic evidence of disease) in the second year should discontinue treatment. Patients who have evidence of disease in the second year but, in the opinion of their treating physician, may derive additional benefit from continuing treatment may continue treatment beyond 2 years. Platinum-sensitive recurrent high-grade epithelial ovarian cancer (including fallopian tube cancer or primary peritoneal cancer): It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity occurs. Maintenance treatment in combination with bevacizumab: Treatment may be continued for 2 years or until disease progression or unacceptable toxicity occurs. Patients who achieve a complete response (no radiologic evidence of disease) in the second year should discontinue treatment. Patients who have evidence of disease in the second year but, in the opinion of their treating physician, may derive additional benefit from continuing treatment may continue treatment beyond 2 years. (Refer to the prescribing information for bevacizumab.) Adjuvant treatment after surgery in patients with gBRCA-mutated, HER2-negative, high-risk early breast cancer: It is recommended that patients continue treatment for up to 1 year or until disease recurrence or unacceptable toxicity occurs. Patients who are hormone receptor-positive should continue concomitant endocrine therapy. HER2-negative metastatic breast cancer: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity occurs. Maintenance treatment after first-line treatment of metastatic pancreatic cancer: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity occurs. BRCA-mutated metastatic castration-resistant prostate cancer: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity occurs. Combination therapy with abiraterone and prednisolone for the treatment of metastatic castration-resistant prostate cancer: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity occurs. When Lynparza is used in combination with abiraterone, refer to the prescribing information for the recommended dosage of abiraterone (see section 12, Information for Healthcare Professionals, under Precautions for Use). First-line maintenance treatment in combination with durvalumab for advanced or recurrent endometrial cancer: It is recommended that treatment be continued until progression of the underlying disease or unacceptable toxicity occurs. When this medicine is administered in combination with durvalumab, refer to the prescribing information for the recommended dosage of durvalumab (see section 12, Information for Healthcare Professionals, under Precautions for Use). The recommended dose reduction is 250 mg (one 150mg tablet and one 100mg tablet) twice daily (equivalent to a total daily dose of 500mg). If further dose reduction is required, a reduction to 200mg (two 100mg tablets) twice daily (equivalent to a total daily dose of 400mg) is recommended. Concomitant use with CYP3A inhibitors Concomitant administration with strong or moderate CYP3A inhibitors is not recommended; consider alternative treatment. If concomitant administration with a strong CYP3A inhibitor is necessary, it is recommended that the dose of this medicine be reduced to 100mg (one 100mg tablet) twice daily (equivalent to a total daily dose of 200mg). If concomitant administration with a moderate CYP3A inhibitor is necessary, it is recommended that the dose of this medicine be reduced to 150mg (one 150mg tablet) twice daily (equivalent to a total daily dose of 300mg) (see section 4, Interactions).

This drug may cause serious blood diseases such as bone marrow dysplasia syndrome or acute myeloid leukemia; therefore, any abnormal symptoms during treatment should be consulted with a healthcare professional immediately. There is a risk of venous thromboembolism, particularly pulmonary embolism, so if symptoms such as breathlessness or leg swelling occur, the patient should visit the hospital immediately. Pneumonitis may occur; if respiratory symptoms such as cough, shortness of breath, or fever develop or worsen, the patient must stop taking the medication and undergo immediate examination. This medication can harm a fetus, so pregnant women should not take it, and fertile women and male patients should use effective contraception during and for a certain period after treatment. Hematological abnormalities like anemia and leukopenia occur frequently, requiring regular blood tests before and during treatment. Liver function abnormalities can occur rarely, so monitoring of liver function tests and symptoms is necessary, and if liver damage is suspected, the medication should be stopped. Symptoms such as fatigue, dizziness, and weakness may occur, necessitating caution when driving or operating machinery. The drug has many drug interactions; taking it with specific antibiotics, antivirals, grapefruit juice, etc., can change its efficacy, so patients must inform healthcare professionals of any medications they are taking. Precautions regarding pregnancy tests and contraception are necessary, and nursing is advised to be avoided during and for a certain period after the use of this drug. It is unsafe to use this medication in patients with severe kidney or liver dysfunction, and elderly patients can use it without special dosage adjustments, albeit with caution. There are no specific antidotes for overdose, so general supportive treatment should be followed according to a doctor's instructions. Keep this medication out of the reach of children and store it in its original container to maintain quality.

• Myelodysplastic syndrome
• acute myeloid leukemia
• venous thromboembolism
• pulmonary embolism
• pneumonia
• anemia
• nausea
• fatigue
• weakness
• vomiting

This medication must be stored in a sealed container to avoid exposure to air or moisture. Additionally, it is safe to store at room temperature, between 1 degree Celsius and 30 degrees Celsius, avoiding excessively hot or cold locations.

Appearance

Green to gray-green, oval, film-coated tablets that are biconvex on both sides

Package unit

56 tablets (8 tablets/PTP x 7)