List of Chinese instructions for Olaparib/Olaparib

1. Name: Olaparib, Olaparib, Olaparib, Lipadro, Lynparza

2. Indications:

Olaparib/Olaparib (Olaparib) is indicated for the treatment of the following conditions:

1. Ovarian cancer:

(1) First-Line Maintenance Therapy for BRCA-mutated Advanced Ovarian Cancer: Maintenance therapy for adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to first-line platinum-based chemotherapy.

(2) First-Line Maintenance Treatment of HRD-Positive Advanced Ovarian Cancer: In combination with bevacizumab, for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined as follows: deleterious or suspected deleterious BRCA mutations, and/or genomic instability.

(3) Maintenance therapy for BRCA-mutated recurrent ovarian cancer: Maintenance therapy for adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.

2. Breast cancer:

(1) Adjuvant therapy for BRCA-mutated HER2-negative high-risk early breast cancer: Adjuvant therapy for adult patients with harmful or suspected harmful gBRCAm human epidermal growth factor receptor 2 (HER2)-negative high-risk early ovarian cancer who have received neoadjuvant or adjuvant chemotherapy.

(2) BRCA-mutated HER2-negative metastatic breast cancer: Adult patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic cancer who have received chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have received prior endocrine therapy or be considered unsuitable for endocrine therapy.

3. Pancreatic cancer:

(1) First-line maintenance therapy for BRCA-mutated metastatic pancreatic cancer: Maintenance therapy for adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic cancer who have not progressed on at least 16 weeks of first-line platinum-based chemotherapy.

4. Prostate cancer:

(1) HRR-mutated metastatic castration-resistant prostate cancer (mCRPC): Adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR)-mutated mCRPC who have progressed on prior treatment with enzalutamide or abiraterone.

(2) BRCA-mutated mCRPC: In combination with abiterone, prednisone, or prednisone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) mCRPC.

3. Usage and dosage:

1. Before treatment: Select patients to receive olaparib treatment based on the presence of harmful or suspected harmful HRR gene mutations, including BRCA mutations, or genomic instability based on indications, biomarkers, and sample types.

2. Recommended dose: Lynparza is available in the form of tablets. The recommended dose is 300 mg taken orally twice a day, with or without food. Swallow tablet whole. Do not chew, crush, dissolve, or split tablets. If a patient misses a dose of olaparib, instruct the patient to take the next dose at the scheduled time.

(1) For patients with HRD-positive advanced ovarian cancer, the recommended dose of bevacizumab is 15 mg/kg every three weeks, and the dosing period should be 15 months, including chemotherapy and maintenance periods.

(2) For patients with BRCA mutation-converted mCRPC, the recommended dose of abiraterone is 1,000 mg orally once a day, and abiraterone should be taken orally 5 mg twice a day in combination with prednisone or prednisolone. Patients with mCRPC should also receive concurrent gonadotropin-releasing hormone (GnRH) analog therapy or should undergo bilateral orchiectomy.

3. Medication duration:

(1) Ovarian cancer: Continue treatment until disease progression, unacceptable toxicity, or completion of 2 years of treatment. Patients who achieve complete response (no radiographic evidence of disease) after 2 years should discontinue treatment. Patients with evidence of disease within 2 years may be treated after 2 years if they would derive further benefit from continued treatment.

(2) Breast cancer: Continue treatment for a total of 1 year, or until disease recurrence or unacceptable toxicity, whichever occurs first. According to current clinical practice guidelines, patients receiving olaparib for hormone receptor-positive HER2-negative cancer should continue to receive concomitant endocrine therapy.

(3) Pancreatic cancer, prostate cancer: Continue treatment until disease progression or unacceptable toxicity.

4. Dose adjustment: In order to control adverse reactions, consider interrupting treatment or reducing the dose. It is recommended that the initial dose may be reduced to 250 mg twice daily; if further dose reduction is necessary, reduce to 200 mg twice daily.

4. Adverse reactions:

In clinical studies of olaparib, the most common adverse reactions were nausea, fatigue, anemia (low levels of red blood cells), vomiting, diarrhea, decreased appetite, headache, neutropenia (low levels of neutrophils, a type of white blood cell that fights infection), and taste disturbance , cough, leukopenia (low levels of white blood cells), dizziness, difficulty breathing, and indigestion (heartburn); the most common serious adverse reactions are anemia, neutropenia, fatigue, leukopenia, and thrombocytopenia (low levels of platelets).

5. Storage:

Olaparib is available in 150 mg and 100 mg tablets, and is stored at 20ºC to 25ºC (68ºF to 77ºF), with excursions allowed within the range of 15ºC to 30ºC (59ºF to 86ºF). Please store in the original bottle to protect it from moisture.

6. Special groups:

Women should not breastfeed during treatment with olaparib and for one month after stopping treatment; women of reproductive potential should use effective contraception during treatment and for 6 months after the last dose

7. Mechanism of action:

Olaparib blocks the action of an enzyme called ADP-ribose polymerase (PARP), which helps repair DNA damaged during division of normal and cancer cells. Cancer cells with mutations such as BRCA1 or BRCA2 mutations rely more heavily on PARP to repair their DNA and continue dividing. Therefore, when PARP is blocked, damaged DNA in cancer cells cannot be repaired, and therefore, the cancer cells die.