Olanib Olaparib 150mg Everest

Product Name: Olaparib

Active Ingredient: Olaparib

Specification: 150 mg × 120 tablets/bottle

Manufacturer: Everest Pharmaceuticals

Indications:

Ovarian Cancer

Maintenance treatment for recurrent ovarian cancer: Indicated for the treatment of adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy.

Advanced ovarian cancer with a *BRCA* gene mutation that has previously received three or more lines of chemotherapy.

Breast Cancer

Adult patients with *BRCA*-mutated, HER2-negative metastatic breast cancer who have previously received chemotherapy; for patients with HR-positive breast cancer, they must have previously received endocrine therapy or be considered ineligible for endocrine therapy.

Dosage and Administration:

The recommended dosage is 300 mg (two 150 mg tablets) taken orally twice daily; it may be taken with or without food.

Continue treatment until disease progression or the occurrence of intolerable toxicity.

Olaparib tablets and capsules are not interchangeable, to avoid the risk of overdose.

For patients with moderate renal impairment (creatinine clearance [CLcr] 31–50 mL/min), the dosage should be reduced to 200 mg taken twice daily.

Adverse Reactions:

The most common adverse reactions (≥ 20%) observed in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, neutropenia, leukopenia, nasopharyngitis/upper respiratory tract infection/influenza, respiratory tract infection, diarrhea, arthralgia/myalgia, headache, dyspepsia, decreased appetite, constipation, and stomatitis.

The most common laboratory abnormalities (≥ 25%) were decreased hemoglobin, increased mean corpuscular volume (MCV), lymphopenia, leukopenia, decreased absolute neutrophil count (ANC), increased serum creatinine, and thrombocytopenia.

Warnings and Precautions:

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML); Pneumonitis; Embryo-Fetal Toxicity. Drug Interactions:

CYP3A Inhibitors: Avoid the concomitant use of strong or moderate CYP3A inhibitors. If the use of such inhibitors cannot be avoided, reduce the dosage of Olaparib.

CYP3A Inducers: Avoid the concomitant use of strong or moderate CYP3A inducers, as this may reduce therapeutic efficacy.

Use in Specific Populations:

Women are advised not to breastfeed while taking this medication.

Product Specifications

Product Name: Olaparib 150mg * 120 Tablets/Bottle (Olanib / Everest Olaparib / Lynparza)

Common Name: Olaparib

Active Ingredient: Olaparib

Dosage Form: Tablets

Specification: 150mg * 120 tablets/bottle

Manufacturer: Everest Pharmaceuticals

Indications:

Ovarian Cancer

Maintenance treatment for recurrent ovarian cancer: Indicated for the treatment of adult patients with recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have achieved a complete or partial response to platinum-based chemotherapy.

Advanced ovarian cancer with BRCA gene mutations that has previously received three or more lines of chemotherapy.

Breast Cancer

Adult patients with BRCA gene-mutated, HER2-negative metastatic breast cancer who have previously received chemotherapy; for HR-positive breast cancer patients, prior endocrine therapy is required, or the patient must be considered unsuitable for endocrine therapy.

Dosage and Administration: The recommended dosage is 300mg (two 150mg tablets) taken orally twice daily; it may be taken with or without food.

Continue treatment until disease progression or until intolerable toxicity occurs.

Olaparib tablets and capsules are not interchangeable, to avoid the risk of overdose.

For patients with moderate renal impairment (creatinine clearance [CLcr] between 31 and 50 mL/min), the dosage may be reduced to 200mg, taken twice daily.