Olaparib is indicated for advanced ovarian cancer with germline BRCA mutations

Olaparib instructions

Product Name: LuciOlap

Manufacturer: Lucius Pharmaceuticals

Chinese name: Olaparib

English name: Olaparib

Drug approval number: 10 L 1028/23

 

【Summary】

Olaparib is a poly ADP-glycan polymerase (PARP) inhibitor that was approved by the FDA on December 19, 2014 for the treatment of advanced ovarian cancer with BRCA gene mutations and HER2-metastatic breast cancer with BRCA mutations who have received at least three chemotherapy cycles.

 

【Indications】

1. It is indicated as a single-drug treatment for patients with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA mutations who have been treated with 3 or more lines of chemotherapy.

2. Used to treat germline BRCA gene mutations, HER2-negative metastatic breast cancer, and patients who have previously received chemotherapy including neoadjuvant, adjuvant or targeted chemotherapy for metastatic breast cancer.

 

【Specification】

150mg/tablet, 120 tablets/box.

 

【Storage】

Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).

 

【Usage and Dosage】

The usage and dosage of this product in different dosage forms and specifications may vary. Please read the specific drug instructions for use, or follow the doctor's advice.

Olaparib tablets:

1. This product should be used under the guidance of a doctor who has experience in using anti-tumor drugs.

2. Recommended dose: 300 mg (2 150 mg tablets), twice a day, equivalent to a total daily dose of 600 mg.

3. Patients should start treatment with this product within 8 weeks after the end of platinum-containing chemotherapy and continue treatment until disease progression or unacceptable toxic reactions occur.

4. Dosage: Oral administration. This product should be swallowed whole and should not be chewed, crushed, dissolved or broken. This product can be taken with or without meals.

5. Missed dose: If the patient misses a dose of medication, the next dose should be taken as scheduled.

Dosage Considerations

(1) Targeting adverse events

To manage adverse events, such as nausea, vomiting, diarrhea, anemia, etc., interruption of treatment or dose reduction may be considered.

If a dose reduction is necessary, the recommended dose is reduced to 250 mg (1 150 mg tablet, 1 100 mg tablet), taken twice daily (equivalent to a total daily dose of 500 mg).

If further dose reduction is necessary, the recommended dose is reduced to 200 mg (two 100 mg tablets) taken twice daily (equivalent to a total daily dose of 400 mg).

(2) Concomitant use of cytochrome P450 (CYP) 3A inhibitors

When using this product, it is not recommended to use strong or moderate CYP3A inhibitors in combination, and other alternative drugs should be considered. If a strong CYP3A inhibitor must be used in combination, it is recommended to reduce the dose of this product to 100 mg (1 100 mg tablet), twice a day (equivalent to a total daily dose of 200 mg). If a moderate CYP3A inhibitor must be used in combination, it is recommended to reduce the dose of this product to 150 mg (1 150 mg tablet), twice a day (equivalent to a total daily dose of 300 mg).

Use in Special Populations

(1) Renal impairment: This product can be used in patients with mild renal impairment (creatinine clearance 51-80 mL/min) without dose adjustment. For patients with moderate renal impairment (creatinine clearance 31-50 mL/min), the recommended dose of this product is 200 mg (two 100 mg tablets), twice a day (equivalent to a total daily dose of 400 mg). There is no safety and efficacy data for this product in patients with severe renal impairment or end-stage renal disease (creatinine clearance ≤ 30 mL/min), and this product is not recommended.

(2) Liver impairment: Patients with mild liver impairment (Child-Pugh grade A) can use this product without adjusting the dose. There is no safety and efficacy data for this product in patients with moderate or severe liver impairment, and this product is not recommended.

(3) Children or adolescents: The safety and efficacy of this product in children and adolescents have not been established and is not recommended for use in pediatric patients.

(4) Elderly (>65 years old): No adjustment of the starting dose is required for elderly patients. There are limited clinical data for patients aged 75 years and above.

 

【Adverse Reactions】

1. The most common adverse reactions (≥20%) in clinical trials are:

1) Anemia, nausea, fatigue (including asthenia), vomiting, diarrhea

2) Taste disturbance, indigestion, headache, loss of appetite, nasopharyngitis/pharyngitis/URI

3) Cough, arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash and abdominal pain/discomfort

2. The most common laboratory abnormalities (≥25%) are:

Creatinine increased, mean corpuscular volume increased, hemoglobin decreased, lymphocytes decreased, absolute neutrophil count decreased, and platelets decreased.

 

【Warnings and Precautions】

1. Myelodysplastic syndrome/acute myeloid leukemia: MDS/AML has occurred in patients exposed to olaparib , and some cases have been fatal. Monitor patients for hematologic toxicity at baseline and monthly thereafter. Discontinue if MDS/AML is confirmed.

2. Pneumonitis: Pneumonia has occurred in patients exposed to olaparib and some cases have been fatal. Interrupt treatment if pneumonitis is suspected. Discontinue treatment when confirmed.

3. Embryo-fetal toxicity: Olaparib can cause fetal harm. Advise females of childbearing potential of the potential hazard to the fetus and to avoid pregnancy.

 

【Drug Interactions】

1. CYP3A inhibitors: Avoid the concomitant use of strong and moderate CYP3A inhibitors. If inhibitors cannot be avoided, reduce the dose.

2. CYP3A inducers: Avoid the concomitant use of strong and moderate CYP3A inducers. If moderate CYP3A inducers cannot be avoided, they are recognized to have the potential to reduce efficacy.

 

[Use in special populations]

Nursing mothers: Discontinue treatment or discontinue breastfeeding.