奥拉帕尼胶囊(Lynparza olaparib)

[Function and Indications] Lynparza olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated as monotherapy for patients with deleterious or suspected deleterious germline BRCA mutations (as detected by an FDA-approved test) in advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

[Model and Specifications] 50 mg

[Usage and Dosage] The recommended dose is 400 mg taken twice daily. Continue treatment until disease progression or unacceptable toxicity. For adverse reactions, consider dose interruption of treatment or dose reduction.

[Precautions] Exposure to Lynparza occurred in patients with myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), some of which were fatal. Monitor patients for hematological toxicity at baseline and monthly thereafter. Stop if MDS/AML is confirmed.

Pneumonitis: Exposure to Lynparza olaparib occurred in patients, some of which were fatal. Interrupt treatment if pneumonitis is suspected. Discontinue if pneumonitis is confirmed.

Embryo-fetal toxicity: Lynparza olaparib can cause fetal harm. Advise females with a potential risk to a fetus of reproductive potential to avoid pregnancy.

Adverse reactions and contraindications: The most common adverse reactions (≥20%) in clinical trials were anemia, nausea, fatigue (including asthenia), vomiting, diarrhea, dysgeusia, dyspepsia, headache, decreased appetite, nasopharyngitis/pharyngitis/URI, cough, arthralgia/musculoskeletal pain, myalgia, back pain, dermatitis/rash, and abdominal pain/discomfort.

The most common laboratory abnormalities (≥25%) were increased creatinine, increased mean corpuscular volume, decreased hemoglobin, decreased lymphocytes, decreased absolute neutrophil count, and decreased platelets.

Pregnant women: Discontinue treatment or discontinue breastfeeding.

Drug interactions: CYP3A inhibitors: Avoid concomitant use of strong and moderate CYP3A enzyme inhibitors. If inhibitors cannot be avoided, reduce dose.

CYP3A Inducers: Avoid concomitant use of strong and moderate CYP3A inducers. If moderate CYP3A inducers cannot be avoided, be aware of the potential for reduced efficacy.