CV: DEEP VEIN THROMBOSIS.
Derm: dermatitis/rash.
GI: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
Hemat: anemia, lymphopenia, neutropenia, thrombocytopenia, MYELODYSPLASTIC SYNDROME (MDS)/ACUTE MYELOID LEUKEMIA (AML).
Metab: ↓ appetite.
MS: arthralgia, back pain, myalgia.
Neuro: fatigue, headache, dysgeusia, weakness.
Resp: cough, PNEUMONITIS, PULMONARY EMBOLISM.
First-Line Maintenance Treatment of BRCA-Mutated Advanced Ovarian Cancer or Advanced Ovarian Cancer (in Combination with Bevacizumab)
- PO (Adults): 300 mg twice daily until disease progression, unacceptable toxicity, or completion of 2 yr of treatment. If complete response achieved after 2 yr of treatment (i.e., no radiological evidence of disease), can stop therapy. If evidence of disease at 2 yr, may continue therapy. Concurrent use of strong CYP3A4 inhibitor: 100 mg twice daily until disease progression, unacceptable toxicity, or completion of 2 yr of treatment. If complete response achieved after 2 yr of treatment (i.e., no radiological evidence of disease), can stop therapy. If evidence of disease at 2 yr, may continue therapy. Concurrent use of moderate CYP3A4 inhibitor: 150 mg twice daily until disease progression, unacceptable toxicity, or completion of 2 yr of treatment. If complete response achieved after 2 yr of treatment (i.e., no radiological evidence of disease), can stop therapy. If evidence of disease at 2 yr, may continue therapy.
Renal Impairment
- PO (Adults): CCr 31–50 mL/min: 200 mg twice daily until disease progression, unacceptable toxicity, or completion of 2 yr of treatment. If complete response achieved after 2 yr of treatment (i.e., no radiological evidence of disease), can stop therapy. If evidence of disease at 2 yr, may continue therapy.
Adjuvant Treatment of Germline BRCA-Mutated HER2-Negative High Risk Early Breast Cancer
- PO (Adults): 300 mg twice daily for 1 yr or until disease recurrence or unacceptable toxicity, whichever occurs first. Concurrent use of strong CYP3A4 inhibitor: 100 mg twice daily for 1 yr or until disease recurrence or unacceptable toxicity, whichever occurs first. Concurrent use of moderate CYP3A4 inhibitor: 150 mg twice daily for 1 yr or until disease recurrence or unacceptable toxicity, whichever occurs first.
Renal Impairment
- PO (Adults): CCr 31–50 mL/min: 200 mg twice daily for 1 yr or until disease recurrence or unacceptable toxicity, whichever occurs first.
Recurrent Ovarian Cancer, Germline BRCA-Mutated HER2–Negative Metastatic Breast Cancer, Germline BRCA-Mutated Metastatic Pancreatic Adenocarcinoma, HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer, BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer
- PO (Adults): 300 mg twice daily until disease progression or unacceptable toxicity. Concurrent use of strong CYP3A4 inhibitor: 100 mg twice daily until disease progression or unacceptable toxicity. Concurrent use of moderate CYP3A4 inhibitor: 150 mg twice daily until disease progression or unacceptable toxicity.
Renal Impairment
- PO (Adults): CCr 31–50 mL/min: 200 mg twice daily until disease progression or unacceptable toxicity.
Therapeutic Classification: antineoplastics
Pharmacologic Classification: enzyme inhibitors
Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Metabolism/Excretion: Extensively metabolized (mostly by the CYP3A isoenzyme); 15% excreted unchanged in urine, 6% in feces.
Half-life: 14.9 hr.