Olaparib Dosage

Usual Adult Dose for Ovarian Cancer

Patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy:
CAPSULES:
400 mg (eight 50 mg capsules) orally twice a day
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity
TABLETS:
300 mg (two 150 mg tablets) orally twice daily; the 100-mg tablet is available for dose reduction
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity

Patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy
TABLETS:
300 mg (two 150 mg tablets) orally twice daily; the 100-mg tablet is available for dose reduction
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity


Comments:
-NOTE: This drug is available as 50 mg capsules (50 mg) OR 100 and 150 mg tablets; do not substitute capsules with tablets on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
-This drug may be taken with or without food.
-Capsules should be swallowed whole and not chewed, dissolved, or opened. Do not take capsules which appear deformed or show evidence of leakage.
-Tablets should be swallowed whole and not chewed, dissolved, crushed, or divided.
-If a patient misses a dose, instruct them to take their next dose at its scheduled time.

Uses:
-For patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy; patients should be selected based on an approved test for the presence of deleterious or suspected deleterious germline BRCA-mutations
-For the maintenance therapy patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy

Usual Adult Dose for Breast Cancer

TABLETS:
300 mg (two 150 mg tablets) orally twice daily; the 100-mg tablet is available for dose reduction
Duration of therapy: Continue treatment until disease progression or unacceptable toxicity

Comments:
-Tablets should be swallowed whole and not chewed, dissolved, crushed, or divided.
-If a patient misses a dose, instruct them to take their next dose at its scheduled time.

Use: For patients with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting; patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy; patients should be selected based on an approved test

Renal Dose Adjustments

CAPSULES:
-Mild renal impairment (CrCl 51 to 80 mL/min): No adjustment required.
-Moderate renal impairment (CrCl 31 to 50 mL/min): 300 mg (six 50 mg capsules) twice a day, for a total daily dose of 600 mg
-Severe renal impairment (CrCl less than 30 mL/min) or end stage renal disease: Data not available

TABLETS:
-Mild renal impairment (CrCl 51 to 80 mL/min): No adjustment required.
-Moderate renal impairment (CrCl 31 to 50 mL/min): 200 mg (two 100 mg tablets) twice day, for a total daily dose of 400 mg
-Severe renal impairment (CrCl less than 30 mL/min) or end stage renal disease: Data not available

Liver Dose Adjustments

CAPSULES/TABLETS:
-Mild hepatic impairment (Child-Pugh A): No adjustment recommended.
-Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment: Data not available

Dose Adjustments

CAPSULES:
-First dose reduction: 200 mg (four 50 mg capsules) orally twice a day, for a total daily dose of 400 mg
-Second dose reduction: 100 mg (two 50 mg capsules) orally twice a day, for a total daily dose of 200 mg
TABLETS:
-First dose reduction: 250 mg (one 150 mg tablet and one 100 mg tablet) orally twice a day, for a total daily dose of 500 mg
-Second dose reduction: 200 mg (two 100 mg tablets) orally twice a day for a total daily dose of 400 mg, for a total daily dose of 400 mg

Avoid concomitant use of CYP450 3A inhibitors and consider alternative agents. If concomitant use cannot be avoided:
CAPSULES:
-Reduce dose to 200 mg (four 50 mg capsules) orally twice a day when used with moderate CYP450 3A inhibitor
-Reduce dose to 150 mg (three 50 mg capsules) orally twice a day when used with strong CYP450 3A inhibitor
TABLETS:
-Reduce dose to 150 mg (one 150 mg tablet) orally twice a day when used with moderate CYP450 3A inhibitor
-Reduce dose to 100 mg (one 100 mg tablet) orally twice a day when used with strong CYP450 3A inhibitor

Precautions

CONTRAINDICATIONS:
-None

Safety and efficacy have not been established in patients younger than 18 years.
This drug is not recommended for use in children.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-NOTE: This drug is available as 50 mg capsules (50 mg) OR 100 and 150 mg tablets; do not substitute capsules with tablets on a milligram-to-milligram basis due to differences in the dosing and bioavailability of each formulation.
-This drug may be taken with or without food.
-Capsules should be swallowed whole and not chewed, dissolved, or opened. Do not take capsules which appear deformed or show evidence of leakage.
-Tablets should be swallowed whole and not chewed, dissolved, crushed, or divided.
-If a patient misses a dose, instruct them to take their next dose at its scheduled time.
-Advise patients to avoid grapefruit, grapefruit juice, and Seville oranges during treatment as they may increase the level of this drug in the blood.

Monitoring:
-Monitor complete blood count testing at baseline and monthly thereafter.
-For prolonged hematological toxicities, monitor blood counts weekly and interrupt treatment until recovery.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer