From the Guidelines
Olaparib is typically given twice daily, with patients taking tablets every 12 hours, at a standard dose of 300 mg twice daily (total daily dose of 600 mg). This dosing schedule is based on the most recent and highest quality study, which is the SOLO-1 Phase III Randomized Trial 1. The trial demonstrated that maintenance olaparib reduced the risk of progression or death compared with placebo by 70% (PFS: HR, 0.30; 95% CI, 0.23 to 0.41; P < .0001) in patients with newly diagnosed advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer with a mutation in BRCA1, BRCA2, or both.
Some key points to consider when administering olaparib include:
- The medication should be taken on an empty stomach, with patients advised to wait at least one hour after taking it before eating.
- The twice-daily dosing schedule is important for maintaining therapeutic blood levels of the medication since olaparib has a relatively short half-life.
- Dose reductions may be necessary if patients experience significant side effects, but the twice-daily frequency is maintained even with lower doses.
- For maintenance treatment in various cancers such as ovarian, breast, pancreatic, and prostate cancers, this dosing schedule is continued until disease progression or unacceptable toxicity occurs, which can mean patients remain on the medication for months to years.
It's also worth noting that other studies, such as the PAOLA-1 trial 1 and the PRIMA trial 1, have also evaluated the efficacy and safety of olaparib in different patient populations, but the SOLO-1 trial provides the most relevant and up-to-date information on the dosing schedule of olaparib. Additionally, the ASCO guideline 1 and the FDA approval 1 also support the use of olaparib at a dose of 300 mg twice daily.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Olaparib Administration
- Olaparib is administered in different formulations, including capsules and tablets, with varying dosing instructions 2, 3.
- The originally approved capsule formulation is dosed at 400 mg twice daily, requiring patients to take eight 50 mg capsules twice daily 2.
- The recommended tablet dose is 300 mg twice daily, consisting of two 150 mg tablets, which offers greater convenience for patients 2, 3.
- Patients taking 400 mg of the capsules twice daily should be switched to 300 mg of the tablets twice daily when transitioning between formulations 3.
Dosing Considerations
- The capsule and tablet formulations have different bioavailability, and physicians must strictly adhere to the dosing instructions provided in the prescribing information 2, 3.
- In patients on a reduced dose of 200 mg capsules twice daily, consider switching to 250 mg twice daily of the tablet formulation 3.
- In patients on 100 mg capsules twice daily, consider 200 mg tablets twice daily 3.
- Particular care should be taken in transitioning patients who are on a reduced dose due to anemia, and close monitoring is recommended for the first 3 months with further dose reductions based on tolerability 3.
Clinical Trials and Studies
- Phase III studies with the tablet formulation are ongoing for multiple tumor types, including ovarian cancer 2.
- The SOLO-2 trial results support the use of the tablet formulation for maintenance treatment of recurrent ovarian cancer 2.
- Other studies, such as the PAOLA-1 trial, have investigated the use of olaparib in combination with bevacizumab for first-line maintenance treatment of advanced ovarian cancer 4.
- A phase 1b trial has also explored the combination of olaparib with the PI3K inhibitor alpelisib for patients with epithelial ovarian cancer 5.