Flash VIG-news: LYNPARZA® (olaparib): risk of medication errors with new pharmaceutical form

LYNPARZA® capsules (50 mg) and LYNPARZA® tablets (100 mg and 150 mg) are not interchangeable on a milligram by milligram basis due to variations in dose/dosage and the biological availability of each formulation.

Since November 1, 2018, the new formulation of LYNPARZA® (olaparib) in the form of tablets (100 mg en 150 mg) has been on the market in Belgium. The FAMHP wants to make health care practitioners aware of the risk of medication errors.

The dosage for LYNPARZA® tablets and capsules is different:

  • For 50 mg capsules: 400 mg two times a day (meaning 8 capsules in the morning and in the evening);
  • For 150 mg tablets: 300 mg two times a day (meaning 2 tablets in the morning and in the evening);

100 mg tablets are only used for dose reductions in tablet  form.

Capsules and tablets are not substitutable on a milligram by milligram basis: there is a risk of overdose and of more adverse events when the dose of the capsules is used for the tablets. In addition, there is a chance of reduced efficacy when the dose of the tablets is used for the capsules.

In order to avoid medication errors, prescribing physicians must specify the formulation and the dose of LYNPARZA® on every prescription, and pharmacists must make sure that they deliver the correct formulation to patients.

You can find more information on the doses is available in the Direct Healthcare Professional Communication (DHPC) distributed by AstraZeneca and published on the website of the FAMHP.

Patients must be informed about the correct dose they must take. For patients switching from capsules to tablets, there must be an explanation of how the doses of each pharmaceutical form differ in milligrams.

This information is included in the Summary of Product Characteristics (SPC), the package insert of both formulations of LYNPARZA® and are available on the website of the FAMHP.

LYNPARZA® tablets are indicated as a monotherapy for the maintenance treatment of adult patients with platinum-sensitive, recurring high-grade epithelial ovarian, tubal or primary peritoneal cancer that display a response (complete or partial) to chemotherapy containing platinum.

LYNPARZA® capsules are indicated as a monotherapy for the maintenance treatment of adult patients with BRCA-mutated (in germline and/or somatic) platinum-sensitive, recurring high-grade serosa epithelial ovarian, tubal or primary peritoneal cancer that display a response (complete or partial) to chemotherapy containing platinum.

Last updated on
30/01/2019