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Class: Biological Therapy
Generic Name: Olaparib
Trade Name: Lynparza™

For which conditions is Lynparza approved for? Lynparza is approved for the following:

  • Advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy.

Aadvanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy.

  • Ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, as maintenance treatment, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
  • Advanced ovarian cancer with a certain type of abnormal inherited BRCA gene, and have received treatment with 3 or more prior types of chemotherapy medicines.

Aa certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy.

  • Metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy.
  • Prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone.

What is the mechanism of action? Lynparza is a targeted drug called a PARP inhibitor. The PARP enzyme plays a role in DNA repair, including the repair of DNA damage from chemotherapy. Drugs that inhibit this enzyme may contribute to cancer cell death and increased sensitivity to chemotherapy.

How is Lynparza typically given (administered)? Lynparza is given as a capsule.

How are patients typically monitored? Before you start taking Lynparza and while you are on treatment, your doctor will check your blood cell counts to make sure you’re not developing a serious bone marrow disorder or cancer. Your doctor will also regularly check your lung function and monitor you for inflammation in your lung tissue.

What are the common side effects of treatment with Lynparza as a single agent?

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  • Nausea
  • Fatigue
  • Anemia
  • Vomiting
  • Diarrhea
  • Decreased appetite
  • Headache
  • Changes in taste
  • Cough
  • Neutropenia
  • Shortness of breath
  • Dizziness
  • Indigestion
  • Leukopenia
  • Thrombocytopenia

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all of your medical conditions, especially if you have: Lung or breathing problems Liver problems Kidney problems
  • Avoid grapefruit, grapefruit juice and Seville oranges during treatment with Lynparza. Grapefruit and Seville oranges may increase the level of Lynparza in your blood.
  • Take Lynparza exactly as your healthcare provider tells you.
  • Swallow Lynparza capsules whole. Do not chew, dissolve, or open the capsules.
  • Do not take Lynparza capsules if they look damaged or show signs of leakage.
  • If you miss a dose of Lynparza, take your next dose at your usual scheduled time. Do not take an extra dose to make up for a missed dose.
  • If you take too much Lynparza, call your healthcare provider or go to the nearest emergency room right away.

Are there any special precautions patients should be aware of before starting treatment?

  • Tell your doctor if you are pregnant or plan to become pregnant. Lynparza may harm your unborn baby, so you should not become pregnant during treatment. If you become pregnant during treatment or think you may be pregnant, tell your healthcare provider right away.
  • Women who are able to become pregnant should use effective birth control during treatment with Lynparza and for one month after the last dose.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Lynparza will pass into your breast milk. You and your healthcare provider should decide if you will take Lynparza or breastfeed—you should not do both.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of the medicines you take and show them to your healthcare providers and pharmacist when you get a new medicine.

When should patients notify their physician?

  • Tell your doctor right away if you have signs of bone marrow problems called myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Symptoms may include: Weakness Weight loss Fever Frequent infections Blood in urine or stool Shortness of breath Feeling very tired Bruising or bleeding more easily
  • Tell your doctor if you have any new or worsening symptoms of lung problems. These include: Shortness of breath Fever Cough Wheezing
  • Tell your doctor about any side effects that bother you or don’t go away.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Updated 4/21