Class: Biological Therapy

Generic Name: Olaparib

Trade Name: Lynparza™

For which conditions is this drug approved? Lynparza is used treat women with advanced ovarian cancer who have: a) received previous treatment with three or more prior chemotherapy medicines or a combination of chemotherapy medicines; and b) have a certain type of abnormal inherited BRCA gene.

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. You’ll take it two times a day.

How are patients typically monitored? Before you start taking Lynparza and while you’re 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 (occur in 30% or more of patients) side effects of treatment with Lynparza?

• Anemia
• Abdominal pain and discomfort
• Nausea
• Vomiting
• Diarrhea
• Fatigue, loss of strength, and weakness

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Lynparza?

• Decreased appetite
• Difficult or labored respiration
• Upper respiratory tract infection
• Joint pain
• Muscle pain
• Back pain
• Cough
• Rash
• Change to sense of taste

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.