Understanding possible side effects

When starting any medication, you should be aware of the possible side effects it has—not just how well it may work.

What are the possible side effects of LYNPARZA?

LYNPARZA may cause serious side effects that can lead to death, including bone marrow and lung problems.

It is important to know the potential side effects of any medication you are taking. Be sure to keep track of any side effects you experience while taking LYNPARZA and share them with your healthcare team.

The most common side effects of LYNPARZA are:

  • Anemia
  • Nausea or vomiting
  • Tiredness or weakness
  • Diarrhea
  • Indigestion or heartburn
  • Headache
  • Loss of appetite
  • Changes in how food tastes
  • Changes in kidney function blood tests
  • Sore throat or runny nose
  • Upper respiratory infection
  • Cough
  • Pain in the joints, muscles, and back
  • Rash
  • Pain or discomfort in the stomach area

In a study, the majority of side effects observed with LYNPARZA were rated as mild or moderate.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of LYNPARZA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-10881-800-FDA-1088 or visit www.FDA.gov/medwatch.

Keep a record

It is important to keep a record of any side effects you may experience, as well as any medicines you take.

  • Consider using a journal to write down all symptoms, how long they lasted, and what you did to relieve them so that you can discuss these details with your physician
  • Keep a list of all your medicines to show your healthcare provider and pharmacist when you get new medicine

My LYNPARZA support program

Your doctor may have experience managing common side effects. The My LYNPARZA program provides you with a treatment journal to help you keep track

Get my treatment journal

How LYNPARZA can help

Learn about the results of the clinical studies of LYNPARZA

See the results

BRCA Testing

Testing for a BRCA1/BRCA2 mutation will help determine who may be eligible for treatment with LYNPARZA

Get the facts

INDICATION

LYNPARZA is a prescription medicine used to treat women with advanced ovarian cancer who have received previous treatment with 3 or more prior chemotherapy medicines or a combination of chemotherapy medicines for their cancer, and have a certain type of abnormal inherited BRCA gene.

Your healthcare provider will perform a test to make sure that LYNPARZA is right for you.

Please see Important Safety Information below.

IMPORTANT SAFETY INFORMATION

There are no contraindications (a condition in which the treatment should not be used) for LYNPARZA.

LYNPARZA may cause serious side effects that can lead to death including bone marrow problems and lung problems. Some people who have..Read More ovarian cancer or who have received previous treatment with chemotherapy, radiotherapy or certain other medicines for their cancer have developed bone marrow problems called Myelodysplastic syndrome (MDS) or Acute Myeloid Leukemia (AML) during treatment with LYNPARZA. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.

Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms to discuss with your healthcare provider include weakness, weight loss, fever, frequent infections, blood in your urine/stool, shortness of breath, feeling very tired, and bruising or bleeding more easily.

You will undergo blood tests before, and every month during, treatment with LYNPARZA to monitor your blood cell counts. Weekly blood tests will be performed if you have low blood cell counts that last a long time. Your healthcare provider may stop treatment with LYNPARZA until your blood cell counts improve.

Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis (inflammation of the lungs).

Before you take LYNPARZA, tell your healthcare provider about all of your medical conditions including:

  • lung or breathing problems
  • liver problems
  • kidney problems
  • are pregnant or plan to become pregnant. LYNPARZA can harm your unborn baby and may cause loss of pregnancy (miscarriage).
    • If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after receiving the last dose of LYNPARZA.
    • Talk to your healthcare provider about birth control methods that may be right for you.
    • Tell your healthcare provider right away if you become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby.

Avoid grapefruit, grapefruit juice and Seville oranges during treatment as they may increase the levels of LYNPARZA in your blood.

The most common side effects are anemia, nausea or vomiting, tiredness or weakness, diarrhea, indigestion or heartburn, headache, loss of appetite, changes in how food tastes, changes in kidney function blood tests, sore throat or runny nose, upper respiratory infection, cough, pain in the joints, muscles, and back, rash, and pain or discomfort in the stomach area.

These are not all the possible side effects of LYNPARZA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088 1-800-FDA-1088.

Please see complete Prescribing Information, including Patient Information (Medication Guide).

The information on this Web site should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about LYNPARZA, talk to your doctor or pharmacist. Only you and your healthcare professional can decide if LYNPARZA is right for you.