Safety information for LYNPARZA

Serious LYNPARZA side effects

LYNPARZA may cause serious side effects that can lead to death, including bone marrow problems called Myelodysplastic Syndrome (MDS) or a type of cancer of the blood called Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your health care 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 may include:

  • Weakness
  • Weight loss
  • Fever
  • Frequent infections
  • Blood in urine or stool
  • Shortness of breath
  • Feeling very tired
  • Bruising or bleeding more easily

Your health care provider will do blood tests to check your blood cell counts:

  • Before treatment with LYNPARZA
  • Every month during treatment with LYNPARZA
  • Weekly if you have low blood cell counts that last a long time. Your health care provider may stop treatment with LYNPARZA until your blood cell counts improve

Tell your health care provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your health care provider may do a chest x-ray if you have any of these symptoms. Your health care provider may temporarily stop treatment or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Talk to your health care provider immediately if you are experiencing any of these symptoms while taking LYNPARZA.

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Common LYNPARZA side effects

It’s normal to be concerned about side effects. However, health care providers are trained to manage potential side effects. Before you begin treatment, consider talking to your health care provider about how he or she plans to help manage side effects. They may decide to prescribe medicines to treat some of these symptoms. During treatment, keep track of any side effects that you experience with LYNPARZA and share them with your health care provider.

Here is a list of the most common side effects when taking LYNPARZA tablets:

  • Nausea or vomiting
  • Tiredness or weakness
  • Diarrhea
  • Headache
  • Changes in kidney function blood tests
  • Low number of platelets
  • Changes in the way food tastes
  • Loss of appetite
  • Low number of red or white blood cells
  • Mouth sores
  • Respiratory infections

These are not all the possible side effects of LYNPARZA.

Your health care provider may help you manage your side effects.

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

Important Safety Information

WHAT IS LYNPARZA?

LYNPARZA is a prescription medicine used for:

  • The maintenance treatment of adults with ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy
  • The treatment of adults who have a certain type of abnormal inherited BRCA gene advanced ovarian cancer and have received treatment with 3 or more prior types of chemotherapy medicines. Your health care provider will perform a test to make sure that LYNPARZA is right for you

It is not known if LYNPARZA is safe and effective in children.

IMPORTANT SAFETY INFORMATION

LYNPARZA may cause serious side effects, including:

Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your health care 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 may include: weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.

Your health care provider will do blood tests to check your blood cell counts:

  • Before treatment with LYNPARZA
  • Every month during treatment with LYNPARZA
  • Weekly if you have low blood cell counts that last a long time. Your health care provider may stop treatment with LYNPARZA until your blood cell counts improve

Lung problems (pneumonitis). Tell your health care provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your health care provider may do a chest x-ray if you have any of these symptoms. Your health care provider may temporarily stop treatment or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.

Before you take LYNPARZA, tell your health care provider about all your medical conditions, including if you:

  • Have lung or breathing problems
  • Have liver problems
  • Have 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 health care 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 health care provider about birth control methods that may be right for you
    • Tell your health care 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 with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your health care provider about the best way to feed your baby during this time

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.

How should I take LYNPARZA?

  • Take LYNPARZA tablets exactly as your health care provider tells you
  • Your health care provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
  • LYNPARZA comes as tablets and capsules. LYNPARZA tablets and capsules are not the same. If your health care provider prescribes LYNPARZA tablets for you, do not take LYNPARZA capsules. Do not take more than 4 LYNPARZA tablets in 1 day. If you have any questions about LYNPARZA, talk to your health care provider or pharmacist
  • Take LYNPARZA by mouth 2 times a day
  • Each dose should be taken about 12 hours apart
  • Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the tablets
  • Take LYNPARZA with or without food
  • 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 health care provider or go to the nearest hospital emergency room right away

What should I avoid while taking LYNPARZA?

  • Avoid grapefruit, grapefruit juice, Seville oranges, and Seville orange juice during treatment with LYNPARZA since they may increase the level of LYNPARZA in your blood

LYNPARZA may cause serious side effects. The most common side effects of LYNPARZA are:

  • Nausea or vomiting. Tell your health care provider if you get nausea or vomiting. Your health care provider may prescribe medicines to treat these symptoms
  • Tiredness or weakness
  • Diarrhea
  • Headache
  • Changes in kidney function blood test
  • Low number of platelets
  • Changes in the way food tastes
  • Loss of appetite
  • Low number of red or white blood cells
  • Mouth sores
  • Respiratory infections
  • Indigestion or heartburn
  • Sore throat or runny nose
  • Upper respiratory infection
  • Cough
  • Pain in the joints, muscles, and back
  • Rash
  • Pain or discomfort in the stomach area

These are not all the possible side effects of LYNPARZA. Call your health care 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 for LYNPARZA tablets and complete Prescribing Information for LYNPARZA capsules, including Patient Information (Medication Guides).