WHAT IS LYNPARZA?
LYNPARZA is a prescription medicine used to treat adults:
- who have 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 or
- who have 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. Your health care provider will perform a test to make sure that LYNPARZA is right for you
- who have a 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. 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 or breast 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 or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.
Before taking LYNPARZA, tell your health care provider about all of your medical conditions, including if you:
- have lung or breathing problems
- have kidney problems
- are pregnant, become 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 the last dose of LYNPARZA. Talk to your health care provider about birth control methods that may be right for you
- Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
- Do not donate sperm during treatment with LYNPARZA and for 3 months after your final dose
- 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 right away if you become pregnant.
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 (see above). 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
- low number of red or white blood cells
- tiredness or weakness
- sore throat or runny nose
- joint, muscle, and back pain
- changes in the way food tastes
- loss of appetite
- mouth sores
- respiratory infections
- changes in kidney function blood test
- low number of platelets
- indigestion or heartburn
These are not all the possible side effects of LYNPARZA. Call your health care provider for medical advice about side effects.