"The U.S. Food and Drug Administration today granted accelerated approval to Lynparza (olaparib), a new drug treatment for women with advanced ovarian cancer associated with defective BRCA genes, as detected by an FDA-approved test.
Gemzar Consumer (continued)
Temporary hair loss may occur. Normal hair growth should return after treatment has ended.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: dizziness/lightheadedness, fainting, mouth sores, numbness/tingling of hands/feet, sudden weight gain, swelling of ankles/feet, severe stomach/abdominal pain, easy bleeding/bruising, cough, difficulty catching your breath (shortness of breath, wheezing), unusual tiredness, fast/irregular heartbeat, change in amount of urine, dark urine, yellowing of the eyes/skin.
Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, weakness on one side of the body, slurred speech, vision changes, confusion, seizures, severe headache.
This medication can lower your ability to fight an infection (bone marrow depression). Notify your doctor promptly if you develop any signs of infection (e.g., high fever, chills, persistent sore throat).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Gemzar (gemcitabine hcl) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using gemcitabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone marrow problems (e.g., leukopenia, thrombocytopenia, anemia), heart problems (e.g., irregular heartbeat, heart failure), kidney problems, liver problems, radiation therapy.
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine.
Wash your hands well to prevent the spread of infections.
To lower the chance of getting cut, bruised or injured, use caution with sharp objects like safety razors or nail cutters, and avoid activities such as contact sports. Use a soft-bristle toothbrush to lessen the risk of bleeding gums.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor.
It is not known whether this medication passes into breast milk. Because of the potential harm to the nursing infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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