"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.
Hexalen Consumer (continued)
Nausea, vomiting, or loss of appetite may occur. Nausea and vomiting can be severe. In some cases, your doctor may reduce your dose or prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.
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.
Temporary hair loss may rarely occur. Normal hair growth should return after treatment has ended.
Tell your doctor immediately if any of these unlikely but serious side effects occur: change in the amount of urine.
Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing eyes/skin, dark urine, severe stomach/abdominal pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe 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 Hexalen (altretamine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking altretamine, 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: kidney disease, liver disease, brain/nerve disorders, blood/bone marrow disorders (e.g., low levels of platelets/white blood cells/red blood cells).
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Wash your hands well to prevent the spread of infections.
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is not recommended for use during pregnancy. It may harm an unborn baby. Therefore, it is important to prevent pregnancy while taking this medication. Consult your doctor for more details and to discuss the use of reliable forms of birth control (e.g., condoms, birth control pills) while taking this medication. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is not known whether this drug passes into breast milk. Because of the possible risk to the 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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