"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.
Advise patients about the symptoms of infusion related reactions and to seek immediate medical attention if they develop any of these symptoms [see WARNINGS AND PRECAUTIONS].
Advise patients to contact their healthcare provider for a new onset fever or symptoms of infection.
Advise patients to notify their healthcare provider if they experience tingling or burning, redness, flaking, bothersome swelling, small blisters, or small sores on the palms of their hands or soles of their feet (symptoms of Hand-Foot Syndrome) [see WARNINGS AND PRECAUTIONS].
Advise patients to notify their healthcare provider if they develop painful redness, swelling, or sores in the mouth (symptoms of stomatitis).
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider with a known or suspected pregnancy [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].
Advise females and males of reproductive potential to use effective contraception during and for 6 months following treatment with DOXIL [see Use In Specific Populations].
Lactation Advise females not to breastfeed during treatment with DOXIL [see Use In Specific Populations].
Discoloration of Urine and Body Fluids
Inform patients that following DOXIL administration, a reddish-orange color to the urine and other body fluids may be observed. This nontoxic reaction is due to the color of the product and will dissipate as the drug is eliminated from the body.
Last reviewed on RxList: 3/10/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Doxil Information
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