New Treatment for Basal Cell Carcinoma Approved by FDA

Eileen Bailey Health Guide
  • Basal cell carcinoma (BCC) is the most common type of skin cancer and treatment consists of surgery to remove the tumor, radiation, cryosurgery (freezing the tumor), photodynamic therapy and topical medications (for superficial BCCs only.)  Recently, however, the FDA approved the first medication to treat advanced basal cell carcinomas - those that have spread or come back after surgery and those which are not treatable through radiation and surgery.

     

    Erivedge is a capsule which is taken daily and as of now, is not available at local drugstores, but is distributed only through specialty pharmacies. It is manufactured by Genentech, which is part of the pharmaceutical company Roche.

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    Common side effects of Erivedge include:

    • Muscle cramps/joint aches
    • Hair loss
    • Weight loss/decreased appetite
    • Fatigue
    • Nausea/vomiting/stomach upset
    • Diarrhea or constipation

    As with all medication, if you are experiencing side effects which are interfering with your ability to carry out our daily activities or that do not go away, you should speak with your doctor. You can report side effects to either Genentach (1-888-835-2555) or the FDA (1-800-FDA-1088). Although this medication has gone through extensive clinical trials, it is important that both the manufacturer and the FDA continue to be aware of side effects.

     

    Pregnancy and Erivedge

     

    Erivedge can harm your unborn child. Women who are or may become pregnant should not take this medication, possible severe birth defects or death of the fetus  can continue for seven months after stopping Erivedge. If there is a chance you can become pregnant, you should have a pregnancy test completed within one week of beginning the medication. Before starting Erivedge, you should talk with your doctor about birth control and begin using a highly effective method. If you have unprotected sex while taking this medication, you should immediately speak with your doctor.

     

    Some of the possible birth defects include:

    • Severe midline defects which include tongue tie, cleft lip or palate, neural tube defects, heart murmurs and other nervous system defects
    • Missing digits (fingers and toes)
    • Irreversible malformations

    While taking this medication, and for two months after stopping this medication, it is suggested that condoms with spermicide during every sexual intercourse encounter to prevent pregnancy from occurring.

     

    In addition to pregnancy, it is not yet known whether this medication is transferred through breast milk, therefore, if you have a young child and are nursing, you should speak to your doctor about whether it is best to discontinue nursing or to not take this medication during this time.

     

    If you are pregnant and have been exposed to Erivedge, you can report this to the pregnancy pharmacovigilance program to help better understand the possible effects on unborn children. You can contact the Genentech Adverse Event Line at (888) 835-2555.

     

    Additional Medications for Basal Cell Carcinoma

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    Erivedge is the first medication that has been approved by the FDA to treat advanced BCC, however, in the future additional medications may be available. Texas Oncology, located in Amarillo, TX, is currently running a clinical study to test a medication that is aimed at stopping BCC from spreading if surgery is no longer an option for treatment. In the future, those with advanced BCC may have different options for treatment.

     

    References:

     

    "Basal Cell Carcinoma Treatment Options," Date Unknown, Staff Writer, The Skin Cancer Foundation

     

    "Boxed Warning and Additional Important Safety Information," 2012, Genentech USA

     

    "Erivedge Medication Guide," 2012, Genentech USA

     

    "FDA Approves Skin Cancer Drug," 2012, Jan 30, Staff Writer, FloridaToday.com

     

    "Making Progress in Skin Care Treatment," 2012, Feb 8, Staff Writer, CBS NewsChannel10

     

Published On: February 10, 2012