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All Names： Erivedge，vismodegib
Indications：basal cell carcinoma
Manufacturer：Novartis, Switzerland
Customs Clearance Procedure：If the customs requires the package for customs clearance, please pay the customs clearance fee according to the content of EMS SMS and customs regulations.
INDICATIONS AND USAGE
ERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery and who are not candidates for radiation.
DOSAGE
Important Safety Information
Verify pregnancy status of females of reproductive potential within 7 days prior to initiating ERIVEDGE.
Recommended Dosage
The recommended dosage of ERIVEDGE is 150 mg taken orally once daily, with or without food, until disease progression or until unacceptable toxicity.
Swallow capsules whole. Do not open or crush capsules.
If a dose of ERIVEDGE is missed, resume dosing with the next scheduled dose.
ADVERSE REACTIONS
Severe skin reactions. Severe skin reactions have happened in some people taking ERIVEDGE. You may need to be treated in a hospital because these severe skin reactions can be life-threatening or lead to death.
Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:
blisters or peeling of your skin
blisters on your lip, or around your mouth or eyes
mouth sores or genital sores
high fever or flu-like symptoms
enlarged lymph nodes
skin pain and burning
Your healthcare provider may permanently stop ERIVEDGE if you develop a severe skin reaction.
Bone growth problems. Bone growth problems have happened in children who have been exposed to ERIVEDGE. These problems may continue even after stopping treatment with ERIVEDGE.
The common side effects of ERIVEDGE are:
muscle spasms
hair loss
change in how things taste or loss of taste
weight loss
tiredness
nausea
diarrhea
decreased appetite
constipation
joint pain
Vomiting
ERIVEDGE can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrhea is permanent. Talk to your healthcare provider if you have concerns about fertility.
For full information, please refer to:
https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/eb368bb6-80e3-4df9-8a85-91df0a2ada6a/spl-doc?hl=Erivedge
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