Clinical trials are studies that researchers use to find better ways to treat diseases and cancers, using real patient volunteers.
The results from clinical trials are useful in helping doctors understand how a medicine may help patients with a certain disease or cancer.
In basal cell carcinoma, a complete responder is a patient who no longer has evidence of the disease following treatment.
Basal cell carcinoma may be locally advanced if:
Basal cell carcinoma may be metastatic if it has spread to other parts of the body, such as the lymph nodes, lungs, or bones.
In basal cell carcinoma, a non-responder is a patient who still has evidence of the disease following treatment.
In basal cell carcinoma, a partial responder is a patient who experiences a reduction in tumor size following treatment.
A specialty pharmacy is a state-licensed pharmacy that provides medications used to treat rare or serious health problems.
Targeted therapy is a kind of cancer treatment that attacks certain cells. As a targeted therapy, Erivedge works differently than traditional chemotherapies.
Targeted therapy can affect both cancer and healthy cells.
Erivedge® (vismodegib) capsule is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.
It is not known if Erivedge is safe and effective in children.
Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.
There is a Pregnancy Exposure Registry for females taking Erivedge who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with Erivedge, you or your healthcare provider should report your pregnancy to Genentech at (888) 835-2555.
Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:
Your healthcare provider may permanently stop Erivedge if you develop a severe skin reaction.
Erivedge can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrha is permanent. Talk to your healthcare provided if you have concerns about fertility.
These are not all of the possible side effects of Erivedge. Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Please see full Prescribing Information for additional Important Safety Information, including serious side effects, and the Medication Guide.
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