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Important information about a change to ZELBORAF® (vemurafenib) packaging
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What you may expect from treatment with ZELBORAF
ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma. Learn more about the possible benefits of ZELBORAF and how to manage possible side effects.Find out more ▸
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Patient Partners offers patients taking ZELBORAF access to an oncology nurse to answer ZELBORAF treatment questions, 24 hours a day.Learn more ▸
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What is ZELBORAF?
ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal “BRAF” gene.
Your healthcare provider will perform a test to make sure that ZELBORAF is right for you.
ZELBORAF is not used to treat melanoma with a normal BRAF gene. It is not known if ZELBORAF is safe and effective in children under 18 years of age.
Important Safety Information
What is the most important information I should know about ZELBORAF?
ZELBORAF can cause serious side effects, including:
- Risk of cancers. ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). New melanoma lesions have occurred in people who take ZELBORAF. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (SCC). Talk with your healthcare provider about your risk for these cancers
Check your skin and tell your doctor right away about any skin changes, including:
- A new wart
- A skin sore or reddish bump that bleeds or does not heal
- A change in size or color of a mole
Your doctor should check your skin before you start taking ZELBORAF, and every 2 months while you are taking ZELBORAF, to look for any new skin cancers. Your doctor may continue to check your skin for 6 months after you stop taking ZELBORAF.
Your doctor should also check for cancers that may not occur on the skin. Tell your doctor about any new symptoms that you get while taking ZELBORAF.
What should I tell my doctor before taking ZELBORAF?
Before you take ZELBORAF, tell your doctor if you:
- Have any heart problems, including a condition called long QT syndrome
- Have liver or kidney problems
- Have had or are planning to receive radiation therapy
- Have been told that you have low blood levels of potassium, calcium, or magnesium
- Have any other medical conditions
- Are pregnant or plan to become pregnant. ZELBORAF can harm your unborn baby
- Females who are able to become pregnant, and males who take ZELBORAF, should use birth control during treatment and for at least 2 months after stopping ZELBORAF
- Talk to your doctor about birth control methods that may be right for you
- Tell your doctor right away if you become pregnant during treatment with ZELBORAF
- Are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take ZELBORAF or breastfeed. You should not do both
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What should I avoid while taking ZELBORAF?
Avoid sunlight while you are taking ZELBORAF. ZELBORAF can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:
- When you go outside, wear clothes that protect your skin, including your head, face, hands, arms, and legs
- Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher
What are the possible side effects of ZELBORAF?
- Allergic reactions can happen while taking your ZELBORAF, and can be severe. Stop taking ZELBORAF and get medical help right away if you get any of these symptoms of an allergic reaction:
- Rash or redness all over your body
- Trouble breathing or swallowing
- Swelling of the face, lips, or tongue
- Throat tightness or hoarseness
- Feel faint
- Fast heartbeat
- Severe skin reactions. Stop taking ZELBORAF and call your doctor right away if you get a skin rash with any of the following symptoms, because you may have a severe skin reaction:
- Blisters on your skin
- Blisters or sores in your mouth
- Peeling of your skin
- Redness or swelling of your face, hands, or soles of your feet
- Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your doctor should do tests before you start taking ZELBORAF and during your treatment with ZELBORAF to check the electrical activity of your heart. Tell your doctor right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly or fast while taking ZELBORAF. These may be symptoms related to QT prolongation
- Liver injury. Your doctor should do blood tests to check your liver function before you start taking ZELBORAF and during treatment. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment:
- Yellowing of your skin or the white part of your eyes
- Dark or brown (tea color) urine
- Nausea or vomiting
- Loss of appetite
- Pain on the right side of your stomach
- Eye problems. Tell your doctor right away if you get any of these symptoms during treatment with ZELBORAF:
- Eye pain, swelling, or redness
- Blurred vision or other vision changes
- Worsening side effects from radiation treatment. Tell your healthcare provider if you have had or are planning to receive radiation therapy.
The most common side effects include:
- Joint pain
- Hair loss
- Sunburn or sun sensitivity
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ZELBORAF. For more information about side effects, ask your doctor or pharmacist.
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.