Zelboraf (vemurafenib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Zelboraf is used to treat metastatic melanoma (skin cancer).
Zelboraf may also be used for purposes not listed in this medication guide.
Important information
Do not use Zelboraf if you are pregnant. It could harm the unborn baby.
Before you take Zelboraf, tell your doctor if you have liver disease, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.
Using Zelboraf may increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away.
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Many drugs can interact with vemurafenib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Before taking this medicine
You should not use Zelboraf if you are allergic to vemurafenib.
To make sure you can safely use Zelboraf, tell your doctor if you have any of these other conditions:
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liver disease;
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a heart rhythm disorder;
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a personal or family history of Long QT syndrome;
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an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
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if you take any other medicines, including antibiotics, antidepressants, heart rhythm medication, or medicine to treat mental illness.
Using Zelboraf may increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away.
FDA pregnancy category D. Do not use Zelboraf if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. Follow your doctor"s instructions about how long to prevent pregnancy after your treatment ends.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether vemurafenib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Zelboraf.
How should I take Zelboraf?
Before you start treatment with Zelboraf, your doctor may perform tests to make sure vemurafenib is the best treatment for your type of skin cancer.
Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take this medicine with a full glass of water. You may take Zelboraf with or without food.
Take the medicine every 12 hours, at the same time each day.
Do not crush, chew, or break a Zelboraf tablet. Swallow it whole.
While using Zelboraf, you may need frequent blood tests to check your liver function.
To make sure this medication is not causing harmful effects, your skin condition will need to be checked often. Your heart function may also need to be tested with an electrocardiogram (ECG or EKG) on a regular basis. You may also need eye exams. Your cancer treatments may be delayed based on the results of these tests.
Your doctor may want to check your skin for several months after you stop using Zelboraf. Visit your doctor regularly.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 4 hours away. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid?
Vemurafenib can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.
Avoid exposure to sunlight or tanning beds. Zelboraf can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.
Zelboraf side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Zelboraf: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using Zelboraf and call your doctor at once if you have:
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new or worsening skin lesions;
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headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
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vision changes;
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eye pain or redness, puffy eyes;
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severe eye redness, small white or yellow patches on the surface of your eye;
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signs of inflammation in your body -swollen glands, flu symptoms, easy bruising or bleeding, severe tingling or numbness, muscle weakness, new or worsening cough, trouble breathing;
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liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Zelboraf side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Zelboraf?
Many drugs can interact with Zelboraf, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
