Zelboraf is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Zelboraf is used to treat melanoma (skin cancer) that has spread to other parts of the body or cannot be removed by surgery.

Zelboraf is also used to treat Erdheim-Chester Disease (a rare blood cancer).

Zelboraf is used only if your cancer has a specific genetic marker (an abnormal "BRAF" gene). Your doctor will test you for this gene.

Zelboraf is used to treat melanoma, but this medicine can increase your risk of developing other types of skin cancer. Report any new or worsening skin lesions to your doctor right away.

Many drugs can interact with vemurafenib. Tell your doctor about all your current medicines and any you start or stop using

Take Zelboraf exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Zelboraf with a full glass of water. You may take this medicine with or without food.

Take the medicine every 12 hours, at the same time each day.

Do not crush, chew, or break a tablet. Swallow the tablet whole.

If you vomit shortly after taking Zelboraf, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

While using Zelboraf, you may need frequent blood tests to check your liver or kidney 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 this medicine. Visit your doctor regularly.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Melanoma - Metastatic:

Maintenance dose: 960 mg orally every 12 hours with or without a meal
Duration of therapy: Treat patients until disease progression or unacceptable toxicity occurs.

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of treatment.
-A missed dose can be taken up to 4 hours prior to the next dose.
-Do not take an additional dose if vomiting occurs after administration, but continue with the next scheduled dose.

Use: BRAF V600 mutation-positive unresectable or metastatic melanoma

You should not use Zelboraf if you are allergic to vemurafenib.

To make sure Zelboraf is safe for you, tell your doctor if you have ever had:

• liver or kidney disease;

• heart problems;

• long QT syndrome (in you or a family member); or

• an electrolyte imbalance (such as low levels of calcium, potassium, or magnesium in your blood).

Tell your doctor about all radiation treatments you are scheduled to receive, or have received in the past.

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.

Vemurafenib may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, and for 2 weeks after your last dose. Tell your doctor if you become pregnant.

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 and for at least 2 weeks after your last 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.

Do not take an extra dose if you vomit shortly after taking Zelboraf. Wait until your next scheduled dose to take the medicine again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid exposure to sunlight or tanning beds. Vemurafenib can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Vemurafenib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's 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.

Get emergency medical help if you have signs of an allergic reaction to Zelboraf (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. This reaction may occur several weeks after you began using Zelboraf.

Stop using this medicine and call your doctor at once if you have:

• skin changes - a new wart or lesion, a skin sore or red bump that bleeds or does not heal, or any change in the size or color of a mole;

• unusual thickening of tissues under the skin on the palms of your hands or the soles of your feet;

• a finger or fingers that feel tight or are bent inward;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• eye problems - vision changes, eye pain or swelling, severe eye redness, small white or yellow patches on the surface of your eye; or

• liver problems - stomach pain (upper right side), nausea, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Zelboraf side effects may include:

• joint pain;

• feeling tired;

• nausea;

• hair loss;

• mild rash or itching;

• skin growths; or

• sunburn, increased sensitivity to sunlight.

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.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

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.