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

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

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

Vemurafenib may also be used for purposes not listed in this medication guide.

Vemurafenib is used to treat melanoma, but vemurafenib 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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take the medicine every 12 hours, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

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

You will need frequent medical tests.

To make sure vemurafenib 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.

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

Your doctor may want to check your skin for several months after you stop using vemurafenib. Visit your doctor regularly.

Usual Adult Dose for Melanoma -- Metastatic:

960 mg orally every 12 hours until disease progression or unacceptable toxicity

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of therapy.

Use: BRAF V600 mutation-positive unresectable or metastatic melanoma

Usual Adult Dose for Histiocytosis:

960 mg orally every 12 hours until disease progression or unacceptable toxicity

Comments:
-Confirm the presence of BRAF V600E mutation in tumor specimens prior to initiation of therapy.

Use: For Erdheim-Chester Disease (ECD) with BRAF V600 mutation

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

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 vemurafenib 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.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 4 hours. Do not use two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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

Get emergency medical help if you have signs of an allergic reaction (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, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Vemurafenib may cause serious side effects. Stop using vemurafenib 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 side effects of vemurafenib 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 affect vemurafenib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to vemurafenib. Your doctor will check your skin before starting treatment, every 2 months during your treatment, and for up to 6 months after treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.