Zelboraf - Vemurafenib Tablets

What is this medication?

VEMURAFENIB (vem ue RAF e nib) treats skin cancer. It may also be used to treat blood and bone marrow cancers. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Zelboraf

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Eye disease, vision problems
• Heart disease
• History of irregular heartbeat
• History of low levels of calcium, magnesium, or potassium in the blood
• Kidney disease
• Liver disease
• Recent or ongoing radiation therapy
• An unusual or allergic reaction to vemurafenib, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Take it as directed on the prescription label. Do not cut, crush, or chew this medication. Swallow tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is less than 4 hours until your next scheduled dose, do not make up for the missed dose and just take your next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Fluconazole
• Pimozide
• Posaconazole
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Antiviral medications for HIV or AIDS
• Caffeine
• Certain antibiotics, such as clarithromycin, erythromycin, telithromycin
• Certain medications for fungal infections, such as itraconazole, ketoconazole, voriconazole
• Certain medications for irregular heart beat
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Certain medications that treat or prevent blood clots, such as warfarin
• Dextromethorphan
• Digoxin
• Nefazodone
• Midazolam
• Other medications that cause heart rhythm changes, such as dofetilide, ziprasidone
• Rifabutin
• Rifampin
• Rifapentine
• St. John's wort, Hypericum perforatum
• Tizanidine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need to have blood work while taking this medication.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. You might also notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Talk to your care team about your risk of cancer. You may be more at risk for certain types of cancers if you take this medication.

Tell your care team right away if you have any change in your eyesight.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

Talk to your care team if you wish to become pregnant or think you are pregnant. This medication can cause serious birth defects if taken during pregnancy and for 2 weeks after stopping therapy. Talk to your care team about effective forms of contraception. Do not breast-feed an infant while taking this medication and for 2 weeks after your last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Eye pain, redness, irritation, or discharge with blurry or decreased vision
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Lump under the skin in the arch of the foot
• Lump under the skin over hands, bent finger
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Fatigue
• Hair loss
• Itching
• Joint pain
• Nausea
• Sensitivity to light

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep this medication in the original container. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer wanted or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.