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Vemurafenib Oral Tablet (VEMURAFENIB - ORAL)

For treating cancer.

Brand Name(s): Zelboraf

Generic Name: Vemurafenib

Instructions

Swallow the medicine without crushing or chewing it.

Keep the medicine in its original container.

This medicine may be taken with or without food.

Swallow with a full glass (8 oz) of water unless your doctor gives you different instructions.

This medicine will work best if you take it at about the same time every day.

Store at room temperature away from heat, light, and moisture. Do not keep in the bathroom.

Please ask your doctor, nurse, or pharmacist how to discard unused medicines safely.

If you vomit after taking a dose, do not take an extra dose. Take your next dose at the usual time.

This medicine can make you sensitive to the sun. Use sunscreen or protective clothing when in sun.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is less than 4 hours to the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

This medicine is associated with a rare but very serious medical condition. Please speak with your doctor about symptoms you should look out for while on this medicine. Notify your doctor immediately if you develop those symptoms.

This medicine may cause damage to your muscles. Please call your doctor immediately if you notice any unusual pain or weakness in your muscles.

This medicine has been associated with a rare but serious skin rash. If you notice any red, peeling or blistered skin, contact your doctor immediately.

This medicine may increase the risk of cancer. Ask your doctor about the benefits and risks.

This medicine is associated with a rare, but serious problem of the liver. Speak to your doctor about the early signs of liver problems and the benefits and risks of using this medicine.

Do not use the medication any more than instructed.

Contact your doctor if you notice a change in the amount or darkening of your urine.

Do not breastfeed while on this medicine. You may safely start breastfeeding 2 weeks after stopping treatment.

This medicine can hurt a new baby in the womb. If you become pregnant while on this medicine, tell your doctor immediately. Your doctor may switch you to a different medicine.

Women must use reliable forms of birth control while taking this medicine and for 2 weeks after stopping to prevent pregnancy.

Do not take St. John's wort while on this medicine.

Women who are pregnant or in their childbearing years should not touch or handle this medicine. This medicine can be absorbed through the woman's skin and harm the unborn baby.

Contact your doctor immediately if you experience any swelling of your hands, face, lips, eyes, throat or tongue.

Do not share this medicine with anyone who has not been prescribed this medicine.

Some patients have serious side effects from this medicine. Ask your pharmacist to show you the information from the Food and Drug Administration (FDA) and discuss it with you.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

  • diarrhea
  • hair loss
  • nausea and vomiting

Call your doctor or get medical help right away if you notice any of these more serious side effects:

  • swelling of the legs, feet, and hands
  • pain in the eye
  • fainting
  • fast or irregular heart beats
  • lightheadedness
  • signs of liver damage (such as yellowing of eye or skin, dark urine, or unusual tiredness)
  • joint or muscle pain
  • red, peeling or blistering skin
  • change in the size or color of a skin mole
  • thickening or hardening of skin in the palms of the hands or soles of the feet
  • skin sores
  • difficulty swallowing
  • urinating less often
  • blood in urine
  • blurring or changes of vision
  • vision problems - blind spots or dark spots

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.

Please speak with your doctor, nurse, or pharmacist if you have any questions about this medicine.

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