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Zelboraf

Generic Name: vemurafenib (VEM ue RAF e nib)
Brand Names: Zelboraf

What is Zelboraf?

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

Zelboraf is used to treat metastatic melanoma (skin cancer).

Zelboraf is used only if your tumor has a specific genetic marker, for which your doctor will test.

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.

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, 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 Zelboraf is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • heart disease;

  • a heart rhythm disorder;

  • personal or family history of long QT syndrome;

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

  • if you take any other medicines, including antibiotics, antidepressants, heart rhythm medication, or medicine to treat mental illness.

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 can harm an unborn baby. Use birth control to prevent pregnancy while you are using Zelboraf, whether you are a man or a woman. Zelboraf use by either parent may cause birth defects. Keep using birth control for at least 2 months after your last dose.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Zelboraf.

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 this medicine.

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 tablet. Swallow it whole.

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 Zelboraf. Visit your doctor regularly.

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

Zelboraf dosing information

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

See also: Dosage Information (in more detail)

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.

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

What happens if I overdose?

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

What should I avoid while taking Zelboraf?

This medicine 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.

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.

Zelboraf side effects

Get emergency medical help if you have signs of an allergic reaction to Zelboraf: hives, red skin rash; feeling light-headed; fast heart rate; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Zelboraf 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;

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • vision changes;

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

  • kidney problems - little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • 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;

  • 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

  • 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:

  • joint pain;

  • tired feeling;

  • nausea;

  • hair loss;

  • mild rash or itching;

  • skin growths; or

  • blurred vision, increased sensitivity of your eyes to light.

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 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.

Where can I get more information?

  • Your pharmacist can provide more information about Zelboraf.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Zelboraf only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.11. Revision Date: 2016-07-05, 4:16:31 PM.

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