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Overview: Zelboraf is used to treat certain types of cancer and a rare blood disorder. Common side effects include joint pain, rashes, hair loss, and sensitivity to sunlight. Call your health care provider right away if you get a fever, rash, blisters or any other skin changes, shortness of breath, or chest pain. These could be symptoms of a serious side effect. Keep all appointments with your health care provider before, during, and after taking Zelboraf. Zelboraf is a tablet that is swallowed. 

Uses

What is Zelboraf used for?

Zelboraf (vemurafenib) is commonly used to treat certain types of melanoma and a rare blood disorder called Erdheim-Chester disease (ECD).

Your health care provider can do a test to see if your condition should be treated with Zelboraf.

Zelboraf may also be used for other conditions as determined by your health care provider.

How does Zelboraf work (mechanism of action)?

Zelboraf is a type of medicine known as a kinase inhibitor. It works by targeting specific proteins in certain cancer cells. By blocking the action of these proteins, Zelboraf can help prevent cancer cells from growing or spreading.

How is Zelboraf supplied (dosage forms)?

Brands and other names

  • Zelboraf

Dosage forms and strengths

  • 240 mg oral tablets

How should I store Zelboraf?

Zelboraf should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you’re transporting it. Store it in a cool, dry place. Keep Zelboraf in its original container with the lid tightly closed.

Side Effects

What are the most common side effects of Zelboraf?

The most common side effects of Zelboraf are listed below. These side effects may vary, depending on why you are taking Zelboraf. Tell your health care provider if you have any of these side effects that bother you.

  • Joint pain
  • Rash (see below)
  • Hair loss
  • Tiredness
  • Sensitivity to sunlight (see below)
  • Nausea
  • Itching
  • Warts
  • Heart rhythm changes (see below)

There may be other side effects of Zelboraf that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Zelboraf?

While less common, the most serious side effects of Zelboraf are described below, along with what to do if they happen.

Severe Allergic Reactions. Zelboraf may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for drug reaction with eosinophilia and systemic symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body, including your liver, kidneys, and heart. Stop taking Zelboraf and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Shortness of breath, trouble swallowing, or throat tightness
  • Swelling in your feet, ankles, or legs
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain
  • Dark-colored pee
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Cancer. Zelboraf can cause a new cancer to develop or cause a previously treated cancer to recur (come back). Tell your health care provider about any new symptoms that you may get. Also tell your health care provider right away about any changes to your skin, such as changes to moles or new sores, bumps, or warts. Keep all appointments with your health care provider before, during, and after taking Zelboraf.

Rash or Severe Skin Reactions. Zelboraf can commonly cause a rash, but it can also cause severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, stop taking Zelboraf and call your health care provider right away. Get emergency help if you have any of the following symptoms of SJS or TEN.

  • Painful skin that looks burned and peels off
  • Flat rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes
  • Flu-like symptoms, including a fever, chills, and muscle aches

Heart Rhythm Changes. Zelboraf may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including those who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Keep all appointments with your health care provider, including for bloodwork, before starting and while taking Zelboraf. Tell your health care provider right away if you faint, feel dizzy or lightheaded, or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Zelboraf. Keep all appointments for bloodwork while you are taking Zelboraf. Call your health care provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Sensitivity to Sunlight. Your skin may be very sensitive to light from the sun and devices that give off similar light, such as sunlamps and tanning beds, while you are taking Zelboraf. This is called photosensitivity. You should avoid being in sunlight while you are taking Zelboraf. Use sunscreen and wear a hat and clothes that cover your skin if you need to be in the sunlight. Exposure to this kind of light, even for a short time, can cause your skin to be severely sunburned, blistered, or swollen. Tell your health care provider right away if any of these happen.

Vision Problems. Zelboraf may cause eye inflammation (uveitis), blurry vision, and sensitivity to light. Keep all scheduled eye exams before starting and while taking Zelboraf. Call your health care provider right away if you have any of the following symptoms.

  • Eye pain, redness, or swelling
  • Vision changes, such as blurred or double vision
  • Worsening vision
  • Sensitivity to light
  • Floaters (tiny dots or specks in your vision)

Kidney Damage. Kidney damage can happen when taking Zelboraf. Call your health care provider right away if you have any of the following symptoms of kidney damage.

  • Reduced need to pee
  • Swelling in your feet, ankles, or legs
  • Weakness or unusual tiredness
  • A hard time catching your breath or chest pain/pressure
  • Confusion
  • Nausea
  • Seizures

Thickening of Connective Tissue. Zelboraf may cause connective tissue to form, particularly in the palm of your hand or at the bottom of your foot. When it happens in your hand, it is called Dupuytren’s contracture. When it is at the bottom of your foot, it is a plantar fibroma. Tell your health care provider right away if you have changes in the skin on your hands or feet, or if your toes or fingers are stuck in a bent position.

Warnings & Precautions

Who should not use Zelboraf?

Allergies to Ingredients. People who are allergic to any of the following should not take Zelboraf.

  • Vemurafenib
  • Zelboraf
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Zelboraf.

What should I know about Zelboraf before using it?

Do not take Zelboraf unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Zelboraf with other people, even if they have the same condition as you. It may harm them.

Keep Zelboraf out of the reach of children.

Do not crush or chew Zelboraf.

If you throw up (vomit) after taking your Zelboraf dose, do not take another dose. Take your next dose at the usual time.

Keep all appointments, including for bloodwork, before starting and while you are taking Zelboraf. This helps your health care provider know if this medicine is safe for you.

What should I tell my health care provider before using Zelboraf?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Zelboraf is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Other Medicines and Supplements. Zelboraf may interact with other medicines and supplements. Before taking Zelboraf, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Zelboraf may harm an unborn baby. If you can get pregnant, you should use effective birth control while taking Zelboraf and for two weeks after your last dose. Talk to your health care provider about your birth control options. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant.

Breastfeeding. It is not known if Zelboraf passes into breast milk. You should not breastfeed while taking Zelboraf and for two weeks after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Zelboraf?

For more information about Zelboraf, you can visit the drugmaker’s website at www.zelboraf.com or call them at 877-436-3683.

Interactions

Does Zelboraf interact with foods or drinks?

Zelboraf may interact with caffeine, which may increase the amount of caffeine in your body and the risk of possible caffeine side effects.

Grapefruit interacts with Zelboraf. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Zelboraf. This is because grapefruit can make your body less able to break down Zelboraf, which can lead to high levels of the medicine and an increased risk of side effects.

It is unknown if drinking alcohol will affect Zelboraf, but heavy drinking can slow your immune response and make it harder for your body to fight cancer.

Does Zelboraf interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. 

In particular, make sure that you discuss if you are using any of the following before taking Zelboraf.

  • St. John’s wort, which is a supplement that may be used for depression
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • Any medicine for seizures, such as carbamazepine, phenytoin, or phenobarbital
  • A muscle relaxant, such as tizanidine (Zanaflex)
  • Ipilimumab (Yervoy), which is an immunotherapy medicine used to treat certain types of cancer
  • Digoxin (Lanoxin), which is a medicine used to treat an irregular heartbeat and some types of heart failure
  • Fluconazole (Diflucan), itraconazole (Sporanox, Tolsura), ketoconazole, posaconazole (Noxafil), or voriconazole (Vfend), which are medicines used for fungal infections
  • Warfarin, which is a blood thinner
  • Any medicine that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Many other medicines may alter the blood levels of Zelboraf, and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Zelboraf. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Zelboraf?

If you or someone else has used too much Zelboraf, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Zelboraf?

If you miss a dose, take it as soon as you remember. If it is less than four hours until your next dose, skip the missed dose and only take the next dose at the usual time. Do not take double or extra doses.