Zelboraf (vemurafenib) is a targeted therapy that’s used to treat a type of skin cancer called melanoma and a rare blood cancer called Erdheim-Chester disease (ECD). These cancers must have a certain mutation called a BRAF mutation in order for you to use Zelboraf (vemurafenib) as treatment. This medication is a tablet that you take by mouth, but some side effects can include tiredness, joint pain, and rash.
Zelboraf (vemurafenib) is a kinase inhibitor known as a BRAF inhibitor. The BRAF protein helps cells (including cancer cells) grow. And when the BRAF protein is mutated, the cancer can grow uncontrollably and spread more quickly. By blocking BRAF, Zelboraf (vemurafenib) helps stop tumor growth.
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
The side effects below were reported by people with melanoma during clinical studies. Side effects might differ for people with Erdheim-Chester disease.
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Blistering, peeling, or loosening of the skin
bloating or swelling of the face, arms, hands, lower legs, or feet
bloody urine
blurred vision or other change in vision
chills
decreased frequency or amount of urine
dizziness
fainting
fast or irregular heartbeat
increased sensitivity of the skin to sunlight
increased thirst
itching or skin rash
joint or muscle pain
loss of appetite
lower back or side pain
lump or growth on the skin
pain in the ankles or knees
painful, red lumps under the skin, mostly on the legs
paralysis of the nerves
rapid weight gain
rash with flat lesions or small raised lesions on the skin
red skin lesions, often with a purple center
red, irritated eyes
redness or other discoloration of the skin
redness, soreness, swelling, or itching of the skin
scaling of the skin on the hands and feet
sensitivity of the eye to light
severe sunburn
sores, ulcers, or white spots in the mouth or on the lips
sores, welts, or blisters
tearing
tingling of the hands and feet
tiredness
trouble breathing
ulceration of the skin
unusual tiredness or weakness
unusual weight gain or loss
vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Back or bone pain
burning, itching, and pain in the hairy areas, or pus at the root of the hair
change in taste
decreased appetite
decreased weight
difficulty having a bowel movement
difficulty with moving
hair loss or thinning of the hair
headache
lack or loss of strength
loss of taste
muscle stiffness
pain in the arms or legs
sunburn
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
People who don’t have BRAF-mutated melanoma (or any other type of cancer without a BRAF mutation) shouldn’t take Zelboraf (vemurafenib). This medication is specifically approved for people with this mutation. What’s more, lab studies show that it’s possible for Zelboraf (vemurafenib) to raise the risk of cancer growth (instead of stopping growth) if the cancer doesn’t have a BRAF mutation. Talk to your provider if you’re unsure whether you have a BRAF mutation or not.
Some people experienced hair loss while taking Zelboraf (vemurafenib), but complete hair loss is unlikely. Sometimes, people’s hair changed texture (became curlier) or changed color. If you do notice hair loss, using a soft-bristled brush, only washing your hair when necessary, and using mild shampoos are things you can do to help manage this effect. You might also want to talk to your provider because there can be other causes of hair loss.
It depends. If you have a history of heart problems, talk to your provider before starting Zelboraf (vemurafenib). People born with certain heart rhythm problems (such as long QT syndrome) shouldn’t take Zelboraf (vemurafenib) because the medication might worsen this problem. Some people with heart problems might still be able to take Zelboraf (vemurafenib), but the provider might need to check the electrical activity of the heart more often with an electrocardiogram (EKG) or other lab tests.
Some people experience nausea while taking Zelboraf (vemurafenib), but it’s usually mild. Your provider might give you an antiemetic medication, like ondansetron (Zofran) or prochlorperazine, to help prevent or manage nausea. Contact your provider if you have severe nausea while taking Zelboraf (vemurafenib).
Yes, you can still go outdoors while you’re taking Zelboraf (vemurafenib). But the medication might cause your skin to be more sensitive to sunlight and burn more easily. For this reason, make sure you take extra precautions to protect your skin whenever you step outside. Use broad-spectrum sunscreen that protects against both UVA and UVB. Your provider might also recommend wearing sun-protective clothing.
There are some medications that you should avoid taking if possible while you’re taking Zelboraf (vemurafenib). For example, certain seizure medications, like phenytoin (Dilantin) and carbamazepine (Tegretol), can cause Zelboraf (vemurafenib) to not work as well. Other medications, like clarithromycin or diltiazem (Cardizem), can raise the levels of Zelboraf (vemurafenib) in your body and raise your risk of side effects. Your provider or pharmacist will review all the medications that you’re taking before you start Zelboraf (vemurafenib) to make sure there aren’t any interactions.
How long your treatment with Zelboraf (vemurafenib) lasts depends on many things, like the type of cancer or condition you have. It also depends on how well the medication is working for you and whether you’re having any side effects, both of which your provider will regularly discuss with you about. They can see how well the medication is working for you based on your scan results, lab tests, and symptoms. Make sure to let your provider know if you experience any side effects during treatment, such as severe rash, joint pain, or nausea. Don’t stop taking Zelboraf (vemurafenib) without first discussing with your provider.
Zelboraf (vemurafenib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Some people taking Zelboraf (vemurafenib) developed a new cancer. In studies, these cancers included different kinds of skin cancer and other non-skin cancers. While you’re taking Zelboraf (vemurafenib), your provider will monitor you for new signs and symptoms of cancer, especially skin cancers. If you notice a new sore on your skin or any skin changes while taking Zelboraf (vemurafenib), contact your provider.
Zelboraf (vemurafenib) isn’t recommended for people with conditions without a BRAF mutation. Lab studies have shown that if a BRAF inhibitor is used to treat a condition that doesn’t have a BRAF mutation, it might cause cancer cells to grow. For this reason, BRAF inhibitors like Zelboraf (vemurafenib) should only be used in people with certain BRAF mutations. Your provider will confirm that you have a BRAF mutation before you start taking Zelboraf (vemurafenib).
It’s possible for people taking Zelboraf (vemurafenib) to experience serious allergic reactions, including anaphylaxis. Severe symptoms can include rash, red and swollen skin, low blood pressure, and a serious reaction called drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). If you have a new rash, fever, swollen lymph nodes, or trouble breathing, seek medical attention right away.
Some people taking Zelboraf (vemurafenib) have had changes in their heart rhythm, also called QT prolongation. This lengthens the time it takes for your heart to recharge after each beat. Tell your provider about all the medical conditions you have and the medications you take. If you’re born with this heart rhythm problem (long QT syndrome) or if you take another medication that can raise your risk of this heart rhythm problem, it might not be safe for you to take Zelboraf (vemurafenib). In some cases, your provider might still prescribe Zelboraf (vemurafenib).
During treatment, your provider will track the electrical activity of your heart using a test called an electrocardiogram (EKG). If the EKG shows that you have a heart rhythm problem and you experience symptoms, such as dizziness, chest pain, or weakness, your provider might switch you to a different medication.
Some people taking Zelboraf (vemurafenib) have developed liver damage, sometimes causing the liver to not work as well. Since the liver plays a role in helping your body stop any bleeding, liver damage can sometimes affect your body’s ability to clot blood when it needs to.
During treatment, your provider will track your liver health through lab tests on a regular basis, usually every month. And if your levels are concerning, you might need to pause or stop Zelboraf (vemurafenib) while your provider looks into it. Most people don’t feel any noticeable symptoms when this happens, so it’s important to keep up with your lab work regularly. If you have stomach pain, yellowish skin, or yellow around the whites of your eyes, call your provider right away, as these can be symptoms of liver problems.
Zelboraf (vemurafenib) might cause your skin to be more sensitive to the sun and make it easier for you to get a sunburn. This reaction can be mild or severe. If possible, avoid being in direct sunlight while taking Zelboraf (vemurafenib). If you do go outdoors, wear protective clothing and broad-spectrum UVA/UVB sunscreen with an SPF of at least 30. If you have a skin rash after being outdoors, contact your provider.
Rarely, Zelboraf (vemurafenib) can also cause severe and sometimes life-threatening skin reactions that happen with or without infections. These reactions include Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Tell your provider right away if you develop painful blisters, skin wounds, peeling skin, flu-like symptoms, or fever. These are signs of a serious skin reaction that need immediate medical attention.
Though uncommon, some people taking Zelboraf (vemurafenib) experienced vision changes. These changes included blurry vision, light sensitivity, and swelling inside their eye (also called uveitis). Contact your provider right away if you have vision changes, eye pain, or light sensitivity. You might have to pause treatment while your provider or an ophthalmologist checks your eyes for problems.
While unknown, it’s possible for Zelboraf (vemurafenib) to harm an unborn baby based on the way the medication works. Because of these risks, if you’re able to get pregnant, you should use birth control while taking Zelboraf (vemurafenib) and for 2 weeks after the last dose. Let your provider know right away if you become pregnant while taking Zelboraf (vemurafenib).
People who take Zelboraf (vemurafenib) and receive radiation therapy for cancer treatment are at risk for having a reaction at the site where they received the radiation. This reaction is called radiation recall. It can happen if you’ve had radiation before, during, or after treatment with Zelboraf (vemurafenib). The reaction happens most commonly on the skin, but it can occur in any organ that has gotten radiation. These reactions can range from mild (e.g., rash, dry skin) to life-threatening (e.g., severe wounds, bleeding). Talk to your provider if you’re taking Zelboraf (vemurafenib) and you’ve had radiation therapy.
Some people taking Zelboraf (vemurafenib) develop higher levels of creatinine in their blood, which can suggest kidney damage. Most times, these elevations in creatinine levels are mild. But in some cases, there can be serious kidney damage, including kidney failure. You might not have any symptoms if your kidneys aren’t working as well. For this reason, your provider will check your kidney function regularly with lab tests while you’re taking Zelboraf (vemurafenib).
Though uncommon, some people taking Zelboraf (vemurafenib) have experienced changes in their hands or feet. One condition, called Dupuytren’s contracture, causes the fingers to bend toward the palm. Another condition, called plantar fibromatosis, causes tissue growth on the bottom of the foot. These conditions can be painful and lead to difficulty walking. Most cases were mild or moderate, but sometimes can be severe and affect daily life. If you notice any changes to your hands or feet, contact your provider right away.
The usual dose is 960 mg (four 240 mg tablets) by mouth every 12 hours.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.