Vemurafenib (Zelboraf ®)
Vemurafenib, also known as Zelboraf ®, is used to treat melanoma that has spread to other parts of the body or that can’t be removed by surgery.
This information describes vemurafenib, how it is given and some of its possible side effects. It should ideally be read with our information about melanoma.
You’ll see your hospital doctor regularly while you have this treatment so they can monitor its effects. The information here should help you discuss any queries about your treatment and its side effects with your specialist nurse, doctor or oncology pharmacist.
Vemurafenib is a type of treatment called a kinase inhibitor (also known as a cancer growth blocker. Kinase inhibitors interfere with the production of important proteins in the body called kinases, which regulate how cells grow and divide.
Vemurafenib only works for melanomas that have a change (mutation) in a gene called BRAF. The change in the BRAF gene leads to the production of a changed (mutated) BRAF protein. This protein helps melanoma tumours to grow. Vemurafenib works by blocking (inhibiting) the changed BRAF protein. This can stop the melanoma cells from growing and dividing.
Doctors can find out if your melanoma has a mutation in the BRAF gene. They do this by testing a piece of melanoma that has already been removed during tests to diagnose the melanoma or during surgery.
When vemurafenib is used
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Vemurafenib can be used when a melanoma that has the mutated BRAF gene has either spread to other parts of the body or can’t be removed by surgery. It’s use on the NHS varies:
In England and Wales the National Institute for Health and Care Excellence (NICE) gives advice on which new drugs or treatments should be available on the NHS. It recommends that vemurafenib is available on the NHS in England and Wales.
In Scotland the Scottish Medicines Consortium (SMC) advises on the use of new drugs within the NHS. It doesn’t recommend the use of vemurafenib, so this means the drug isn’t widely available.
In Northern Ireland, you can find out if vemurafenib is available on the NHS from your hospital team.
We have information about what you can do if a treatment isn’t available on the NHS in your area.
What vemurafenib looks like
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Vemurafenib comes as a 240mg oval tablet which is a light pink/light orange colour.
How vemurafenib is taken
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You’ll be asked to take four vemurafenib tablets in the morning and four more 12 hours later. Each time you take four tablets, this will be a dose of 960mg (4 x 240mg).
take the tablets at the same time in the morning and evening each day
not take the tablets regularly on an empty stomach
swallow the tablets whole with a glass of water.
You usually take vemurafenib for as long as it controls your melanoma. Rarely, it may be stopped if it causes severe side effects.
Possible side effects of vemurafenib
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Each person’s reaction to cancer treatment is different. Some people have very few side effects while others may experience more. The side effects described here won’t affect everyone having this treatment.
We have outlined the most common side effects but haven't included those that are rare and therefore unlikely to affect you. If you notice any effects that aren't listed here, discuss them with your specialist nurse or doctor.
Mild skin changes
Some mild skin changes are common with vemurafenib. They include a rash, itching, dry or scaly skin or the development of warts. You should tell your specialist nurse or doctor if you develop any of these changes as they may be able to prescribe creams and ointments to help.
Effects on the hands and/or feet
You may notice redness of the palms of your hands and soles of your feet. Sometimes, your hands and feet can become sore or swollen. There may also be changes in sensation, such as numbness or tingling. If you notice this, let your specialist nurse or doctor know.
Occasionally, if the soreness doesn’t settle or if blistering develops, your doctor may reduce the dose of vemurafenib or temporarily stop the treatment. Very occasionally, people may need to stop having the treatment permanently.
Sensitivity to light
During treatment with vemurafenib, your skin will be more sensitive to daylight (even on a cloudy day) and sunlight. When you’re outdoors, you should always wear a sunscreen with a high sun protection factor (SPF) of at least 30. Some doctors and specialist nurses advise using a suncreen with an SPF of 50, so check this with your hospital team. They’ll also advise you to put sunblock on your lips and to cover up with clothing and a hat.
Other skin cancers
Some people may develop other types of skin cancer (squamous cell and less commonly basal cell skin cancer) while taking vemurafenib. Usually, these skin cancers are easily removed with surgery. You’ll be asked to check your skin regularly for signs of these cancers, such as a small lump or an area that looks scaly, bleeds or has a hard horny cap. Your specialist nurse or doctor will tell you what to look out for and will also check your skin when you’re seen in clinic. If you notice anything unusual between clinic appointments, let your specialist nurse or doctor know.
Loss of appetite
Some people lose their appetite while taking vemurafenib. This can be mild and may only last a few days. If it doesn’t improve, you can ask to see a dietitian or specialist nurse at your hospital. They can give you advice on improving your appetite and keeping to a healthy weight.
You may notice that food tastes different. A dietitian or specialist nurse at your hospital can give you advice about ways of coping with this.
You may have more frequent or loose bowel movements. This can usually be controlled with medicine, but tell your doctor if it’s severe or continues. It’s important to drink plenty of fluids if you have diarrhoea.
You may get constipated. It usually helps to drink plenty of fluids, include more fibre in your diet and do some gentle exercise. You may need to take medicine to help with this (laxatives). Your doctor can prescribe these or you can buy them at a pharmacy.
Feeling sick (nausea) or being sick (vomiting)
Your doctor can prescribe anti-sickness (anti-emetic) drugs to prevent, or greatly reduce, nausea or vomiting. If the sickness isn't controlled, or if it continues, tell your specialist nurse or doctor. They can prescribe other anti-sickness drugs that may be more effective.
If fatigue occurs, it’s usually mild. It’s important to try to pace yourself and get as much rest as you need. Try to balance this with taking some gentle exercise, such as short walks, which will help.
Effects on the hair
Your hair may become thinner while you’re taking vemurafenib. This includes body hair, such as your eyelashes and eyebrows, as well as hair on your head. Changes to your hair are usually temporary and improve during or after stopping treatment. However, sometimes changes can be permanent. Some people may find that their hair has a different texture when it grows back.
Muscle and joint pain
This may occur during treatment. Your doctor can prescribe painkillers and/or anti-inflammatory drugs to help.
Most commonly, this causes ankle swelling. Fluid retention often settles without treatment, but if it doesn’t, drugs that make you pass more urine (diuretics) can help get rid of some of the fluid.
Vemurafenib can sometimes cause a cough. If this happens, let your doctor know so they can give you medicines to help.
Fever and chills
Fever and chills may occur when you first start your treatment but they don’t usually last long. Your doctor may prescribe medicines to help. Some people continue to have occasional fevers throughout their treatment.
Very occasionally, vemurafenib can cause headaches. Let your doctor or nurse know if this happens, as they can give you painkillers for it.
Weakness in the face muscles
Vemurafenib can sometimes cause weakness or paralysis in one side of the face. This may cause your mouth to droop and it may be difficult to close the eye on the affected side of your face. The paralysis is usually temporary and resolves when you stop taking the drug.
In a small number of people, vemurafenib can cause the heartbeat to become irregular or fast (sometimes known as palpitations). If you have palpitations or you feel faint, tell your doctor immediately. Tests to see how well your heart is working will be carried out before you start taking vemurafenib. These tests may also be done again during your treatment.
You may have eye pain, swelling, redness or, less commonly, changes to your vision such as blurred vision. Let your specialist nurse or doctor know straight away if you develop any of these problems.
Vemurafenib can sometimes cause a serious allergic reaction. However, this is uncommon. Signs of this include swelling of the face, lips or tongue, a rash, dizziness or breathlessness. It’s important to tell your doctor or nurse as soon as possible if you have any of these symptoms, and to stop taking the tablets. During office hours, you should contact the clinic or ward where you had your treatment. Your chemotherapy nurse or doctor will tell you who to contact during evenings or weekends. Don't try to treat symptoms yourself with other medicines.
Effects on the liver
Rarely, vemurafenib may cause changes in the way your liver works. Your doctor will monitor this closely by taking regular blood samples to check your liver is working properly.
It’s important to let your specialist nurse or doctor know if you feel unwell or have any side effects, even if they’re not mentioned above.
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Some medicines, including those that you can buy in a shop or chemist, can be harmful to take when you’re having vemurafenib. It’s very important to tell your cancer doctor about any medicines you're taking, including over-the-counter drugs, complementary therapies and herbal drugs. You shouldn’t take any new medicines or over-the-counter drugs while you are on vemurafenib without checking with your specialist nurse or doctor first.
Your ability to become pregnant or father a child may be affected by having this treatment. It's important to discuss fertility with your doctor before starting treatment.
Little is known about the effects of vemurafenib on a developing baby. It’s therefore not advisable to become pregnant or father a child while taking this drug.
It’s not known whether vemurafenib is present in semen or vaginal fluids. To protect your partner, it’s safest to use a barrier form of contraception during your treatment and for a couple of months afterwards.
There is a potential risk that vemurafenib may be present in breast milk, so women are advised not to breastfeed during treatment and for a few months afterwards.
If you’re admitted to hospital for a reason not related to the cancer, it’s important to tell the doctors and nurses looking after you that you’re having vemurafenib treatment. You should tell them the name of your cancer specialist so they can ask for advice.
It’s important to know who you should contact if you have any problems or troublesome side effects when you’re at home. When you start treatment, you should be given a 24-hour helpline number you can ring if you have any concerns. If you aren’t given a helpline number, ask your specialist nurse or doctor who to contact during office hours, during evenings and during weekends.
Things to remember about vemurafenib tablets
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It's important to take your tablets as directed by your doctor.
Always tell any doctors treating you for non-cancerous conditions that you are taking a course of vemurafenib tablets that should not be stopped or restarted without advice from your cancer specialist.
Keep the tablets in the original packaging and store them at room temperature away from heat and direct sunlight.
Keep the tablets in a safe place, out of the reach of children.
If your doctor decides to stop the treatment, return any tablets you have to the pharmacist. Don't flush them down the toilet or throw them away.
If you forget to take a dose of vemurafenib, check with your specialist nurse or doctor what you should do. Don’t take a double dose to make up for a dose you have forgotten.
This information has been compiled using information from a number of reliable sources, including:
electronic Medicines Compendium (eMC). Package leaflet: Information for the user: Zelboraf 240 mg film-coated tablets. www.medicines.org.uk (accessed May 2013).
National Institute for Health and Care Excellence (NICE). Vemurafenib for treating locally advanced or metastatic BRAF V600 mutation-positive malignant melanoma (NICE technology appraisal guidance 269). December 2012 (accessed January 2013)
Scottish Medicines Consortium (SMC). Vemurafenib 240mg film-coated tablet (Zelboraf®) (SMC No 792/12). September 2012.
British Medical Association and Royal Pharmaceutical Society of Great Britain. British National Formulary. 65th edition. 2013.
With thanks to: Lynda Pyle, Senior Research Nurse; Dr Paul Nathan, Consultant Medical Oncologist; Ms Christine Clarke, Macmillan Lead Pharmacist; Dr Samra Turajlic, Clinical Fellow and Dr James Larkin, Consultant Medical Oncologist.
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