Vemurafenib (Oral route)
Uses of This Medicine:
Vemurafenib is used to treat melanoma (a type of skin cancer) that has spread or that cannot be removed by surgery. It is only used if the melanoma cells have the BRAF V600E mutation. Your doctor will use a special test to look for this mutation. Vemurafenib belongs to the group of medicines called antineoplastics (cancer medicines).
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of vemurafenib in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vemurafenib in the elderly. However, elderly patients are more likely to have unwanted effects (eg, skin problems, decreased appetite, fast heartbeat, nausea, or swelling of the hands, feet, or legs) which may require caution in patients receiving vemurafenib.
|All Trimesters||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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.
- Arsenic Trioxide
- Eslicarbazepine Acetate
- Perflutren Lipid Microsphere
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- St John's Wort
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bradycardia (slow heartbeat) or
- Congenital long QT syndrome (abnormal heart rhythm) or
- Congestive heart failure or
- Mineral imbalance (eg, blood levels of potassium, calcium, magnesium) or
- QT prolongation (abnormal heart rhythm) or
- Skin cancer, history of—May cause side effects to become worse.
Proper Use of This Medicine:
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed even if you feel well. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Swallow the tablet whole with a glass of water. Do not crush, break, or chew it.
You may take this medicine with or without food.
If you vomit after taking this medicine, do not take an extra dose. Wait and take your next dose at the normal time.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablet):
- For melanoma (skin cancer):
- Adults—960 milligrams (mg) (four 240 mg tablets) two times a day. The first dose should be taken in the morning, and the second dose in the evening. The 2 doses should be taken 12 hours apart.
- Children—Use and dose must be determined by your doctor.
- For melanoma (skin cancer):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 4 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests and an ECG (electrocardiogram) may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Women should use an effective form of birth control during treatment and for 2 months after stopping it. Men should use condoms during sexual intercourse during treatment and for 2 months after stopping it. If a pregnancy occurs while using this medicine, tell your doctor right away.
This medicine may increase your risk of having new skin cancers such as cutaneous squamous cell carcinoma, keratoacanthoma, and melanoma. It may also cause other cancers like noncutaneous squamous cell carcinoma of the head and neck. This is more likely to occur if you are more than 65 years of age, have too much sun exposure, or have a history of skin cancer. Your doctor may want to check for new skin lesions before treatment and every 2 months while you are using this medicine.
This medicine may cause serious types of allergic reactions, including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, lightheadedness or dizziness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth with this medicine.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills with this medicine.
This medicine may cause changes to your heart rhythm, such as a condition called QT prolongation. Contact your doctor right away if you feel dizzy or faint, or have fast, pounding, or uneven heartbeats.
This medicine may make your skin more sensitive to sunlight. Use sunscreen or sunblock lotions and lip balms with a sun protection factor (SPF) of at least 30 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 AM and 3 PM. Avoid sunlamps and tanning beds.
Check with your doctor right away if blurred vision, difficulty with reading, eye pain, or any other vision change occurs with this medicine. Your doctor may want an ophthalmologist (eye doctor) to check your eyes.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects of This Medicine:
- More common
- Blistering, peeling, or loosening of the skin
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision or other change in vision
- eye pain
- fast or irregular heartbeat
- increased sensitivity of the skin to sunlight
- joint or muscle 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 skin
- scaling of the skin on the hands and feet
- sensitivity of the eye to light
- severe sunburn
- skin rash
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- sores, welting, or blisters
- tingling of the hands and feet
- ulceration of the skin
- unusual tiredness or weakness
- unusual weight gain or loss
- 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 (stool)
- difficulty with moving
- dry skin
- hair loss or thinning of the hair
- lack or loss of strength
- loss of taste
- muscle stiffness
- pain in the arms or legs
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:
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:
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.
Last Updated: 11/4/2014