Zelboraf 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. This product is available in the tablet dosage form.
2 What to Know Before Using
Before using Zelboraf, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.
For this medicine, the following should be considered:
Allergies: 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.
Pediatric Population: 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.
Geriatric Population: 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.
Pregnancy: All Trimesters: Category 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.
Breastfeeding: 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.
Drug Interactions: 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.
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.
Other Interactions: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.
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:
Proper usage of Zelboraf requires strict adherence to your doctor’s orders. 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.
Dosing: 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.
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.
Missed Dose: 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.
Storage: 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.
4 Precautions to Take
Before using Zelboraf, there are some precautions you must take. 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 in 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.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
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.
It is important to tell your doctor if you have had or are planning to receive radiation treatment while you are taking this medicine.
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.
5 Potential Side Effects
As with many medications, there are several potential side effects associated with Zelboraf. 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:
blistering, peeling or loosening of the skin
bloating or swelling of the face, arms, hands, lower legs, or feet
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:
back or bone pain
burning, itching, and pain in the hairy areas, or pus at the root of the hair
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.
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