Generic Name: vemurafenib (VEM-ue-RAF-e-nib)
Brand Name: Zelboraf
Zelboraf is used for:
Treating certain types of skin cancer. It may also be used for other conditions as determined by your doctor.
Zelboraf is a kinase inhibitor. It works by preventing the growth of cancer cells.
Do NOT use Zelboraf if:
- you are allergic to any ingredient in Zelboraf
- you have a history of certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome)
- you have uncorrected low blood electrolyte levels (eg, potassium, calcium, magnesium)
- you are taking asenapine, citalopram, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zelboraf:
Some medical conditions may interact with Zelboraf. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of heart problems (eg, congestive heart failure, slow or irregular heartbeat), high blood pressure, diabetes, fainting, liver or kidney problems, skin cancer, nerve or nervous system problems, eye or vision problems, pancreas problems (eg, pancreatitis), or low blood electrolyte levels (eg, calcium, potassium, magnesium)
- if you have a family history of QT prolongation or sudden death due to heart problems before the age of 50 years old
- if you have vomiting, diarrhea, dehydration, or an eating disorder, or you are following a strict diet
- if you have skin problems or you have chronic sun exposure
Some MEDICINES MAY INTERACT with Zelboraf. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for blood thinning, cancer, cough, Cushing syndrome, depression or other mental or mood problems, emergency contraception, hepatitis C, HIV, immune system suppression, infections, irregular heartbeat or other heart problems, lung or breathing problems, narcotic abuse or dependence, nausea or vomiting, pain, seizures, swelling or fluid retention), multivitamin products, or herbal or dietary supplements (eg, St. John's wort) because they may interact with Zelboraf. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Zelboraf
This may not be a complete list of all interactions that may occur. Ask your health care provider if Zelboraf may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Zelboraf:
Use Zelboraf as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zelboraf comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Zelboraf refilled.
- Take Zelboraf by mouth with or without food.
- Swallow Zelboraf whole with a glass of water. Do not break, crush, or chew before swallowing.
- Take Zelboraf in the morning and in the evening, about 12 hours apart unless your doctor directs you otherwise.
- Continue to take Zelboraf even if you feel well. Do not miss any doses.
- If you vomit after taking a dose of Zelboraf, do not take an extra dose. Take the next dose at the regular time.
- If you miss a dose of Zelboraf, take it as soon as possible. If it is within 4 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Zelboraf.
Important safety information:
- Zelboraf may cause dizziness, tiredness, weakness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Zelboraf with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do NOT take more than the recommended dose, change your dose, or stop taking Zelboraf without checking with your doctor.
- Tell your doctor or dentist that you take Zelboraf before you receive any medical or dental care, emergency care, or surgery.
- Before using Zelboraf, tell your doctor if you take a medicine that contains caffeine or if you consume large amounts of food or drink that contain caffeine (eg, coffee, tea, cocoa, cola, chocolate).
- Zelboraf may increase the risk of a certain other type of skin cancer. The risk may be greater in elderly patients and in patients with chronic sun exposure or with a history of skin cancer. Contact your doctor right away if you experience a new wart, a change in size or color of a mole, or any other skin changes (eg, skin sore or reddish bump that bleeds or does not heal). Your doctor will check your skin for changes while you are taking Zelboraf and for up to 6 months after the last dose.
- Zelboraf may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Zelboraf. Use a sunscreen and lip balm, and wear protective clothing if you must be outside for more than a short time.
- Do not father a child while you are taking Zelboraf or for at least 2 months after you stop taking it. If you think your sexual partner is pregnant, contact your doctor right away.
- Women who may become pregnant and men must use an effective form of birth control while taking Zelboraf and for at least 2 months after stopping it. If you have questions about effective birth control, talk with your doctor.
- LAB TESTS and/or medical tests, including blood pressure, chest computed tomographic (CT) scans, electrocardiograms (ECGs), liver function tests, eye exams, blood electrolyte levels, pelvic and anal exams, and skin evaluations, may be performed while you use Zelboraf. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Zelboraf with caution in the ELDERLY; they may be more sensitive to its effects, especially a certain other type of skin cancer.
- Zelboraf should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Zelboraf may cause harm to the fetus. Do not become pregnant while you are taking it or for at least 2 months after you stop taking it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Zelboraf while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking Zelboraf.
Possible side effects of Zelboraf:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; diarrhea; dizziness; dry skin; hair loss; headache; joint pain; loss of appetite; nausea; taste changes; thickening of the skin; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning, numbness, or tingling; eye pain, swelling, or redness; fainting; fast or irregular heartbeat; fever; light-headedness; mouth sores or blisters; muscle pain, weakness, or cramping; red, swollen, blistered, or peeling skin; seizures; severe or persistent dizziness or headache; swelling of the hands, feet, or ankles; symptoms of dehydration (eg, very dry mouth or eyes, sluggishness, unusual weakness); symptoms of liver problems (eg, dark urine; pale stools; yellowing of the eyes or skin; unusual tiredness, nausea, or vomiting; persistent loss of appetite; severe stomach pain); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); tingling, pain, redness, or swelling of the palms of the hands and soles of the feet; vision changes (eg, blurred vision, sensitivity to light).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Zelboraf:
Store Zelboraf at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Zelboraf in the original container with the lid tightly closed. Keep Zelboraf out of the reach of children and away from pets.
- If you have any questions about Zelboraf, please talk with your doctor, pharmacist, or other health care provider.
- Zelboraf is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Zelboraf or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zelboraf. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zelboraf. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Zelboraf.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.