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Zelboraf

Zelboraf

Vemurafenib

Zelboraf (Vemurafenib) belongs to a group of cancer fighting medications called antineoplastics, and more specifically to a group of medications called protein kinase inhibitors. Zelboraf (Vemurafenib) works by recognizing and attaching to certain types of cancer cells.

Available form

Tablet

Dosage

240mg

Manufacturers

Hoffmann-la Roche

Generic brand of

Vemurafenib

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Zelboraf information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

The usual dose of Zelboraf (Vemurafenib) is 960 mg (4 tablets) once in the morning and 960 mg (4 tablets) once in the evening, about 12 hours apart. You may take Zelboraf (Vemurafenib) on an empty stomach or with food as long as you take it the same way each time. Swallow the tablets whole with a glass of water. Do not crush or chew the tablets. Avoid drinking grapefruit juice while you are taking Zelboraf (Vemurafenib).

If you vomit soon after taking the medication, do not take another dose to replace the vomited dose.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Zelboraf (Vemurafenib) exactly as prescribed by your doctor.

If you miss a dose and it is more than 4 hours before your next dose, take it as soon as possible and continue with your regular schedule. If it is less than 4 hours before your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Zelboraf (Vemurafenib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g., down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Zelboraf (Vemurafenib). If you are concerned about side effects, discuss the risks and benefits of Zelboraf (Vemurafenib) with your doctor.

The following side effects have been reported by at least 1% of people taking Zelboraf (Vemurafenib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

back pain
Constipation
cough
Diarrhea
dizziness
Fever
hair loss
headache
high blood pressure
inflammation of the hair root
loss of appetite
nausea
pain in joint, muscle, back, or extremities
rash, itching, dry skin
redness, skin peeling, or blisters on hand and feet (Palmar plantar syndrome)
skin problems, including Warts
sun sensitivity
taste changes
thickening of the tissues under the soles of feet and palms of hands
tingling or burning sensation in hands and feet (peripheral Neuropathy)
tiredness
vomiting
weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
eye pain, redness, or swelling
heartburn
inflammation in the lungs (e.g., fever, chills, shortness of breath, cough)
pain when swallowing
signs and symptoms of cutaneous squamous cell cancer including new skin sores, warts, reddish bumps, a sore that bleeds or does not heal, or a change in size, shape, or colour of a mole
signs of kidney failure (e.g., decreased urine production, swelling in the ankles or feet, fatigue, abdominal pain)
signs and symptoms of abnormal liver function including skin or whites of the eyes turning yellow, feeling tired, dark or brown coloured urine, nausea or vomiting or not wanting to eat
signs and symptoms of changes in heart rhythm including feeling dizzy or faint, seizures, palpitations, and feeling a rapid, pounding, or irregular heartbeat
redness, inflammation, or burning sensation at site of previous radiation therapy
unusual infections (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

allergic reactions including rash, feeling faint, trouble breathing, or swelling of the face, lips, or tongue
signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Zelboraf (Vemurafenib).

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.

Abnormal heart rhythms: Zelboraf (Vemurafenib) can cause abnormal heart rhythms by affecting the electrical activity of the heart. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation, and should not be used in combination with Zelboraf (Vemurafenib). You are more at risk for this type of abnormal heart rhythm and its complications if you:

are female
are over 65 years of age
have a family history of sudden cardiac death
have a history of heart disease or abnormal heart rhythms
have a slow heart rate
have congenital prolongation of the QT interval
have Diabetes
have had a Stroke
have low potassium, magnesium, or calcium levels
have nutritional deficiencies

Your doctor will monitor your heart rhythm regularly while you are taking Zelboraf (Vemurafenib) with a test called an electrocardiogram (ECG). You should not take Zelboraf (Vemurafenib) if your ECG already shows that you have QT prolongation or if you are taking a medication that can cause QT prolongation

Allergic reactions: Some people may develop a Anaphylaxis (severe allergic reaction) to Zelboraf (Vemurafenib). This reaction may involve a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering, swollen face or throat, or difficulty breathing.

Grapefruit juice: Grapefruit juice affects how Zelboraf (Vemurafenib) is removed from the body and may cause too much of the medication to build up in the body and cause possibly harmful side effects. People should not drink grapefruit juice or eat grapefruit at any time while taking Zelboraf (Vemurafenib) for treatment.

High blood pressure: Zelboraf (Vemurafenib) may increase your blood pressure. Your doctor will monitor your blood pressure while you are taking Zelboraf (Vemurafenib). If you have high blood pressure, discuss with your doctor how Zelboraf (Vemurafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zelboraf (Vemurafenib), and whether any special monitoring is needed.

Kidney function: Zelboraf (Vemurafenib) can cause decreased kidney function or kidney failure. If you have a history of decreased kidney function, discuss with your doctor how Zelboraf (Vemurafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zelboraf (Vemurafenib), and whether any special monitoring is needed.

If you experience puffy hands, face or feet, high blood pressure, unusual muscle cramping, or darkened urine, Zelboraf (Vemurafenib) may be affecting how well your kidneys are working. If you notice any of these symptoms, contact your doctor as soon as possible.

Liver function: Decreased liver function or liver disease may cause Zelboraf (Vemurafenib) to build up in the body, causing side effects. Zelboraf (Vemurafenib) may also reduce liver function and can cause liver failure resulting in death. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Your doctor may want to test your liver function regularly with blood tests while you are taking Zelboraf (Vemurafenib). This often allows reduced liver function to be identified before it becomes too severe.

Other cancers: There have been reports of Zelboraf (Vemurafenib) causing unexpected development of other cancers such as squamous cell carcinoma of the head and neck. It may also speed up the growth of other cancers, such as certain blood cancers and pancreatic cancer. While you are using Zelboraf (Vemurafenib), your doctor may want to conduct screening tests periodically to ensure that any new cancers are identified and treated as early as possible. If you have any history of cancer other than this melanoma, discuss with your doctor how Zelboraf (Vemurafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zelboraf (Vemurafenib), and whether any special monitoring is needed.

Pancreatitis: Zelboraf (Vemurafenib) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Zelboraf (Vemurafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Zelboraf (Vemurafenib), and whether any special monitoring is needed.

Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.

Radiation treatment: Receiving radiation therapy while taking Zelboraf (Vemurafenib) may result in extreme radiation Burns to the treated area. Using Zelboraf (Vemurafenib) while being treated with radiation is not recommended. If you have had radiation treatment in the past, Zelboraf (Vemurafenib) may cause a condition called radiation recall, where the skin that had been treated with radiation becomes inflamed again.

Skin: Zelboraf (Vemurafenib) may cause changes in your skin, including a new melanoma and cutaneous squamous cell carcinoma. Talk to your doctor if there are any changes in your skin while taking Zelboraf (Vemurafenib) and up to 6 months after the last dose. Changes include new skin sores, warts, reddish bumps, a sore that bleeds or does not heal, or a change in size, shape, or colour of a mole.

Zelboraf (Vemurafenib) may also cause extra sensitivity to sunlight. Use sunscreen with SPF greater than 30 and protective clothing while taking Zelboraf (Vemurafenib).

Vision: Zelboraf (Vemurafenib) may cause inflammation in the eye. It may also contribute to a blockage of the blood vessels that lead out of the eye. If you notice any vision changes or problems, contact your doctor as soon as possible.

Women: Women may be more at risk for experiencing certain side effects from Zelboraf (Vemurafenib), including rash, sensitivity to sunlight, and joint pain.

Pregnancy: Zelboraf (Vemurafenib) may harm an unborn child. Zelboraf (Vemurafenib) should not be used during pregnancy unless the benefits outweigh the risks. Women who may become pregnant must use an effective birth control method while taking Zelboraf (Vemurafenib) and for at least 6 months after taking the last dose of medication. If you become pregnant while taking Zelboraf (Vemurafenib), contact your doctor immediately.

Breast-feeding: It is not known if Zelboraf (Vemurafenib) passes into breast milk. If you are a breast-feeding mother and are taking Zelboraf (Vemurafenib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children and adolescents: The safety and effectiveness of using Zelboraf (Vemurafenib) have not been established for children and adolescents younger than 18 years of age.

Seniors: People aged 65 years or older may be more at risk for experiencing certain side effects from Zelboraf (Vemurafenib), including cutaneous squamous cell carcinoma, decreased appetite, and heart conditions.

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