Zelboraf

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.

240 mg
Each oval, biconvex, pinkish white to orange white, film-coated tablet with "VEM" engraved on one side, contains Zelboraf (Vemurafenib) 240 mg. Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose acetate succinate (HPMC-AS), and magnesium stearate. Film-coating contains iron oxide red (E172), macrogol 3350, polyvinyl alcohol, talc, and titanium dioxide (E171).

Do not take Zelboraf (Vemurafenib) if you are allergic to Zelboraf (Vemurafenib) or any ingredients of the medication.

There may be an interaction between Zelboraf (Vemurafenib) and any of the following:

• Aliskiren
• Amiodarone
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apalutamide
• Aprepitant
• "azole" antifungal medications (e.g., fluconazole, ketoconazole, Voriconazole)
• beta-blockers (e.g. Carvedilol, Nadolol, Propranolol)
• beta-2 agonists (long-acting) (e.g., Indacaterol, salmeterol)
• Bicalutamide
• Bosentan
• Bromazepam
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• caffeine
• Carbamazepine
• certain protein kinase inhibitors (e.g., Bosutinib, Crizotinib, Dabrafenib, Dasatinib, imatinib, Nilotinib, Sunitinib)
• chloroquine
• Citalopram
• Cobicistat
• Colchicine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone)
• Cyclosporine
• dabigatran
• Deferasirox
• Degarelix
• Dextromethorphan
• Digoxin
• Dipyridamole
• Disopyramide
• dofetilide
• Domperidone
• Dronedarone
• Duloxetine
• Edoxaban
• Elagolix
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Flecainide
• Flutamide
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Hepatitis C antiviral medications (e.g., daclatasvir, ledipasvir, sofosbuvir,)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, saquinavir, ritonavir, indinavir)
• Hydrocodone
• ivermectin
• lidocaine
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• Methadone
• midazolam
• Mexiletine
• mifepristone
• Mirtazapine
• Modafinil
• narcotic pain medications (e.g., Morphine, methadone)
• Naloxegol
• other cancer medications (e.g., Doxorubicin, Etoposide, Ipilimumab, Methotrexate, Mitotane, Tamoxifen, Venetoclax, Vinblastine, Vincristine)
• pentamidine
• Phenobarbital
• Phenytoin
• Porfimer
• Primaquine
• primidone
• procainamide
• Propafenone
• Prucalopride
• quinidine
• quinine
• quinolone antibiotics (moxifloxacin, levofloxacin, ciprofloxacin)
• Ranitidine
• rifabutin
• Rasagiline
• rifampin
• Romidepsin
• Ropinirole
• Rivaroxaban
• St. John's wort
• Sertraline
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Silodosin
• sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• tacrolimus
• Tetrabenazine
• Theophylline
• Tizanidine
• Tocilizumab
• Tolvaptan
• tricyclic antidepressants (Amitriptyline, Clomipramine, Desipramine, Imipramine)
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Zelboraf (Vemurafenib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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.