Zelboraf

Zelboraf is a prescription medication used to treat melanoma, a type of skin cancer. Zelboraf belongs to a group of drugs called kinase inhibitors. These drugs work by blocking the action of a protein that signals cancer cells to multiply, slowing or stopping the spread of cancer cells.

This medication comes in tablet form and is usually taken twice daily, with or without food.

Common side effects of Zelbora include joint pain, rash, hair loss, and tiredness.

Zelboraf is a prescription medicine used to treat a type of skin cancer called melanoma

• that has spread to other parts of the body or cannot be removed by surgery, and
• that has a certain type of abnormal "BRAF" gene

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Genentech, Inc.

Zelboraf may cause serious side effects. See "Zelboraf Precautions" section.

The most common side effects of Zelboraf include:

• joint pain
• rash
• hair loss
• tiredness
• sunburn or sun sensitivity
• nausea
• itching
• warts

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all possible side effects of Zelboraf. For more information about side effects, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you take:

• the blood thinner warfarin sodium (Coumadin, Jantoven)
• antifungal medicines, such as ketoconazole (Nizoral), itraconazole (Sporanox, Onmel), or voriconazole (Vfend)
• certain antibiotic medicines, such as telithromycin (Ketek), clarithromycin (Biaxin, Biaxin XL), rifampin (Rifater, Rifimate, Rimactane, Rifadin), rifabutin (Mycobutin), rifapentine (Prifin)
• HIV medicines, such as atazanavir sulfate (Reyataz), saquinavir mesylate (Invirase), ritonavir (Kaletra), indinavir sulfate (Crixivan), nelfinavir mesylate (Viracept)
• seizure medicines, such as phenytoin (Dilantin-125, Dilantin, phenobarbital (Solfoton), or carbamazepine (Carbitrol, Equetro, Tegretol, Tegretol-XR, Teril, Epitol)
• the anti-depressant medicine, nafazodone hydrochloride
• medicines to treat irregular heart beat
• ipilimumab (Yervoy)

Know the medicines you take. Keep a list to show your healthcare provider and pharmacist when you get a new medicine.

Serious side effects have been reported including:

• Zelboraf may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). CuSCC usually does not spread to other parts of the body. Zelboraf may also cause an increased risk for developing keratoacanthoma (skin tumor that grows rapidly, especially in older people, and resembles a carcinoma but does not spread), and melanoma (dangerous skin cancer).

Check your skin and tell your healthcare provider right away about any skin changes including a:

• new wart
• skin sore or reddish bump that bleeds or does not heal
• change in size or color of a mole

A healthcare provider should check your skin before you start taking Zelboraf, and every two months while taking Zelboraf to look for any new skin cancers. Your healthcare provider may continue to check your skin for six months after you stop taking Zelboraf.

• Sun sensitivity. Avoid sunlight while you are taking Zelboraf. Zelboraf can make your skin sensitive to sunlight. You may burn more easily and get severe sunburns. To help protect against sunburn:
  • When you go outside, wear clothes that protect your skin, including head, face, hands, arms, and legs.
  • Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
• Serious allergic reactions (hypersensitivity reactions). Stop taking Zelboraf and seek medical treatment if you experience rash, swelling, redness or any skin reaction while on this medication.
  • rash, redness all over body
  • feeling faint
  • trouble breathing or swallowing
  • throat tightness or hoarseness
  • fast heartbeat
  • swelling of face, lips or tongue

• Severe skin reactions. Stop taking Zelboraf and call your healthcare provider right away if you get a skin rash with any of the following symptoms because you may have a severe skin reaction:

  • blisters on skin
  • blisters or sores in mouth
  • peeling of skin
  • fever
  • redness or swelling of face, hands, or soles of feet
• Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life-threatening. Your healthcare provider should do tests before you start taking Zelboraf, if your dose changes, at certain other times during treatment, and after you stop treatment with Zelboraf, to check the levels of potassium, magnesium, and calcium in your blood, and check the electrical activity of your heart with an ECG.
  Tell your healthcare provider right away if you feel faint, lightheaded, dizzy or feel your heart beating irregularly or fast while taking Zelboraf. These may be symptoms related to QT prolongation.
• Abnormal liver function tests. Your healthcare provider should do blood tests to check your liver function before you start taking Zelboraf and during treatment. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment:
  • your skin or the whites of your eyes turn yellow
  • you feel tired
  • your urine turns dark or brown (tea color)
  • you have nausea or vomiting
  • you do not want to eat
  • pain on the right side of your stomach
• Eye problems. You should have your eyes examined before and while you are taking your Zelboraf . Tell your healthcare provider right away if you get these symptoms during treatment with Zelboraf:
  • eye pain, swelling, or redness
  • blurred vision or other vision changes during treatment with Zelboraf 

Grapefruit and grapefruit juice may interact with Zelboraf and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you start taking Zelboraf, tell your healthcare provider if you:

• have any heart problems, including a condition called long QT syndrome
• have liver or kidney problems
• have been told that you have low blood levels of potassium, calcium, or magnesium
• plan to have surgery, dental or other medical procedures
• have any other medical conditions
• are pregnant or plan to become pregnant. Zelboraf may harm your unborn baby.
  • Females who are able to become pregnant, and males who take Zelboraf should use birth control during treatment and for 2 months after stopping Zelboraf.
  • Talk to your healthcare provider about birth control methods that may be right for you.
  • Tell your healthcare provider right away if you become pregnant during treatment with Zelboraf.
• are breastfeeding or plan to breastfeed. It is not known if Zelboraf passes into your breast milk. You and your healthcare provider should decide if you will take Zelboraf or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C.

• Females who are able to become pregnant and males who take Zelboraf should use birth control during treatment and for 2 months after stopping Zelboraf.
• Talk to your healthcare provider about birth control methods that may be right for you.
• Tell your healthcare provider right away if you become pregnant during treatment with Zelboraf.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Zelboraf passes into your breast milk. You and your healthcare provider should decide if you will take Zelboraf or breastfeed. You should not do both.

• Take Zelboraf exactly as your healthcare provider tells you. Do not change your dose or stop Zelboraf unless your healthcare provider tells you.
• Zelboraf is taken in the morning and in the evening, about 12 hours apart.
• Take Zelboraf with or without a meal.
• Swallow the tablets whole with a glass of water. Do not chew or crush Zelboraf tablets.
• If you miss a dose, take it as soon as you remember. If it is within 4 hours of your next scheduled dose, just take your next dose at your regular time. Do not make up for the missed dose.
• Do not take 2 doses of Zelboraf at the same time.
• If you take too much Zelboraf, call your healthcare provider right away.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Zelboraf is 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal.

Zelboraf tablets should be swallowed whole with a glass of water. Zelboraf tablets should not be chewed or crushed.

If you take too much Zelboraf call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Zelboraf is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Zelboraf at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Zelboraf in the original container with the lid tightly closed.
• Ask your healthcare provider or pharmacist how to safely throw away (dispose of) any unused or expired Zelboraf.
• Keep Zelboraf and all medicine out of the reach of children.