Important Safety Information & Indication
IMPORTANT: If your healthcare provider prescribes ZELBORAF (vemurafenib), also read the Medication Guide that comes with ZELBORAF.
What is COTELLIC?
COTELLIC is a prescription medicine that is used with the medicine ZELBORAF, 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
Your healthcare provider will perform a test to make sure that COTELLIC is right for you.
It is not known if COTELLIC is safe and effective in children under 18 years of age.
Before you take COTELLIC and ZELBORAF, tell your healthcare provider about all of your medical conditions, including if you:
- have skin problems or history of skin problems, other than melanoma
- have bleeding problems, any medical conditions and/or on any medications that increase your risk of bleeding
- have heart problems, including a condition called long QT syndrome
- have eye problems
- have liver or kidney problems
- have muscle problems
- have had or are planning to receive radiation therapy
- have been told that you have low blood levels of potassium, calcium, or magnesium
- are pregnant or plan to become pregnant. COTELLIC and ZELBORAF can harm your unborn baby.
- Females who are able to become pregnant should use effective birth control during treatment with COTELLIC and ZELBORAF, and for 2 weeks after the final dose of COTELLIC or ZELBORAF (whichever is taken later).
- 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 or think you are pregnant during treatment with COTELLIC and ZELBORAF.
- are breastfeeding or plan to breastfeed. It is not known if COTELLIC or ZELBORAF passes into your breast milk. Do not breastfeed during treatment with COTELLIC and ZELBORAF and for 2 weeks after the final dose of COTELLIC or ZELBORAF (whichever is taken later). Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the blood levels of COTELLIC.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take COTELLIC and ZELBORAF in combination?
- Take COTELLIC and ZELBORAF exactly as your healthcare provider tells you. Do not change your dose or stop taking COTELLIC and ZELBORAF unless your healthcare provider tells you to.
- Take COTELLIC one time a day for 21 days, followed by 7 days off treatment, to complete a 28-day treatment cycle.
- Take ZELBORAF every 12 hours for every day in the 28-day cycle (no rest period).
- Do not crush or chew ZELBORAF tablets.
- Take COTELLIC and ZELBORAF with or without food.
- If you vomit after taking your dose of COTELLIC or ZELBORAF, do not take an additional dose. Take your next dose as scheduled.
- If you miss a dose of COTELLIC, take your next dose as scheduled.
- If you miss a dose of ZELBORAF, 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.
- If you take too much ZELBORAF, call your healthcare provider or go the nearest hospital emergency room right away.
What should I avoid during treatment with COTELLIC and ZELBORAF?
Avoid sunlight during treatment with COTELLIC and ZELBORAF. COTELLIC and 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 your head, face, hands, arms, and legs.
- Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.
What are the possible side effects of COTELLIC and ZELBORAF?
COTELLIC and ZELBORAF may cause serious side effects, including:
- Risk of new skin cancers. COTELLIC in combination with ZELBORAF may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma, or basal cell carcinoma). New melanoma lesions have occurred in people who take ZELBORAF.
- Check your skin regularly and tell your healthcare provider right away if you have any skin changes including:
- new wart
- skin sore or reddish bump that bleeds or does not heal
- change in size or color of a mole
Your healthcare provider should check your skin before you start taking COTELLIC and ZELBORAF, and every 2 months during treatment with COTELLIC and ZELBORAF. Your healthcare provider may continue to check your skin for 6 months after you stop taking COTELLIC and ZELBORAF.
- Risk of other cancers. ZELBORAF may also cause another type of cancer called non-cutaneous squamous cell carcinoma (non-cuSCC). Talk with your healthcare provider about your risk for these cancers.
Your healthcare provider should also check for cancers that may not occur on the skin. Tell your healthcare provider about any new symptoms that develop during treatment with COTELLIC and ZELBORAF.
- Bleeding problems. COTELLIC can cause serious bleeding problems.
Call your healthcare provider and get medical attention right away if you get any signs of bleeding, including:
- red or black stools (looks like tar)
- blood in your urine
- cough up or vomit blood
- stomach (abdominal) pain
- unusual vaginal bleeding
- dizziness or weakness
- Heart problems. Your healthcare provider should do tests before and during treatment to check your heart function. Tell your healthcare provider if you get any of these signs and symptoms of heart problems:
- persistent coughing or wheezing
- shortness of breath
- swelling of your ankles and feet
- increased heart rate
- Allergic reactions can happen while taking ZELBORAF, and can be severe. Stop taking ZELBORAF and get medical help right away if you get any of these symptoms of an allergic reaction:
- rash or redness all over your body
- trouble breathing or swallowing
- throat tightness or hoarseness
- feel faint
- fast heartbeat
- Severe rash and other severe skin reactions. Tell your healthcare provider right away if you get any of these symptoms:
- a rash that covers a large area of your body
- peeling skin
Stop taking ZELBORAF and call your doctor right away if you get a skin rash with any of the following symptoms, because you may have a severe skin reaction:
- blisters on your skin
- blisters or sores in your mouth
- peeling of your skin
- redness or swelling of your face, hands, or soles of your feet
- Eye problems. Tell your healthcare provider right away if you get any of these symptoms:
- blurred vision
- partly missing vision or loss of vision
- see halos
- eye pain, swelling, or redness
- any other vision changes
- Changes in the electrical activity of your heart called QT prolongation. QT prolongation can cause irregular heartbeats that can be life threatening. Your doctor should do tests before you start taking ZELBORAF and during your treatment with ZELBORAF to check the electrical activity of your heart and your body salts (electrolytes). Tell your doctor 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.
- Liver problems or liver injury. Your healthcare provider should do blood tests to check your liver function before and during treatment. Tell your healthcare provider right away if you get any of these symptoms:
- yellowing of your skin or the white of your eyes
- dark or brown (tea color) urine
- nausea or vomiting
- feeling tired or weak
- loss of appetite
- pain in the right side of your stomach
- Muscle problems (rhabdomyolysis). COTELLIC can cause muscle problems that can be severe. Treatment with COTELLIC may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. Your healthcare provider should do a blood test to check your levels of CPK before and during treatment. Tell your healthcare provider right away if you get any of these symptoms:
- muscle aches or pain
- muscle spasms and weakness
- dark, reddish urine
- Skin sensitivity to sunlight (photosensitivity). Skin sensitivity to sunlight during treatment with COTELLIC and ZELBORAF is common and can sometimes be severe. Tell your healthcare provider if you get any of these symptoms:
- red, painful, itchy skin that is hot to touch
- sun rash
- skin irritation
- bumps or tiny papules
- thickened, dry, wrinkled skin
- Worsening side effects from radiation treatment that can sometimes be severe or lead to death. Tell your healthcare provider if you have had or are planning to receive radiation therapy.
- Kidney injury. Your healthcare provider should do blood tests to check your kidney function before you start taking ZELBORAF and during treatment.
- Connective tissue disorders. Tell your healthcare provider if you develop an unusual thickening of the palms of your hands along with tightening of the fingers inward or any unusual thickening of the soles of your feet which may be painful.
See “What should I avoid during treatment with COTELLIC and ZELBORAF?” for information on protecting your skin during treatment with COTELLIC and ZELBORAF.
The most common side effects of COTELLIC in combination with ZELBORAF include:
- sunburn or sun sensitivity
Your healthcare provider will take blood tests during treatment with COTELLIC in combination with ZELBORAF. The most common changes to blood tests include:
- increased blood levels of liver enzymes (GGT, ALT, or AST)
- increased blood level of enzyme from muscle (creatine phosphokinase)
- decreased blood level of phosphate, sodium or potassium
- increased blood level of liver or bone enzyme (alkaline phosphatase)
- decreased blood level of a type of white blood cell (lymphocyte)
These are not all the possible side effects of COTELLIC and ZELBORAF.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Genentech at (888)-835-2555.