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. A patient’s healthcare provider will perform a test to make sure that Cotellic is right for the patient.

WHAT IS

ADVANCED MELANOMA?

MELANOMA IS AN AGGRESSIVE AND DEADLY TYPE OF SKIN CANCER AND IS ONE OF THE ONLY CANCERS WITH A RISING INCIDENCE.1

IF THE DISEASE ADVANCES BY SPREADING NEARBY OR TO OTHER ORGANS, IT COULD BECOME DEADLY.2,3

More than

10,000

MELANOMA DEATHS

will occur in the U.S. in 2016 –
THAT’S ONE DEATH PER HOUR1

APPROXIMATELY 50% of
melanoma cells have a
mutation in the BRAF protein4

16%

of people living with metastatic melanoma survive 5 YEARS1

HOW THE MEDICINES MAY WORK (MECHANISMS OF ACTION)

COTELLIC PLUS ZELBORAF FOR UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATION

A series of proteins called the MAPK cell signaling pathway help control cell growth and survival. When some BRAF proteins are mutated in advanced melanoma, abnormal growth signals are sent into the cell, causing tumors to grow.5-7

Zelboraf is designed to work inside melanoma cells to inhibit some mutated forms of BRAF.5-7

Cotellic is an inhibitor of some forms of MEK, a protein in the same cell signaling pathway and also found in melanoma cells. When used in combination, Cotellic and Zelboraf are thought to reduce cancer cell growth compared to Zelboraf alone.5-7

coBRIM STUDY RESULTS

coBRIM is a Phase III study evaluating the safety and efficacy of Cotellic plus Zelboraf compared to Zelboraf plus placebo in 495 patients with BRAF V600 mutation-positive unresectable locally advanced or metastatic melanoma (detected by the cobas® 4800 BRAF Mutation Test) and previously untreated for advanced disease.8


In clinical trials, the combination of Cotellic and Zelboraf was shown to:

  • help control patients' disease: this combination reduced the risk of the disease worsening or death by nearly half compared to those patients taking Zelboraf alone.8
  • helped patients live longer: this combination reduced the risk of death by about one-third (37%) compared with Zelboraf alone.8
  • help shrink tumors: more than two-thirds of patients (70%) taking the combination therapy had their tumors shrink compared to 50% of patients who were only taking Zelboraf.8

Possible serious side effects with Cotellic include risk of skin cancers, increased risk of bleeding, heart problems that can lead to inadequate pumping of the blood by the heart, rash, eye problems, abnormal liver test or liver injury, increased levels of an enzyme in the blood, and photosensitivity. The most common side effects of Cotellic include diarrhea, sunburn or sun sensitivity, nausea, fever and vomiting. Cotellic can also cause changes in blood test results.8

44%

reduction in the risk of disease worsening or death (hazard ratio=0.56, 95% confidence interval 0.45-0.70; p<0.001)8

12.3

months median progression-free survival with Cotellic plus Zelboraf compared to 7.2 months for Zelboraf alone8

Important Safety Information

Important: If a patient’s healthcare provider prescribes Zelboraf (vemurafenib), the patient should also read the Medication Guide that comes with Zelboraf.

 

Cotellic Indication

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.

 

A patient’s healthcare provider will perform a test to make sure that Cotellic is right for the patient. It is not known if Cotellic is safe and effective in children under 18 years of age.

 

Before taking Cotellic, patients should tell their healthcare provider about all of their medical conditions, including if they:

  • have skin problems or history of skin problems, other than melanoma
  • have bleeding problems, any medical conditions and/or on any medications that increase the risk of bleeding
  • have heart problems
  • have eye problems
  • have liver problems
  • have muscle problems
  • are pregnant or plan to become pregnant. Cotellic and Zelboraf can harm an unborn baby
    • Females who are able to become pregnant should use effective birth control during treatment with Cotellic, and for two weeks after the final dose of Cotellic
    • Patients should talk to their healthcare provider about birth control methods that may be right for them
    • Patients should tell their healthcare provider right away if they become pregnant or think they are pregnant during treatment with Cotellic and Zelboraf
  • are breastfeeding or plan to breastfeed. It is not known if Cotellic passes into breast milk. Patients should not breastfeed during treatment with Cotellic and for two weeks after the final dose. Patients should talk to their healthcare provider about the best way to feed their baby during this time

 

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Certain medicines may affect the blood levels of Cotellic.

 

Patients should know the medicines they take and keep a list of them to show their healthcare provider and pharmacist when they get a new medicine.

 

How should patients take Cotellic?

  • Patients should take Cotellic exactly as their healthcare provider tells them. Patients should not change their dose or stop taking Cotellic unless their healthcare provider tells them to
  • Patients should take Cotellic one time a day for 21 days, followed by seven days off treatment, to complete a 28-day treatment cycle
  • Patients can take Cotellic with or without food
  • If a patient misses a dose of Cotellic or vomits after taking their dose, they should take their next dose as scheduled

 

What should patients avoid during treatment with Cotellic?
Patients should avoid sunlight during treatment with Cotellic. Cotellic can make a patient’s skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn:

  • When a patient goes outside, they should wear clothes that protect their skin, including their head, face, hands, arms and legs.
  • They should use lip balm and a broad-spectrum sunscreen with SPF 30 or higher

 

What are the possible side effects of Cotellic?
Cotellic may cause serious side effects, including:

 

  • Risk of new skin cancers. Cotellic may cause new skin cancers (cutaneous squamous cell carcinoma, keratoacanthoma or basal cell carcinoma).
    Patients should check their skin regularly and tell their healthcare provider right away if they 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

    A patient’s healthcare provider should check the patient’s skin before they start taking Cotellic, and every two months during treatment with Cotellic. A patient’s healthcare provider may continue to check the patient’s skin for six months after the patient stops taking Cotellic. A patient’s healthcare provider should also check for cancers that may not occur on the skin. Patients should tell their healthcare provider about any new symptoms that develop during treatment with Cotellic.

 

  • Bleeding problems. Cotellic can cause serious bleeding problems
    Patients should call their healthcare provider and get medical attention right away if they get any signs of bleeding, including:
    • red or black stools (looks like tar)
    • blood in their urine
    • headaches
    • cough up or vomit blood
    • stomach (abdominal) pain
    • unusual vaginal bleeding
    • dizziness or weakness

 

  • Heart problems. A patient’s healthcare provider should do tests before and during treatment to check the patient’s heart function. Patients should tell their healthcare provider if they get any of these signs and symptoms of heart problems:
    • persistent coughing or wheezing
    • shortness of breath
    • swelling of their ankles and feet
    • tiredness
    • increased heart rate

 

  • Severe rash. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • a rash that covers a large area of their body
    • blisters
    • peeling skin

 

  • Eye problems. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • blurred vision
    • partly missing vision or loss of vision
    • see halos
    • any other vision changes

    A patient’s healthcare provider should check the patient’s eyes if the patient notices any of the symptoms above.

 

  • Liver problems. A patient’s healthcare provider should do blood tests to check the patient’s liver function before and during treatment. Patients should tell their healthcare provider right away if they get any of these symptoms:
    • yellowing of their skin or the white of their eyes
    • dark or brown (tea color) urine
    • nausea or vomiting
    • feeling tired or weak
    • loss of appetite

 

  • Muscle problems (rhabdomyolysis). Cotellic can cause muscle problems that can be severe. Treatment with Cotellic may increase the level of an enzyme in the blood called creatine phosphokinase (CPK) and may be a sign of muscle damage. A patient’s healthcare provider should do a blood test to check the patient’s levels of CPK before and during treatment. Patients should tell their healthcare provider right away if they 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 is common and can sometimes be severe. Patients should tell their healthcare provider if they 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

 

See “What should patients avoid during treatment with Cotellic?” for information on protecting the skin during treatment with Cotellic.

 

The most common side effects of Cotellic include:

  • diarrhea
  • nausea
  • fever
  • vomiting
  • sunburn or sun sensitivity

 

A patient’s healthcare provider will take blood tests during treatment with Cotellic. 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)

 

Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of Cotellic.

 

Patients should call their doctor for medical advice about side effects. Patients may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835-2555.

 

Please see Full Cotellic Prescribing Information and Patient Information for additional Important Safety Information at www.cotellic.com.