Zelboraf® & Cotellic® combination therapy

(vemurafenib) & (cobimetinib)

Pronounced Zel-bor-af & Co-tell-ic

Zelboraf, also known as vemurafenib, is a targeted therapy used to treat a type of skin cancer called melanoma. It is registered by Medsafe for the treatment of adult patients with melanoma which:

  • Has spread to other parts of the body (metastatic) or cannot be removed by surgery, and
  • Has a certain type of abnormal gene (the BRAF gene).

Cotellic, also known as cobimetinib, is a different type of targeted therapy for the treatment of melanoma, which is used in combination with Zelboraf. The combination of Zelboraf and Cotellic has been shown to work better than Zelboraf alone.

Ask your doctor if Zelboraf and Cotellic are right for you.

How Zelboraf and Cotellic combination treatment works

How Zelboraf works

BRAF is a protein that tells cells when to grow and divide. When it works properly, cells grow and divide at a normal rate.

However, in about 50% of melanoma cases the BRAF protein is faulty. The signals that normally switch the protein off do not work, causing the cells to multiply too quickly and create tumours. It’s like a light circuit in your home that has been built with a faulty switch — no matter how many times you click it up and down, the light remains on.

Zelboraf targets the faulty BRAF protein to help stop the melanoma cells from growing and dividing.

How Cotellic works

The MEK pathway is another mechanism that manages cell production in a healthy body. If it stops working properly cell growth may become uncontrolled, resulting in the development and growth of tumours.

Cotellic is a MEK inhibitor, which means it works by stopping MEK1 and/or MEK2 proteins from overworking. It is not approved to be used on its own — only in combination with Zelboraf.

How Zelboraf and Cotellic combination therapy works

Combination therapy turns off two switches in the circuit and therefore blocks the stimulus that encourages the growth of melanoma.

Possible side effects of Zelboraf and Cotellic combination therapy

All medicines have side effects. You will find a list of known side effects for Zelboraf in the Consumer Medicine Information here. And a list of known side effects for Cotellic in the Consumer Medicine Information here.

You can find some useful tips in the Zelboraf and Cotellic Combination Treatment Patient Booklet by clicking here.

Always talk to your doctor if you have any questions or concerns.

Clinical trial data

The efficacy and safety of Zelboraf and Cotellic as treatment for patients with melanoma has been studied in clinical trials.

If you would like to know more about these clinical trials, please talk to your doctor.

Keep in mind that everyone is different, and the response and benefit you may experience cannot be predicted.

Ask your doctor if Zelboraf and Cotellic combination therapy is right for you. 

How to access Zelboraf and Cotellic combination therapy

Zelboraf and Cotellic are registered by Medsafe, but not publicly funded by PHARMAC. This means you will have to pay for these medicines. Paying for treatment requires careful thought, but there are financial options that may help you fund private treatment. If you have health insurance, carefully check what’s covered — every health insurance provider has different rules and benefits that cover cancer treatment, surgery, tests and specialist appointments.

Roche also offers support through a Cost Share Programme.

The Zelboraf and Cotellic Cost Share Programme
• Caps the total amount you will pay for your medicine.
• Spreads the costs overtime, so not all of it has to be paid immediately.
• Provides you with ongoing treatment at no cost once you reach the cap (other costs such as doctor fees and dispensing fees will still apply).

If you are considering treatment with Zelboraf and Cotellic combination therapy, ask your doctor about:

• How much will the medicine cost me?
• What benefits might the medicine give me?
• What are the possible risks or side effects?
• Is the Cost Share Programme available to me for this medicine?

Both Zelboraf and Cotellic come in tablet form, so you can take them at home.
All treatments need to be considered in line with your individual situation.

Ask your doctor if Zelboraf and Cotellic combination therapy is the right treatment for you.

Ready to take the next step?

Making decisions about treatment options involves working through the advantages and disadvantages, so you can decide what may work best for you and your loved ones. 

Because every situation is different, it’s important to speak to your doctor to find out if Zelboraf and Cotellic combination therapy is right for you.

Talking to your doctor about Zelboraf and Cotellic combination therapy

We’ve put together a discussion guide to help you begin a conversation with your doctor about Zelboraf and Cotellic. Print it off, take it along to your next appointment, and take notes in the spaces provided.

For further information about private treatment providers click here.

You can also talk to your current doctor about referral to a private doctor or treatment centre.

To learn more about how medicines become available in New Zealand, click here.

Handy resources

Zelboraf Consumer Medicine Information
Click Here
Cotellic Consumer Medicine Information
Click Here

Cotellic® (cobimetinib), 20 mg film-coated tablets, is a Prescription Medicine used in combination with Zelboraf® (vemurafenib) to treat a skin cancer called metastatic (spreading) melanoma that has a mutation (abnormal change) in the BRAF gene.

As Cotellic is taken together with Zelboraf, also read the Consumer Medicine Information for Zelboraf before you take these medicines.

Do not use Cotellic if: you are allergic to cobimetinib or any ingredients in Cotellic tablets.

Before taking Cotellic, tell your doctor if: you have any eye problems; you have any heart problems; you have any liver problems; you have any medical conditions that increase your risk of bleeding; you have any muscle problems; you have any problems with your kidneys; you are pregnant or breastfeeding, or plan to become pregnant or breastfeed; you are allergic to any other medicines, foods, dyes or preservatives; you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food store.

While you are taking Cotellic, tell your doctor if you notice any skin changes such as crusty, non-healing sores, small lumps that are red, pale or pearly in colour, or new spots, freckles or any moles changing in colour. Avoid going out in the sun. Cotellic can make your skin more sensitive to sunlight. You may burn more easily and get severe sunburn.  Avoid grapefruit juice while taking Cotellic. Tell your doctor if you become pregnant while taking Cotellic.  Be careful driving or operating machinery until you know how Cotellic affects you, as Cotellic may affect your vision.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following:  new or worsening problems with your eyes or vision (blurred vision, loss of vision or other vision changes, changes in colour, seeing a blurred outline around objects, eye pain, swelling or redness); a rash that covers a large area of your body, blisters, or peeling skin; symptoms of muscle damage (muscle aches, spasms or weakness,  dark, reddish urine); symptoms of a serious bleeding problem (red or black stools that look like tar, blood in your urine or stools, unusual vaginal bleeding, headaches, dizziness, or feeling weak); symptoms of an allergic reaction (shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin); symptoms of heart problems (persistent coughing or wheezing, shortness of breath, tiredness, increased heart rate, swelling of your ankles and feet).

Possible common side-effects may also include: diarrhoea, nausea or vomiting; fever or chills; symptoms of dehydration (dry or sticky mouth, low or no urine output, urine looks dark yellow, no tears or sunken eyes); symptoms of anaemia (tiredness, headaches, being short of breath when exercising, dizziness and looking pale); sunburn or sun sensitivity; coughing, difficulty breathing or wheezing; skin problems (rashes, spots, itching, dry or scaly skin, hardened or thickened areas of the skin, painful red lumps or warts).

Cotellic has risks and benefits. Ask your doctor if Cotellic is right for you. Use strictly as directed. If symptoms continue or you have side effects, see your healthcare professional. For further information on Cotellic, please talk to your health professional or visit www.medsafe.govt.nz for Cotellic Consumer Medicine Information.

Cotellic is not funded by PHARMAC. You will need to pay for this medicine. A prescription charge and normal doctor fees may apply.

 

Zelboraf® (vemurafenib), 240 mg film-coated tablets, is a Prescription Medicine used to treat a skin cancer called metastatic (spreading) melanoma that has a mutation (abnormal change) in the BRAF gene.

Do not use Zelboraf if: you are allergic to vemurafenib or any ingredients listed on the pack.

Before taking Zelboraf, tell your doctor if: you have a heart disorder or liver or kidney problems; you are pregnant or breast-feeding or plan to become pregnant or breastfeed; you have low levels of potassium, calcium or magnesium in your blood; you have been previously diagnosed with other types of cancer or received radiation treatment; you are allergic to any other medicines, foods, dyes or preservatives; you are taking any other medicines, including any that you have bought from a pharmacy, supermarket or health food store.

While you are taking Zelboraf: tell your doctor if you notice any skin changes such as a new wart, a skin sore or reddish bump or a sore that bleeds or does not heal. Avoid going out in the sun. Zelboraf can make your skin more sensitive to sunlight and you may burn more easily and get severe sunburn. Tell your doctor if you become pregnant while taking Zelboraf.

Tell your doctor immediately or go to your nearest Accident and Emergency Centre if you notice any of the following: difficulty breathing, chest tightness or wheezing; swelling of the face, lips or mouth; severe skin rash, itching, hives; severe blisters or bleeding of your lips, mouth, nose, or eyes; severe skin reaction starting with painful red areas, then large blisters and ends with peeling of layers of skin, accompanied by fever and chills, aching muscles and generally feeling unwell; fever associated with a mild to severe skin rash; severe light-headedness or dizziness, or feel your heart beating irregularly or fast; problems with your eyes or eyesight, such as blurred or altered vision, irritation, eye pain or redness; yellowing of the skin and eyes; light coloured bowel motions; dark coloured urine; severe upper stomach pain, often with nausea and vomiting (signs of inflammation of the pancreas). Possible common side-effects may also include: red skin rashes, itching, dry or scaly skin and hardened or thickened areas of the skin; painful red lumps or patches of skin that may appear darker or harder than usual; skin problems including warts; sunburn; increased sensitivity to light; loss of appetite and weight loss; headache; changes in the way things taste; drooping eyelid and sagging muscles on one side of the face caused by a paralysed nerve in the face (often reversible); tingling, burning or pain in your hands or feet; diarrhoea; constipation; hair loss; joint, muscle or back pain; unusual weakness; feeling sick or vomiting; feeling tired; fever; swelling (usually in the legs); cough; frequent infections such as fever, severe chills, sore throat or mouth ulcers; thickening or appearance of visible cords in the palm of one or both hands.

Zelboraf has risks and benefits. Ask your doctor if Zelboraf is right for you. Use strictly as directed. If symptoms continue or you have side effects, see your healthcare professional. For further information on Zelboraf, please talk to your health professional or visit www.medsafe.govt.nz for Zelboraf Consumer Medicine Information.

Zelboraf is not funded by PHARMAC. You will need to pay for this medicine. A prescription charge and normal doctor fees may apply.

Consumer panel dated 13 May 2019.