KEYTRUDA for advanced melanoma


How is melanoma diagnosed?

It is possible to detect the early signs of melanoma by self-examination; checking regularly for changes in spots, freckles and moles. If anything irregular stands out (a variation in colour, size, shape or sensitivity) the next step is to see a doctor.

The doctor will conduct a physical examination, and possibly a biopsy. They will also ask about any personal or family history with melanoma. They may use a dermascope (a magnifying device) to examine the skin, and feel the lymph nodes near the suspicious spot or mole.

Having a biopsy

If the doctor suspects it is melanoma, they'll take a biopsy to remove the mole, so it can be sent to a pathology laboratory to be examined under a microscope. This is usually a straightforward procedure, and the waiting period is usually about a week before the results come back. If the tests show it is melanoma, surgery may be required to remove a wider margin of surrounding skin.

Other tests

If it is melanoma, the doctor may recommend other tests, such as:

  • blood tests: to check general health
  • a chest X-ray: to see if it's spread to the lungs
  • scans: to see if it's spread to other parts of the body
  • fine needle aspiration: inserted into the lymph nodes, to see if they contain melanoma cells.

The stages of melanoma

  • Stage 0 — (melanoma in situ) abnormal cells are found in the epidermis
  • Stage 1 — the melanoma is not more than 2mm thick
  • Stage 2 — more than 2 to 4mm thick with no spread to the lymph vessels or nodes
  • Stage 3 — any thickness that has spread to lymph vessels or lymph nodes
  • Stage 4 — the melanoma has spread to other parts of the body

Knowing the stage helps doctors plan suitable treatment.

What is the prognosis?

If treated in its early stages, melanoma is more likely to be cured. Over 85% of people diagnosed with early stage melanoma 15 years ago are alive today with no sign of the disease. This percentage has grown steadily over the years with early detection and treatment.

Each patient should talk to their doctor about their own prognosis, as each medical history is unique. As a rule - melanomas on the limbs have a better prognosis than those on the trunk, head or neck.

Treating melanoma

Questions to ask your doctor about melanoma

Who can I talk to?



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Important Safety Information

KEYTRUDA contains the active substance called pembrolizumab and is a medicine that may treat certain cancers by working with your immune system.

KEYTRUDA is available as a 50 mg powder for infusion and 100 mg/4 mL (25 mg/mL) concentrate for solution for infusion.

KEYTRUDA can only be used in children below 18 years of age with MSI-H or dMMR cancers. It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancer of the brain or spinal cord (central nervous system cancers).

Tell your doctor if you have a disease of your immune system such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of your lungs (called pneumonitis); have liver problems; or have any other medical problems.

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. KEYTRUDA can harm your unborn baby. Effective contraception must be used during treatment with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA for woman who could become pregnant.

If you are breastfeeding, tell your doctor. Do not breastfeed while taking KEYTRUDA.

Tell your doctor if you are taking any other medicines, including medicines that can be bought without a prescription from a pharmacy, supermarket or health food shop, or other medicines that make the immune system weak. Examples of these may include steroids, such as prednisone.

KEYTRUDA is given through an IV for about 30 minutes. Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on age and the dose given. Your doctor will decide how many treatments you need. KEYTRUDA may be given in combination with other anti-cancer medicines.

What are the possible side effects of KEYTRUDA?

KEYTRUDA can have some serious side effects. These side effects can sometimes become life- threatening and can lead to death. These side effects may happen any time during treatment or even after treatment has ended. More than one side effect can be experienced at the same time.

Call or see your doctor right away if you develop any of the following symptoms:

Lung problems. Signs and symptoms of lung problems may include shortness of breath, chest pain, or coughing.

Intestinal problems. Signs and symptoms of problems with your intestines may include diarrhea or more bowel movements than usual, stools that are black, tarry, sticky, or have blood or mucus, or severe stomach pain or tenderness.

Liver problems. Signs and symptoms of liver problems may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, your skin looks yellow, the whites of your eyes look yellow, dark urine or you bleed or bruise more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands). Signs and symptoms of hormone gland problems may include rapid heartbeat, weight loss or weight gain, increased sweating, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems. Signs and symptoms of kidney problems may include change in the amount or color of your urine.

Skin problems. Signs and symptoms of skin problems may include rash, itching, blisters, peeling or skin sores, or ulcers in mouth or in lining of nose, throat, or genital area.

Problems in other organs. Signs and symptoms of problems in other organs may include muscle pain or weakness, changes in eyesight, stomach area pain with nausea and vomiting (pancreatitis), shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis), confusion, fever, memory problems, or seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis), or pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis).

Infusion (IV) reactions. Signs and symptoms of infusion reactions may include shortness of breath, itching or rash, dizziness or fever.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Graft-versus-host-disease (GVHD) in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). GVHD may occur if you had this transplant in the past. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

Common side effects:

Very common side effects (may affect more than 1 in 10 people) include: diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain and decreased sodium levels in the blood.

Common side effects (reported in more than 1 in 5 people) when KEYTRUDA was given in combination with chemotherapy include: hair loss, feeling tired, diarrhoea, decrease in white blood cell count, joint pain and rash.

The most common side effects when KEYTRUDA is given in combination with axitinib are: diarrhoea, high blood pressure, fatigue, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands or soles of your feet, nausea, increase in liver enzyme levels, hoarseness, cough and constipation.

The most common side effects when KEYTRUDA is given to children are: fever, vomiting, fatigue, constipation, stomach pain and nausea.

Less common side effects can happen. KEYTRUDA may cause other side effects that are not listed. If you have any side effect that bothers you or that does not go away, tell your doctor.

For more information, please talk to your doctor. The information on the website should be discussed with your healthcare professional and does not replace their advice.

KEYTRUDA has risks and benefits. Talk to your doctor to see if KEYTRUDA is right for you. KEYTRUDA is a funded medicine for patients with melanoma which cannot be removed by surgery alone or when it has spread – restrictions apply. KEYTRUDA is an unfunded medicine for the treatment of melanoma after surgery, and for patients with NSCLC, HNSCC, cHL, urothelial carcinoma, MSI-H/dMMR cancer and RCC. Ask your health professional about the cost of the medicine and any other medical fees that may apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist, or health professional.

Additional product information and the Consumer Medicine Information (CMI) can be obtained by phoning 0800 500 673 or is available via www.medsafe.govt.nz

Based on the CMI and Data Sheet prepared 1 June 2020.

Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. NZ-KEY-00522 TAPS NA 12128 MSD9764 Updated: September 2020.

2015-2020


KEYTRUDA® (pembrolizumab) 50mg powder for infusion

KEYTRUDA® (pembrolizumab) 100 mg/4 mL (25 mg/mL) concentrate for solution for infusion

KEYTRUDA is a Prescription Only Medicine and is used:

  • in the treatment of melanoma which cannot be removed by surgery alone or when it has spread to multiple sites in the body
  • in treatment of melanoma after surgery to help prevent the cancer from coming back
  • in the treatment of a kind of lung cancer called non-small cell lung cancer (NSCLC)
  • in the treatment of classical Hodgkin Lymphoma (cHL)
  • in the treatment of urothelial carcinoma, including bladder cancer
  • in the treatment of a kind of head and neck cancer called head and neck squamous cell carcinoma (HNSCC)
  • in the treatment of a kind of cancer in adults and children that can occur in any part of the body and is shown by a laboratory test to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
  • in combination with axitinib for the treatment of a kind of cancer called renal cell carcinoma (RCC)

KEYTRUDA contains the active substance called pembrolizumab and is a medicine that may treat certain cancers by working with your immune system.

KEYTRUDA can only be used in children below 18 years of age with MSI-H or dMMR cancers. It is not known if KEYTRUDA is safe and effective in children with MSI-H or dMMR cancer of the brain or spinal cord (central nervous system cancers).

Tell your doctor if you have a disease of your immune system such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have pneumonia or swelling of your lungs (called pneumonitis); have liver problems; or have any other medical problems.

If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor. KEYTRUDA can harm your unborn baby. Effective contraception must be used during treatment with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA for woman who could become pregnant.

If you are breastfeeding, tell your doctor. Do not breastfeed while taking KEYTRUDA.

Tell your doctor if you are taking any other medicines, including medicines that can be bought without a prescription from a pharmacy, supermarket or health food shop, or other medicines that make the immune system weak. Examples of these may include steroids, such as prednisone.

KEYTRUDA is given through an IV for about 30 minutes. Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on age and the dose given. Your doctor will decide how many treatments you need. KEYTRUDA may be given in combination with other anti-cancer medicines.

What are the possible side effects of KEYTRUDA?

KEYTRUDA can have some serious side effects. These side effects can sometimes become life- threatening and can lead to death. These side effects may happen any time during treatment or even after treatment has ended. More than one side effect can be experienced at the same time.

Call or see your doctor right away if you develop any of the following symptoms:

Lung problems. Signs and symptoms of lung problems may include shortness of breath, chest pain, or coughing.

Intestinal problems. Signs and symptoms of problems with your intestines may include diarrhea or more bowel movements than usual, stools that are black, tarry, sticky, or have blood or mucus, or severe stomach pain or tenderness.

Liver problems. Signs and symptoms of liver problems may include nausea or vomiting, feeling less hungry, pain on the right side of your stomach, your skin looks yellow, the whites of your eyes look yellow, dark urine or you bleed or bruise more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands). Signs and symptoms of hormone gland problems may include rapid heartbeat, weight loss or weight gain, increased sweating, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, or headaches that will not go away or unusual headache.

Kidney problems. Signs and symptoms of kidney problems may include change in the amount or color of your urine.

Skin problems. Signs and symptoms of skin problems may include rash, itching, blisters, peeling or skin sores, or ulcers in mouth or in lining of nose, throat, or genital area.

Problems in other organs. Signs and symptoms of problems in other organs may include muscle pain or weakness, changes in eyesight, stomach area pain with nausea and vomiting (pancreatitis), shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis), confusion, fever, memory problems, or seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, or eye pain (sarcoidosis), or pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis).

Infusion (IV) reactions. Signs and symptoms of infusion reactions may include shortness of breath, itching or rash, dizziness or fever.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Graft-versus-host-disease (GVHD) in people with bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). GVHD may occur if you had this transplant in the past. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

Common side effects:

Very common side effects (may affect more than 1 in 10 people) include: diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of skin which have lost colour, stomach pain and decreased sodium levels in the blood.

Common side effects (reported in more than 1 in 5 people) when KEYTRUDA was given in combination with chemotherapy include: hair loss, feeling tired, diarrhoea, decrease in white blood cell count, joint pain and rash.

The most common side effects when KEYTRUDA is given in combination with axitinib are: diarrhoea, high blood pressure, fatigue, low levels of thyroid hormone, decreased appetite, blisters or rash on the palms of your hands or soles of your feet, nausea, increase in liver enzyme levels, hoarseness, cough and constipation.

The most common side effects when KEYTRUDA is given to children are: fever, vomiting, fatigue, constipation, stomach pain and nausea.

Less common side effects can happen. KEYTRUDA may cause other side effects that are not listed. If you have any side effect that bothers you or that does not go away, tell your doctor.

For more information, please talk to your doctor. The information on the website should be discussed with your healthcare professional and does not replace their advice.

KEYTRUDA has risks and benefits. Talk to your doctor to see if KEYTRUDA is right for you. KEYTRUDA is a funded medicine for patients with melanoma which cannot be removed by surgery alone or when it has spread – restrictions apply. KEYTRUDA is an unfunded medicine for the treatment of melanoma after surgery, and for patients with NSCLC, HNSCC, cHL, urothelial carcinoma, MSI-H/dMMR cancer and RCC. Ask your health professional about the cost of the medicine and any other medical fees that may apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist, or health professional.

Additional product information and the Consumer Medicine Information (CMI) can be obtained by phoning 0800 500 673 or is available via www.medsafe.govt.nz

Based on the CMI and Data Sheet prepared 1 June 2020.

Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. NZ-KEY-00522 TAPS NA 12128 MSD9764 Updated: September 2020.

Copyright © 2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved.

2015-2020