KEYTRUDA for advanced melanoma


What are the treatment options?

The majority of people treated for early stage melanoma have surgery only. For advanced melanoma, radiation treatment, chemotherapy and immunotherapy can also be used (independently, or in combination). The doctor will advise on the best treatment for each individual’s case of melanoma.

Healthcare team

Initially this will include a team of doctors including a dermatologist, surgeon and plastic surgeon. If treatment is required beyond surgery, the team may also include medical oncologists, radiation oncologists, radiation therapists, oncology nurses, dieticians, social workers, physiotherapists and occupational therapists.

Surgery

Early stage melanoma is usually removed in the initial biopsy. More surgery is commonly then undertaken (removing a wider margin of surrounding skin) to ensure that all the melanoma cells have been removed. This is done under local anaesthetic as a day procedure, or it may require a general anaesthetic and hospitalisation. In most cases, the wound can be stitched together and will heal as a straight scar.

Skin grafts

Sometimes a skin graft is needed. This involves taking a layer of skin from another part of the body to cover the wound. The other possibility is a ‘flap’, where the surgeon will close the wound using a nearby flap of skin.

Post operation

People may experience pain or discomfort in the days following the procedure, in which case the doctor will most likely prescribe painkillers. There is a small risk of infection, haematoma (bruising) and scarring following surgery for melanoma. Occasionally, the skin graft fails.

Sentinel node biopsy

If the melanoma is more than 1mm thick, the surgeon may suggest a sentinel node biopsy (the sentinel node is the first lymph node that drains from the area where the melanoma developed). The sentinel node is removed surgically and examined. If melanoma cells are found in the nodes, the entire group of nodes in that area may be removed (Block dissection).

A potential side effect is lymphoedema (swelling in the part of the body drained by the affected lymph nodes). Treatment includes specialised exercise, massage, skin care and a properly fitted support garment or bandage.

Radiation treatment

Radiation treatment uses radiation to kill melanoma cells. It typically involves treatment to the skin and nearby lymph nodes, and aims to shrink the tumour and/or to reduce the likelihood of recurrence. Treatment is highly targeted, so as to minimise harm to normal body tissue.

Side effects depend on the part of the body being treated. Skin reddening (similar to sunburn) may occur. It’s important to follow the advice given by the treatment team.

Chemotherapy

Chemotherapy uses anti-cancer drugs to stop cancer cells from growing and reproducing. The drugs work by killing cells that divide rapidly, one of the main characteristics of cancer cells. Chemotherapy is usually given intravenously, or via tablets. For multiple melanoma nodules in the limb, chemotherapy may be given directly into the limb blood vessel. This is called limb infusion/perfusion. Chemotherapy is occasionally used as palliative treatment.

Side effects are specific to the chemotherapy drug(s) chosen. They may include the risk of infection, nausea, vomiting, lethargy, and hair loss. Generally, these side effects are temporary. The treatment team can advise on how to manage them.

Targeted therapies

Approximately half of all melanomas have a mutation (change) in a gene called the BRAF oncogene that helps drive their growth. Targeted therapies may block the activity of the mutated form of the BRAF protein.

Personalised drug therapy

Recent advances in melanoma treatment target specific abnormalities in cancer cells.

Immunotherapies, such as KEYTRUDA, are being used to treat advanced melanoma, by helping the immune system to detect and fight cancer cells.

KEYTRUDA may be used as a first treatment option when melanoma has spread (advanced stage 3-4 melanoma that has spread and cannot be removed by surgery.)

Palliative treatment for advanced cancer

Palliative treatment focuses on preventing and managing the symptoms of cancer and side effects of treatment. It aims to improve quality of life. GPs, specialists and palliative care teams in hospitals or hospices all provide palliative treatment for people with cancer.

There are many factors involved in making a treatment decision. You will need to talk through your options with your doctor to decide what treatment option is best for you.

How KEYTRUDA works

Questions to ask your doctor

Who can I talk to?



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Important Safety Information About KEYTRUDA® (pembrolizumab)

KEYTRUDA contains the active substance called pembrolizumab and is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Before you receive KEYTRUDA, tell your doctor if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or plan to have or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have lung or breathing problems; have liver problems; or have any other medical problems.

If you are pregnant or plan to become pregnant, tell your doctor. KEYTRUDA can harm your unborn baby. If you are able to become pregnant, your doctor will give you a pregnancy test before you start treatment. Use effective birth control during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your doctor right away if you think you may be pregnant, or you become pregnant during treatment with KEYTRUDA.

If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Your doctor will give you KEYTRUDA through an IV for about 30 minutes. Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on the dose you are given. Your doctor will decide how many treatments you need.

What are the possible side effects of KEYTRUDA?

KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Side effects may occur with KEYTRUDA. Serious side effects include: lung problems (or pneumonitis); intestinal problems (or colitis) that can lead to tears or holes in your intestine; liver problems (or hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems (including nephritis and kidney failure); skin problems; problems in other organs; infusion (IV) reactions that can sometimes be severe and life-threatening; rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic). Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines and delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Common side effects in people who received KEYTRUDA include feeling tired; pain, including pain in muscles, bones, or joints and stomach area (abdominal) pain; decreased appetite; itching; diarrhoea; nausea; rash; fever; cough; shortness of breath; and constipation.

Common side effects reported in more than 1 in 5 people when KEYTRUDA was given in combination with certain chemotherapy medicines: hair loss, feeling tired, diarrhoea, decreased white blood cell count, joint pain, rash. Less common side effects can happen.

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

Lung problems (pneumonitis). Symptoms of pneumonitis may include shortness of breath, chest pain, or new or worse cough.

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhoea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems, including hepatitis. Signs and symptoms of liver problems may include yellowing of your skin or the whites of your eyes, nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, or bleeding or bruising more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include rapid heartbeat, weight loss or weight gain, increased sweating, feeling more hungry or thirsty, urinating more often than usual, 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, including nephritis and kidney failure. Signs of kidney problems may include change in the amount or color of your urine.

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

Problems in other organs. Signs and symptoms of these problems may include changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; low red blood cells (anemia); swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis); confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis); and shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis).

Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, shortness of breath or wheezing, itching or rash, flushing, dizziness, fever, or feeling like passing out.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection if they are treated with KEYTRUDA.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Based on US Consumer SSI & NZ CMI and Data sheet prepared 29 July 2019.


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

Use: KEYTRUDA 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 the 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)

Side effects: Immune-mediated side effects including inflammation of the lungs, colon, liver, kidneys, pituitary gland, brain, eye, muscles, nervous system, pancreas, and heart, thyroid disorders, type 1 diabetes mellitus. Severe skin reactions including Steven-Johnson syndrome and toxic epidermal necrolysis. Severe infusion reactions including hypersensitivity and anaphylaxis. Transplant recipients: rejection of a transplanted organ, graft-versus-host-disease (in people with a bone marrow transplant using donor cells). Very common side effects include diarrhoea, nausea, itching, rash, joint pain, back pain, feeling tired, cough, patches of discoloured skin, stomach pain, decreased levels of sodium in blood. Hair loss, tiredness, diarrhoea, a decrease in white-blood cell count, joint pain, and rash were reported when given in combination with chemotherapy. You may experience more than one side effect at the same time.

All medicines have risks and benefits. Talk to your doctor to see if KEYTRUDA is right for you. KEYTRUDA is a funded medicine for melanoma patients - restrictions apply. KEYTRUDA is an unfunded medicine for treatment of melanoma after surgery, NSCLC, HNSCC, cHL and urothelial carcinoma patients. Ask your health professional 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.

Based on Data Sheet prepared 29 July 2019. Marketed by: Merck Sharp & Dohme (New Zealand) Limited, Newmarket, Auckland. For additional product information, consult the Consumer Medicine Information (CMI), available on request, phone 0800 500 673 or refer to the Medsafe website medsafe.govt.nz.

See full indications
KEYTRUDA is a prescription medicine used to treat:
  • a kind of skin cancer called melanoma
  • a kind of lung cancer called non-small cell lung cancer
  • a kind of cancer called classical Hodgkin Lymphoma
  • a kind of cancer called urothelial carcinoma, including bladder cancer
  • a kind of head and neck cancer called head and neck squamous cell carcinoma
Important Safety Information About KEYTRUDA® (pembrolizumab)

KEYTRUDA contains the active substance called pembrolizumab and is a medicine that may treat certain cancers by working with your immune system. KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Before you receive KEYTRUDA, tell your doctor if you have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus; have had an organ transplant or plan to have or have had a bone marrow (stem cell) transplant that used donor stem cells (allogeneic); have lung or breathing problems; have liver problems; or have any other medical problems.

If you are pregnant or plan to become pregnant, tell your doctor. KEYTRUDA can harm your unborn baby. If you are able to become pregnant, your doctor will give you a pregnancy test before you start treatment. Use effective birth control during treatment and for at least 4 months after the final dose of KEYTRUDA. Tell your doctor right away if you think you may be pregnant, or you become pregnant during treatment with KEYTRUDA.

If you are breastfeeding or plan to breastfeed, tell your doctor. It is not known if KEYTRUDA passes into your breast milk. Do not breastfeed during treatment with KEYTRUDA and for 4 months after your final dose of KEYTRUDA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Your doctor will give you KEYTRUDA through an IV for about 30 minutes. Most people get KEYTRUDA every 3 weeks or every 6 weeks, depending on the dose you are given. Your doctor will decide how many treatments you need.

What are the possible side effects of KEYTRUDA?

KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen any time during treatment or even after your treatment has ended.

Side effects may occur with KEYTRUDA. Serious side effects include: lung problems (or pneumonitis); intestinal problems (or colitis) that can lead to tears or holes in your intestine; liver problems (or hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems (including nephritis and kidney failure); skin problems; problems in other organs; infusion (IV) reactions that can sometimes be severe and life-threatening; rejection of a transplanted organ; and complications in people with a bone marrow transplant that uses donor stem cells (allogeneic). Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines and delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Common side effects in people who received KEYTRUDA include feeling tired; pain, including pain in muscles, bones, or joints and stomach area (abdominal) pain; decreased appetite; itching; diarrhoea; nausea; rash; fever; cough; shortness of breath; and constipation.

Common side effects reported in more than 1 in 5 people when KEYTRUDA was given in combination with certain chemotherapy medicines: hair loss, feeling tired, diarrhoea, decreased white blood cell count, joint pain, rash. Less common side effects can happen.

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

Lung problems (pneumonitis). Symptoms of pneumonitis may include shortness of breath, chest pain, or new or worse cough.

Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhoea or more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; or severe stomach-area (abdomen) pain or tenderness.

Liver problems, including hepatitis. Signs and symptoms of liver problems may include yellowing of your skin or the whites of your eyes, nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine, or bleeding or bruising more easily than normal.

Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include rapid heartbeat, weight loss or weight gain, increased sweating, feeling more hungry or thirsty, urinating more often than usual, 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, including nephritis and kidney failure. Signs of kidney problems may include change in the amount or color of your urine.

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

Problems in other organs. Signs and symptoms of these problems may include changes in eyesight; severe or persistent muscle or joint pains; severe muscle weakness; low red blood cells (anemia); swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis); confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, or seizures (encephalitis); and shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis).

Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs and symptoms of infusion reactions may include chills or shaking, shortness of breath or wheezing, itching or rash, flushing, dizziness, fever, or feeling like passing out.

Rejection of a transplanted organ. People who have had an organ transplant may have an increased risk of organ transplant rejection if they are treated with KEYTRUDA.

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with KEYTRUDA. Your doctor will monitor you for the following signs and symptoms: skin rash, liver inflammation, abdominal pain, and diarrhoea.

Getting medical treatment right away may help keep these problems from becoming more serious. Your doctor will check you for these problems during treatment with KEYTRUDA. Your doctor may treat you with corticosteroid or hormone replacement medicines. Your doctor may also need to delay or completely stop treatment with KEYTRUDA if you have severe side effects.

Based on US Consumer SSI & NZ CMI and Data sheet prepared 29 July 2019.

Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. NZ-KEY-00178 TAPS NA11321 First issued November 2017 essence MSD9245 Updated: October 2019.