About KEYTRUDA


What to expect if you are prescribed KEYTRUDA

The information below can help give you an idea of how treatment with KEYTRUDA works. Before you start KEYTRUDA, your Oncologist/Specialist and Nurse will ask you about your general health, any other medical conditions, and if you are taking any medicines.

During your treatment with KEYTRUDA, there will be regular appointments to monitor your health and any potential side effects.

Medical tests that you may need while on treatment with KEYTRUDA:

Taking Keytruda - Tests

Scans

Taking Keytruda - Tests

X-rays

Taking Keytruda - Tests

Blood tests

These tests will help your Oncologist/Specialist keep track of how you are responding to treatment and to check for any side effects.

It's important to let your Oncologist/Specialist or nurse know about any side effects that bother you or do not go away. Side effects can be better managed if reported early. If left untreated, side effects can become serious and may even be life-threatening.

How KEYTRUDA is given

KEYTRUDA is given by an injection via a vein in your arm (intravenous infusion) over 30 minutes. KEYTRUDA is usually given once every 3 weeks or every 6 weeks, depending on the dose you are given.

Your treatment will usually be given by your Oncologist/Specialist or Nurse in a hospital clinic. Your Oncologist/Specialist will decide how many treatments you need.

KEYTRUDA may be given in combination with other anti-cancer medicines. It is important that you also read the Consumer Medicine Information for these other medicines. If you have any questions about these medicines, please ask your doctor.

Taking Keytruda

Intravenous infusion

Taking Keytruda

Over 30 minutes

Taking Keytruda

Once every 3 or 6 weeks depending on the dose you are given

The information on the website should always be discussed with your healthcare professional and does not replace their advice.

KEYTRUDA side effects

Access to KEYTRUDA

Find out more about KEYTRUDA


References:
KEYTRUDA Data Sheet  

KEYTRUDA Consumer Medicine Information

Cancer Council Australia. 2019. Understanding Immunotherapy. A guide for people affected by cancer. Available at: https://www.cancer.org.au/cancer-information/treatment/immunotherapy.
Accessed on: 30.09.2020



NZ-KEY-00437 TAPS NA 12224 Last Updated December 2020

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KEYTRUDA has risks and benefits. Additional product information and the KEYTRUDA Consumer Medicine Information (CMI) can be obtained by phoning MSD on 0800 500 673 or is available at www.medsafe.govt.nz

IMPORTANT SAFETY INFORMATION

KEYTRUDA can only be used in children below 18 years of age with cHL, or 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); 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); inflammation of the blood vessels (vasculitis); or pain in the upper right part of the stomach, swelling of the liver or spleen, fatigue, itching or yellowing of the skin or whites of eyes.

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, rash, swelling of the lining of the digestive system (for example mouth, intestines) and mouth sores.

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 alone to children are: fever, vomiting, headache, stomach pain, decrease in number of red blood cells, cough, and constipation.

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.

Based on the KEYTRUDA CMI dated 21 May 2021.

Merck Sharp & Dohme (New Zealand) Limited, Level 3, 123 Carlton Gore Road, Newmarket, Auckland.

TAPS NA 13013 TAPS DA 2152PC NZ-KEY-00522 Last Updated August 2021

Copyright © 2016-2021 Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved


KEYTRUDA has risks and benefits. Additional product information and the KEYTRUDA Consumer Medicine Information (CMI) can be obtained by phoning MSD on 0800 500 673 or is available at www.medsafe.govt.nz

KEYTRUDA® (pembrolizumab) 100 mg/4 mL concentrate solution for infusion is a Prescription Medicine and is used to treat:

  • a kind of skin cancer called melanoma
  • a kind of lung cancer called non-small cell lung cancer (NSCLC)
  • a kind of cancer in adults and children called classical Hodgkin Lymphoma (cHL)
  • a kind of cancer called urothelial carcinoma, including bladder cancer
  • a kind of head and neck cancer called head and neck squamous cell carcinoma (HNSCC)
  • 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)
  • a kind of cancer called renal cell carcinoma (RCC)

Ask your doctor if KEYTRUDA is right for you. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist, or health professional.

KEYTRUDA is funded for the treatment of melanoma which has spread and cannot be removed by surgery – restrictions apply. KEYTRUDA is unfunded for the treatment of melanoma after surgery, NSCLC, HNSCC, cHL, urothelial carcinoma (including bladder cancer), MSI-H/dMMR cancer and RCC. Ask your health professional about the cost of the medicine and any other medical fees that may apply.

IMPORTANT SAFETY INFORMATION

KEYTRUDA can only be used in children below 18 years of age with cHL, or 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); 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); inflammation of the blood vessels (vasculitis); or pain in the upper right part of the stomach, swelling of the liver or spleen, fatigue, itching or yellowing of the skin or whites of eyes.

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, rash, swelling of the lining of the digestive system (for example mouth, intestines) and mouth sores.

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 alone to children are: fever, vomiting, headache, stomach pain, decrease in number of red blood cells, cough, and constipation.

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.

Based on the KEYTRUDA CMI dated 21 May 2021.

Merck Sharp & Dohme (New Zealand) Limited, Level 3, 123 Carlton Gore Road, Newmarket, Auckland.

TAPS NA 13013 TAPS DA 2152PC NZ-KEY-00522 Last Updated August 2021

Copyright © 2016-2021 Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved.