About KEYTRUDA


What are the side effects?

Side effects may occur while taking KEYTRUDA.

KEYTRUDA works with the body’s immune system to help detect and fight certain types of cancer. KEYTRUDA can also cause the immune system to affect healthy cells in other parts of the body.

KEYTRUDA can cause some serious side effects. These side effects can sometimes become life-threatening and can lead to death. These side effects may happen anytime during treatment or even after your treatment has ended. You may experience more than one side effect at the same time.

It is important side effects are treated as early as possible.

It’s important that the Oncologist/Specialist is made aware as soon as possible if a patient notices any side effects or symptoms. Early treatment of side effects may stop them becoming more serious.

If you have any of the following symptoms, call or see your doctor right away.

Signs and symptoms of lung problems

  • shortness of breath
  • chest pain
  • coughing

Signs and symptoms of problems with your intestines

  • diarrhoea or more bowel movements than usual
  • your stools are black, tarry, sticky or have blood or mucus
  • severe stomach pain or tenderness

Signs and symptoms of liver problems

  • 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
  • you bleed or bruise more easily than normal

Signs and symptoms of kidney problems

  • changes in the amount or colour of your urine

Signs and symptoms of hormone gland problems
(especially the thyroid, pituitary, and adrenal glands)

  • rapid heart beat
  • weight loss
  • increased sweating
  • weight gain
  • hair loss
  • feeling cold
  • constipation
  • your voice gets deeper
  • muscle aches
  • dizziness or fainting
  • headaches that will not go away or unusual headache

Signs and symptoms of blood sugar problems

  • feeling more hungry or thirsty
  • needing to urinate more often
  • weight loss

Signs and symptoms of skin problems

  • rash
  • itching
  • skin blistering, peeling or sores
  • ulcers in mouth or in lining of nose, throat, or genital area

Signs and symptoms of problems in other organs

  • 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)

Signs and symptoms of infusion (IV) reactions

  • shortness of breath
  • itching or rash
  • dizziness
  • fever

There are possible side effects of treatment with KEYTRUDA in people who have received a transplant.

 

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 effect 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, decreased sodium levels in the blood.

The following side effects have been reported in more than 1 in 5 people when KEYTRUDA was given in combination with chemotherapy: hair loss, feeling tired, diarrhoea, decrease in white blood cell count, joint pain, rash.

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

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

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

Access to KEYTRUDA

Find out more about KEYTRUDA

What KEYTRUDA is used for


Reference:
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

READ MORE

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

Merck Sharp & Dohme (New Zealand) Limited, Level 3, 123 Carlton Gore Road, Newmarket, Auckland. TAPS DA 2150KN

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. 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 19 January 2021.

NZ-KEY-00522 Last updated March 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

Merck Sharp & Dohme (New Zealand) Limited, Level 3, 123 Carlton Gore Road, Newmarket, Auckland. TAPS DA 2045KN

KEYTRUDA® (pembrolizumab) is a Prescription Only 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)

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

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, 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. 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 19 January 2021.

NZ-KEY-00522 Last updated March 2021

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