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KEYTRUDA®

CONTACT DETAILS Your Oncologist/Specialist

Name

Phone

Phone (after hours)

Name

Phone

Phone (after hours)

Your Specialist Nurse

Name

Phone

Phone (after hours)

Your Treatment Centre

MANAGE

NOTES

MONITOR

START

ABOUT About KEYTRUDA

How KEYTRUDA works

How KEYTRUDA works with your immune system

How KEYTRUDA is given

Effects on fertility

Working during treatment

KEYTRUDA treatment experience

Side effects may occur while taking KEYTRUDA

Common side effects

Immune side effects

Managing side effects

Be involved with your KEYTRUDA treatment

More information

Notes for my next appointment

About KEYTRUDA

KEYTRUDA is a prescription medicine used to treat a number of cancers:

• Melanoma*

• A sub-type of lung cancer called non-small cell lung cancer (NSCLC)**

• A blood cancer called Hodgkin lymphoma**

• A bladder cancer called urothelial carcinoma**

• A head and neck cancer called head and neck squamous cell carcinoma (HNSCC)**

• Microsatellite Instability-High (MSI-H) or deficient Mismatch Repair (dMMR) cancer in adults and children.**

KEYTRUDA contains the active substance pembrolizumab and works with the immune system to help find and destroy cancer cells.

KEYTRUDA is currently being trialled to determine which other cancer types may benefit from this treatment.

Talk to your doctor to see if KEYTRUDA is right for you. Use strictly as directed. If you have side effects, see your Doctor, Pharmacist or Healthcare Professional.

*KEYTRUDA is fully funded under special authority criteria for people with advanced stage 3-4 melanoma that has spread and cannot be removed by surgery. KEYTRUDA is not funded for advanced stage 3-4 melanoma that has been removed by surgery.**KEYTRUDA is registered but not funded for the treatment of NSCLC, Hodgkin lymphoma, urothelial cancer, HNSCC and MSI-H/dMMR. It is available privately. Funding applications have been sent to PHARMAC for NSCLC, Hodgkin lymphoma and urothelial cancer.

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How KEYTRUDA works

KEYTRUDA is known as immuno-oncology (or immunotherapy) because it works with the body’s immune system to help find and destroy cancer cells. KEYTRUDA helps the immune system do what it is designed to do; help detect and fight disease.

KEYTRUDA is not chemotherapy. Chemotherapy involves the use of medicines to kill or slow the growth of cancer cells.

Cancer cells may use PD-1 pathway to hide from T cells

T cells help detect and fight cancer cells

KEYTRUDAblocks PD-1 pathway to help prevent cancer cells from hiding

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How KEYTRUDA works with your immune system

The immune system is the body’s natural defence against disease. It sends types of cells called T cells through the body to find and fight infections and diseases - including cancer.

Some cancer cells grow by hiding from the immune system. Immuno-oncology drugs like KEYTRUDA work with the immune system to help find and fight certain cancer cells.

The immune system finds and fights cancer cells

as they grow, before they form tumours.

The immune system destroys some cancer cells, but other cancer cells may

hide from the immune system. These hiding cancer cells can then grow into tumours.

KEYTRUDA helps the immune system find

and treat cancer cells.

immune system KEYTRUDA

cancer cells

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STARTKEYTRUDA HAS BEEN PRESCRIBED FOR YOU TO TREAT A TYPE OF CANCER.

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, often referred to as ‘cycles’.

The recommended dose of KEYTRUDA in paediatric patients is 2 mg/kg (up to a maximum of 200 mg) every 3 weeks for MSI-H/dMMR cancer.

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

For stage 3 melanoma treatment after surgery, KEYTRUDA is given for a maximum duration of 12 months.

Over 30 minutes Once every 3 weeks or every 6 weeks

Intravenous infusion

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Considerations before treatment

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 breast feed 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.

Other considerationsYour Oncologist/Specialist will review your general health, such as your age, liver and kidney function prior to treatment.

Working during treatmentIt may be possible for you to continue working during treatment with KEYTRUDA, but you may not be able to maintain your usual work commitments because of your condition or side effects associated with therapy.

Talk with your Nurse, Healthcare Professional or the Cancer Society (contact details at the end of brochure) for advice on talking to your employer about your condition and ability to work.

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MONITORDURING YOUR TREATMENT WITH KEYTRUDA, THERE WILL BE REGULAR APPOINTMENTS TO MONITOR YOUR HEALTH AND ANY SIDE EFFECTS.

KEYTRUDA treatment experience

Before starting KEYTRUDA, your Oncologist/Specialist and Nurse would have asked you about your general health and any other medical problems.

Medical tests that you may need during your treatment with KEYTRUDA may include:

These tests will help your Oncologist/Specialist keep track of how you are responding to treatment.

Scans Blood TestsX-rays

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Side effects may occur while taking KEYTRUDA

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

KEYTRUDA can cause your immune system to affect healthy cells in other parts of your body. These side effects can sometimes become serious.

It is important side effects are treated as early as possible. Tell your Oncologist/Specialist if you notice any side effects or symptoms. Early treatment of side effects may stop them becoming more serious.

You may be able to continue KEYTRUDA treatment if side effects are treated early. However, you may need to stop KEYTRUDA treatment if side effects become more serious.

Common side effects

Report any side effects to your Oncologist/Specialist or Nurse immediately. They will advise you on the best management approach.

These are the most common side effects that you may notice while taking KEYTRUDA. Common side effects that occurred in more than 1 in 10 people during KEYTRUDA clinical trials included:

For other side effects that affected less than 1 in 10 people speak to your Oncologist/Specialist or Nurse, or refer to the Consumer Medicine Information for KEYTRUDA. Consumer Medicine Information (CMI) is available on request from your Oncologist/Specialist or Nurse or at medsafe.govt.nz/consumers/cmi/k/Keytruda.pdf

• 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

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Immune side effects

As KEYTRUDA works with the immune system, there are specific side effects that may result from its action on the immune system.

It is important to watch for these immune side effects so they can be treated quickly. This may allow you to continue with KEYTRUDA treatment.

You may not have to stop KEYTRUDA treatment if your side effects are manageable.

The next section guides you through possible immune side effects. Your Oncologist/Specialist or Nurse will decide how to manage these side effects. KEYTRUDA treatment may be delayed or stopped if these side effects are severe.

Pituitary gland

Adrenal glands

Large intestine

Thyroid gland

Lungs

Liver

Small intestine

Immune side effects can occur in the highlighted areas.

Brain

Nervous system

Kidneys

Skin

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MANAGEBE INVOLVED WITH YOUR TREATMENT AND DISCUSS ANY SIDE EFFECTS WITH YOUR ONCOLOGIST/SPECIALIST OR NURSE SO THEY CAN BE TREATED QUICKLY.

Managing side effects

Call or see your Oncologist/Specialist or Nurse right away if you develop any symptoms of the following side effects.

They will advise you on the best way to manage any side effects.

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 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 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)

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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 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 blood sugar problems

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

Signs and symptoms of infusion (IV) reactions

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

Be involved with your KEYTRUDA treatment

Your regular appointments with your treatment team (eg. Oncologist/Specialist, Nurse, Pharmacist, Dietician, Physiotherapist) will allow you to get to know them.

It is also important to stay in contact with your Oncologist/Specialist and Nurse if you experience any side effects during treatment. Call your clinic or get medical treatment right away. This may help to prevent them from becoming more serious.

If you miss any appointments, call your Oncologist/Specialist or Nurse as soon as possible to make a new appointment.

Tell other Healthcare Professionals, such as your Doctors, Dentists and Pharmacists that you are being treated with KEYTRUDA.

If you plan to start on any new medicine, including those available without a prescription, tell your Doctor, Dentist or Pharmacist that you are being treated with KEYTRUDA.

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More information

If you have more questions about KEYTRUDA, other parts of your treatment or your condition, please talk to your Oncologist/Specialist or Nurse, refer to the Consumer Medicine Information (CMI) at www.medsafe.govt.nz or visit www.fightcancer.co.nz

Here are other services that can help you with information and support:

Cancer Societywww.cancernz.org.nzTel: 0800 CANCER/0800 226 237

Lung Foundation New Zealand www.lungfoundation.org.nz Tel: (+64) 021 959 450

Melanoma New Zealandwww.melanoma.org.nzTel: 0800 463 526

Beyond Fivewww.beyondfive.org.au

Lynch Syndrome NZ Facebook Pagewww.facebook.com/LynchSyndromeNZ/

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My notes:

Questions to ask my Oncologist/Specialist:

My notes:

Questions to ask my Oncologist/Specialist:

DATE DATE

Notes for my next appointment

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My notes:

Questions to ask my Oncologist/Specialist:

My notes:

Questions to ask my Oncologist/Specialist:

DATE DATE

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References Consumer Medicine Information for KEYTRUDA. KEYTRUDA Data Sheet. References to support this information can be provided on request.

KEYTRUDA (pembrolizumab) 50mg powder for infusionKEYTRUDA (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 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).

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, adrenal insufficiency. 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 diarrhea, 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. Common side effects in children include fever, vomiting, fatigue, constipation stomach pain and nausea. 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). 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, urothelial carcinoma and MSI-H/dMMR cancer 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 28 November 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 www.medsafe.govt.nz.

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-00252 TAPS MRS5381 December 2019 MSD9497