KEYTRUDA Working with your immune system to help fight cancer www.fightcancer.co.nz
CONTACT DETAILS Your Oncologist/Specialist Name Phone Phone (after hours) Your Specialist Nurse Name Phone Phone (after hours) Your Treatment Centre Name Phone Phone (after hours)
ABOUT About KEYTRUDA How KEYTRUDA works How KEYTRUDA works with your immune system START How KEYTRUDA is given Effects on fertility Working during treatment MONITOR KEYTRUDA treatment experience Side effects may occur while taking KEYTRUDA Common side effects Immune side effects MANAGE Managing side effects Be involved with your KEYTRUDA treatment NOTES 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 s lymphoma** A bladder cancer called Urothelial carcinoma.** KEYTRUDA is also currently being trialled in a number of new cancer types. KEYTRUDA works with the immune system to help find and destroy cancer cells. 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 contains the active substance pembrolizumab. *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 registered for the treatment of NSCLC, Hodgkin s lymphoma and Urothelial Carcinoma, is not currently funded but is available privately. Funding applications have been sent to PHARMAC for both NSCLC and Hodgkin s lymphoma.
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 KEYTRUDA blocks PD-1 pathway to help prevent cancer cells from hiding T cells help detect and fight cancer cells
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. immune system cancer cells KEYTRUDA 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.
START KEYTRUDA HAS BEEN PRESCRIBED FOR YOU TO TREAT A TYPE OF CANCER. START
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, often referred to as cycles. 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. Intravenous infusion Over 30 minutes Once every 3 weeks
Considerations before treatment It is not known if KEYTRUDA has effects on fertility and there is currently no information on its use in pregnant or breastfeeding women. Your Oncologist/Specialist will discuss the risks and benefits of treatment with you. Other considerations Your Oncologist/Specialist will review your general health, such as your age, liver and kidney function prior to treatment. Working during treatment It 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.
MONITOR DURING YOUR TREATMENT WITH KEYTRUDA, THERE WILL BE REGULAR APPOINTMENTS TO MONITOR YOUR HEALTH AND ANY SIDE EFFECTS. MONITOR
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: Scans X-rays Blood Tests These tests will help your Oncologist/Specialist keep track of how you are responding to treatment.
Side effects may occur while taking KEYTRUDA During your treatment with KEYTRUDA, there will be regular appointments 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: Feeling tired Itching Rash Nausea Diarrhoea Joint Pain 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
Immune side effects Pituitary gland 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. Thyroid gland Lungs Liver Small intestine Adrenal glands Large intestine Immune side effects can occur in the highlighted areas.
MANAGE BE INVOLVED WITH YOUR TREATMENT AND DISCUSS ANY SIDE EFFECTS WITH YOUR ONCOLOGIST/SPECIALIST OR NURSE SO THEY CAN BE TREATED QUICKLY. MANAGE
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)
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 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 infusion (IV) reactions shortness of breath itching or rash dizziness fever Signs and symptoms of blood sugar problems feeling more hungry or thirsty needing to urinate more often weight loss
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.
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 Cancer Society www.cancernz.org.nz Tel: 0800 CANCER/0800 226 237 Lung Foundation New Zealand www.lungfoundation.org.nz Tel: (+64) 021 959 450 Melanoma New Zealand www.melanoma.org.nz Tel: 0800 463 526 MSD Merck Sharp & Dohme (NZ) Limited Level 3, 123 Carlton Gore Road, Newmarket, Auckland 1023 Tel: Customer Services 0800 500 673 www.msd-newzealand.com
Notes for my next appointment DATE DATE My notes: My notes: Questions to ask my Oncologist/Specialist: Questions to ask my Oncologist/Specialist:
DATE DATE My notes: My notes: Questions to ask my Oncologist/Specialist: Questions to ask my Oncologist/Specialist:
References Consumer Medicine Information for KEYTRUDA. KEYTRUDA Data Sheet. KEYTRUDA (pembrolizumab) 50mg powder 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 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. 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. 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. Tiredness, nausea, vomiting, diarrhea, constipation, shortness of breath, rash, itching, headache, hair loss, and, infections of the upper respiratory tract 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 NSCLC, 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 25 September 2017. 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 2017 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. All rights reserved. Copyright 2017 Merck Sharp & Dohme (New Zealand) Limited. Level 3, 123 Carlton Gore Road, Newmarket, Auckland. All rights reserved. ONCO-1230760-0009 TAPS MR5381 October 2017 MSD8526 V17.2