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«Package leaflet: Information for the patient KEYTRUDA® 50 mg powder for concentrate for solution for infusion pembrolizumab This medicine is subject ...»

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Package leaflet: Information for the patient

KEYTRUDA® 50 mg powder for concentrate for solution for infusion

pembrolizumab

This medicine is subject to additional monitoring. This will allow quick identification of new

safety information. You can help by reporting any side effects you may get. See the end of section 4

for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important

information for you.

- Keep this leaflet. You may need to read it again.

- It is important that you keep the Alert Card with you during treatment.

- If you have any further questions, ask your doctor.

- If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What KEYTRUDA is and what it is used for

2. What you need to know before you are given KEYTRUDA

3. How you are given KEYTRUDA

4. Possible side effects

5. How to store KEYTRUDA

6. Contents of the pack and other information

1. What KEYTRUDA is and what it is used for KEYTRUDA contains the active substance pembrolizumab, which is a monoclonal antibody.

KEYTRUDA works by helping your immune system fight your cancer.

KEYTRUDA is used in adults to treat:

 a kind of skin cancer called melanoma  a kind of lung cancer called non-small cell lung cancer.

People get KEYTRUDA when their cancer has spread or cannot be taken out by surgery.

2. What you need to know before you are given KEYTRUDA

You should not be given KEYTRUDA:

- if you are allergic to pembrolizumab or any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). Talk to your doctor if you are not sure.

Warnings and precautions Talk to your doctor or nurse before receiving KEYTRUDA.

Before you get KEYTRUDA, tell your doctor if you:

- have an autoimmune disease (a condition where the body attacks its own cells)

- have pneumonia or inflammation of your lungs (called pneumonitis)

- were previously given ipilimumab, another medicine for treating melanoma, and experienced serious side effects because of that medicine

- had an allergic reaction to other monoclonal antibody therapies

- have or have had chronic viral infection of the liver, including hepatitis B (HBV) or hepatitis C (HCV)

- have human immunodeficiency virus (HIV) infection or acquired immune deficiency syndrome (AIDS)

- have liver damage or have had a liver transplant

- have kidney damage or have had a kidney transplant.

When you get KEYTRUDA, you can have some serious side effects.

If you have any of the following conditions, call or see your doctor right away. Your doctor may give you other medicines in order to prevent more severe complications and reduce your symptoms. Your doctor may withhold the next dose of KEYTRUDA or stop your treatment with KEYTRUDA.

- inflammation of the lungs, which may include shortness of breath, chest pain or coughing

- inflammation of the intestines, which may include diarrhoea or more bowel movements than usual, black, tarry, sticky stools or stools with blood or mucus, severe stomach pain or tenderness, nausea, vomiting

- inflammation of the liver, which may include nausea or vomiting, feeling less hungry, pain on the right side of stomach, yellowing of skin or whites of eyes, dark urine or bleeding or bruising more easily than normal

- inflammation of the kidneys, which may include changes in the amount or colour of your urine

- inflammation of hormone glands (especially the thyroid, pituitary and adrenal glands), which may include rapid heartbeat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, deeper voice, muscle aches, dizziness or fainting, headaches that will not go away or unusual headache

- type 1 diabetes, which may include feeling more hungry or thirsty than usual, need to urinate more often or weight loss

- inflammation of the eyes, which may include changes in eyesight

- inflammation in the muscles, which may include muscle pain or weakness

- inflammation of the pancreas, which may include abdominal pain, nausea and vomiting

- inflammation of the skin, which may include rash

- infusion reactions, which may include shortness of breath, itching or rash, dizziness or fever Children and adolescents KEYTRUDA should not to be used in children and adolescents below 18 years of age.

Other medicines and KEYTRUDA Tell your doctor

- If you are taking other medicines that make your immune system weak. Examples of these may include corticosteroids, such as prednisone. These medicines may interfere with the effect of KEYTRUDA. However, once you are treated with KEYTRUDA, your doctor may give you corticosteroids to reduce the side-effects that you may have with KEYTRUDA.

- If you are taking, have recently taken or might take any other medicines.

Pregnancy

- You must not use KEYTRUDA if you are pregnant unless your doctor specifically recommends it.

- If you are pregnant, think you may be pregnant or are planning to have a baby, tell your doctor.





- KEYTRUDA can cause harm or death to your unborn baby.

- If you are a woman who could become pregnant, you must use adequate birth control while you are being treated with KEYTRUDA and for at least 4 months after your last dose.

Breast-feeding

- If you are breast-feeding, tell your doctor.

- Do not breast-feed while taking KEYTRUDA.

- It is not known if KEYTRUDA passes into your breast milk.

Driving and using machines Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are feeling well. Feeling tired or weak is a very common side effect of KEYTRUDA. This can affect your ability to drive or to use machines.

3. How you are given KEYTRUDA KEYTRUDA will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.

- Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about 30 minutes, every 3 weeks.

- Your doctor will decide how many treatments you need.

The recommended dose is 2 mg of pembrolizumab per kilogram of your body weight.

If you miss an appointment to get KEYTRUDA

- Call your doctor right away to reschedule your appointment.

- It is very important that you do not miss a dose of this medicine.

If you stop receiving KEYTRUDA Stopping your treatment may stop the effect of the medicine. Do not stop treatment with KEYTRUDA unless you have discussed this with your doctor.

If you have any further questions about your treatment, ask your doctor.

You will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregivers.

4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them.

When you get KEYTRUDA, you can have some serious side effects. See section 2.

The following side effects have been reported in clinical trials:

Very common (may affect more than 1 in 10 people)

- diarrhoea; nausea

- itching; skin rash

- joint pain

- feeling tired Common (may affect up to 1 in 10 people)

- decrease in the number of red blood cells

- thyroid gland problems; hot flush

- feeling less hungry

- headache; dizziness; change in your sense of taste

- inflammation of the lungs; shortness of breath; cough

- inflammation of the intestines; dry mouth

- dry eye

- stomach pain; constipation; vomiting

- red raised rash sometimes with blisters; patches of skin which have lost colour; acne-like skin problem; dry, itchy skin

- muscle pain, aches or tenderness; pain in the muscles and bones; pain in arms or legs; joint pain with swelling

- swelling; unusual tiredness or weakness; chills; flu-like illness; fever

- increased liver enzyme levels in the blood; abnormal kidney function test

- reaction related to the infusion of the medicine Uncommon (may affect up to 1 in 100 people)

- a decreased number of white blood cells (neutrophils, leukocytes, lymphocytes and eosinophils); decrease in the number of platelets (bruising or bleeding more easily)

- inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid

- type 1 diabetes; decreased sodium, potassium and calcium in the blood

- trouble sleeping

- seizure; lack of energy; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs

- inflammation of the eyes; eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light; seeing spots

- high blood pressure

- inflammation of the pancreas

- inflammation of the liver

- thickened, sometimes scaly, skin growth; hair loss; tender red bumps under the skin;

inflammation of the skin; hair colour changes; small skin bumps, lumps or sores

- inflammation of the sheath that surrounds tendons

- inflammation of the kidneys

- increased level of amylase, an enzyme that breaks down starch; increased calcium in the blood Rare (may affect up to 1 in 1,000 people)

- inflammation response against platelets or red blood cells

- a temporary inflammation of the nerves that cause pain, weakness, and paralysis in the extremities; a condition in which the muscles become weak and tire easily

- a hole in the small intestines Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax:

+353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie Malta: ADR Reporting at: www.medicinesauthority.gov.mt/adrportal

5. How to store KEYTRUDA Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Chemical and physical in-use stability of the reconstituted and diluted solution has been demonstrated for 24 hours at room temperature (at or below 25°C). From a microbiological point of view, the product must be used immediately. The reconstituted or diluted solution must not be frozen. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours. This 24 hour hold may include up to 6 hours at room temperature (at or below 25°C); any additional hold time must be at 2°C – 8°C. If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use.

Do not store any unused portion of the infusion solution for reuse. Any unused medicine or waste material should be disposed of in accordance with local requirements.

6. Contents of the pack and other information What KEYTRUDA contains The active substance is pembrolizumab. One vial contains 50 mg of pembrolizumab.

After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.

The other ingredients are L-histidine, L-histidine hydrochloride monohydrate, sucrose and polysorbate 80.

What KEYTRUDA looks like and contents of the pack KEYTRUDA is a white to off-white lyophilised powder.

It is available in cartons containing one glass vial.

Marketing Authorisation Holder Merck Sharp & Dohme Limited Hertford Road Hoddesdon Hertfordshire EN11 9BU United Kingdom Manufacturer Schering-Plough Labo NV Industriepark 30 B-2220 Heist-op-den-Berg Belgium For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

Malta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@merck.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@merck.com United Kingdom Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com This leaflet was last revised August 2016 Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

PIL.KTD.16.UK.4891 X001G

The following information is intended for healthcare professionals only:

Preparation and administration

• Prior to reconstitution, the vial of lyophilised powder can be out of refrigeration (temperatures at or below 25°C) for up to 24 hours.

• Aseptically add 2.3 mL of water for injections to yield a 25 mg/mL (pH 5.2-5.8) solution of KEYTRUDA. Each vial contains an excess fill of 10 mg (0.4 mL) to ensure the recovery of 50 mg of KEYTRUDA per vial. After reconstitution, 1 mL of concentrate contains 25 mg of pembrolizumab.

• To avoid foaming, deliver the water along the walls of the vial and not directly on the lyophilised powder.

• Slowly swirl the vial to allow reconstitution of the lyophilised powder. Allow up to 5 minutes for the bubbles to clear. Do not shake the vial.

• Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration. Reconstituted KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution. Discard the vial if visible particles are observed.



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