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Keytruda (pembrolizumab) – Package leaflet - L01

Updated on site: 08-Oct-2017

Medication nameKeytruda
ATC CodeL01
Substancepembrolizumab
ManufacturerMerck Sharp

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

a kind of cancer called classical Hodgkin lymphoma.

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

-have kidney damage

-have had a solid organ transplant

When you get KEYTRUDA, you can have some serious side effects. You may experience more than one side effect at the same time.

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 (possibly fatal)

-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, itching, skin blistering, peeling or sores, and/or ulcers in mouth or in lining of nose, throat, or genital area (possibly fatal)

-infusion reactions, which may include shortness of breath, itching or rash, dizziness or fever

Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with KEYTRUDA. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant. If you are having a stem cell transplant, tell your transplant doctor that you have received pembrolizumab in the past.

Children and adolescents

KEYTRUDA should not 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:

-200 mg of pembrolizumab if you have non-small cell lung cancer that has not been previously treated with chemotherapy or classical Hodgkin lymphoma.

-2 mg of pembrolizumab per kilogram of your body weight if you have melanoma or if you have non-small cell lung cancer that has been previously treated with chemotherapy.

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:

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

-diarrhoea; nausea

-itching; skin rash

-feeling tired

Common (may affect up to 1 in 10 people)

-joint pain

-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; 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; inflammation of the skin; acne-like skin problem; 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

-an immune disorder that can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis)

-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

-tender red bumps under the skin

-itching, skin blistering, peeling or sores, and/or ulcers in mouth or in lining of nose, throat, or genital area (toxic epidermal necrolysis or Stevens-Johnson syndrome)

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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).

From a microbiological point of view, the reconstituted or diluted solution should be used immediately. The reconstituted or diluted solution must not be frozen. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 24 hours at 2°C to 8°C. This 24 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°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:

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel. + 370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000

e-mail@msd.de

(+31 23 5153153)

 

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Ελλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Polska

Merck Sharp & Dohme de España, S.A.

MSD Polska Sp. z o.o.

Tel: +34 91 321 06 00

Tel: +48 22 549 51 00

msd_info@merck.com

msdpolska@merck.com

France

Portugal

MSD France

Merck Sharp & Dohme, Lda

Tél: + 33 (0) 1 80 46 40 40

Tel: +351 21 4465700

 

clic@merck.com

Hrvatska

România

Merck Sharp & Dohme d.o.o.

Merck Sharp & Dohme Romania S.R.L.

Tel: + 385 1 6611 333

Tel: +40 21 529 29 00

croatia_info@merck.com

msdromania@merck.com

Ireland

Slovenija

Merck Sharp & Dohme Ireland (Human Health)

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Limited

Tel: +386 1 5204 201

Tel: +353 (0)1 2998700

msd.slovenia@merck.com

medinfo_ireland@merck.com

 

Ísland

Slovenská republika

Vistor hf.

Merck Sharp & Dohme, s. r. o.

Sími: + 354 535 7000

Tel: +421 2 58282010

 

dpoc_czechslovak@merck.com

Italia

Suomi/Finland

MSD Italia S.r.l.

MSD Finland Oy

Tel: +39 06 361911

Puh/Tel: +358 (0)9 804 650

medicalinformation.it@merck.com

info@msd.fi

Κύπρος

Sverige

Merck Sharp & Dohme Cyprus Limited

Merck Sharp & Dohme (Sweden) AB

Τηλ.: 800 00 673 (+357 22866700)

Tel: +46 77 5700488

cyprus_info@merck.com

medicinskinfo@merck.com

Latvija

United Kingdom

SIA Merck Sharp & Dohme Latvija

Merck Sharp & Dohme Limited

Tel: + 371 67364224

Tel: +44 (0) 1992 467272

msd_lv@merck.com

medicalinformationuk@merck.com

This leaflet was last revised in

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

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.

Withdraw the required volume up to 2 mL (50 mg) of KEYTRUDA and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Mix diluted solution by gentle inversion.

From a microbiological point of view, the reconstituted or diluted solution should be used immediately. The reconstituted or diluted solution must not be frozen. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 24 hours at 2°C to 8°C. This 24 hour total hold from reconstitution may include up to 6 hours at room temperature (at or below 25°C). If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. Administer the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.

Do not co-administer other medicinal products through the same infusion line.

KEYTRUDA is for single use only. Discard any unused portion left in the vial.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Package leaflet: Information for the patient

KEYTRUDA 25 mg/mL 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

a kind of cancer called classical Hodgkin lymphoma.

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

-have kidney damage

-have had a solid organ transplant

When you get KEYTRUDA, you can have some serious side effects. You may experience more than one side effect at the same time.

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 (possibly fatal)

-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, itching, skin blistering, peeling or sores, and/or ulcers in mouth or in lining of nose, throat, or genital area (possibly fatal)

-infusion reactions, which may include shortness of breath, itching or rash, dizziness or fever

Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with KEYTRUDA. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant. If you are having a stem cell transplant, tell your transplant doctor that you have received pembrolizumab in the past.

Children and adolescents

KEYTRUDA should not 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:

-200 mg of pembrolizumab if you have non-small cell lung cancer that has not been previously treated with chemotherapy or classical Hodgkin lymphoma.

-2 mg of pembrolizumab per kilogram of your body weight if you have melanoma or if you have non-small cell lung cancer that has been previously treated with chemotherapy.

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:

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

-diarrhoea; nausea

-itching; skin rash

-feeling tired

Common (may affect up to 1 in 10 people)

-joint pain

-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; 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; inflammation of the skin; acne-like skin problem; 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

-an immune disorder that can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis)

-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

-tender red bumps under the skin

-itching, skin blistering, peeling or sores, and/or ulcers in mouth or in lining of nose, throat, or genital area (toxic epidermal necrolysis or Stevens-Johnson syndrome)

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 via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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).

Do not freeze.

Store in the original carton in order to protect from light.

From a microbiological point of view, the product, once diluted, should be used immediately. The diluted solution must not be frozen. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 24 hours at 2ºC to 8ºC. This 24 hour hold may include up to 6 hours at room temperature (at or below 25°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 of 4 mL contains 100 mg of pembrolizumab.

Each mL of concentrate contains 25 mg of pembrolizumab.

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

What KEYTRUDA looks like and contents of the pack

KEYTRUDA is a clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 – 5.8. 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:

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693 (+32(0)27766211)

Tel. + 370 5 278 02 47

dpoc_belux@merck.com

msd_lietuva@merck.com

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД

MSD Belgium BVBA/SPRL

Тел.: +359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel: +420 233 010 111

Tel.: +36 1 888 5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

Malta

MSD Danmark ApS

Merck Sharp & Dohme Cyprus Limited

Tlf: + 45 4482 4000

Tel: 8007 4433 (+356 99917558)

dkmail@merck.com

malta_info@merck.com

Deutschland

Nederland

MSD SHARP & DOHME GMBH

Merck Sharp & Dohme BV

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Tel: 0800 9999000

e-mail@msd.de

(+31 23 5153153)

 

medicalinfo.nl@merck.com

Eesti

Norge

Merck Sharp & Dohme OÜ

MSD (Norge) AS

Tel.: +372 6144 200

Tlf: +47 32 20 73 00

msdeesti@merck.com

msdnorge@msd.no

Ελλάδα

Österreich

MSD Α.Φ.Β.Ε.Ε.

Merck Sharp & Dohme Ges.m.b.H.

Τηλ: +30 210 98 97 300

Tel: +43 (0) 1 26 044

dpoc_greece@merck.com

msd-medizin@merck.com

España

Polska

Merck Sharp & Dohme de España, S.A.

MSD Polska Sp. z o.o.

Tel: +34 91 321 06 00

Tel: +48 22 549 51 00

msd_info@merck.com

msdpolska@merck.com

France

Portugal

MSD France

Merck Sharp & Dohme, Lda

Tél: + 33 (0) 1 80 46 40 40

Tel: +351 21 4465700

 

clic@merck.com

Hrvatska

România

Merck Sharp & Dohme d.o.o.

Merck Sharp & Dohme Romania S.R.L.

Tel: + 385 1 6611 333

Tel: +40 21 529 29 00

croatia_info@merck.com

msdromania@merck.com

Ireland

Slovenija

Merck Sharp & Dohme Ireland (Human Health)

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Limited

Tel: +386 1 5204 201

Tel: +353 (0)1 2998700

msd.slovenia@merck.com

medinfo_ireland@merck.com

 

Ísland

Slovenská republika

Vistor hf.

Merck Sharp & Dohme, s. r. o.

Sími: + 354 535 7000

Tel: +421 2 58282010

 

dpoc_czechslovak@merck.com

Italia

Suomi/Finland

MSD Italia S.r.l.

MSD Finland Oy

Tel: +39 06 361911

Puh/Tel: +358 (0)9 804 650

medicalinformation.it@merck.com

info@msd.fi

Κύπρος

Sverige

Merck Sharp & Dohme Cyprus Limited

Merck Sharp & Dohme (Sweden) AB

Τηλ.: 800 00 673 (+357 22866700)

Tel: +46 77 5700488

cyprus_info@merck.com

medicinskinfo@merck.com

Latvija

United Kingdom

SIA Merck Sharp & Dohme Latvija

Merck Sharp & Dohme Limited

Tel: + 371 67364224

Tel: +44 (0) 1992 467272

msd_lv@merck.com

medicalinformationuk@merck.com

This leaflet was last revised in

 

Other sources of information

 

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

The following information is intended for healthcare professionals only:

Preparation and administration of the infusion

Do not shake the vial.

Equilibrate the vial to room temperature (at or below 25°C).

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

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

Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. Each vial contains an excess fill of 0.25 ml (total content per vial 4.25 ml) to ensure the recovery of 4 ml of concentrate. Mix diluted solution by gentle inversion.

From a microbiological point of view, the product, once diluted, should be used immediately. The diluted solution must not be frozen. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 24 hours at 2ºC to 8ºC. This 24 hour hold may include up to 6 hours at room temperature (at or below 25°C). If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. Administer

the infusion solution intravenously over 30 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 to 5 µm in-line or add-on filter.

Do not co-administer other medicinal products through the same infusion line.

KEYTRUDA is for single use only. Discard any unused portion left in the vial.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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