KEYTRUDA 25 mg/mL concentrate for infusion solution

Introduction

Package Leaflet: Information for the Patient

KEYTRUDA 25mg/ml concentrate for solution for infusion

pembrolizumab

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 always carry the patient information card with you during treatment.
• If you have any further questions, ask your doctor.
• If you experience side effects, ask your doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What is KEYTRUDA and what is it used for
2. What you need to know before you are given KEYTRUDA
3. How KEYTRUDA is given
4. Possible side effects
5. Storage of KEYTRUDA
6. Contents of the pack and other information

1. What is KEYTRUDA and what is it 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 type of skin cancer called melanoma
• a type of lung cancer called non-small cell lung cancer
• a type of cancer called malignant pleural mesothelioma (MPM) that affects the lining of the lungs and chest wall
• a type of cancer called classical Hodgkin lymphoma
• a type of cancer called bladder cancer (urothelial carcinoma)
• a type of head and neck cancer called squamous cell carcinoma of the head and neck
• a type of kidney cancer called renal cell carcinoma
• a type of cancer characterized by having high microsatellite instability (MSI-H) or deficiency of the mismatch repair system (dMMR) in the colon or rectum (called colorectal cancer), in the uterus (called endometrial cancer), in the stomach (called gastric cancer), in the small intestine (called small intestine cancer) or in the bile duct or gallbladder (called biliary tract cancer)
• a type of cancer called esophageal carcinoma
• a type of breast cancer called triple-negative breast cancer
• a type of uterine cancer called endometrial cancer
• a type of cancer called cervical cancer
• a type of stomach cancer called gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
• a type of bile duct or gallbladder cancer called biliary tract cancer.

KEYTRUDA is used in children and adolescents:

• from 3 years of age to treat a type of cancer called classical Hodgkin lymphoma
• from 12 years of age to treat a type of cancer called melanoma.

People receive KEYTRUDA when their cancer has spread or cannot be removed by surgery.

People receive KEYTRUDA after surgery to remove melanoma, non-small cell lung cancer, or renal cell carcinoma to help prevent their cancer from coming back (adjuvant treatment).

People receive KEYTRUDA before surgery (neoadjuvant treatment) to treat non-small cell lung cancer or triple-negative breast cancer and then continue to receive KEYTRUDA after surgery (adjuvant treatment) to help prevent their cancer from coming back.

KEYTRUDA may be given in combination with other cancer medicines with or without radiation therapy. It is important that you also read the package leaflets of these other medicines. If you have any questions about these medicines, ask your doctor.

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

You should not be given KEYTRUDA

• if you are allergic to pembrolizumab or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”). If you are unsure, consult your doctor.

Warnings and precautions

Talk to your doctor or nurse before you receive KEYTRUDA.

Before you receive KEYTRUDA, tell your doctor if:

• you have an autoimmune disease (a disease in which the body attacks its own cells)
• you have pneumonia or inflammation of the lungs (called pneumonitis)
• you have been previously treated with ipilimumab, another medicine for treating melanoma, and have had severe side effects due to this medicine
• you have had an allergic reaction to other treatments with monoclonal antibodies
• you have or have had chronic liver infection with viruses, such as hepatitis B or hepatitis C
• you have human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
• you have liver damage
• you have kidney damage
• you have had a solid organ transplant or a bone marrow transplant (stem cell transplant) that uses donor stem cells (allogenic).

KEYTRUDA works on your immune system. It can cause inflammation in parts of your body. The risk of these side effects may be greater if you already have an autoimmune disease (a disease in which the body attacks its own cells). You may also have frequent flare-ups of your autoimmune disease, which are usually mild.

When you receive KEYTRUDA, you may experience some serious side effects. These side effects can sometimes be life-threatening and can cause death. These side effects can occur at any time during treatment or even after your treatment has ended. You may have more than one side effect at the same time.

If you experience any of the following conditions, call or go to your doctor immediately. Your doctor may give you other medicines to prevent more serious complications and reduce your symptoms. Your doctor may delay the next dose of KEYTRUDA or stop treatment with KEYTRUDA.

• inflammation of the lungs, which can include difficulty breathing, chest pain, or cough
• inflammation of the intestines that can include diarrhea or more bowel movements than usual, black, tarry, sticky, or bloody stools, or stools with mucus, abdominal pain or tenderness, nausea, vomiting
• inflammation of the liver, which can include nausea or vomiting, loss of appetite, pain in the right upper stomach, yellowing of the skin or the white part of the eyes, dark urine, or bleeding or bruising more easily than usual
• inflammation of the kidneys, which can include changes in the amount or color of urine
• inflammation of the hormone glands (especially the thyroid, pituitary, and adrenal glands), which can include rapid heartbeat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, deepened voice, muscle aches, dizziness or fainting, headaches that do not go away or unusual headache
• type 1 diabetes, including diabetic ketoacidosis (acids in the blood produced by diabetes), symptoms that can include feeling more hungry or thirsty than usual, needing to urinate more often, or weight loss, feeling tired or feeling unwell, stomach pain, rapid and deep breathing, confusion, tendency to sleep more than usual, sweet smell on your breath, sweet or metallic taste in your mouth, or a different smell in your urine or sweat
• inflammation of the eyes, which can include changes in vision
• inflammation of the muscles, which can include muscle pain or weakness
• inflammation of the heart muscle, which can include shortness of breath, irregular heartbeat, feeling tired or chest pain (myocarditis)
• inflammation of the pancreas, which can include abdominal pain, nausea, and vomiting
• inflammation of the skin, which can include rash, itching, blistering, peeling, or ulcers on the skin and/or ulcers in the mouth or on the mucous membranes of the nose, throat, or genital area
• an immune disorder that can affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
• inflammation of the brain, which can include confusion, fever, memory problems, or seizures (encephalitis)
• pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems, such as needing to urinate more often, urinary incontinence, difficulty urinating, and constipation (myelitis)
• inflammation and scarring of the bile ducts, which can include pain in the upper right stomach, swelling of the liver or spleen, fatigue, itching, or yellowing of the skin or the white part of the eyes (sclerosing cholangitis)
• inflammation of the stomach (gastritis)
• decreased function of the parathyroid gland, which can include muscle cramps or spasms, fatigue, and weakness (hypoparathyroidism)
• inflammation of the layer that covers the heart, which can include chest pain, shortness of breath, or feeling tired (pericarditis)
• infusion reactions, which can include difficulty breathing, itching, or rash, dizziness, or fever

Complications, including graft-versus-host disease (GVHD), in people with a bone marrow transplant (stem cell transplant) that uses donor stem cells (allogenic).These complications can be serious and can be life-threatening. They can occur if you have had this type of transplant in the past or if you are going to have it in the future. Your doctor will monitor you for signs and symptoms, which can include rash, liver inflammation, abdominal pain, or diarrhea.

Children and adolescents

Do not give KEYTRUDA to children under 18 years of age, except in children:

• from 3 years of age with classical Hodgkin lymphoma
• from 12 years of age with melanoma.

Other medicines and KEYTRUDA

Talk to your doctor

• If you are taking other medicines that weaken your immune system. Some examples of these may be corticosteroids, such as prednisone. These medicines can affect the effect of KEYTRUDA. However, once you are on treatment with KEYTRUDA, your doctor may give you corticosteroids to reduce the side effects you may have with KEYTRUDA. You may also be given corticosteroids before receiving KEYTRUDA in combination with chemotherapy to prevent and/or treat nausea, vomiting, and other side effects caused by chemotherapy.
• If you are taking, have recently taken, or might take any other medicine.

Pregnancy

• You should not use KEYTRUDA if you are pregnant unless your doctor specifically recommends it.
• If you are pregnant, think you may be pregnant, or plan to become pregnant, talk to your doctor.
• KEYTRUDA may harm or kill your unborn baby.
• If you are a woman who could become pregnant, you must use a suitable method of contraception while you are being treated with KEYTRUDA and for at least 4 months after your last dose.

Breast-feeding

• If you are breast-feeding, talk to your doctor.
• Do not breast-feed while you are taking KEYTRUDA.
• It is not known if KEYTRUDA passes into breast milk.

Driving and using machines

KEYTRUDA has a mild effect on your ability to drive or use machines. Feeling dizzy, tired, or weak are possible side effects of KEYTRUDA. Do not drive or use machines after you have been given KEYTRUDA unless you are sure you are well.

3. How KEYTRUDA is given

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

• The recommended dose of KEYTRUDA in adults is 200 mg every 3 weeks or 400 mg every 6 weeks.
• The recommended dose of KEYTRUDA in children and adolescents from 3 years of age with classical Hodgkin lymphoma and adolescents from 12 years of age with melanoma is 2 mg/kg of body weight (up to a maximum of 200 mg) every 3 weeks.
• Your doctor will give you KEYTRUDA through a vein (intravenously) over about 30 minutes.
• Your doctor will decide how many treatments you need.

If you miss a KEYTRUDA appointment

• Call your doctor immediately to reschedule your appointment.
• It is very important that you do not miss any dose of this medicine.

If you stop treatment with KEYTRUDA

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

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

You will also find this information on the patient information card that your doctor has given you. It is important that you keep this information card and show it to your partner or caregivers.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

When you receive KEYTRUDA, you may experience serious adverse effects. See section 2.

The following adverse effects have been reported with pembrolizumab as monotherapy:

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

• decrease in the number of red blood cells
• reduced activity of the thyroid gland
• decreased appetite
• headache
• shortness of breath; cough
• diarrhea; stomach pain; nausea; vomiting; constipation
• itching; skin rash
• pain in the muscles and bones; joint pain
• feeling of fatigue; unusual fatigue or weakness; swelling; fever

Common (may affect up to 1 in 10 people)

• lung infection
• decrease in the number of platelets (bruising or bleeding more easily); decrease in the number of white blood cells (neutrophils, lymphocytes)
• reactions related to the infusion of the medicine
• overactive thyroid gland; hot flashes
• decrease in sodium, potassium, or calcium in the blood
• difficulty sleeping
• dizziness; inflammation of the nerves that causes numbness, weakness, tingling, or burning of the arms and legs; lack of energy; change in taste
• dry eye
• abnormal heart rhythm
• high blood pressure
• inflammation of the lungs
• inflammation of the intestines; dry mouth
• inflammation of the liver
• inflamed, red, rash, sometimes with blisters; skin inflammation; skin patches that have lost color; dryness and itching of the skin; hair loss; skin problem similar to acne
• muscle pain; ongoing or increased sensitivity; pain in the arms or legs; joint pain with swelling
• flu-like illness; chills
• elevated levels of liver enzymes in the blood; elevated calcium levels in the blood; abnormal kidney function tests

Uncommon (may affect up to 1 in 100 people)

• decreased number of white blood cells (leukocytes); inflammatory response against platelets; increased number of white blood cells (eosinophils)
• an immune disorder that can affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
• decreased secretion of hormones produced by the adrenal glands; inflammation of the pituitary gland located at the base of the brain; thyroid inflammation
• type 1 diabetes, including diabetic ketoacidosis
• a condition in which the muscles weaken and tire easily; seizures
• eye inflammation; eye pain, irritation, itching, or redness; discomfort in the light; seeing spots
• inflammation of the heart muscle, which can include shortness of breath, irregular heartbeat, feeling of fatigue, or chest pain (myocarditis); inflammation of the layer that covers the heart, which can include chest pain, shortness of breath, or feeling of fatigue (pericarditis); fluid accumulation around the heart
• pancreas inflammation; stomach inflammation; an ulcer that forms in the inner lining of the stomach or in the upper part of the small intestine
• thickening or peeling of the skin; small bumps, lumps, or blisters on the skin; changes in hair color
• inflammation of the tissue that surrounds the tendons
• kidney inflammation
• increased levels of amylase, an enzyme that breaks down starch

Rare (may affect up to 1 in 1,000 people)

• inflammatory response against red blood cells, a disease called hemophagocytic lymphohistiocytosis, in which the immune system produces too many cells that fight infections, called histiocytes and lymphocytes, which can cause various symptoms; feeling of weakness, dizziness, shortness of breath, or if the skin is pale (signs of low red blood cell count, possibly due to a type of anemia called pure red cell aplasia)
• decreased function of the parathyroid gland, which can include muscle cramps or spasms, fatigue, and weakness
• temporary inflammation of the nerves that causes pain, weakness, and paralysis in the limbs (Guillain-Barré syndrome); brain inflammation, which can include confusion, fever, memory problems, or seizures (encephalitis); pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems, such as frequent urination, urinary incontinence, difficulty urinating, and constipation (myelitis); inflammation of the optic nerve that can cause vision loss in one or both eyes, eye pain with movement, and/or loss of color vision (optic neuritis); inflammation of the membrane that surrounds the spinal cord and brain, which can manifest with neck stiffness, headache, fever, eye sensitivity to light, nausea, or vomiting (meningitis)
• inflammation of blood vessels
• lack or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency); perforation in the small intestine; celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods that contain gluten)
• inflammation of the bile ducts
• itching, blistering, peeling, or ulcers on the skin and/or ulcers in the mouth or on the mucous membranes of the nose, throat, or genital area (Stevens-Johnson syndrome or toxic epidermal necrolysis); soft red lumps under the skin
• a disease in which the immune system attacks the glands that produce moisture in the body, such as tears and saliva (Sjögren's syndrome)
• bladder inflammation, which can manifest as frequent and/or painful urination, need to urinate, blood in the urine, pain, or pressure in the lower abdomen

The following adverse effects have been reported in clinical trials with pembrolizumab in combination with chemotherapy or chemotherapy with radiotherapy:

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

• decrease in the number of red blood cells; decrease in the number of white blood cells (neutrophils); decrease in the number of platelets (bruising or bleeding more easily)
• reduced activity of the thyroid gland
• decrease in potassium levels in the blood; decreased appetite
• difficulty sleeping
• inflammation of the nerves that causes numbness, weakness, tingling, or burning of the arms and legs; headache; dizziness
• shortness of breath; cough
• diarrhea; nausea; vomiting; stomach pain; constipation
• skin rash; hair loss; itching
• pain in the muscles and bones; joint pain
• feeling of fatigue; unusual fatigue or weakness; fever; swelling
• elevated levels of the liver enzyme alanine aminotransferase in the blood; elevated levels of the liver enzyme aspartate aminotransferase in the blood;

Common (may affect up to 1 in 10 people)

• lung infection
• decrease in the number of white blood cells (neutrophils) with fever; decrease in the number of white blood cells (leukocytes, lymphocytes)
• reactions related to the infusion of the medicine
• decreased secretion of hormones produced by the adrenal glands; overactive thyroid gland; thyroid inflammation
• decrease in sodium or calcium levels in the blood
• change in taste
• dry eye
• abnormal heart rhythm
• high blood pressure
• inflammation of the lungs
• inflammation of the intestines; inflammation of the stomach; dry mouth
• inflammation of the liver
• inflamed, red, rash, sometimes with blisters; skin inflammation; skin problem similar to acne; dryness and itching of the skin
• muscle pain; ongoing or increased sensitivity; pain in the arms or legs; joint pain with swelling
• kidney damage
• flu-like illness; chills
• increased bilirubin levels in the blood; elevated levels of the liver enzyme alkaline phosphatase in the blood; abnormal kidney function tests; elevated calcium levels in the blood

Uncommon (may affect up to 1 in 100 people)

• inflammatory response against red blood cells
• inflammation of the pituitary gland located at the base of the brain
• type 1 diabetes, including diabetic ketoacidosis

• brain inflammation, which can manifest as confusion, fever, memory problems, or seizures (encephalitis); seizures; lack of energy

• eye inflammation; eye pain, irritation, itching, or redness; discomfort in the light; seeing spots
• inflammation of the heart muscle, which can include shortness of breath, irregular heartbeat, feeling of fatigue, or chest pain (myocarditis); inflammation of the layer that covers the heart, which can include chest pain, shortness of breath, or feeling of fatigue (pericarditis); fluid accumulation around the heart
• inflammation of blood vessels
• an ulcer that forms in the inner lining of the stomach or in the upper part of the small intestine
• dryness, itching of the skin; thickening or peeling of the skin; skin patches that have lost color; small bumps, lumps, or blisters on the skin; changes in hair color
• inflammation of the tissue that surrounds the tendons
• kidney inflammation; bladder inflammation, which can manifest as frequent and/or painful urination, need to urinate, blood in the urine, pain, or pressure in the lower abdomen
• increased levels of amylase, an enzyme that breaks down starch

Rare (may affect up to 1 in 1,000 people)

• inflammatory response against platelets
• an immune disorder that can affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
• decreased function of the parathyroid gland, which can include muscle cramps or spasms, fatigue, and weakness

• a condition in which the muscles weaken and tire easily; temporary inflammation of the nerves that causes pain, weakness, and paralysis in the limbs (Guillain-Barré syndrome); pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems, such as frequent urination, urinary incontinence, difficulty urinating, and constipation (myelitis); inflammation of the optic nerve that can cause vision loss in one or both eyes, eye pain with movement, and/or loss of color vision (optic neuritis); inflammation of the membrane that surrounds the spinal cord and brain, which can manifest with neck stiffness, headache, fever, eye sensitivity to light, nausea, or vomiting (meningitis)

• lack or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency); perforation in the small intestine; celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods that contain gluten)
• inflammation of the bile ducts
• itching, blistering, peeling, or ulcers on the skin and/or ulcers in the mouth or on the mucous membranes of the nose, throat, or genital area (Stevens-Johnson syndrome or toxic epidermal necrolysis); soft red lumps under the skin; changes in hair color
• a disease in which the immune system attacks the glands that produce moisture in the body, such as tears and saliva (Sjögren's syndrome)

The following adverse effects have been reported in clinical trials with pembrolizumab in combination with axitinib or lenvatinib:

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

• urinary tract infections (increased frequency of urination and painful urination)
• decrease in the number of red blood cells
• decreased activity of the thyroid gland
• decreased appetite
• headache; change in taste
• high blood pressure
• difficulty breathing; cough
• diarrhea; stomach pain; nausea; vomiting; constipation
• skin rash; itching
• joint pain; muscle and bone pain; muscle pain; ongoing or increased sensitivity; pain in the arms or legs
• feeling of fatigue; unusual fatigue or weakness; inflammation; fever
• increased levels of lipase, an enzyme that breaks down fats; increased levels of liver enzymes in the blood; abnormal kidney function tests

Common (may affect up to 1 in 10 people)

• lung infection
• decrease in the number of white blood cells (neutrophils, lymphocytes, leukocytes); decrease in the number of platelets (bruising or bleeding more easily)
• reactions related to the infusion of the medicine
• decreased secretion of hormones produced by the adrenal glands; overactive thyroid gland; thyroid inflammation
• decrease in sodium, potassium, or calcium levels in the blood
• difficulty sleeping
• dizziness; inflammation of the nerves that causes numbness, weakness, tingling, or burning of the arms and legs; lack of energy
• dry eye
• abnormal heart rhythm
• inflammation of the lungs
• inflammation of the intestines; pancreas inflammation; stomach inflammation; dry mouth
• inflammation of the liver
• inflamed, red, rash, sometimes with blisters; skin inflammation; dry skin; skin problem similar to acne; hair loss
• joint pain with swelling
• kidney inflammation
• flu-like illness; chills
• increased levels of amylase, an enzyme that breaks down starch; increased bilirubin levels in the blood; increased levels of the liver enzyme alkaline phosphatase in the blood; elevated calcium levels in the blood

Uncommon (may affect up to 1 in 100 people)

• increased number of white blood cells (eosinophils)
• inflammation of the pituitary gland located at the base of the brain
• type 1 diabetes, including diabetic ketoacidosis
• a condition in which the muscles weaken and tire easily; brain inflammation, which can manifest as confusion, fever, memory problems, or seizures (encephalitis)
• eye inflammation; eye pain, irritation, itching, or redness; discomfort in the light; seeing spots
• inflammation of the heart muscle, which can include shortness of breath, irregular heartbeat, feeling of fatigue, or chest pain (myocarditis); fluid accumulation around the heart
• inflammation of blood vessels
• an ulcer that forms in the inner lining of the stomach or in the upper part of the small intestine
• dryness, itching of the skin; thickening or peeling of the skin; skin patches that have lost color; small bumps, lumps, or blisters on the skin; changes in hair color
• inflammation of the tissue that surrounds the tendons

Rare (may affect up to 1 in 1,000 people)

• decreased function of the parathyroid gland, which can include muscle cramps or spasms, fatigue, and weakness
• inflammation of the optic nerve that can cause vision loss in one or both eyes, eye pain with movement, and/or loss of color vision (optic neuritis)
• perforation in the small intestine
• itching, blistering, peeling, or ulcers on the skin and/or ulcers in the mouth or on the mucous membranes of the nose, throat, or genital area (toxic epidermal necrolysis or Stevens-Johnson syndrome)
• a disease in which the immune system attacks the glands that produce moisture in the body, such as tears and saliva (Sjögren's syndrome)
• bladder inflammation, which can manifest as frequent and/or painful urination, need to urinate, blood in the urine, pain, or pressure in the lower abdomen

Other adverse effects that have been reported with unknown frequency (cannot be estimated from the available data)

• lack or reduction of digestive enzymes produced by the pancreas (exocrine pancreatic insufficiency); celiac disease (characterized by symptoms such as stomach pain, diarrhea, and bloating after consuming foods that contain gluten)

The rash is more common when KEYTRUDA is administered in combination with enfortumab vedotin than when KEYTRUDA is administered alone.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, even if they are possible adverse effects that are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of KEYTRUDA

Unopened vial

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 on the vial after EXP. The expiry date refers to the last day of the month shown.

Store in a refrigerator (between 2 °C and 8 °C).

Do not freeze.

Store in the original package to protect from light.

After preparation for infusion

Chemical and physical stability has been demonstrated for up to 42 days between 2 °C and 8 °C or between 23 °C and 27 °C. From a microbiological point of view, the product, once diluted, should be used immediately. The diluted solution should not be frozen. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 7 days between 2 °C and 8 °C, or 12 hours at room temperature, unless the dilution has been made in controlled and validated aseptic conditions. If refrigerated, allow the vials and/or intravenous bags to reach room temperature before use.

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

6. Package contents and additional information

Composition of KEYTRUDA

The active substance is pembrolizumab.

One 4 ml vial 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.

Appearance and package contents of the product

KEYTRUDA is a clear to slightly opalescent, colorless to slightly yellow solution, with a pH between 5.2 and 5.8.

It is available in packs containing one or two glass vials.

Not all pack sizes may be marketed.

Marketing authorisation holder

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer

Organon Heist bv

Industriepark 30

2220 Heist-op-den-Berg

Belgium

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For further information, please contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

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