Package leaflet: Information for the patient

KEYTRUDA 25 mg/mL concentrate for solution for infusion

pembrolizumab
Please 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 card with you during treatment.
If you have any questions, ask your doctor.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

What KEYTRUDA is and what it is used for
What you need to know before you are given KEYTRUDA
How KEYTRUDA will be given to you
Possible side effects
How to store KEYTRUDA
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 the immune system fight 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) affecting 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 head and neck squamous cell carcinoma
a type of kidney cancer called renal cell carcinoma
a type of cancer characterized by high microsatellite instability (MSI-H, microsatellite instability-high) or mismatch repair deficiency (dMMR, mismatch repair deficient) in the colon or rectum (called colorectal carcinoma), uterus (called endometrial carcinoma), stomach (called gastric carcinoma), small intestine (called small intestine carcinoma), or bile duct or gallbladder (called biliary tract carcinoma)
a type of cancer called esophageal carcinoma
a type of breast cancer called triple-negative breast cancer
a type of uterine cancer called endometrial carcinoma
a type of cancer called cervical carcinoma
a type of stomach cancer called gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
a type of cancer of the bile duct or gallbladder called biliary tract carcinoma
a type of cancer called ovarian carcinoma

KEYTRUDA is used in children and adolescents:

aged 3 years and older to treat a type of cancer called classical Hodgkin lymphoma
aged 12 years and older to treat a type of cancer called melanoma.

People take KEYTRUDA when cancer has spread or cannot be removed surgically.
People take KEYTRUDA after surgery to remove melanoma, non-small cell lung cancer, or renal cell carcinoma to help prevent cancer from returning (adjuvant therapy).
People take KEYTRUDA before surgery (neoadjuvant therapy) to treat non-small cell lung cancer, triple-negative breast cancer, or head and neck squamous cell carcinoma, and then continue taking KEYTRUDA after surgery (adjuvant therapy) to help prevent cancer from returning.
KEYTRUDA may be given in combination with other anticancer medicines, with or without radiotherapy. It is important to also read the package leaflets of these other medicines. If you have any questions about these medicines, consult your doctor.

2. What you should know before being given KEYTRUDA

KEYTRUDA must not be given to you:

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”). Consult your doctor if you are unsure. Warnings and precautions Talk to your doctor or nurse before treatment with KEYTRUDA.

Before you are given KEYTRUDA, inform your doctor if:

you have an autoimmune disease (a condition in which the body attacks its own cells)
you have a lung infection or inflammation of the lungs (called pneumonitis)
you have previously been treated with ipilimumab, another medicine used to treat melanoma, and experienced severe side effects from that medicine
you have had an allergic reaction to other monoclonal antibody therapies
you have or have had chronic viral liver infection, including hepatitis B (HBV) or hepatitis C (HCV)
you have human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
you have liver damage
you have kidney damage
you have received a solid organ transplant or an allogeneic hematopoietic stem cell transplant (using donor stem cells)

KEYTRUDA acts on the immune system. It may cause inflammation in certain parts of the body. The risk of these side effects may be higher if you already have an autoimmune disease (a condition in which the body attacks its own cells). Additionally, autoimmune disease flares may occur frequently, which in most cases are mild.
Administration of KEYTRUDA may cause some serious side effects. These side effects can sometimes become potentially life-threatening and may lead to death. These side effects may occur at any time during treatment or even after treatment has ended. You may experience more than one side effect simultaneously.
If you develop any of the following conditions, call your doctor or go immediately to see them. Your doctor may prescribe additional medicines to prevent more serious complications and to reduce symptoms. Your doctor may suspend the next dose of KEYTRUDA or discontinue treatment with KEYTRUDA.

inflammation of the lungs, which may include shortness of breath, chest pain, or cough
inflammation of the intestine, which may include diarrhoea or more frequent bowel movements than usual, dark, tarry, sticky stools or stools containing blood or mucus, severe pain or tenderness in the abdomen, nausea, vomiting
inflammation of the liver, which may include nausea or vomiting, loss of appetite, pain in the right side of the abdomen, yellowing of the skin or the whites of the eyes, dark urine, or easier than normal occurrence of bleeding or bruising
inflammation of the kidneys, which may include changes in the amount or colour of urine
inflammation of hormone-producing glands (especially thyroid, pituitary, and adrenal glands), which may include rapid heartbeat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, deeper voice, muscle pain, dizziness or fainting, headache that does not go away or an unusual headache
type 1 diabetes, including diabetic ketoacidosis (acid in the blood caused by diabetes), symptoms of which may include increased appetite or thirst, need to urinate more often, weight loss, feeling tired or unwell, stomach pain, fast and deep breathing, confusion, unusual drowsiness, sweet smell on the breath, sweet or metallic taste in the mouth, or different smell of urine or sweat
inflammation of the eyes, which may include changes in vision
inflammation in the muscles, which may include muscle pain or weakness
inflammation of the heart muscle, which may include shortness of breath, irregular heartbeat, feeling tired, or chest pain (myocarditis)
inflammation of the pancreas, which may include abdominal pain, nausea, and vomiting
inflammation of the skin, which may include rash, itching, blisters, peeling or sores on the skin, and/or ulcers in the mouth, nasal mucosa, throat, or genital area
an immune system disorder that may affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
inflammation of the brain, which may present with confusion, fever, memory problems, or seizures (encephalitis)
pain, numbness, tingling, or weakness in the arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating, and constipation (myelitis)
inflammation and scarring of the bile ducts, which may include pain in the upper right side of the abdomen, swelling of the liver or spleen, fatigue, itching, or yellowing of the skin or the whites of the eyes (sclerosing cholangitis)
inflammation of the stomach (gastritis)
reduced function of the parathyroid gland, which may include muscle cramps or spasms, fatigue, and weakness (hypoparathyroidism)
inflammation of the lining of the heart, which may include chest pain, shortness of breath, or feeling tired (pericarditis)
infusion reactions, which may include shortness of breath, itching or rash, dizziness, or fever

Complications, including graft-versus-host disease (GVHD), in patients who have received an allogeneic hematopoietic stem cell transplant (using donor stem cells). These complications can be serious and may lead to death. They may occur if you have previously undergone this type of transplant or if you will undergo it in the future. Your doctor will monitor you for signs and symptoms, which may include rash, liver inflammation, abdominal pain, or diarrhoea.

Children and adolescents
KEYTRUDA must not be given to children under 18 years of age, except for children:

aged 3 years and older with classical Hodgkin lymphoma
aged 12 years and older with melanoma.

Other medicines and KEYTRUDA
Inform your doctor:

if you are taking other medicines that weaken the immune system.
Examples of such medicines include corticosteroids, such as prednisone.
These medicines may interfere with the effect of KEYTRUDA.
However, once you are being treated with KEYTRUDA, your doctor may prescribe corticosteroids to reduce side effects associated with KEYTRUDA.
Corticosteroids may also be prescribed before receiving KEYTRUDA in combination with chemotherapy, to prevent and/or treat nausea, vomiting, and other side effects caused by chemotherapy.
if you are currently taking, have recently taken, or might take any other medicines.

Pregnancy

KEYTRUDA must not be used during pregnancy unless specifically recommended by your doctor.
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, inform your doctor.
KEYTRUDA may harm or cause death to your unborn child.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with KEYTRUDA and for at least 4 months after the last dose.

Breast-feeding

If you are breast-feeding, inform your doctor.
Do not breast-feed during treatment with KEYTRUDA.
It is not known whether KEYTRUDA passes into breast milk.

Driving and using machines
KEYTRUDA has a minor influence on the ability to drive or use machines. Possible side effects of KEYTRUDA include dizziness, fatigue, or weakness. Do not drive or operate machinery after receiving KEYTRUDA unless you are certain you feel well.

KEYTRUDA contains polysorbate 80
This medicine contains 0.2 mg of polysorbate 80 per mL of concentrate. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

3. How KEYTRUDA will be administered to you

KEYTRUDA will be administered to you in a hospital or clinic under the supervision of a doctor experienced 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 aged 3 years and older with classical Hodgkin’s lymphoma, and in adolescents aged 12 years and older with melanoma, is 2 mg/kg body weight (up to a maximum of 200 mg) every 3 weeks.
Your doctor will administer KEYTRUDA through an intravenous infusion (into a vein) which will last approximately 30 minutes.
Your doctor may change the way your treatment is administered, switching from KEYTRUDA given by intravenous infusion to KEYTRUDA given by subcutaneous injection.
Your doctor will decide how many treatments you need. If you miss an appointment for administration of KEYTRUDA
- Contact your doctor immediately to reschedule your appointment.
- It is very important not to miss any dose. If you stop treatment with KEYTRUDA If you stop treatment, the effect of the medicine may cease. Do not stop treatment with KEYTRUDA unless you have discussed it with your doctor first.

If you have any doubts about your treatment, speak with your doctor.
Patient card
You will also find this information on the patient card provided to you by your doctor. It is important that you keep this card and show it to your partner or caregivers.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious side effects may occur during treatment with KEYTRUDA. See section 2.

The following side effects have been reported with KEYTRUDA alone:

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

decrease in red blood cell count
reduced thyroid gland activity
decreased appetite
headache
shortness of breath; cough
diarrhoea; stomach pain; nausea; vomiting; constipation
itching; skin rash
muscle and bone pain; joint pain
feeling tired; unusual tiredness or weakness; swelling; fever

Common (may affect up to 1 in 10 people)

lung infection
decrease in platelet count (increased tendency to bruise or bleed); decrease in white blood cell count (neutrophils, lymphocytes)
reactions related to medicine infusion
overactive thyroid gland; hot flushes
decreased levels of sodium, potassium, or calcium in the blood
sleep disorders
dizziness; nerve inflammation causing numbness, weakness, tingling, or burning in arms and legs; lack of energy; altered taste sensation
dry eyes
abnormal heart rhythm
high blood pressure
lung inflammation
intestinal inflammation; dry mouth
liver inflammation
raised, red skin rash, sometimes with blisters; skin inflammation; patches of skin that have lost colour; dry, itchy skin; hair loss; acne-like skin problems
muscle pain, tenderness, or soreness; pain in arms or legs; joint pain with swelling
flu-like illness; chills
increased liver enzyme levels in the blood; increased calcium levels in the blood; abnormal kidney function tests

Uncommon (may affect up to 1 in 100 people)

low white blood cell count (leucocytes); inflammatory response against platelets; increased white blood cell count (eosinophils)
an immune system disorder that may affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
decreased secretion of hormones produced by the adrenal glands; inflammation of the pituitary gland (hypophysis) located at the base of the brain; thyroid inflammation
type 1 diabetes, including diabetic ketoacidosis
a condition in which muscles become weak and tire easily; epileptic seizures
eye inflammation; eye pain, irritation, itching, or redness; discomfort in bright light; seeing spots
inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, fatigue, or chest pain (myocarditis); inflammation of the heart lining, which may present as chest pain, shortness of breath, or fatigue (pericarditis); fluid accumulation around the heart
pancreas inflammation; stomach inflammation; a sore developing in the inner lining of the stomach or upper small intestine
thickened skin growths, sometimes scaly; small swellings, bumps, or sores on the skin; change in hair colour
inflammation of the sheath covering the tendons
kidney inflammation
increased amylase levels, an enzyme that breaks down starches

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

inflammatory response against red blood cells; a condition called haemophagocytic lymphohistiocytosis, in which the immune system produces excessive numbers of infection-fighting cells called histiocytes and lymphocytes, which may cause various symptoms; feeling weak, lightheadedness, shortness of breath, or pale skin (signs of low red blood cell levels, possibly due to a type of anaemia called pure red cell aplasia)
reduced parathyroid gland function, which may present as muscle cramps or spasms, fatigue, and weakness
a temporary inflammatory condition of the nerves causing pain, weakness, and paralysis in the limbs (Guillain-Barré syndrome); brain inflammation, which may present as confusion, fever, memory problems, or epileptic seizures (encephalitis); pain, numbness, tingling, or weakness in arms or legs; bladder or bowel problems including increased frequency of urination, urinary incontinence, difficulty urinating, and constipation (myelitis); swelling of the optic nerve that may cause loss of vision in one or both eyes, eye movement pain, and/or loss of colour vision (optic neuritis); inflammation of the membrane surrounding the spinal cord and brain, presenting as neck stiffness, headache, fever, light sensitivity, nausea, or vomiting (meningitis)
blood vessel inflammation
lack of or reduced digestive enzymes produced by the pancreas (pancreatic exocrine insufficiency); a hole in the small intestine; coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and abdominal bloating after consuming foods containing gluten)
bile duct inflammation
itching, blisters, peeling, or sores on the skin and/or ulcers in the mouth, nasal mucosa, throat, or genital area (Stevens-Johnson syndrome or toxic epidermal necrolysis); formation under the skin of red, swollen, painful areas
a condition in which the immune system attacks glands producing external secretions essential for the body, such as tears and saliva (Sjögren's syndrome)
bladder inflammation, which may present as frequent and/or painful urination, urgency to urinate, blood in the urine, or pain or pressure in the lower abdomen

The following side effects have been reported in clinical studies with KEYTRUDA in combination with chemotherapy, radiotherapy, or chemoradiotherapy:

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

decrease in red blood cell count; reduced white blood cell count (neutrophils); decrease in platelet count (increased tendency to bruise or bleed)
reduced thyroid gland activity
low potassium levels in the blood; decreased appetite
sleep disorders
nerve inflammation causing numbness, weakness, tingling, or burning in arms and legs; headache
shortness of breath; cough
diarrhoea; nausea; vomiting; stomach pain; constipation
hair loss; itching; skin rash
joint pain; muscle and bone pain
feeling tired; unusual tiredness or weakness; fever; swelling
increased blood levels of the liver enzyme alanine aminotransferase; increased blood levels of the liver enzyme aspartate aminotransferase

Common (may affect up to 1 in 10 people)

lung infection
reduced white blood cell count (neutrophils) with fever; reduced white blood cell count (leucocytes, lymphocytes)
reaction related to medicine infusion
decreased secretion of hormones produced by the adrenal glands; overactive thyroid gland; thyroid inflammation
decreased levels of sodium or calcium in the blood
dizziness; altered taste sensation
dry eyes
abnormal heart rhythm
high blood pressure
lung inflammation
intestinal inflammation; stomach inflammation; dry mouth
liver inflammation
raised, red skin rash, sometimes with blisters; skin inflammation; acne-like skin problems; dry, itchy skin
muscle pain, tenderness, or soreness; pain in arms or legs; joint pain with swelling
sudden kidney damage
flu-like illness; chills
increased bilirubin levels in the blood; increased blood levels of the liver enzyme alkaline phosphatase; abnormal kidney function tests; increased calcium levels in the blood

Uncommon (may affect up to 1 in 100 people)

inflammatory response against red blood cells; increased white blood cell count (eosinophils)
inflammation of the pituitary gland (hypophysis) located at the base of the brain
type 1 diabetes, including diabetic ketoacidosis
brain inflammation, which may present as confusion, fever, memory problems, or epileptic seizures (encephalitis); lack of energy
eye inflammation; eye pain, irritation, itching, or redness; discomfort in bright light; seeing spots
inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, fatigue, or chest pain (myocarditis); inflammation of the heart lining, which may present as chest pain, shortness of breath, or fatigue (pericarditis); fluid accumulation around the heart
blood vessel inflammation
pancreas inflammation; a sore developing in the inner lining of the stomach or upper small intestine
thickened skin growths, sometimes scaly; skin patches that have lost colour; small swellings, bumps, or sores on the skin
inflammation of the sheath covering the tendons
kidney inflammation; bladder inflammation, which may present as frequent and/or painful urination, urgency to urinate, blood in the urine, or pain or pressure in the lower abdomen
increased amylase levels, an enzyme that breaks down starches

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

inflammatory response against platelets
an immune system disorder that may affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
reduced parathyroid gland function, which may present as muscle cramps or spasms, fatigue, and weakness
a condition in which muscles become weak and tire easily; temporary nerve inflammation causing pain, weakness, and paralysis in the limbs (Guillain-Barré syndrome); pain, numbness, tingling, or weakness in arms or legs; bladder or bowel problems including increased frequency of urination, urinary incontin游戏副本

5. How to store 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 label of the
vial after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Keep in the original carton to protect the medicine from light.

After reconstitution of the infusion
Chemical and physical in-use stability has been demonstrated for up to 42 days at a temperature
between 2 °C and 8 °C or between 23 °C and 27 °C. From a microbiological standpoint, once diluted,
the medicine should be used immediately. The diluted solution must not be frozen. If the medicine is
not used immediately, the duration and conditions of storage prior to use are the responsibility of the
user and normally should not exceed 7 days between 2 °C and 8 °C or 12 hours at room temperature,
unless dilution has been carried out under controlled and validated aseptic conditions. If refrigerated,
vials and/or intravenous infusion bags should be brought to room temperature before use.
Do not store any unused portions of the infusion solution for later reuse. Unused medicine and waste
materials derived from this medicine must be disposed of in accordance with local regulations.

6. Package contents and other information

What KEYTRUDA contains
The active substance is pembrolizumab.
A 4 mL vial contains 100 mg of pembrolizumab.
Each mL of concentrate contains 25 mg of pembrolizumab.
The other components are L-histidine, L-histidine monohydrochloride monohydrate, sucrose, polysorbate 80, and
water for injections.

Description of the appearance of KEYTRUDA and contents of the pack
KEYTRUDA is a solution ranging from clear to slightly opalescent, colourless to slightly yellow,
pH 5.2 – 5.8.
It is available in cardboard packs containing one or two glass vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211
[email protected]

България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
[email protected]

Česká republika
Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000
[email protected]

Danmark
MSD Danmark ApS
Tlf.: +45 4482 4000
[email protected]

Deutschland
MSD Sharp & Dohme GmbH
Tel.: +49 (0) 89 20 300 4500
[email protected]

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 614 4200
[email protected]

Ελλάδα
MSD Α.Φ.ΕΕ.
Τηλ : +30 210 98 97 300
[email protected]

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
[email protected]

France
MSD France
Tél: +33 (0)1 80 46 40 40
[email protected]

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: +385 1 6611 333
[email protected]

Ireland
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
[email protected]

Ísland
Vistor ehf.
Sími: +354 535 7000
[email protected]

Italia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911)
[email protected]

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
[email protected]

Latvija
SIA Merck Sharp & Dohme Latvija
Tel.: +371 67025300
[email protected]

Lietuva
UAB Merck Sharp & Dohme
Tel. +370 5 2780 247
[email protected]

Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211
[email protected]

Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300
[email protected]

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
[email protected]

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000 (+31 23 5153153)
[email protected]

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
[email protected]

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
[email protected]

Polska
MSD Polska Sp. z o.o.
Tel: +48 22 549 51 00
[email protected]

Portugal
Merck Sharp & Dohme, Lda
Tel.: +351 21 4465700
[email protected]

România
Merck Sharp & Dohme Romania S.R.L.
Tel.: +40 21 529 29 00
[email protected]

Slovenija
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201
[email protected]

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel.: +421 2 58282010
[email protected]

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
[email protected]

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu.

The following information is intended exclusively for healthcare professionals:

Preparation and administration of the infusion

Do not shake the vial.
Bring the vial to room temperature (≤ 25 °C).
Prior to dilution, the liquid vial may remain outside the refrigerator (at temperatures ≤ 25 °C) for up to 24 hours.
Parenteral medicines should be inspected visually before administration to check for particulate matter and discoloration. The concentrate is a solution ranging from clear to slightly opalescent, colorless to slightly yellow. Discard the vial if visible particles are observed.
Withdraw the required volume of concentrate up to a maximum of 4 mL (100 mg) and transfer it into an intravenous infusion bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration between 1 and 10 mg/mL. Each vial contains an overfill of 0.25 mL (total content per vial 4.25 mL) to ensure recovery of 4 mL of concentrate. Mix the diluted solution gently by inverting.
Chemical and physical in-use stability has been demonstrated for up to 42 days at temperatures between 2 °C and 8 °C or between 23 °C and 27 °C. From a microbiological standpoint, once diluted, the medicinal product should be used immediately. The diluted solution must not be frozen. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 7 days at 2 °C to 8 °C or 12 hours at room temperature, unless dilution has taken place under controlled and validated aseptic conditions. If refrigerated, vials and/or intravenous infusion bags must be brought to room temperature before use. Translucent to white protein particles may be observed in the diluted solution. Administer the infusion solution intravenously over 30 minutes using a sterile, pyrogen-free in-line or add-on filter with low protein binding, with pore size between 0.2 and 5 µm.
Do not co-administer other medicinal products using the same infusion line.
KEYTRUDA is for single use only. Discard any unused medicinal product remaining in the vial.

Any unused medicinal product and waste material derived from this medicinal product should be disposed of in accordance with
local regulations.

Patient information leaflet

KEYTRUDA 395 mg injectable solution, 790 mg injectable solution

pembrolizumab
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

Keep this leaflet. You may need to read it again.
It is important that you keep the patient card with you during treatment.
If you have any questions, ask your doctor.
If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet

What KEYTRUDA is and what it is used for
What you need to know before you are administered KEYTRUDA
How KEYTRUDA injectable solution will be administered to you
Possible side effects
How to store KEYTRUDA
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 the immune system fight 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) affecting 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 head and neck squamous cell carcinoma
a type of kidney cancer called renal cell carcinoma
a type of cancer characterized by high microsatellite instability (MSI-H, microsatellite instability-high) or mismatch repair deficiency (dMMR, mismatch repair deficient) of the colon or rectum (called colorectal carcinoma), uterus (called endometrial carcinoma), stomach (called gastric carcinoma), small intestine (called small intestinal carcinoma), or bile duct or gallbladder (called biliary tract carcinoma)
a type of cancer called oesophageal carcinoma
a type of breast cancer called triple-negative breast cancer
a type of cancer of the uterus called endometrial carcinoma
a type of cancer called cervical carcinoma
a type of stomach cancer called gastric adenocarcinoma or gastroesophageal junction adenocarcinoma
a type of cancer of the bile duct or gallbladder called biliary tract carcinoma
a type of cancer called ovarian carcinoma

People take KEYTRUDA when the cancer has spread or cannot be removed surgically.
People take KEYTRUDA after surgery to remove melanoma, non-small cell lung cancer, or renal cell carcinoma to help prevent the cancer from returning (adjuvant therapy).
People take KEYTRUDA before surgery (neoadjuvant therapy) to treat non-small cell lung cancer, triple-negative breast cancer, or head and neck squamous cell carcinoma, and then continue taking KEYTRUDA after surgery (adjuvant therapy) to help prevent the cancer from returning.
KEYTRUDA may be given in combination with other anticancer medicines, with or without radiotherapy. It is important to also read the package leaflets of these other medicines. If you have any doubts about these medicines, consult your doctor.

2. What you should know before you are given KEYTRUDA

KEYTRUDA must not be given to you:

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”). Contact your doctor if you are unsure.

Warnings and precautions
Contact your doctor or nurse before treatment with KEYTRUDA. Inform your doctor before you are given KEYTRUDA if:

you have an autoimmune disease (a condition in which the body attacks its own cells)
you have a lung infection or inflammation of the lungs (called pneumonitis)
you have previously been treated with ipilimumab, another medicine used to treat melanoma, and experienced severe side effects from that medicine
you have had an allergic reaction to other monoclonal antibody therapies
you have or have had chronic viral liver infection, including hepatitis B (HBV) or hepatitis C (HCV)
you have human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)
you have liver damage
you have kidney damage
you have received a solid organ transplant or a bone marrow transplant (stem cells) using donor stem cells (allogeneic)

KEYTRUDA acts on the immune system. It may cause inflammation in certain parts of the body.
The risk of these side effects may be higher if you already have an autoimmune disease (a
condition in which the body attacks its own cells). In addition, flare-ups of autoimmune disease may occur more frequently, although in most cases they are mild.
Administration of KEYTRUDA may cause serious side effects. These side effects can sometimes become potentially life-threatening and may lead to death. These side effects may occur at any time during treatment or even after treatment has ended. More than one side effect may occur simultaneously.
If you experience any of the following conditions, call your doctor or seek immediate medical attention. Your doctor may prescribe additional medicines to prevent more serious complications and reduce symptoms. Your doctor may withhold the next dose of KEYTRUDA or discontinue treatment with KEYTRUDA.

inflammation of the lungs, which may include shortness of breath, chest pain, or cough
inflammation of the intestine, which may include diarrhoea or more frequent bowel movements than usual, dark, tarry, sticky stools or stools containing blood or mucus, severe pain or discomfort in the abdomen, nausea, vomiting
inflammation of the liver, which may include nausea or vomiting, loss of appetite, pain in the right side of the abdomen, yellowing of the skin or whites of the eyes, dark urine, or easier than normal bruising or bleeding
inflammation of the kidneys, which may include changes in the amount or colour of urine
inflammation of hormone glands (especially thyroid, pituitary, and adrenal glands), which may include rapid heartbeat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, deeper voice, muscle pain, dizziness or fainting, persistent headache, or an unusual headache
type 1 diabetes, including diabetic ketoacidosis (acid in the blood caused by diabetes), symptoms of which may include increased appetite or thirst, more frequent urination or weight loss, feeling tired or unwell, stomach pain, fast and deep breathing, confusion, unusual drowsiness, sweet-smelling breath, sweet or metallic taste in the mouth, or unusual odour of urine or sweat
inflammation of the eyes, which may include changes in vision
inflammation in muscles, which may include muscle pain or weakness
inflammation of the heart muscle, which may include shortness of breath, irregular heartbeat, feeling tired or chest pain (myocarditis)
inflammation of the pancreas, which may include abdominal pain, nausea and vomiting
inflammation of the skin, which may include rash, itching, blisters, peeling or sores on the skin and/or ulcers in the mouth or nasal mucosa, throat or genital area
an immune system disorder that may affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis)
inflammation of the brain, which may present as confusion, fever, memory problems or seizures (encephalitis)
pain, numbness, tingling or weakness in arms or legs; bladder or bowel problems including needing to urinate more frequently, urinary incontinence, difficulty urinating and constipation (myelitis)
inflammation and scarring of the bile ducts, which may include pain in the upper right part of the abdomen, swelling of the liver or spleen, fatigue, itching or yellowing of the skin or whites of the eyes (sclerosing cholangitis)
inflammation of the stomach (gastritis)
reduced function of the parathyroid gland, which may include muscle cramps or spasms, fatigue and weakness (hypoparathyroidism)
inflammation of the lining of the heart, which may include chest pain, shortness of breath or feeling tired (pericarditis)
infusion reactions, which may include shortness of breath, itching or rash, dizziness or fever

Complications, including graft-versus-host disease (GVHD), in patients who have received an allogeneic haematopoietic stem cell transplant (bone marrow transplant).
These complications can be severe and may lead to death. They may occur if you have previously undergone this type of transplant or if you will undergo it in the future. Your doctor will monitor you for signs and symptoms, which may include rash, liver inflammation, abdominal pain or diarrhoea.

Children and adolescents
KEYTRUDA injectable solution must not be administered to children under 18 years of age.
Other formulations of this medicine may be more suitable for children; please consult your doctor or pharmacist.

Other medicines and KEYTRUDA
Inform your doctor:

if you are taking other medicines that weaken the immune system.
Examples of such medicines include corticosteroids, such as prednisone.
These medicines may interfere with the effect of KEYTRUDA.
However, once you are on treatment with KEYTRUDA, your doctor may prescribe corticosteroids to reduce side effects associated with KEYTRUDA.
Corticosteroids may also be prescribed before receiving KEYTRUDA in combination with chemotherapy, to prevent and/or treat nausea, vomiting and other chemotherapy-related side effects.
if you are currently taking, have recently taken, or might take any other medicine.

Pregnancy

KEYTRUDA must not be used during pregnancy unless specifically recommended by your doctor.
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, inform your doctor.
KEYTRUDA may harm or cause death to the unborn child.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with KEYTRUDA and for at least 4 months after the last dose.

Breastfeeding

If you are breastfeeding, inform your doctor.
Do not breastfeed during treatment with KEYTRUDA.
It is not known whether KEYTRUDA passes into breast milk.

Driving and using machines
KEYTRUDA has a minor influence on the ability to drive or use machines. Possible side effects of KEYTRUDA include dizziness, fatigue or weakness. Do not drive or operate machinery after receiving KEYTRUDA unless you are certain you feel well.

KEYTRUDA injectable solution contains polysorbate 80
This medicine contains 0.2 mg of polysorbate 80 per mL of solution. Polysorbates may cause allergic reactions. Inform your doctor if you have known allergies.

KEYTRUDA injectable solution contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How KEYTRUDA injectable solution will be administered to you

KEYTRUDA will be administered to you under the supervision of a physician experienced in the treatment of cancer.

The recommended dose of KEYTRUDA in adults is:
395 mg every 3 weeks, or
790 mg every 6 weeks.
Your doctor will administer KEYTRUDA by subcutaneous injection (under the skin) in the abdominal or thigh area. This takes approximately 1–2 minutes.
The doctor or nurse will perform the injection at a site where the skin is not damaged, tender, bruised, scarred, scaly, or red, and will select a new injection site for each dose.
Your doctor may change the method of administration of the treatment, switching from subcutaneous injection of KEYTRUDA to intravenous infusion of KEYTRUDA.
Your doctor will determine the number of treatments you need.

If you miss an appointment for KEYTRUDA administration

Contact your doctor immediately to reschedule an appointment.
It is very important not to miss a dose. If you stop treatment with KEYTRUDA If you discontinue treatment, the effect of the medicine may cease. Do not stop treatment with KEYTRUDA without first discussing it with your doctor.

If you have any questions about your treatment, speak with your doctor.
Patient information card
You will also find this information in the patient information card provided to you by your doctor. It is important that you keep this card and show it to your partner or caregivers.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Serious side effects may occur during treatment with KEYTRUDA. See section 2.
Local injection site reactions have been reported when KEYTRUDA is administered as a subcutaneous injection. The frequency of local injection site reactions is common (may affect up to 1 in 10 people).
Side effects observed with intravenous infusion of KEYTRUDA may also occur with subcutaneous injection of KEYTRUDA.

The following side effects have been reported with KEYTRUDA administered by intravenous infusion alone:

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

decrease in red blood cell count
reduced thyroid gland activity
decreased appetite
headache
shortness of breath; cough
diarrhoea; stomach pain; nausea; vomiting; constipation
itching; skin rash
muscle and bone pain; joint pain
feeling tired; unusual tiredness or weakness; swelling; fever

Common (may affect up to 1 in 10 people)

lung infection
decrease in platelet count (increased bruising or bleeding); decrease in white blood cell count (neutrophils, lymphocytes)
reactions related to medicine administration
overactive thyroid gland; hot flushes
low sodium, potassium, or calcium levels in the blood
sleep disorders
dizziness; nerve inflammation causing numbness, weakness, tingling, or burning in arms and legs; lack of energy; change in taste sensation
dry eyes
abnormal heart rhythm
high blood pressure
lung inflammation
intestinal inflammation; dry mouth
liver inflammation
raised, red skin rash, sometimes with blisters; skin inflammation; patches of skin that have lost colour; dry, itchy skin; hair loss; acne-like skin problems
muscle pain, tenderness, or soreness; pain in arms or legs; joint pain with swelling
flu-like illness; chills
increased liver enzyme levels in blood; increased blood calcium levels; abnormal kidney function tests

Uncommon (may affect up to 1 in 100 people)

low white blood cell count (leucocytes); inflammatory response against platelets; increased white blood cell count (eosinophils)
an immune system disorder that may affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
decreased secretion of hormones from adrenal glands; inflammation of the pituitary gland (hypophysis) located at the base of the brain; thyroid inflammation
type 1 diabetes, including diabetic ketoacidosis
a condition in which muscles become weak and tire easily; epileptic seizures
eye inflammation; eye pain, irritation, itching, or redness; discomfort in bright light; seeing spots
heart muscle inflammation, which may present as shortness of breath, irregular heartbeat, fatigue, or chest pain (myocarditis); inflammation of the heart lining, which may present as chest pain, shortness of breath, or fatigue (pericarditis); fluid accumulation around the heart
pancreas inflammation; stomach inflammation; an ulcer developing in the inner lining of the stomach or upper small intestine
growth of thickened skin, sometimes scaly; small swellings, bumps, or sores on the skin; change in hair colour

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

inflammatory response against red blood cells; a condition called haemophagocytic lymphohistiocytosis, in which the immune system produces too many infection-fighting cells called histiocytes and lymphocytes, which may cause various symptoms; feeling weak, lightheaded, short of breath, or pale skin (signs of low red blood cell count, possibly due to a type of anaemia called pure red cell aplasia)
reduced parathyroid gland function, which may present as muscle cramps or spasms, fatigue, and weakness
temporary nerve inflammation causing pain, weakness, and paralysis in limbs (Guillain-Barré syndrome); brain inflammation, which may present as confusion, fever, memory problems, or seizures (encephalitis); pain, numbness, tingling, or weakness in arms or legs; bladder or bowel problems including increased frequency of urination, urinary incontinence, difficulty urinating, and constipation (myelitis); optic nerve swelling which may cause vision loss in one or both eyes, eye movement pain, and/or loss of colour vision (optic neuritis); inflammation of the membrane around the spinal cord and brain, presenting as neck stiffness, headache, fever, light sensitivity, nausea, or vomiting (meningitis)
blood vessel inflammation
lack or reduction of digestive enzymes produced by the pancreas (pancreatic exocrine insufficiency); a hole in the small intestine; coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and abdominal bloating after consuming gluten-containing foods)
bile duct inflammation
itching, blisters, peeling or sores on the skin and/or mouth ulcers or ulcers in the nasal mucosa, throat, or genital area (Stevens-Johnson syndrome or toxic epidermal necrolysis); formation under the skin of red, painful, swollen areas
a condition in which the immune system attacks glands producing external secretions useful to the body, such as tears and saliva (Sjögren's syndrome)
bladder inflammation, which may present as frequent and/or painful urination, urgency to urinate, blood in urine, or pain/pressure in the lower abdomen

The following side effects have been reported in clinical studies with KEYTRUDA administered by intravenous infusion in combination with chemotherapy, radiotherapy, or chemoradiotherapy:

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

decrease in red blood cell count; low white blood cell count (neutrophils); decrease in platelet count (increased bruising or bleeding)
reduced thyroid gland activity
low potassium levels in blood; decreased appetite
sleep disorders
nerve inflammation causing numbness, weakness, tingling, or burning in arms and legs; headache
shortness of breath; cough
diarrhoea; nausea; vomiting; stomach pain; constipation
hair loss; itching; skin rash
joint pain; muscle and bone pain
feeling tired; unusual tiredness or weakness; fever; swelling
increased blood levels of the liver enzyme alanine aminotransferase; increased blood levels of the liver enzyme aspartate aminotransferase

Common (may affect up to 1 in 10 people)

lung infection
low white blood cell count (neutrophils) with fever; low white blood cell count (leucocytes, lymphocytes)
reaction related to medicine administration
decreased secretion of hormones from adrenal glands; overactive thyroid gland; thyroid inflammation
low sodium or calcium levels in blood
dizziness; change in taste sensation
dry eyes
abnormal heart rhythm
high blood pressure
lung inflammation
intestinal inflammation; stomach inflammation; dry mouth
liver inflammation
raised, red skin rash, sometimes with blisters; skin inflammation; acne-like skin problems; dry, itchy skin
muscle pain, tenderness, or soreness; pain in arms or legs; joint pain with swelling
sudden kidney injury
flu-like illness; chills
increased bilirubin levels in blood; increased blood levels of the liver enzyme alkaline phosphatase; abnormal kidney function tests; increased blood calcium levels

Uncommon (may affect up to 1 in 100 people)

inflammatory response against red blood cells; increased white blood cell count (eosinophils)
inflammation of the pituitary gland (hypophysis) located at the base of the brain
type 1 diabetes, including diabetic ketoacidosis
brain inflammation, which may present as confusion, fever, memory problems, or seizures (encephalitis); lack of energy
eye inflammation; eye pain, irritation, itching, or redness; discomfort in bright light; seeing spots
heart muscle inflammation, which may present as shortness of breath, irregular heartbeat, fatigue, or chest pain (myocarditis); inflammation of the heart lining, which may present as chest pain, shortness of breath, or fatigue (pericarditis); fluid accumulation around the heart
blood vessel inflammation
pancreas inflammation; an ulcer developing in the inner lining of the stomach or upper small intestine
growth of thickened skin, sometimes scaly; loss of skin colour in patches; small swellings, bumps, or sores on the skin
inflammation of the sheath covering tendons
kidney inflammation; bladder inflammation, which may present as frequent and/or painful urination, urgency to urinate, blood in urine, or pain/pressure in lower abdomen
increased blood levels of amylase, an enzyme that breaks down starches

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

inflammatory response against platelets
an immune system disorder that may affect the lungs, skin, eyes, and/or lymph nodes (sarcoidosis)
reduced parathyroid gland function, which may present as muscle cramps or spasms, fatigue, and weakness
a condition in which muscles become weak and tire easily; temporary nerve inflammation causing pain, weakness, and paralysis in limbs (Guillain-Barré syndrome); pain, numbness, tingling, or weakness in arms or legs; bladder or bowel problems including increased frequency of urination, urinary incontinence, difficulty urinating, and constipation (myelitis); optic nerve swelling which may cause vision loss in one or both eyes, eye movement pain, and/or loss of colour vision (optic neuritis); seizures; inflammation of the membrane around the spinal cord and brain, presenting as neck stiffness, headache, fever, light sensitivity, nausea, or vomiting (meningitis)
lack or reduction of digestive enzymes produced by the pancreas (pancreatic exocrine insufficiency); a hole in the small intestine; coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and abdominal bloating after consuming gluten-containing foods)
bile duct inflammation
itching, blisters, peeling or sores on the skin and/or ulcers in the mouth or nasal mucosa, throat, or genital area (Stevens-Johnson syndrome); formation under the skin of red, painful, swollen areas; change in hair colour
a condition in which the immune system attacks glands producing external secretions useful to the body, such as tears and saliva (Sjögren's syndrome)

The following side effects have been reported in clinical studies with KEYTRUDA administered by intravenous infusion in combination with axitinib or lenvatinib:

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

urinary tract infections (increased frequency of urination and pain during urination)
decrease in red blood cell count
reduced thyroid gland activity
decreased appetite
headache; change in taste sensation
high blood pressure
shortness of breath; cough
diarrhoea; stomach pain; nausea; vomiting; constipation
skin rash; itching
joint pain; muscle and bone pain; muscle pain, tenderness, or soreness; pain in arms or legs
feeling tired; unusual tiredness or weakness; swelling; fever
increased blood levels of lipase, an enzyme that breaks down fats; increased liver enzyme levels in blood; abnormal kidney function tests

Common (may affect up to 1 in 10 people)

lung infection
low white blood cell count (neutrophils, lymphocytes, leucocytes); decrease in platelet count (increased bruising or bleeding)
reaction related to medicine administration
decreased secretion of hormones from adrenal glands; overactive thyroid gland; thyroid inflammation
low sodium, potassium, or calcium levels in blood
sleep disorders
dizziness; nerve inflammation causing numbness, weakness, tingling, or burning in arms and legs; lack of energy
dry eyes
abnormal heart rhythm
lung inflammation
intestinal inflammation; pancreas inflammation; stomach inflammation; dry mouth
liver inflammation
raised, red skin rash, sometimes with blisters; skin inflammation; dry skin; acne-like skin problems; hair loss
joint pain with swelling
kidney inflammation
flu-like illness; chills
increased blood levels of amylase, an enzyme that breaks down starches; increased bilirubin levels in blood; increased blood levels of the liver enzyme alkaline phosphatase; increased blood calcium levels

Uncommon (may affect up to 1 in 100 people)

increased white blood cell count (eosinophils)
inflammation of the pituitary gland (hypophysis) located at the base of the brain
type 1 diabetes, including diabetic ketoacidosis
a condition in which muscles become weak and tire easily; brain inflammation, which may present as confusion, fever, memory problems, or seizures (encephalitis)
eye inflammation; eye pain, irritation, itching, or redness; discomfort in bright light; seeing spots
heart muscle inflammation, which may present as shortness of breath, irregular heartbeat, fatigue, or chest pain (myocarditis); fluid accumulation around the heart
blood vessel inflammation
an ulcer developing in the inner lining of the stomach or upper small intestine
dry, itchy skin; growth of thickened skin, sometimes scaly; patches of skin that have lost colour; small swellings, bumps, or sores on the skin; change in hair colour
inflammation of the sheath covering tendons

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

reduced parathyroid gland function, which may present as muscle cramps or spasms, fatigue, and weakness
optic nerve swelling which may cause vision loss in one or both eyes, eye movement pain, and/or loss of colour vision (optic neuritis)
a hole in the small intestine
itching, blisters, peeling or sores on the skin and/or ulcers in the mouth or nasal mucosa, throat, or genital area (toxic epidermal necrolysis or Stevens-Johnson syndrome)
a condition in which the immune system attacks glands producing external secretions useful to the body, such as tears and saliva (Sjögren's syndrome)
bladder inflammation, which may present as frequent and/or painful urination, urgency to urinate, blood in urine, or pain/pressure in lower abdomen

Other side effects reported with unknown frequency (frequency cannot be estimated from available data)

lack or reduction of digestive enzymes produced by the pancreas (pancreatic exocrine insufficiency); coeliac disease (characterised by symptoms such as stomach pain, diarrhoea, and abdominal bloating after consuming gluten-containing foods)

Skin rash is more common when KEYTRUDA is administered in combination with enfortumab vedotin compared to when KEYTRUDA is administered alone.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store KEYTRUDA

Unopened vial
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the label of the vial after Exp. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C–8 °C).
Do not freeze.
Keep in the original carton to protect from light.

Prepared syringe
After transfer from the vial to the syringe, the chemical and physical in-use stability of KEYTRUDA injectable solution has been demonstrated for up to 30 days at a temperature of 2 °C to 8 °C (protected from light) and up to 24 hours at room temperature (under normal light conditions). From a microbiological standpoint, the solution should be used immediately once transferred from the vial to the syringe. If the medicine is not used immediately, the storage times and conditions prior to use are the responsibility of the user and normally should not exceed 8 hours at room temperature or 24 hours at a temperature between 2 °C and 8 °C, unless the preparation has been carried out under controlled and validated aseptic conditions. The 24-hour period may include up to 8 hours at room temperature (≤25 °C). Discard if the storage time exceeds these limits. If refrigerated, the filled syringe must be brought to room temperature for at least 30 minutes before administration. The filled syringe must not be frozen.
Do not store any unused portions of the injectable solution for later use. Any unused medicine and waste material derived from this medicine must be disposed of in accordance with local regulations.

6. Package contents and other information

What KEYTRUDA contains
The active substance is pembrolizumab.
One 2.4 mL vial of injectable solution contains 395 mg of pembrolizumab. One 4.8 mL vial of injectable solution contains 790 mg of pembrolizumab.
Each mL of injectable solution contains 165 mg of pembrolizumab.
The other components are recombinant human hyaluronidase alfa, L-histidine, L-histidine hydrochloride monohydrate, L-methionine, sucrose, polysorbate 80, and water for injections.

Description of the appearance of KEYTRUDA and contents of the pack
KEYTRUDA is a solution that ranges from clear to slightly opalescent, colourless to slightly yellow, with pH 5.3 – 5.9.
It is available in cartons containing one glass vial.

Marketing Authorisation Holder and Manufacturer
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem
The Netherlands