Keytruda
pembrolizumab
pembrolizumab
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 KEYTRUDA is and what it is used for
What you need to know before you are given KEYTRUDA
How you are given KEYTRUDA
Possible side effects
How to store KEYTRUDA
Contents of the pack and other information
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
a kind of cancer called bladder cancer (urothelial carcinoma)
a kind of head and neck cancer called head and neck squamous cell carcinoma.
a kind of kidney cancer called renal cell carcinoma
a kind of cancer that is determined to be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) in the colon or rectum (called colorectal cancer), uterus (called endometrial cancer), stomach (called gastric cancer), small bowel (called small intestine cancer), or bile duct or gallbladder (called biliary tract cancer)
a kind of cancer called oesophageal carcinoma
a kind of breast cancer called triple-negative breast cancer
a kind of uterine cancer called endometrial carcinoma
a kind of cancer called cervical cancer
KEYTRUDA is used in children and adolescents:
aged 3 years and older to treat a kind of cancer called classical Hodgkin lymphoma
aged 12 years and older to treat a kind of cancer called melanoma.
People get KEYTRUDA when their cancer has spread or cannot be taken out by surgery.
People get KEYTRUDA after they have had surgery to remove melanoma or renal cell carcinoma to help prevent their cancer from coming back (adjuvant therapy).
People get KEYTRUDA before surgery (neoadjuvant therapy) to treat triple-negative breast cancer and then continued after surgery (adjuvant therapy) to help prevent their cancer from coming back.
KEYTRUDA may be given in combination with other anti-cancer medicines. It is important that you also read the package leaflets for these other medicines. If you have any questions about these medicines, ask your doctor.
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 ofthe pack and other information”). Talk to your doctor ifyou are not sure.
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 or a bone marrow (stem cell) transplant that used donor stem cells (allogeneic)
When you get KEYTRUDA, you can have some serious side effects. These side effects can sometimes become life-threatening and can lead to death. These side effects may happen anytime during treatment or even after your treatment has ended. 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
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, including diabetic ketoacidosis (acid in the blood produced from diabetes), symptoms may include feeling more hungry or thirsty than usual, need to urinate more often or weight loss, feeling tired or feeling sick, stomach pain, fast and deep breathing, confusion, unusual sleepiness, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat
inflammation of the eyes, which may include changes in eyesight
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
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
an immune disorder that can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis)
inflammation of the brain, which may include 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 part of the stomach, swelling of the liver or spleen, fatigue, itching, or yellowing of the skin or the whites of eyes (cholangitis sclerosing)
inflammation of the stomach (gastritis)
infusion reactions, which may include shortness of breath, itching or rash, dizziness or fever
Do not give KEYTRUDA to children under 18 years of age, except for children:
with classical Hodgkin lymphoma aged 3 years and older
with melanoma aged 12 years and older.
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. Corticosteroids may also be given to you 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 medicines.
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.
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.
KEYTRUDA has a minor 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 feeling well.
KEYTRUDA will be given to you in a hospital or clinic under the supervision of a doctor experienced in cancer treatment.
The recommended dose of KEYTRUDA in adults is either 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 lymphoma and adolescents aged 12 years and older with melanoma, is 2 mg/kg bodyweight (up to a maximum of 200 mg) every 3 weeks.
Your doctor will give you KEYTRUDA through an infusion into your vein (intravenous) for about 30 minutes.
Your doctor will decide how many treatments you need.
Call your doctor right away to reschedule your appointment.
It is very important that you do not miss a dose of this medicine.
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.
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 with pembrolizumab alone:
decrease in the number of red blood cells
reduced thyroid gland activity
feeling less hungry
headache
shortness of breath; cough
diarrhoea; stomach pain; nausea; vomiting; constipation
itching; skin rash
pain in muscle and bones; joint pain
feeling tired; unusual tiredness or weakness; swelling; fever
lung infection
decrease in the number of platelets (bruising or bleeding more easily); decrease in the number of white blood cell (neutrophils; lymphocytes)
reactions related to the infusion of the medicine
overactive thyroid gland activity; hot flush
decreased sodium, potassium, or calcium in the blood
trouble sleeping
dizziness; inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; lack of energy; change in your sense of taste
dry eye
abnormal heart rhythm
high blood pressure
inflammation of the lungs
inflammation of the intestines; dry mouth
inflammation of the liver
red raised rash sometimes with blisters; patches of skin which have lost colour; inflammation of the skin; dry, itchy skin; hair loss; acne-like skin problem
muscle pain, aches or tenderness; pain in arms or legs; joint pain with swelling
chills; flu-like illness
increased liver enzyme levels in the blood; increased calcium in the blood; abnormal kidney function test
a decreased number of white blood cells (leukocytes and eosinophils)
inflammation response against platelets
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 situated at the base of the brain; inflammation of the thyroid
type 1 diabetes, including diabetic ketoacidosis
a condition in which the muscles become weak and tire easily; seizure
inflammation of the eyes; eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light; seeing spots
inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired, or chest pain
inflammation of the covering of the heart; accumulation of fluid around the heart
inflammation of the pancreas
inflammation of the stomach
a sore that develops on the inside lining of your stomach or upper part of your small intestine
thickened, sometimes scaly, skin growth; 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
inflammation response against red blood cells; feeling weak, lightheaded, short of breath or if your skin looks pale (signs of low level of red blood cells, possibly due to a type of anaemia called pure red cell aplasia); a condition called haemophagocytic lymphohistiocytosis, where the immune system makes too many infection fighting cells called histiocytes and lymphocytes that may cause various symptoms
a temporary inflammation of the nerves that causes pain, weakness, and paralysis in the extremities
inflammation of the brain, which may present as 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 of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, eye sensitivity to light, nausea or vomiting (meningitis)
inflammation of the blood vessels
a hole in the small intestines
inflammation of the bile ducts
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 (Stevens-Johnson syndrome or toxic epidermal necrolysis)
disease in which the immune system attacks the glands that make moisture for the body, such as
tears and saliva (Sjogren’s syndrome)
inflammation of the bladder. Signs and symptoms may include frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen
The following side effects have been reported in clinical studies with pembrolizumab in combination with chemotherapy:
decreased number of white blood cells (neutrophils, leukocytes); decrease in the number of red blood cells; decrease in the number of platelets (bruising or bleeding more easily)
reduced thyroid gland activity
decreased potassium in the blood; feeling less hungry
trouble sleeping
inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; headache; dizziness; change in your sense of taste
shortness of breath; cough
nausea; diarrhoea; vomiting; stomach pain; constipation
hair loss; skin rash; itching
joint pain; pain in the muscles and bones; muscle pain, aches or tenderness
unusual tiredness or weakness; fever; swelling
increased blood level of the liver enzyme alanine aminotransferase; increased blood level of the liver enzyme aspartate aminotransferase
lung infection
decreased number of white blood cells (neutrophils) with a fever; decreased number of white blood cells (lymphocytes)
reaction related to the infusion of the medicine
decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid; overactive thyroid gland activity
decreased sodium or calcium in the blood
lack of energy
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
red raised rash, sometimes with blisters; acne-like skin problem; inflammation of the skin; dry, itchy skin
pain in arms or legs; joint pain with swelling
sudden kidney damage
flu-like illness; chills
abnormal kidney function test; increased blood level of the liver enzyme alkaline phosphatase; increased calcium in the blood; increased bilirubin in the blood
a decreased number of white blood cells (eosinophils)
inflammation of the pituitary gland situated at the base of the brain
type 1 diabetes, including diabetic ketoacidosis
inflammation of the brain, which may present as confusion, fever, memory problems or seizures (encephalitis); seizure
inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired, or chest pain; accumulation of fluid around the heart; inflammation of the covering of the heart
inflammation of the blood vessels
inflammation of the pancreas; a sore that develops on the inside lining of your stomach or upper part of your small intestine
thickened, sometimes scaly, skin growth; patches of skin that have lost colour; small skin bumps, lumps or sores
inflammation of the sheath that surrounds tendons
inflammation of the kidneys; inflammation of the bladder, which may present as frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen
increased level of amylase, an enzyme that breaks down starch
inflammation response against red blood cells or platelets
an immune disorder that can affect the lungs, skin, eyes and/or lymph nodes (sarcoidosis)
condition known as Guillain- Barré syndrome, which causes muscle weakness on both sides of the body, and can be severe; a condition in which the muscles become weak and tire easily
inflammation of the eyes; eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light; seeing spots
a hole in the small intestines
inflammation of the bile ducts
itching, skin blistering, peeling or sores, and/or ulcers in mouth or in lining of nose, throat, or genital area (Stevens-Johnson syndrome); tender red bumps under the skin; hair colour changes
disease in which the immune system attacks the glands that make moisture for the body, such as
tears and saliva (Sjogren’s syndrome)
The following side effects have been reported in clinical studies with pembrolizumab in combination with axitinib or lenvatinib:
urinary infections (increased frequency in urination and pain in passing urine)
decrease in the number of red blood cells
reduced thyroid activity
feeling less hungry
headache; change in your sense of taste
high blood pressure
shortness of breath; cough
diarrhoea; stomach pain; nausea; vomiting; constipation
skin rash; itching
joint pain; pain in the muscles and bones; muscle pain, aches or tenderness; pain in arms or legs
feeling tired; unusual tiredness or weakness; swelling; fever
increased levels of lipase, an enzyme that breaks down fats; increased liver enzyme levels in the blood; abnormal kidney function test
lung infection
decreased number of white blood cells (neutrophils, leukocytes, lymphocytes); decrease in the number of platelets (bruising or bleeding more easily)
reaction related to the infusion of the medicine
decreased secretion of hormones produced by the adrenal glands; increased thyroid gland activity; inflammation of the thyroid
decreased sodium, potassium, or calcium in the blood
trouble sleeping
dizziness, lack of energy, inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs
dry eye
abnormal heart rhythm
inflammation of the lungs
inflammation of the intestines; inflammation of the pancreas; inflammation of the stomach; dry mouth
inflammation of the liver
red raised rash, sometimes with blisters; inflammation of the skin; dry, itchy skin; acne-like skin problem; hair loss
joint pain with swelling
inflammation of the kidneys
flu-like illness; chills
increased levels of amylase, an enzyme that breaks down starch; increased liver enzyme levels in the blood; increased blood levels of a liver enzyme known as alkaline phosphatase; increased calcium in the blood
decreased number of white blood cells (eosinophils)
inflammation of the pituitary gland situated at the base of the brain
type 1 diabetes, including diabetic ketoacidosis
a condition in which the muscles become weak and tire easily; inflammation of the brain, which may present as confusion, fever, memory problems or seizures (encephalitis)
inflammation of the eyes; eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light; seeing spots
inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired, or chest pain; accumulation of fluid around the heart
inflammation of the blood vessels
a sore that develops on the inside lining of your stomach or upper part of your small intestine
inflammation of the skin; thickened, sometimes scaly, skin growth; patches of skin which have lost colour; small skin bumps, lumps or sores; hair colour changes
inflammation of the sheath that surrounds tendons
a hole in the small intestines
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)
disease in which the immune system attacks the glands that make moisture for the body, such as
tears and saliva (Sjogren’s syndrome)
inflammation of the bladder, which may present as frequent and/or painful urination, urge to pass urine, blood in urine, pain or pressure in lower abdomen
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.
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 96 hours at 2ºC to 8ºC. This 96-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.
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.
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.
2031 BN Haarlem The Netherlands
Schering-Plough Labo NV | |
Industriepark 30 | |
B-2220 Heist-op-den-Berg | |
Belgium | |
Merck Sharp & Dohme B.V. Waarderweg 39
2031 BN Haarlem The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel. + 370 5 278 02 47
Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: +36 1 888 5300
MSD Danmark ApS Tlf: + 45 4482 4000
Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
MSD Sharp & Dohme GmbH
Tel: 0800 673 673 673 (+49 (0) 89 4561 0)
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153)
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel: +48 22 549 51 00
MSD France
Tél: + 33 (0) 1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: +40 21 529 29 00
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 5204 201
Vistor hf.
Sími: + 354 535 7000
Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911)
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija Tel: + 371 67364224
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
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 96 hours at 2ºC to 8ºC. This 96-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. Translucent to white proteinaceous particles may be seen in diluted solution. 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.