Keytruda - Consumer Medicine Information
|Manufacture:||Merck and Co., Inc.|
|Condition:||Melanoma, Melanoma, Metastatic, Non-Small Cell Lung Cancer|
|Form:||Liquid solution, Intravenous (IV)|
|Ingredients:||pembrolizumab, L-histidine, polysorbate-80, and sucrose|
What is Keytruda (key-true-duh) Used For
KEYTRUDA is a prescription medicine used to treat a kind of skin cancer called melanoma.
KEYTRUDA may be used when your melanoma:
- has spread or cannot be removed by surgery (advanced melanoma), and,
- after you have tried a medicine called ipilimumab and it did not work or is no longer working and,
- if your tumour has an abnormal “BRAF” gene, and you also have tried a different medicine called a BRAF or MEK inhibitor, and it did not work or is no longer working.
It is not known if KEYTRUDA is safe and effective in children less than 18 years of age.
People get KEYTRUDA when their skin cancer has spread or cannot be taken out by surgery.
How does Keytruda Work
KEYTRUDA works by helping your immune system fight your cancer.
What are the Ingredients in Keytruda
The active substance is pembrolizumab.
The other ingredients are L-histidine, polysorbate-80, and sucrose.
Keytruda comes in the Following Dosage Forms
Powder for solution for infusion, 50 mg per vial
Do not Use Keytruda If
- you are allergic to pembrolizumab or any other ingredients in KEYTRUDA
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take KEYTRUDA. Talk about any health conditions or problems you may have, including if you:
- have a disease of your immune system like Crohn’s, ulcerative colitis or lupus
- had an organ transplant (like a kidney transplant)
- have pneumonia or inflammation of your lungs (called pneumonitis)
- have liver damage
- take other medicines that make your immune system weak. Examples of these may include steroids, such as prednisone.
- 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.
- You must use effective contraception while you are being treated with KEYTRUDA and for at least 4 months after the last dose of KEYTRUDA if you are a woman who could become pregnant.
- If you are breast-feeding, tell your doctor.
- Do not breast-feed while taking KEYTRUDA.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How You are Given Keytruda
- Your doctor will give you KEYTRUDA through an infusion into your vein (IV) for about 30 minutes.
- Most people get KEYTRUDA every 3 weeks.
- Your doctor will decide how many treatments you need.
The recommended dose is 2 mg of pembrolizumab per kilogram of your body weight.
If You Miss an Appointment to Get Keytruda
- Call your doctor right away to reschedule your appointment.
- It is very important that you do not miss a dose of this medicine.
What are Possible Side Effects from Using Keytruda
These are not all the possible side effects you may feel when taking KEYTRUDA. If you experience any side effects not listed here, contact your healthcare professional.
The following side effects have been reported in clinical trials:
Very Common (May Affect More Than 1 in 10 People)
- diarrhea, nausea
- itching, rash
- joint pain
- feeling tired
- feeling less hungry
Common (May Affect up to 2 in 100 People)
- flu-like illness
- underactive function of the pituitary gland, underactive function of the thyroid, overactive function of the thyroid
- dizziness or spinning sensation, dry mouth, headache, decreased sense of touch, sleepiness, weakness, numbness or tingling of your hands or feet
- bruising or bleeding more easily
- dry eye, changes in vision
- shortness of breath, inflammation of the lungs, wheezing
- stomach pain, constipation, heartburn, nausea, vomiting
- dry skin, redness of the skin, night sweats, skin discolouration, red raised skin rash, patches of skin which have lost colour
- back pain, joint swelling, muscle spasms, muscle weakness, muscle aches, pain in arms or legs
- unusual tiredness or weakness, chest pain, chills, swelling of the face, legs or arms, pain, fever, tumour pain
- changes in test results:
- decrease in the number of red blood cells o abnormal liver enzyme levels in the blood
- abnormal levels of thyroid hormones in the blood
- weight loss
Serious Side Effects and what to do About Them
|Symptom / effect||Talk to your healthcare professional|
|Only if severe||In all cases|
Inflammation of the lungs (pneumonitis) which can cause shortness of breath, chest pain, or coughing
|Inflammation of the intestines (colitis) which can cause diarrhea or more bowel movements than usual, black, tarry, sticky stools or stools with blood or mucus, severe stomach pain or tenderness||✓|
|Inflammation of the liver (hepatitis) which can cause nausea or vomiting, feeling less hungry, pain on the right side of stomach, yellowing of skin or whites of eyes, dark urine, bleeding or bruising more easily than normal||✓|
|Inflammation of the pituitary or thyroid gland (hypophysitis, hypopituitarism, including secondary adrenal insufficiency; hyperthyroidism,hypothyroidism) which can cause rapid heart beat, weight loss, increased sweating, weight gain, hair loss, feeling cold, constipation, your voice gets deeper, muscle aches, dizziness or fainting, headaches that will not go away or unusual headache||✓|
Inflammation of the kidneys (nephritis) which can cause changes in the amount or colour of your urine
|Blood sugar problems (type 1 diabetes mellitus) which can cause hunger or thirst, a need to urinate more often, or weight loss||✓|
|Problems in other organs such as skin, muscle or eyes, which can cause rash, muscle pain or weakness or changes in eyesight.||✓|
|Problems in the pancreas, which can cause abdominal pain, nausea, and vomiting||✓|
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Suspected Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701C
Ottawa, Ontario K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.Also, to report an adverse event related to KEYTRUDA, please contact Merck Canada at 1‐800‐567‐2594.
It is unlikely that you will be asked to store KEYTRUDA yourself. It will be stored in the hospital or clinic where it is given to you.
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C to 8°C).
If You Want More Information About Keytruda
- Talk to Your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; or Merck Canada website www.merck.ca, or by calling Merck Canada at 1-800-567-2594.