Pembrolizumab 100 mg/4 mL (25 mg/mL) solution in a single-dose vial injection

What is Pembrolizumab used for :

Pembrolizumab is a medication that is used to treat the following indications:

• Melanoma (type of skin cancer); when cancer cannot be removed by surgery or has spread in the body, or to prevent your skin cancer from returning after its surgical removal.


• Non-small cell lung cancer (NSCLC; a type of lung cancer); in combination with other chemotherapy medicines (platinum and pemetrexed) when your cancer does not have an abnormal “ALK” or “EGFR” gene, has spread and is of a specific type called “non-squamous”.


• This medicine may also be used in combination with the chemotherapy medicines carboplatin and either paclitaxel or paclitaxel as your primary treatment when your lung cancer has already spread and of a specific type called “squamous”.


• It may additionally be used alone as your primary treatment when you have stage 3 lung cancer (has not spread outside your chest) that cannot be treated with surgery or chemotherapy with radiation or when your NSCLC has already spread to other parts of your body and your tumor does not have an abnormal “EGFR” or “ALK” gene and is positive for “PD-L1”.


• This medication may be used alone when you already have undergone chemotherapy (containing platinum) to treat your advanced NSCLC, and your therapy was not effective or is no longer effective and your tumor is positive for “PD-L1” with an abnormal “EGFR” or “ALK” gene for which you have taken an EGFR or ALK inhibitor medication that was not effective or is no longer effective.


• Small cell lung cancer (SCLC; a type of lung cancer); when your lung cancer is advanced (has already spread) and you have already taken two or more types of chemotherapy (including one chemotherapy medicine that has platinum, and that was not effective or is no longer effective).


• A type of cancer known as head and neck squamous cell cancer (HNSCC); when used with the chemotherapy medications a platinum and fluorouracil as your primary treatment and your neck and head cancer has already spread or came back and you cannot undergo a surgical removal for it.


• It may also be used alone as your primary treatment when your tumor is positive for “PD-L1” and your head and neck cancer has already spread or came back and you cannot undergo a surgical removal for it.


• This medicine may also be used alone when your head and neck cancer has already spread or came back and you have already undergone chemotherapy (containing platinum) that was not effective or is no longer effective.


• Classical Hodgkin lymphoma (cHL; a type of cancer); when used in adults and children who have already received a treatment that was not effective or is no longer effective or their cancer came back after they have undergone three or more types of therapy.


• Primary mediastinal B-cell lymphoma (PMBCL; a type of cancer); when used in adults and children who have already received a treatment that was not effective or is no longer effective or when the cancer came back after receiving two or more types of therapy.


• Urothelial carcinoma (a type of bladder and urinary tract cancer); when your cancer is at high risk for spreading to other tissues but has not spread yet and your tumor belongs to a type known as “carcinoma in situ”, and you have already received Bacillus Calmette-Guerin (BCG) that was not effective and you cannot undergo surgical removal of your bladder.


• It may also be used when your bladder or urinary tract cancer has already spread or you are not able to remove it by surgery and chemotherapy (containing cisplatin), and your tumor is positive for “PD-L1”, or you cannot take cisplatin or carboplatin (cancer medicines), or you have already undergone chemotherapy (containing platinum) that was not effective or is no longer effective.


• A type of cancer that is proven by a laboratory test to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor; when used in adults and children to treat cancer that has already spread or cannot be surgically removed, and has advanced after therapy, and who did not have satisfactory therapy alternatives, or who have rectal or colon cancer, and have already undergone chemotherapy (with oxaliplatin, fluoropyrimidine and irinotecan) that was not effective or is no longer effective.


• It is not clear yet if this medicine is effective and safe in children who have MSI-H cancers of the spinal cord or brain.


• Gastric or gastroesophageal junction (GEJ) adenocarcinoma (type of stomach cancer); when your tumor tests positive for “PD-L1” and came back or has already spread and you have undergone two or more types of chemotherapy (including platinum and fluoropyrimidine) that was not effective or is no longer effective, and if your tumor contains an abnormal “HER2/neu” gene and you have also taken a HER2/neu-targeted medication that was not effective or is no longer effective.


• Squamous cell carcinoma of the esophagus (a type of cancer); when your cancer came back or has already spread, and your tumor is positive for “PD-L1” and you have taken one or more types of therapy that was not effective or is no longer effective.


• Cervical cancer that is positive for “PD-L1”; when your cancer came back or has spread or cannot be surgically removed, and you have undergone chemotherapy that was not effective or is no longer effective.


• Hepatocellular carcinoma (a type of liver cancer); when you have already taken the medication sorafenib.


• Merkel cell carcinoma (MCC; a type of skin cancer); in adults and children with cancer that has already spread or relapsed.


• Renal cell carcinoma (RCC; a type of kidney cancer); when used with the medication axitinib as your primary treatment when your cancer has already spread or when you are not able to undergo surgery to remove it.


• Endometrial carcinoma (a type of uterine cancer); when used with the medication lenvatinib and your tumors are not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have already undergone anti-cancer treatment that was not effective or is no longer effective, and you cannot undergo radiation therapy or radiation to remove it.

Do not take Pembrolizumab :

• If you are allergic to Pembrolizumab or any of the ingredients in this medicine.

Warnings and precautions :

• Talk to your doctor or pharmacist if you develop allergic reactions such as shortness of breath, skin rash, swelling of the face or neck, decreased blood pressure and dizziness.


• This medication acts by working on your immune system and therefore may cause your immune system to act against your normal tissues and organs in any part of your body, which may cause severe or life-threatening problems that can lead to death.


• These problems may occur anytime during therapy or even after finishing your treatment.


• This medication may cause immune-mediated pneumonitis (lung disorder that can cause respiratory problems).


• Talk to your doctor if you experience signs or symptoms of respiratory problems like, difficulty breathing and cough.


• Your doctor may either withhold the medication or completely stop it.


• This medicine may cause immune-mediated liver damage and toxicity.


• Your doctor may recommend monitoring for changes in your liver function and may decide accordingly whether to withhold the medicine or to completely stop it.


• Talk to your doctor if you experience signs of liver damage like, white stools, pale skin and eyes, fatigue and abdominal pain.


• This medicine may cause immune-mediated endocrinopathies (hormonal disorders), like adrenal insufficiency, hypophysitis (acute or chronic inflammation of the pituitary gland), thyroid problems and type1 diabetes (high blood glucose levels).


• Your doctor may decide to withhold the medicine or completely stop it if you experience any of these problems.


• Talk to your doctor if you experience high blood glucose signs like, excessive thirst, increased appetite and excessive urination or thyroid dysfunction signs like, heat or cold intolerance, changes in appetite, palpitations, weight changes, pale skin, or signs of signs of hypophysitis like, headache and vision loss, or signs of adrenal insufficiency like nausea, low blood pressure, extreme fatigue and weight loss.


• This medicine may cause immune-mediated nephritis (kidney damage).


• Your doctor will monitor for changes in your kidney function and may either withhold the medicine or completely stop it depending on your results.


• Talk to your doctor if you experience signs of nephritis, like frequent urination, cloudy urine, pelvic pain, blood or pus in the urine, burning sensation when urinating, nausea and vomiting.


• This medicine may cause immune-mediated skin adverse reactions, like, Stevens Johnson syndrome and toxic epidermal necrolysis (TEN).


• Your doctor may either withhold the medicine or completely stop it if this happens.


• Talk to your doctor immediately if you experience Stevens-Johnson syndrome signs which is a rare, serious disease of the skin that usually begins with signs of a flu and followed by a severe and painful skin rash with blisters, or if you experience toxic epidermal necrolysis which is a skin problem that may spread to eyes, mouth, throat, genitals, urethra and anus, and is manifested by signs, like, painful, red area that spreads rapidly, peeling without blistering, fever, discomfort, raw areas of skin.


• If you have had an organ transplant, you may be at higher risk of organ transplant rejection. Your doctor should inform you about the signs and symptoms that you should report and will follow up with you, based on the type of organ transplant that you have had.


• This medication may cause infusion reactions.


• Your healthcare provider should stop the medicine completely if a severe reaction happens.


• This medicine may cause harm to your baby if taken during pregnancy.


• Do not take this medicine during pregnancy and make sure to use effective contraceptive method (birth control) while taking this medication if you are a woman of child bearing potential.


• Make sure to tell your doctor before starting this medicine if you have immune system problems like lupus, Crohn’s disease or ulcerative colitis.


• Make sure to tell your doctor before starting this medicine if you have lung or breathing problems or if you have previously had an organ transplant (e.g. liver or kidney) or if you have had or plan to have a stem cell transplant using donor stem cells (allogeneic).


• Make sure to tell your doctor before starting this medicine if you have liver problems or any other medical problems.

Possible side effects :

• Include signs of an allergic reaction, like rash and itching, signs of lung problems, like, chest pain, shortness of breath and new or worse cough, signs of intestinal problems, like, frequent bowels, diarrhea, stools that are black, tarry, sticky, or have blood or mucus, severe stomach area pain or tenderness, signs of liver problems, like, nausea, yellowing of your skin or the whites of your eyes, vomiting, pain on the right side of your stomach area, bleeding or easy bruising and dark urine, signs of hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas), like, rapid heartbeat, weight changes, sweating, increased appetite or thirst, frequent urination, feeling cold, headaches, hair loss, hoarseness, constipation, weakness, muscle aches and dizziness or fainting, signs of kidney problems, like, change in the amount or color of your urine, signs of skin problems, like, blisters, itching, peeling, rash and painful sores or ulcers in your nose, mouth, throat, or genital area, signs of problems in other organs, like, vision changes, muscle pain, weakness and low red blood cells, swollen lymph nodes, cough, rash or tender lumps on skin, shortness of breath, eye pain, fever, nausea, confusion, balance problems, vomiting, memory problems, stiff neck or seizures (encephalitis), irregular heartbeat, tiredness, or chest pain, signs of infusion reactions, like, shaking, difficulty breathing, chills, itching, rash, flushing, fever.


• Dizziness and feeling like passing out and signs of organ transplant rejection (your doctor should inform you about the signs and symptoms that you should report and will follow up with you, based on the type of organ transplant that you have had) and signs of graft-versus-host-disease (GVHD) in patients who have received a bone marrow (stem cell) transplant from donor stem cells.

Common side effects:

• When pembrolizumab is given as a single agent include fatigue, muscle and bone pain, itching, decreased appetite, diarrhea, nausea, rash, fever, cough, constipation, difficulty breathing, pain and abdominal pain.

Common side effects:

• When pembrolizumab is given in combination with chemotherapy include fatigue, constipation, nausea, diarrhea, rash, decreased appetite, vomiting, cough, fever, difficulty breathing, hair loss, peripheral neuropathy, mucosal inflammation and mouth soreness.

Common side effects:

• When pembrolizumab is given in combination with axitinib include diarrhea, fatigue, liver toxicity, high blood pressure, hypothyroidism (underactive thyroid gland), decreased appetite, nausea, palmar-plantar erythrodysesthesia (redness, swelling, and pain on the palms of the hands and/or the soles of the feet), mouth soreness and mucosal inflammation, rash, constipation, cough and hoarseness.

Common side effects:

• when pembrolizumab is given in combination with lenvatinib include fatigue, muscle pain, high blood pressure, diarrhea, decreased appetite, nausea, hypothyroidism, mouth soreness, vomiting, abdominal pain, decreased weight, headache, hoarseness, constipation, urinary tract infection, bleeding events, low magnesium levels, palmar-plantar erythrodysesthesia, cough, rash and difficulty breathing.

Other medicines and Pembrolizumab :

Tell your doctor or pharmacist if you are:

• Taking, have recently taken or might take any other medications including vitamins, prescription medicines, over-the-counter medicines and herbal supplements.


• keep a list of the medications that you take.

How to take Pembrolizumab :

• Your doctor will be giving you your pembrolizumab doses intravenously (into your vein) through an intravenous (IV) line over a period of 30 minutes.


• This medicine is usually given every 3 weeks.


• Your doctor will determine the number of treatments that you need.


• Your doctor will ask for blood tests to monitor you for any side effects.

How to store Pembrolizumab :

• Store medication in its original container in the refrigerator at 2° to 8°C until time of use.


• Do not freeze the medication.


• Protect medication from direct sunlight.