Pembrolizumab Intravenous

In the U.S.

• Keytruda

Available Dosage Forms:

• Powder for Solution
• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

Pembrolizumab injection is used to treat melanoma (a type of skin cancer) that has spread or cannot be removed by surgery.

Pembrolizumab injection is used alone to treat non-small cell lung cancer (NSCLC) that has spread, and whose tumors express PD-L1. pembrolizumab is also used in combination with pemetrexed and carboplatin to treat NSCLC that has spread.

Pembrolizumab injection is also used to treat urothelial carcinoma (a type of urinary tract cancer) that has spread throughout the body (metastatic) or cannot be removed by surgery (advanced). pembrolizumab is given to patients who have received other cancer medicines (eg, platinum) but did not work well.

Pembrolizumab injection is also used to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) solid tumor or colorectal cancer (cancer of the colon or rectum) that has spread or cannot be removed by surgery. It is given to patients who have received other cancer treatments (eg, fluoropyrimidine, oxaliplatin, irinotecan) but did not work well.

pembrolizumab is also used to treat head and neck squamous cell cancer (HNSCC) that has spread. It is only used after receiving platinum-containing chemotherapy. pembrolizumab is also used to treat classical Hodgkin lymphoma in adults and children who have received other medicines that did not work well.

Pembrolizumab is a monoclonal antibody that changes the immune system to help control the growth of cancer cells.

pembrolizumab is to be given only by or under the immediate supervision of your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• body aches or pain
• chills
• constipation
• cough
• depressed mood
• difficulty with breathing
• difficulty with moving
• dry skin and hair
• ear congestion
• feeling cold
• fever
• hair loss
• headache
• hoarseness or husky voice
• loss of voice
• muscle cramps, pain, and stiffness
• pain in the joints
• pale skin
• rapid weight gain
• runny or stuffy nose
• slowed heartbeat
• sneezing
• sore throat
• tingling of the hands or feet
• trouble breathing
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

• Chest pain
• general feeling of discomfort or illness
• nervousness
• pain
• sensitivity to heat
• stomach cramps
• sweating
• tenderness
• thickening of bronchial secretions
• trouble sleeping
• watery or bloody diarrhea
• weight loss

• Back, leg, or stomach pains
• bleeding gums
• blurred vision or other change in vision
• cracks in the skin
• darkened urine
• difficulty with moving
• drowsiness
• eye pain
• fast heartbeat
• general body swelling
• general tiredness and weakness
• indigestion
• light-colored stools
• loss of appetite
• loss of heat from the body
• nausea or vomiting
• nosebleeds
• pain, swelling, or redness in the joints
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• red, swollen skin
• redness of the eye
• scaly skin
• seizures
• sensitivity of the eye to light
• sore throat
• tearing
• upper right abdominal or stomach pain
• yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased appetite
• diarrhea
• dizziness
• headache
• rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tiredness, swelling ankles/feet/hands, itchy skin, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: new/worsening cough, shortness of breath, diarrhea with blood/mucus, symptoms of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine, pink/bloody urine), persistent/unusual headache, dizziness/fainting, vision changes, deepening of the voice, eye redness/pain, sensitivity to light, unusual weakness, joint stiffness/pain, muscle weakness/tenderness/pain, signs of infection (such as sore throat that doesn't go away, fever, chills, burning/painful/frequent/urgent urination), easy bruising/bleeding.

Pembrolizumab may cause hormone gland problems (such as thyroid, pituitary, adrenal, pancreas). Your body could make too much or too little hormone. Tell your doctor right away if you have any symptoms such as: cold or heat intolerance, unexplained weight loss/gain, mental/mood changes, slow/fast/pounding/irregular heartbeat, unusual tiredness, constipation.

This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Get medical help right away if you have any very serious side effects, including: chest pain, seizure.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using pembrolizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: organ transplant.

People who receive a donor stem cell transplant after treatment with pembrolizumab may have very serious (possibly fatal) complications. Ask your doctor for more details.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while receiving this medication and for 4 months after treatment. Consult your doctor for more details and to discuss the use of reliable forms of birth control (such as condoms, birth control pills) while receiving this medication and for 4 months after treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug and for 4 months after stopping treatment is not recommended. Consult your doctor before breast-feeding.