Pronunciation:

pem-broe-LIZ-ue-mab

Brand Names:

• Keytruda

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Pembrolizumab injection is used to treat melanoma (a type of skin cancer) that has spread or cannot be removed by surgery. It is also used to help prevent melanoma from coming back after it and lymph nodes affected by cancer have been removed by surgery in patients with Stage IIB, Stage IIC, or Stage III melanoma.

Pembrolizumab injection is used alone to treat non-small cell lung cancer (NSCLC) that has spread, whose tumors express PD-L1 and do not have an abnormal EGFR or ALK gene in patients who have not received other cancer treatments. It is also used alone to treat NSCLC that has spread, whose tumors express PD-L1 and have an abnormal EGFR or ALK gene in patients who have received other cancer medicines (eg, platinum) that did not work well. Pembrolizumab injection is also used alone as first-line treatment for stage III NSCLC in patients who cannot have surgery or chemotherapy with radiation or for NSCLC that has spread and whose tumors express PD-L1 without an abnormal EGFR or ALK gene. This medicine is also used in combination with pemetrexed and platinum-containing chemotherapy to treat NSCLC that has spread and whose tumors do not have an abnormal EGFR or ALK gene. Pembrolizumab injection is also used together with carboplatin and paclitaxel or nab-paclitaxel to treat squamous NSCLC that has spread. It is also used alone to help prevent lung cancer from coming back after cancer has been removed by surgery and have received other cancer medicines (eg, platinum) in patients with Stage IB and the tumor is 4 centimeter (cm) or larger, Stage II, or Stage IIIA NSCLC.

Pembrolizumab injection is used in combination with platinum and fluorouracil as first-line treatment of head and neck squamous cell cancer (HNSCC) that has spread or cannot be removed by surgery. This medicine is also given to patients whose tumors express PD-L1 or patients who have received other cancer medicines (eg, platinum) that did not work well.

Pembrolizumab injection is used to treat relapsed (cancer that has come back) or refractory (cancer that did not respond to treatment) classical Hodgkin lymphoma (cHL) in adults. This medicine is also used to treat cHL in children who have tried a treatment that did not work, or whose cHL has returned after 2 or more previous lines of treatment.

Pembrolizumab injection is used to treat primary mediastinal large B-cell lymphoma (PMBCL) in patients who have tried a treatment that did not work, or whose PMBCL has returned after 2 or more previous lines of treatment.

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). This medicine is used alone in patients who are not able to receive platinum-containing chemotherapy (eg, carboplatin or cisplatin) or patients who have received platinum-containing chemotherapy that did not work well or used in combination with enfortumab vedotin-ejfv injection in patients who are not able to receive cisplatin-containing chemotherapy. This medicine is also used alone to treat patients with high-risk Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with a tumor type called carcinoma in situ (CIS) with or without papillary tumors who cannot receive or have not decided to have surgery to remove the bladder.

Pembrolizumab injection is also used to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) solid tumor that has spread or cannot be removed by surgery. It is given to patients who have received other cancer treatments that did not work well. This medicine is also used to treat MSI-H or dMMR colorectal cancer (CRC) that has spread or cannot be removed by surgery.

Pembrolizumab injection is also used in combination with other cancer treatments (eg, trastuzumab, fluoropyrimidine, platinum) as first-line treatment of gastric or gastroesophageal junction adenocarcinoma in patients whose cancer has an abnormal HER2 gene and has spread or cannot be removed by surgery.

Pembrolizumab injection is also used to treat esophageal or gastroesophageal junction carcinoma that cannot be cured by surgery or combination of chemotherapy and radiation. It is used in combination with other cancer treatments (eg, fluoropyrimidine, platinum) or alone in patients who have received 1 or more types of cancer treatment that did not work well and whose tumors are squamous and express PD-L1.

Pembrolizumab injection is used in combination with other cancer treatments, with or without bevacizumab, to treat cervical cancer that has returned or spread, or does not go away, and whose tumors express PD-L1. It is also used alone to treat cervical cancer that has returned or spread, and whose tumors express PD-L1 in patients who have received other cancer medicines that did not work well.

Pembrolizumab injection is also used to treat a type of liver cancer called hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib that did not work well.

Pembrolizumab injection is also used to treat a kind of skin cancer called Merkel cell carcinoma (MCC) that has returned or spread, or cutaneous squamous cell carcinoma (cSCC) that has returned or spread and cannot be cured by surgery or radiation.

Pembrolizumab injection is also used in combination with other cancer treatments (eg, axitinib, lenvatinib) as first-line treatment of advanced renal cell carcinoma (RCC), a kind of kidney cancer, in patients whose cancer has spread or cannot be removed by surgery. It is also used alone to treat kidney cancer in patients who are at intermediate-high or high risk of the cancer coming back after surgery to remove all or part of your kidney, or remove all or part of your kidney and surgery to remove cancer that has spread to other parts of the body (metastatic lesions).

Pembrolizumab injection is also used alone to treat microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) advanced endometrial cancer (cancer of the lining of the uterus or womb), in patients who have received other cancer medicines but did not work well and cannot be removed by surgery or radiation. This medicine is also used in combination with lenvatinib to treat advanced endometrial cancer (cancer of the lining of the uterus or womb) that is not MSI-H or dMMR, in patients who have received other cancer medicines but did not work well and cannot be removed by surgery or radiation.

Pembrolizumab injection is also used to treat a type of cancer called tumor mutational burden-high (TMB-H) in patients whose solid tumors have spread or cannot be removed by surgery. It is given to patients who have received other cancer treatments that did not work well and who have no other treatment options.

Pembrolizumab injection is also used together with other cancer medicines before surgery and then continued alone after surgery to treat patients with early-stage triple-negative breast cancer (TNBC) and who are at high risk of the cancer coming back. It is also used together with other cancer medicines to treat patients with TNBC that has spread or cannot be removed by surgery and whose tumors express PD-L1.

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

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pembrolizumab injection in children 12 years of age with melanoma or in children with lymphoma, solid tumors, colorectal cancer, Merkel cell carcinoma, microsatellite instability-high cancer, or tumor mutational burden-high cancer. However, safety and efficacy have not been established in children with other cancers.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pembrolizumab injection in the elderly. However, elderly patients are more likely to have serious unwanted effects, which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Central nervous system (brain and spinal cord) cancer—Safety and efficacy have not been established in patients with solid tumors in the brain and spinal cord.

• Colitis (inflammation of the bowels) or
• Diabetic ketoacidosis or
• Hepatitis (inflammation of the liver) or
• Hyperthyroidism (high levels of thyroid hormone) or
• Hypophysitis (inflammation of the pituitary gland) or
• Hypothyroidism (low levels of thyroid hormone) or
• Immune system problems or
• Nephritis (inflammation of the kidneys) or
• Pneumonitis (inflammation of the lungs) or
• Type 1 diabetes—Use with caution. May make these conditions worse.

• Organ transplant (eg, kidney or liver transplant), recent—Use with caution. May increase risk for organ transplant rejection.

• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes. The infusion will be given every 3 or 6 weeks, depending on your dose. If you are also receiving chemotherapy for NSCLC, pembrolizumab will be given first on the same day.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Colitis (swelling of the colon or bowel) may occur with this medicine. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving this medicine. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

This medicine may cause serious kidney problems (eg, nephritis, kidney failure). Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

Tell your doctor right away if you have changes in your eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving this medicine.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sores or ulcers on the skin, mouth or lips, or swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

This medicine may cause infusion-related reactions. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Side Effects of This Medicine:

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:

More common

Black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

body aches or pain

burning, numbness, tingling, or painful sensations

chills

clay-colored stools

confusion

constipation

cough

dark urine

decreased appetite

depressed mood

difficult, burning, or painful urination

difficulty with breathing

difficulty with moving

dizziness

dry mouth

dry skin and hair

ear congestion

feeling cold

fever

flushing

frequent urge to urinate

fruit-like breath odor

hair loss

headache

hoarseness or husky voice

increased hunger

increased thirst

increased urination

itching, skin rash

joint or bone pain

loss of voice

lower back or side pain

mood or mental changes

muscle cramps, pain, and stiffness

nausea

neck pain

nervousness

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pale skin

pounding in the ears

rapid weight gain

redness, swelling, or pain of the skin

runny or stuffy nose

scaling of the skin on the hands and feet

slow or fast heartbeat

sneezing

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach cramps, pain or tenderness

swelling of the face, ankles, or hands

tingling of the hands or feet

ulceration of the skin

unsteadiness or awkwardness

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

vomiting

weakness in the arms, hands, legs, or feet

yellow eyes or skin

Less common

Blue lips, fingernails, or skin

chest pain or discomfort

decrease in urine output or decrease in urine-concentrating ability

difficulty with chewing, swallowing, or talking

double vision

drooping eyelids

general feeling of discomfort or illness

inability to speak

irregular, fast or slow, or shallow breathing

muscle weakness

pain and swelling in the genitals or anal area

seizures

sensitivity to heat

severe or sudden headache

slurred speech

sweating

temporary blindness

tenderness

thickening of bronchial secretions

trouble sleeping

watery or bloody diarrhea

weakness in the arm or leg on one side of the body, sudden and severe

Rare

Back or leg pain

bleeding gums

blistering, peeling, or loosening of the skin

cracks in the skin

drowsiness

eye pain

general body swelling

indigestion

joint redness or swelling

joint or muscle pain

light-colored stools

loss of heat from the body

nosebleeds

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

red, swollen skin

red irritated eyes

red skin lesions, often with a purple center

redness of the eye

scaly skin

sensitivity of the eye to light

swollen glands

tearing

upper right abdominal or stomach pain

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:

More common

Cracked lips

hair loss or thinning

lack or loss of strength

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

swelling or inflammation of the mouth

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.