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Pembrolizumab (Intravenous route)

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.

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 given to 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. This medicine is also used 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 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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Tofacitinib

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 at least 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.


Last Updated: 3/30/2022
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