Description
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 also used in combination with platinum-containing chemotherapy before surgery in patients who have early stage NSCLC which can be removed by surgery and then used alone after surgery to help prevent lung cancer from coming back.
Pembrolizumab injection is used in combination with pemetrexed and platinum-containing chemotherapy as a first-line treatment for malignant pleural mesothelioma (cancer that affects the lining of the lungs and chest wall) that has spread or cannot be removed by surgery.
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 used to treat urothelial cancer (a type of urinary tract cancer) that has spread throughout the body (metastatic) or cannot be removed by surgery (advanced). This medicine is used in combination with enfortumab vedotin-ejfv injection. It is also 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. 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 decided not 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-positive gene, whose tumors express PD-L1, and has spread or cannot be removed by surgery. This medicine is also used in combination with other cancer treatments (eg, fluoropyrimidine, platinum) as first-line treatment of gastric or gastroesophageal junction adenocarcinoma in patients whose cancer has an abnormal HER2-negative 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. This medicine is also used in combination with chemotherapy and radiation to treat FIGO 2014 stage III to IVA cervical cancer that has spread to other parts of the body.
Pembrolizumab injection is also used to treat a type of liver cancer called hepatocellular carcinoma (HCC) in patients who have HCC after having hepatitis B and have received cancer medicines that did not contain PD-1 or PD-L1 blocking medicine.
Pembrolizumab injection is also used in combination with cisplatin and gemcitabine to treat a type of bile duct or gallbladder cancer called biliary tract cancer (BTC) that has spread or cannot be removed by surgery.
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 and are not candidates for surgery or radiation. This medicine is also used in combination with lenvatinib to treat advanced endometrial cancer that is mismatch repair proficient (pMMR) or not MSI-H in patients who have received other cancer medicines and are not candidates for surgery or radiation. This medicine is also used in combination with other cancer medicines (eg, carboplatin and paclitaxel) and then used alone to treat advanced endometrial cancer that has returned.
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.
This product is available in the following dosage forms:
- Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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) or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.
- Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.
Proper Use
A nurse or other trained health professional will give you this medicine. It is given through an IV catheter placed into one of your veins. It must be given slowly, so the IV 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
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
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.
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