Pembrolizumab (Intravenous route)
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.
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 also used to treat metastatic (cancer that has spread) small cell lung cancer (SCLC) that has progressed in patients who had received platinum-containing chemotherapy or at least one other line of treatment that did not work well.
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.
This medicine is also used to treat classical Hodgkin lymphoma in adults and children who have received other medicines that did not work well.
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 cisplatin and whose tumors express PD-L1, patients who are not able to receive carboplatin or cisplatin, or patients who have received other cancer medicines (eg, platinum) that 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) that did not work well.
Pembrolizumab injection is also used to treat a type of stomach cancer called gastric or gastroesophageal junction adenocarcinoma that has returned or spread, and whose tumors express PD-L1. It is given to patients who have received 2 or more types of cancer treatment (eg, fluoropyrimidine, platinum) that did not work well, or in patients with tumor that has an abnormal HER2/neu gene and have received a HER2/neu-targeted medicine that did not work well.
Pembrolizumab injection is also used to treat squamous cell carcinoma of the esophagus that has returned or spread, and whose tumors express PD-L1. It is given to patients who have received 1 or more types of treatment that did not work well.
Pembrolizumab injection is used to treat cervical cancer that has returned or spread, and whose tumors express PD-L1.
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.
Pembrolizumab injection is also used in combination with axitinib 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.
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pembrolizumab injection in children with advanced melanoma, lymphoma, solid tumors, colorectal cancer, or Merkel cell carcinoma. However, safety and efficacy have not been established in children with other cancers.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pembrolizumab injection in the elderly.
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.
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.
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:
- 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
- Nephritis (inflammation of the kidneys) or
- Pneumonitis (inflammation of the lungs) or
- Type 1 diabetes—Use with caution. May make these conditions 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 weeks. 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.
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. 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.
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 can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills 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:
- More common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- body aches or pain
- clay-colored stools
- dark urine
- decreased appetite
- depressed mood
- difficulty with breathing
- difficulty with moving
- dry skin and hair
- ear congestion
- feeling cold
- hair loss
- hoarseness or husky voice
- itching, skin rash
- loss of voice
- muscle cramps, pain, and stiffness
- pain in the joints
- 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
- sore throat
- stomach pain or tenderness
- tingling of the hands or feet
- troubled breathing with exertion
- ulceration of the skin
- unusual bleeding or bruising
- unusual tiredness or weakness
- unusual weight gain or loss
- yellow eyes or skin
- Less common
- Blue lips, fingernails, or skin
- chest pain or discomfort
- cloudy urine
- decrease in urine output or decrease in urine-concentrating ability
- difficulty in 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
- sensitivity to heat
- severe or sudden headache
- severe tiredness
- slurred speech
- stomach cramps
- temporary blindness
- 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
- weight loss
- Back or leg pain
- bleeding gums
- blurred vision or other change in vision
- cracks in the skin
- dark urine
- eye pain
- general body swelling
- general tiredness and weakness
- joint redness or swelling
- light-colored stools
- loss of appetite
- loss of heat from the body
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- red, swollen skin
- redness of the eye
- scaly skin
- sensitivity of the eye to light
- upper right abdominal or stomach pain
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:
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: 9/5/2019