Pembrolizumab (Intravenous route)
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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.
Pembrolizumab injection is used alone to treat non-small cell lung cancer (NSCLC) that has spread, and whose tumors express PD-L1. This medicine 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). This medicine 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.
This medicine is also used to treat head and neck squamous cell cancer (HNSCC) that has spread. It is only used after receiving platinum-containing chemotherapy. 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 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 immediate 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 have not been performed on the relationship of age to the effects of pembrolizumab injection in the pediatric population. Safety and efficacy have not been established.
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
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:
- Pneumonitis (inflammation of the lungs) or
- Colitis (inflammation of the intestine) 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
- 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 in one of your veins. It must be given slowly, so the needle will have to remain in place for 30 minutes and the infusion will be given every 3 weeks.
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 or forget to use your medicine, call your doctor or pharmacist 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 tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during therapy and for 4 months after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
Tell your doctor right away if you have a cough, shortness of breath, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.
Colitis (inflammation of the colon) 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, a 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 or 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 a 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
- body aches or pain
- depressed mood
- difficulty with breathing
- difficulty with moving
- dry skin and hair
- ear congestion
- feeling cold
- hair loss
- 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
- 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
- Less common
- Chest pain
- general feeling of discomfort or illness
- sensitivity to heat
- stomach cramps
- 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
- eye pain
- fast heartbeat
- general body swelling
- general tiredness and weakness
- light-colored stools
- loss of appetite
- loss of heat from the body
- nausea or vomiting
- 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
- sensitivity of the eye to light
- upper right abdominal or stomach pain
- yellow eyes and skin
- More common
- Decreased appetite
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:
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:
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: 9/4/2017