Description and Brand Names

Drug information provided by: IBM Micromedex

US Brand Name

  1. Keytruda

Descriptions


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. 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 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.

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 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 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 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 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 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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pembrolizumab injection in the elderly.

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. 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:

  • Pneumonitis (inflammation of the lungs) or
  • 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
  • Type 1 diabetes—Use with caution. May make these conditions worse.

Proper Use

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.

Missed Dose

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

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

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

  1. Bloating or swelling of the face, arms, hands, lower legs, or feet
  2. body aches or pain
  3. chills
  4. constipation
  5. cough
  6. depressed mood
  7. difficulty with breathing
  8. difficulty with moving
  9. dry skin and hair
  10. ear congestion
  11. feeling cold
  12. fever
  13. hair loss
  14. headache
  15. hoarseness or husky voice
  16. loss of voice
  17. muscle cramps, pain, and stiffness
  18. pain in the joints
  19. pale skin
  20. rapid weight gain
  21. runny or stuffy nose
  22. slowed heartbeat
  23. sneezing
  24. sore throat
  25. tingling of the hands or feet
  26. troubled breathing with exertion
  27. unusual bleeding or bruising
  28. unusual tiredness or weakness
  29. unusual weight gain or loss

Less common

  1. Chest pain
  2. general feeling of discomfort or illness
  3. nervousness
  4. pain
  5. sensitivity to heat
  6. stomach cramps
  7. sweating
  8. tenderness
  9. thickening of bronchial secretions
  10. trouble sleeping
  11. watery or bloody diarrhea
  12. weight loss

Rare

  1. Back, leg, or stomach pains
  2. bleeding gums
  3. blurred vision or other change in vision
  4. cracks in the skin
  5. dark urine
  6. drowsiness
  7. eye pain
  8. fast heartbeat
  9. general body swelling
  10. general tiredness and weakness
  11. indigestion
  12. joint redness or swelling
  13. light-colored stools
  14. loss of appetite
  15. loss of heat from the body
  16. nausea
  17. nosebleeds
  18. pains in the stomach, side, or abdomen, possibly radiating to the back
  19. pale skin
  20. red, swollen skin
  21. redness of the eye
  22. scaly skin
  23. seizures
  24. sensitivity of the eye to light
  25. tearing
  26. upper right abdominal or stomach pain
  27. vomiting
  28. yellow eyes and skin

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

  1. Decreased appetite
  2. dizziness
  3. rash

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.