Pembrolizumab

Pembrolizumab is a prescription medication used to treat advanced melanoma, a type of lymphoma, advanced non-small cell lung cancer, or recurrent or metastatic (advanced) head and neck cancer, and patients whose cancers have a specific genetic feature. Pembrolizumab is also used to treat locally advanced or metastatic gastric (stomach) cancer after trying other medications. 

Pembrolizumab belongs to a group of drugs called PD-1 Blockers. These help the body's immune system fight cancer.

Pembrolizumab is available in an injectable form to be given directly into a vein (IV) every three weeks by a healthcare professional.

Common side effects of pembrolizumab include fatigue, cough, nausea, itchy skin, and rash.

Pembrolizumab is a prescription medication used to treat:

a kind of skin cancer called melanoma. Pembrolizumab may be used when your melanoma:

• has spread or cannot be removed by surgery (advanced melanoma) and,
• after you have tried a medicine call ipilimumab and it did not work or is no longer working and,
• if your tumor has an abnormal “BRAF” gene, and you also have tried a different medicine called a BRAF inhibitor, and it did not work or is no longer working.

• a kind of lung cancer called non-small cell lung cancer. Pembrolizumab may be used when your lung cancer:

• has spread and has tested positive for “PD-L1” (no prior chemotherapy and with tumors with normal EGFR or ALK genes)
• has spread and you have tried chemotherapy that contains platinum, and it did not work or is no longer working 
• in combination with pemetrexed and carboplatin, as first-line treatment of those with advanced nonsquamous non-small cell lung cancer

For those with a tumor that has an abnormal “EGFR” or “ALK” gene, pembrolizumab can be given if you have already tried a medication for tumors with these abnormal genes.

• classical Hodgkin lymphoma (cHL). This medication may be used for this type of lymphoma in adults and children when:
  • you have tried a treatment and it did not work or
  • your cHL has returned after you received 3 or more types of treatment
• recurrent or metastatic (advanced) head and neck cancer otherwise known as head and neck squamous cell carcinoma (HNSCC). Keytruda may be used when your head and neck cancer continues to progress during or after platinum-containing chemotherapy.
• a kind of urinary tract and bladder cancer called urothelial carcinoma. This medication may be used when your urinary tract cancer or bladder:
  • has spread or cannot be removed by surgery and,
  • you are not able to receive chemotherapy that contains a medicine called cisplatin, or
  • you have received chemotherapy that contains platinum, and it did not work or is no longer working.
• a kind of cancer that is shown to be a microsatellite instability-high (MSI-H) or a mismatch repair deficient (dMMR) solid tumor which is shown by a laboratory test. This medication may be used in adults and children to treat:
  • cancer that has spread or cannot be removed by surgery, and
  • has worsened after receiving treatment, and you no longer have satisfactory treatment options, or
  • you have rectal or colon cancer, and you have received chemotherapy (fluoropyrimidine, oxaliplatin, and irinotecan) but it did not work or is no longer working.
• locally advanced or metastatic gastric (stomach) cancer whose tumors express PD-L1 and have failed two or more previous types of therapy.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Pembrolizumab may be found in some form under the following brand names:

• Keytruda

Serious side effects have been reported with pembrolizumab. See the “Pembrolizumab Precautions” section.

Common side effects of pembrolizumab include the following:

• fatigue
• cough
• nausea
• itchy skin
• rash
• decreased appetite
• constipation
• joint pain
• diarrhea

This is not a complete list of pembrolizumab side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

No drug interactions have been conducted by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with pembrolizumab including:

• Infusion-related reactions. The doctor may need to stop treatment.
• Fetal harm. Pembrolizumab can cause harm to your unborn baby. 
• Pneumonitis (inflammation of the lung tissue). Tell your healthcare provider right away if you have some or all of the following symptoms of pneumonitis.
  • new or worsening cough
  • chest pain
  • shortness of breath
• Colitis. Tell your healthcare provider right away if you have some or all of the following symptoms of colitis.
  • diarrhea
  • severe abdominal pain
• Problems in other organs. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • rash
  • changes in eyesight
  • severe or persistent muscle or joint pains
  • severe muscle weakness
  • low red blood cells (anemia)
• Hepatitis. Tell your healthcare provider right away if you have some or all of the following symptoms of hepatitis.
  • jaundice
  • severe nausea or vomiting
  • easy bruising or bleeding
• Hypophysitis. Tell your healthcare provider right away if you have some or all of the following symptoms of hypophysitis.
  • persistent or unusual headache
  • extreme weakness
  • dizziness or fainting
  • vision changes
• Nephritis (inflammation of the kidney). Tell your healthcare provider right away if you have some or all of the following symptoms of nephritis.
  • swelling of the body (face, ankles, feet)
  • decreased urine output
  • rash
  • changes in blood pressure
  • fatigue
• Hyperthyroidism. Tell your healthcare provider right away if you have some or all of the following symptoms of hyperthyroidism.
  • Increased sweating
  • heat intolerance
  • difficulty sleeping
  • fast and irregular heartbeat
  • goiter, which is an enlarged thyroid that may cause the neck to look swollen
• Hypothyroidism. Tell your healthcare provider right away if you have some or all of the following symptoms of hypothyroidism.
  • Hard stools or constipation
  • Feeling cold
  • Fatigue or weakness
  • Paleness or dry skin
  • Sadness or depression
  • Thin, brittle hair or fingernails
  • Weight gain
  • Slower heart rate

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of pembrolizumab, there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving pembrolizumab, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to pembrolizumab or to any of its ingredients
• have kidney problems
• have liver problems
• have hepatitis
• have thyroid problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Pembrolizumab falls into category D. Based on the mechanism of action of pembrolizumab, pembrolizumab may cause fetal harm when administered to a pregnant woman. Animal reproduction studies have not been done with pembrolizumab. Based on how this medication works, the potential risks of administering pembrolizumab during pregnancy includes an increased rates of abortion or still births.

Since pembrolizumab may cause fetal harm, women of child bearing age should use highly effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if pembrolizumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pembrolizumab.

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Your doctor may reduce the dose of pembrolizumab or even discontinue the medication if you experience certain adverse drug reactions.

If you miss a dose, be sure to make a follow up appointment.

Receive this medication exactly as prescribed by your doctor. 

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your weight

The recommended dose of Keytruda (pembrolizumab) for the treatment of melanoma is 2 mg/kg over 30-minute infusion every 3 weeks.

The recommended dose of Keytruda (pembrolizumab) for the treatment of non-small cell lung cancer is 200 mg over 30-minute infusion every 3 weeks. 

The recommended dose of Keytruda (pembrolizumab) for the treatment of patients with recurrent or advanced head and neck cancer is 200 mg over 30-minute infusion every 3 weeks.

The recommended dose of Keytruda (pembrolizumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) is:

• Adults: 200 mg every 3 weeks 
• Children: 2 mg/kg (up to 200 mg) every 3 weeks 

The recommended dose of Keytruda (pembrolizumab) for the treatment of urinary tract and bladder cancer called urothelial carcinoma is 200 mg every 3 weeks. 

The recommended dose of Keytruda (pembrolizumab) for the treatment of MSI-H Cancer is 200 mg every 3 weeks for adults and 2 mg/kg (up to 200 mg) every 3 weeks for children.

The recommended dose of Keytruda (pembrolizumab) for the treatment of gastric (stomach) cancer is 200 mg every 3 weeks.

Your doctor may reduce the dose if you experience certain adverse drug reactions.

If pembrolizumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

It is important you keep all scheduled appointments for blood work or other laboratory tests.