Generic name: Pembrolizumab

Keytruda® is the trade name for the generic drug pembrolizumab. In some cases, health care professionals may use the generic name pembrolizumab when referring to the trade drug name Keytruda®.

Drug type : Keytruda® is a monoclonal antibody- (For more detail, see "How this drug works," below).

What Keytruda Is Used For:

• Treatment of recurrent or metastatic cervical cancer in patients whose tumors express PD-L1 (combined positive score [CPS] ≥ 1), as determined by an approved test, and with disease progression on or after chemotherapy.
• Treatment of recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma in patients whose tumors express PD-L1 (CPS ≥ 1), as determined by an approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy, and if appropriate, HER2/neu-targeted therapy.
• For the treatment of unresectable or metastatic melanoma.
• For the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection
• Patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy.
• For treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
• Treatment of primary mediastinal large B-cell lymphoma (PMBCL) in adult or pediatric patients with refractory disease who have relapsed after 2 or more prior lines of therapy.
• For treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.
• For treatment of locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.
• For treatment of adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors or colorectal cancer that have progressed following prior treatment.
• For treatment of patients with hepatocellular cancer (HCC) who have been previously treatment with sorafenib.
• For Treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell cancer.
• For first-line treatment plus axitinib of patients with advanced renal cell carcinoma (RCC).
• For treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
• For treatment of patients with advanced esophageal squamous cell cancer whose tumors express PD-L1 as determined by an FDA approved test.
• In combination with the drug lenvatinib for treatment of patients with advanced endometrial cancer.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Keytruda Is Given:

• Keytruda® is given as an intravenous injection through a vein (IV) over 30 minutes every 3 weeks.
• You may receive medications before the infusion to reduce allergic reactions.
• The amount of Keytruda® that you will receive depends on many factors, including your weight, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of Keytruda®:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• A few side effects can occur weeks or months after discontinuation of treatment.
• There are many options to help manage and prevent worsening of side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking Keytruda®:

• Anemia
• Fatigue
• Hyperglycemia
• Hyponatremia
• Hypoalbuminemia
• Itching
• Cough
• Nausea

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Keytruda®:

• Rash
• Decreased appetite
• Hypertriglyceridemia
• Increased liver enzymes
• Hypocalcemia
• Constipation
• Diarrhea
• Arthralgia
• Pain in extremity
• Shortness of breath
• Swelling
• Headache
• Vomiting
• Chills
• Myalgia
• Insomnia
• Abdominal pain
• Back pain
• Fever
• Vitiligo
• Dizziness
• Upper respiratory tract infection

A serious, but uncommon side effect of Keytruda® may be an immune-mediated reaction. When this side effect occurs, it affects primarily the bowels, liver, skin, nerves and the endocrine system. This immune reaction can occur during treatment but can also be seen weeks or months after discontinuation of treatment. Symptoms of this reaction will be monitored throughout treatment (diarrhea, rash, and neuropathy). Lab work will check for elevated liver enzymes and thyroid function.

Contact your health care provider right away if you have any new or worsening symptoms.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° or higher, chills)
• Signs of reaction to the drug (wheezing, chest tightness, itching, bad cough, swelling of the face, lips, tongue or throat)
• New or worsening cough, chest pain, or shortness of breath
• Diarrhea or severe abdominal pain, especially right side
• Blood in your stools or dark stools
• Skin or the whites of your eyes turn yellow
• Persistent or unusual headache, extreme weakness, dizziness or fainting, or vision changes

The following symptoms require medical attention, but are not an emergency. Contact your doctor or health care provider within 24 hours of noticing any of the following:

• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness

• Urine turns dark or brown (tea color)
• Decreased appetite
• Skin rash with or without itching
• Sores in the mouth
• Skin blisters and/or peels
• Numbness or tingling in hands or feet
• Bleed or bruise more easily than normal
• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Keytruda® treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking Keytruda®.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Keytruda® may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Do not conceive a child (get pregnant) while taking Keytruda®. Barrier methods of contraception, such as condoms, are recommended during treatment and for at least 4 months following treatment. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Avoid sun exposure. Wear SPF 30 (or higher) sun block and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Use an electric razor to minimize bleeding
• Get plenty of rest.
• Maintain good nutrition.
• Wash your hands often.
• You may be at risk for infection, report fever or any other signs of infection immediately to your healthcare provider. Try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your healthcare provider.
• Discuss with your health care provider before taking any other medications including over the counter and herbal preparations.
• To help prevent mouth sores use a soft toothbrush, and rinse three times a day with ½ to 1 teaspoon of baking soda and/or ½ to 1 teaspoon of salt mixed with 8 ounces of water.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking Keytruda®, to monitor side effects and check your response to therapy.

How Keytruda Works:

Keytruda® is classified as a monoclonal antibody. Monoclonal antibodies are a relatively new type of “targeted” cancer therapy.

Antibodies are an integral part of the body’s immune system. Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) that has entered the body. The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells (the targets). Then, using animal and human proteins, they create a specific antibody that will attach to the target antigen on the cancer cells. When given to the patient, these monoclonal antibodies will attach to matching antigens like a key fits a lock.

Since monoclonal antibodies target only specific cells, they may cause less toxicity to healthy cells. Monoclonal antibody therapy is usually only given for cancers in which antigens (and the respective antibodies) have been identified already.

Keytruda® is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface. The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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