Description

What is Keytruda

Keytruda (pembrolizumab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Keytruda is used alone or in combination with other medicines to treat certain types of cancer such as:

• advanced skin cancer (melanoma or Merkel cell carcinoma);
• lung cancer;
• small cell lung cancer;
• head and neck cancer;
• classical Hodgkin lymphoma in adults and children;
• primary mediastinal large B-cell lymphoma;
• cancer of the kidney, bladder, and urinary tract;
• liver;
• cancer of the cervix or uterus;
• advanced stomach cancer if your tumor tests positive for “PD-L1” and has a specific genetic marker (an abnormal “HER2/neu” gene);
• a type of cancer called squamous cell carcinoma of the esophagus;
• a type of liver cancer called hepatocellular carcinoma, after you have received the medicine sorafenib;
• a type of kidney cancer called renal cell carcinoma (RCC) when used in combination with the medicine axitinib; or
• a type of uterine cancer called endometrial carcinoma when used in combination with the medicine lenvatinib.

Keytruda is often given when the cancer has spread to other parts of the body, or cannot be surgically removed, or when other cancer treatments did not work or have stopped working.

For some types of cancer, Keytruda is given only if your tumor tests positive for “PD-L1”, or if the tumor has a specific genetic marker (an abnormal “EGFR,” “ALK,” or “HER2/neu” gene).

Important Information

Keytruda can change the way your immune system works, which may cause certain side effects that can lead to serious medical problems.

Keytruda can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed. You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda.

Call your doctor at once if you have: skin problems, vision problems, fever, swollen glands, neck stiffness, chest pain, cough, shortness of breath, muscle or joint pain, pale skin, weakness, diarrhea, severe stomach pain, blood in your stools, bruising or bleeding, dark urine, yellowing of the skin or eyes, a hormonal disorder (frequent headaches, feeling light-headed, rapid heartbeats, a deeper voice, increased thirst or urination, feeling cold, weight gain or loss), or a change in the amount or color of your urine.

Before taking this medicine

Tell your doctor if you have ever had:

• lung disease or a breathing disorder;
• liver disease;
• diabetes, or a thyroid disorder;
• an autoimmune disorder such as lupus, Crohn’s disease, or ulcerative colitis; or
• an organ transplant or stem cell transplant.

You may need to have a negative pregnancy test before starting this treatment. Do not use Keytruda if you are pregnant. Pembrolizumab could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose. Tell your doctor right away if you become pregnant.

Do not breast-feed while using pembrolizumab, and for at least 4 months after your last dose.

How is Keytruda given?

Keytruda is given as an infusion into a vein, usually once every 3 weeks. A healthcare provider will give you this injection.

Your doctor will perform a blood test to make sure Keytruda is the right treatment for your condition.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits.

Keytruda dosing information

Usual Adult Dose of Keytruda for Melanoma – Metastatic:

200 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Usual Adult Dose of Keytruda for Non-Small Cell Lung Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Comments:
-When administering this drug in combination with chemotherapy, it should be administered prior to chemotherapy when given on the same day.

Usual Adult Dose of Keytruda for Head and Neck Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose for Hodgkin’s Disease:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose of Keytruda for Urothelial Carcinoma:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose for Colorectal Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Usual Adult Dose of Keytruda for Solid Tumors:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Usual Adult Dose for Gastric Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose of Keytruda for Cervical Cancer:

Tell your doctor if you have ever had:

• lung disease or a breathing disorder;
• liver disease;
• diabetes, or a thyroid disorder;
• an autoimmune disorder such as lupus, Crohn’s disease, or ulcerative colitis; or
• an organ transplant or stem cell transplant.

You may need to have a negative pregnancy test before starting this treatment. Do not use Keytruda if you are pregnant. Pembrolizumab could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose. Tell your doctor right away if you become pregnant.

Do not breast-feed while using pembrolizumab, and for at least 4 months after your last dose.

How is Keytruda given?

Keytruda is given as an infusion into a vein, usually once every 3 weeks. A healthcare provider will give you this injection.

Your doctor will perform a blood test to make sure Keytruda is the right treatment for your condition.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Keytruda. Do not miss any follow-up visits.

Keytruda dosing information

Usual Adult Dose of Keytruda for Melanoma – Metastatic:

200 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.

Usual Adult Dose of Keytruda for Non-Small Cell Lung Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Comments:
-When administering this drug in combination with chemotherapy, it should be administered prior to chemotherapy when given on the same day.

Usual Adult Dose of Keytruda for Head and Neck Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose for Hodgkin’s Disease:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose of Keytruda for Urothelial Carcinoma:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose for Colorectal Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Usual Adult Dose of Keytruda for Solid Tumors:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression

Usual Adult Dose for Gastric Cancer:

200 mg IV over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.

Usual Adult Dose of Keytruda for Cervical Cancer:

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Keytruda side effects (some are more likely with combination chemotherapy) may include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• low sodium levels, abnormal liver function or thyroid function tests;
• fever, feeling weak or tired;
• cough, hoarse voice, feeling short of breath;
• itching, rash, or hair loss;
• increased blood pressure;
• pain in your muscles, bones, or joints; or
• soreness in or around your mouth, nose, eyes, throat, or vagina.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Keytruda?

Other drugs may interact with Keytruda, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use Keytruda only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.