Keytruda: Uses, Dosage, Interactions, Side Effects, Precautions!

Melanoma

• for patients who have melanoma that cannot be removed by surgery or has spread to other parts of the body. (1.1)
• for adults and children (12 years and older) who have melanoma that has been removed by surgery but may come back. (1.1)

Non-Small Cell Lung Cancer (NSCLC)

• with pemetrexed and platinum drugs, as the first treatment for patients who have non-squamous NSCLC that has spread to other parts of the body and does not have changes in EGFR or ALK genes. (1.2)
• with carboplatin and either paclitaxel or paclitaxel protein-bound, as the first treatment for patients who have squamous NSCLC that has spread to other parts of the body. (1.2)
• alone, as the first treatment for patients who have NSCLC that shows PD-L1 [Tumor Proportion Score (TPS) ?1%] as tested by an FDA-approved test, and does not have changes in EGFR or ALK genes, and is:

o Stage III and cannot be treated with surgery or strong

chemoradiation, or

o has spread to other parts of the body. (1.2, 2.1)

• alone, for patients who have NSCLC that shows PD-L1 (TPS ?1%) as tested by an FDA-approved test, and has gotten worse after treatment with platinum drugs. Patients who have changes in EGFR or ALK genes should get worse on FDA-approved treatment for these changes before getting KEYTRUDA. (1.2, 2.1)
• alone, after surgery and treatment with platinum drugs for adult patients who have Stage IB (T2a ?4 cm), II, or IIIA NSCLC. (1.2)

Head and Neck Squamous Cell Cancer (HNSCC)

• with platinum and FU as the first treatment for patients who have HNSCC that has spread to other parts of the body or cannot be removed by surgery and has come back. (1.3)
• alone, as the first treatment for patients who have HNSCC that has spread to other parts of the body or cannot be removed by surgery and has come back and shows PD-L1 [Combined Positive Score (CPS) ?1] as

What is Keytruda?

Keytruda (pembrolizumab) injection is a kind of medicine that helps your body’s defense system to fight cancer cells. Pembrolizumab is a special medicine that stops the PD-1 (programmed death receptor-1) receptor from letting cancer cells hide from your body’s defense system.

Keytruda can be used by itself or with other medicines to treat some kinds of cancer such as:

• skin cancer (melanoma, Merkel cell carcinoma, squamous cell carcinoma);
• lung cancer;
• cancer of the head and neck;
• a type of blood cancer called classical Hodgkin lymphoma;
• a type of chest cancer called primary mediastinal large B-cell lymphoma;
• cancer of the kidney, bladder, and urinary tract;
• cancer of the colon or rectum;
• liver cancer;
• a type of breast cancer that does not have certain hormones or genes;
• cancer of the cervix or uterus;
• advanced cancer of the stomach or esophagus; or
• a type of cancer that has certain specific DNA changes that can be tested in a lab.”

Keytruda is a medicine that goes into your blood through a needle, usually once every 3 to 6 weeks. A doctor or nurse will put the needle in your arm.

This medicine needs to go in slowly for 30 minutes.

You will need to see your doctor often to check if Keytruda is working well for you. Do not skip any appointments.

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• Keytruda 

Generic name: pembrolizumab [ PEM-broe-LIZ-ue-mab ]

Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Medically reviewed by Judith Stewart, BPharm. Last updated on May 17, 2023.

• Uses
• Warnings
• Before taking
• Side effects
• Interactions
• Dosage
• FAQ

Keytruda (pembrolizumab) injection is a kind of medicine called monoclonal antibodies. Pembrolizumab helps your immune system to slow down or stop the growth and spread of cancer cells in your body. Pembrolizumab is a type of immunotherapy that blocks the PD-1 (programmed death receptor-1) receptor which helps it stop cancer cells from hiding from the immune system.

Keytruda is used by itself or with other medicines to treat some types of cancer such as:

• skin cancer (melanoma, Merkel cell carcinoma, squamous cell carcinoma);
• lung cancer;
• head and neck cancer;
• classical Hodgkin lymphoma;
• primary mediastinal large B-cell lymphoma;
• cancer of the kidney, bladder, and urinary tract;
• colorectal cancer;
• liver cancer;
• triple-negative breast cancer;
• cancer of the cervix or uterus;
• advanced stomach or esophageal cancer; or

a type of cancer that laboratory testing shows to have certain specific DNA mutations.

Keytruda is often given when the cancer has spread to other parts of the body, or cannot be treated with surgery or radiation, 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 been tested for a specific genetic marker (including “EGFR,” “ALK,” “HER2/neu,” or “TMB”). Your doctor will review your specific type of cancer and past treatment history and other available treatments to decide if Keytruda is right for you.

Warnings

Keytruda can cause serious or life-threatening side effects. Some side effects may happen during the injection. 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 decide if it is safe for you to keep getting Keytruda.

Call your doctor right away 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, yellowing of the skin or eyes, a hormonal disorder, or a change in the amount or color of your urine.

Before taking this medicine

To make sure Keytruda is safe for you, tell your doctor if you have ever had:

• a problem with your immune system such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, lupus, or psoriasis;
• received or plan to receive a stem cell transplant that uses donor stem cells;
• an organ transplant;
• radiation to your chest; or

a nerve-muscle problem such as myasthenia gravis or Guillain-Barré syndrome.

Pembrolizumab may harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while using Keytruda and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 4 months after your last dose.

Keytruda pregnancy and breastfeeding warnings (more detail)

How is Keytruda given?

Keytruda is given as an infusion into a vein, usually once every 3 to 6 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly over 30 minutes.

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

Detailed Keytruda dosage information

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Keytruda injection.

What happens if I

Keytruda is a medicine that fights against different kinds of cancer, such as:

• skin cancer,
• lung cancer,
• blood cancer,
• bladder and urinary tract cancer,
• cancer in the head and neck area,
• kidney cancer,
• cancer in the food pipe or stomach area,
• a type of breast cancer that is hard to treat,
• cancer in the womb lining,
• cancer in the cervix (the lower part of the womb),
• some cancers that have a problem with their DNA repair system, such as:
• cancer in the colon or rectum (the last part of the gut),
• cancer in the womb lining,
• cancer in the stomach, small intestine, bile ducts or gallbladder.

Keytruda is mostly used for adults who have cancers that are very serious, have spread to other parts of the body, have come back after treatment or cannot be removed by surgery. Keytruda is also used for children over 3 years old who have blood cancer, and for teenagers over 12 years old who have skin cancer. In some cancers, Keytruda is only given to patients who have a certain amount of a protein called PD-L1 in their tumours or have cancers with a problem with their DNA repair system.

Keytruda is also used to help stop the cancer from coming back after patients had surgery to take out skin cancer or kidney cancer. For food pipe cancer, cervix cancer and breast cancer, Keytruda is used together with chemotherapy or other medicines that fight against cancer. In some patients with breast cancer, Keytruda can be given before and after surgery. It can be used alone or with other medicines for lung cancer, head and neck cancer, womb lining cancer and kidney cancer. For the other cancers, Keytruda is only used alone.”

Keytruda is a medicine that helps fight cancer. You get it through a tube that goes into your vein. The amount of Keytruda you get depends on your weight and how often you get it. You can get it every three weeks or every six weeks.

Sometimes, the doctor may change the schedule or stop the medicine if it causes problems for you. Before you start Keytruda, the doctor may do some tests to see if it is right for you.

You need a prescription to get Keytruda and only a cancer doctor can give it to you. For more details about Keytruda, read the leaflet that comes with it or ask your doctor or pharmacist.”

Skin cancer (melanoma)

Keytruda can help stop skin cancer from getting worse and make patients live longer. A study of 540 patients who had skin cancer before and got treatment showed that after 2 years, the cancer did not grow in 16% of patients who got Keytruda, but it did in almost all patients who got chemotherapy.

Another study looked at 834 patients with skin cancer who got either Keytruda or another medicine, ipilimumab. Patients who got Keytruda had no cancer growth for up to 5.6 months, but patients who got ipilimumab only had 2.8 months. Also, up to 74% of patients who got Keytruda were still alive after 12 months, but only 59% of patients who got ipilimumab.

A third study in 1,019 patients who had surgery and were at high risk of their cancer coming back compared Keytruda to placebo (a fake treatment). After one and a half years, 72% of patients who had Keytruda had no cancer, but only 54% of patients who had placebo.

Another study compared Keytruda to placebo in 976 patients who had not been treated before and had surgery to remove their cancer. After 14.3 months, 11% of patients who got Keytruda had their cancer come back or died, but about 17% of those who got placebo.

Because skin cancer in teenagers is like the disease in adults, Keytruda is expected to work the same in teenagers as it does in adults. The data from adults can be used for teenagers too.

Lung cancer (NSCLC)

Keytruda is also good at stopping lung cancer from getting worse and making patients live longer if their cancer cells have the PD-L1 protein. In a study of about 1,000 patients who had treatment before, patients lived longer with Keytruda alone (about 11 months) than with another cancer medicine called docetaxel (about 8 months) and the time without cancer growth was about 4 months with both treatments. Keytruda worked better in patients who had a lot of PD-L1, with these patients living for 15 months on average, 5 months of which with no cancer growth.

In a second lung cancer study of 305 patients whose tumours had a lot of PD-L1 and who had not been treated before, patients on Keytruda had no cancer growth for about 10 months, but patients on platinum-based chemotherapy only had 6 months.

Keytruda is also good at working with other treatments for a type of NSCLC called ‘non-squamous’ cancer, based on the kind of cancer cells involved. In a study of 616 patients with non-squamous NSCLC that had spread, 69% of patients taking Keytruda with pemetrexed and platinum chemotherapy were alive at 11 months, compared with less than half of patients who only had pemetrexed and platinum chemotherapy. Also, patients who had Keytruda treatment had no cancer growth for 8.8 months on average, but patients who did not have Keytruda only had 4.9 months.

In another study of 559 patients with ‘squamous’ NSCLC that had spread, patients who got Keytruda with carboplatin and paclitaxel or nab-paclitaxel lived on average for 15.9 months, but patients who got placebo with carboplatin and paclitaxel or nab-paclitaxel only lived for 11.3 months. Patients in the Keytruda group had no cancer growth for about 6 months on average, but patients in the placebo group only had 4.8 months.

Hodgkin lymphoma

Keytruda can get rid of some or all of the cancer cells in classical Hodgkin lymphoma that did not get better or came back after previous treatment.

In a main study of 210 adult patients, Keytruda made the cancer go away completely or partly in 71% of the patients; a complete remission happened in 28% of them, meaning they had no more

Kidney cancer

In a research of 861 people with kidney cancer, patients who got Keytruda with another kidney cancer medicine, axitinib, had no growth of their cancer for about 15 months, compared with 11 months for patients who got another kidney cancer medicine, sunitinib, which was used to compare. Keytruda also helps patients with kidney cancer live longer. After 18 months, 81% of the patients who got both medicines were alive, compared with 71% in the sunitinib group.

Another research, with 1,069 people, with kidney cancer compared the effects of Keytruda or everolimus with lenvatinib with the effects of sunitinib. In this research, patients in the Keytruda plus lenvatinib group had no growth of their cancer for about 24 months, while those in the sunitinib group had no growth of their cancer for 9 months.

A third research looked at the effect of Keytruda after surgery in 994 people who had a higher chance of their cancer coming back. After one year, the chance of being alive without the cancer coming back was 86% for patients who got Keytruda treatment compared with 76% for patients who got placebo. After two years, the numbers were 77% for those who got Keytruda and 68% for those who got placebo.

Oesophageal cancer

A main research of 749 people with oesophageal cancer that was advanced or had spread compared Keytruda plus chemotherapy with placebo plus chemotherapy.

Keytruda treatment mainly helped patients whose cancer made high levels of PD-L1. Among these patients, those who got Keytruda lived on average for about 14 months while those who had placebo lived for 9 months. Also, those in the Keytruda group had no growth of their disease for 8 months, compared with 6 months for those in the placebo group.

Triple-negative breast cancer

A main research of 1,174 people with high-risk early stage triple negative breast cancer compared the effects of giving Keytruda before (neoadjuvant treatment) and after (adjuvant treatment) surgery with the effects of giving placebo before and after surgery. All people in the research, whose cancer was locally advanced and at risk of coming back, also had chemotherapy before surgery. The result was that 64% of people who got Keytruda neoadjuvant treatment had no signs of invasive cancer in the breast tissue taken out during surgery compared with 55% of people treated with placebo. Also, after 24 months the chance of being alive without the disease coming back was 88% for people who had Keytruda as neoadjuvant and adjuvant treatment, compared with 81% for those treated with placebo.

Another main research compared Keytruda plus chemotherapy with placebo and chemotherapy in 847 people with untreated triple-negative breast cancer that could not be removed surgically or had spread. Among people with high levels of PD-L1, those in the Keytruda group had no growth of their disease for almost 10 months, while those in the placebo group had no growth of their disease for 5 months. When the research looked at survival (how long they lived), those in the Keytruda group lived longer: 23 months compared with 16 months.”

Cancer of the womb lining

A research of 827 people with cancer of the womb lining compared Keytruda plus lenvatinib with drugs that kill cancer cells (doxorubicin or paclitaxel). People in the Keytruda group stayed for around 7 months without their cancer getting worse, while people in the drugs group stayed for almost 4 months without their cancer getting worse. Also, when the research looked at how long they lived, people in the Keytruda group lived on average for around 18 months compared with 11 months for people in the drugs group.

Cancer of the cervix

Keytruda given with other cancer treatments is also helpful in people with cancer of the cervix that came back after previous treatment or has spread and tested positive for PDL-1 protein.

People who got Keytruda, together with drugs that kill cancer cells, with or without another cancer medicine called bevacizumab, lived on average 10.4 months without their cancer getting worse (273 people) compared with 8.2 months for those who got only drugs that kill cancer cells, with or without bevacizumab (275 people). Also, early data from the research show people who got Keytruda living longer that those who did not.

M2SI-H or dMMR cancers

A main research compared Keytruda with usual treatment, including drugs that kill cancer cells, in 307 people with MSI-H or dMMR colorectal cancer that had spread and who did not get any previous treatment for their cancer. People who got Keytruda stayed for around 17 months without the cancer getting worse compared with 8 months for people who got usual treatments.

Two more researches looked at the effect of Keytruda in people with other MSI-H or dMMR cancers that had spread and came back after previous treatments. Among the people taking part in the research, 124 had a colorectal cancer, 83 had a cancer of the womb lining, 51 had a stomach cancer, 27 had a cancer of the small intestine and 22 had a bile duct cancer.

The part of people whose cancer reacted to Keytruda treatment was about 34% in people with colorectal cancer, 51% in people with cancer of the womb lining, 37% in people with stomach cancer, 56% in people with a small intestine cancer and 41% in those with bile duct cancer.