Keytruda

Generic name: pembrolizumab [ PEM-broe-LIZ-ue-mab ]
Drug class: Anti-PD-1 monoclonal antibodies

What is Keytruda?

Keytruda 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:

melanoma ;
non-small cell lung cancer (NSCLC);
head and neck squamous cell cancer (HNSCC);
classical Hodgkin lymphoma (cHL);
primary mediastinal B-cell lymphoma (PMBCL);
urothelial carcinoma ;
microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors ;
microsatellite instability-high (MSI-H) or mismatch repair deficient colorectal cancer ;
gastric cancer ;
esophageal cancer ;
cervical cancer ;
hepatocellular carcinoma ;
Merkel cell carcinoma ;
renal cell carcinoma ;
endometrial carcinoma ;
tumor mutational burden-high (TMB-H) cancer;
cutaneous squamous cell carcinoma ; or
triple-negative breast cancer .

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, pembrolizumab 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”).

Warnings

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 adrenal gland 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 breastfeed 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 or every 6 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.

Dosing information

Usual Adult Dose for Malignant Melanoma:

Monotherapy for unresectable or metastatic melanoma: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression or unacceptable toxicity

Adjuvant treatment of melanoma: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

Uses:
-Treatment of patients with unresectable or metastatic melanoma
-Adjuvant treatment of patients with melanoma with Stage IIB, IIC, or III melanoma following complete resection.

Usual Adult Dose for Melanoma — Metastatic:

Usual Adult Dose for Non-Small Cell Lung Cancer:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
-Administer this drug prior to chemotherapy when given on the same day

Uses:
-As a single agent for the first-line treatment of patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (Tumor Proportion Score [TPS] 1% or greater) as determined by an FDA-approved test with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation OR metastatic
-As a single agent for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1% or greater) as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy; patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving this drug
-In combination with pemetrexed and platinum chemotherapy for first-line treatment of metastatic NSCLC with no EGFR or ALK genomic tumor aberrations.
-In combination with carboplatin and either paclitaxel or paclitaxel protein-bound for first-line treatment of patients with metastatic squamous NSCLC.

Usual Adult Dose for Head and Neck Cancer:

Usual Adult Dose for Hodgkin’s Disease:

Usual Adult Dose for Lymphoma:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with refractory primary mediastinal large B-cell lymphoma (PMBCL) or who have relapsed after 2 or more prior lines of therapy (not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy)

Usual Adult Dose for Urothelial Carcinoma:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-This drug is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Uses:
-For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-containing chemotherapy
-For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Usual Adult Dose for Bladder Cancer:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until persistent or recurrent high-risk non-muscle invasive bladder cancer (NMIBC), disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, NMIBC with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy

Usual Adult Dose for Colorectal Cancer:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Uses:
-For treatment of patients with unresectable or metastatic microsatellite instability-high MSI-H or mismatch repair deficient dMMR colorectal cancer (CRC).

Usual Adult Dose for Gastric Cancer:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
-Administer this drug prior to trastuzumab and chemotherapy when given on the same day

Comments:
-These indications are approved under accelerated approval based on tumor response rate and durability of response; continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Uses:
-In combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
-As a single agent for patients with recurrent locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 Positive Score (CPS) 1 or greater as determined by an FDA-approved test, with disease progression on or after 2 or more prior lines of therapy including fluoropyrimidine-and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy

Usual Adult Dose for Cervical Cancer:

Usual Adult Dose for Hepatocellular Carcinoma:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
– This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Use: For the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib

Usual Adult Dose for Merkel Cell Carcinoma:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Use: For the treatment of patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)

Usual Adult Dose for Renal Cell Carcinoma:

Adjuvant treatment of renal cell carcinoma (RCC): 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
-Administer this drug in combination with axitinib 5 mg orally twice a day OR lenvatinib 20 mg orally once a day

Comments:
-When axitinib is used in combination with this drug, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer.

Uses:
-In combination with axitinib for the first-line treatment of advanced RCC.
-In combination with lenvatinib, for the first-line treatment of adult patients with advanced RCC.
-For the adjuvant treatment of patients with RCC at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

Usual Adult Dose for Esophageal Carcinoma:

Usual Adult Dose for Endometrial Carcinoma:

COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
-Administer this drug with lenvatinib 20 mg orally once a day

Comments:
-Patients should be selected for combination treatment with lenvatinib based on MSI or MMR status in tumor specimens.

Use: In combination with lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation

Usual Adult Dose for Squamous Cell Carcinoma:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC that is not curable by surgery or radiation

Usual Adult Dose for Breast Cancer:

For treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery:
COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes; administer this drug prior to chemotherapy when given on the same day
-Neoadjuvant treatment in combination with chemotherapy for 24 weeks (8 doses of 200 mg every 3 weeks or
4 doses of 400 mg every 6 weeks) or until disease progression or unacceptable toxicity
-Follow with adjuvant treatment as a single agent for up to 27 weeks (9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks) or until disease recurrence or unacceptable toxicity

For the treatment of patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 (CPS 10 or greater) as determined by an FDA-approved test:
COMBINATION THERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months
-Administer this drug prior to chemotherapy when given on the same day

Comments:
-Patients who experience disease progression or unacceptable toxicity related to this drug with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent therapy with this drug.

Usual Adult Dose for Solid Tumors:

MONOTHERAPY: 200 mg IV every 3 weeks OR 400 mg IV every 6 weeks
-Administer as IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-Because the effect of prior chemotherapy on test results for tumor mutation burden (TMB-H), MSI-H, or dMMR in patients with high-grade gliomas is unclear, it is recommended to test for these markers in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
-This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Uses:
-For the treatment of patients with unresectable or metastatic TMB-H (10 mutations/megabase or greater) solid tumors, as determined by an FDA-approved test that have progressed following prior treatment and who have no satisfactory alternative treatment options.
-For the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Usual Pediatric Dose for Hodgkin’s Disease:

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg
-Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Use: For the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy

Usual Pediatric Dose for Lymphoma:

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg
-Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Uses:
-For the treatment of pediatric patients 6 months or older with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy (this drug is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy)

Usual Pediatric Dose for Merkel Cell Carcinoma:

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg
-Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Use: For the treatment of pediatric patients 6 months or older with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC)

Usual Pediatric Dose for Solid Tumors:

MONOTHERAPY: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg
-Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 24 months

Comments:
-Because the effect of prior chemotherapy on test results for tumor mutation burden (TMB-H), MSI-H, or dMMR in patients with high-grade gliomas is unclear, it is recommended to test for these markers in the primary tumor specimens obtained prior to initiation of temozolomide chemotherapy in patients with high-grade gliomas.
-The safety and effectiveness in pediatric patients with MSI-H central nervous system cancers have not been established.
-This indication is approved under accelerated approval based on tumor response rate and durability of response; continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Uses:
-For the treatment of patients with unresectable or metastatic TMB-H (10 mutations/megabase or greater) solid tumors, as determined by an FDA-approved test that have progressed following prior treatment and who have no satisfactory alternative treatment options.
-For the treatment of patients with unresectable or metastatic, MSI-H or dMMR solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options.

Usual Pediatric Dose for Malignant Melanoma:

12 years or older:
Adjuvant treatment of melanoma: 2 mg/kg IV every 3 weeks; Maximum dose: 200 mg
-Administer as an IV infusion over 30 minutes until disease progression, unacceptable toxicity, or up to 12 months

Use: Adjuvant treatment of pediatric patients 12 years or older with Stage IIB, IIC, or III melanoma following complete resection.

Usual Pediatric Dose for Melanoma — Metastatic:

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 overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving Keytruda?

Pembrolizumab can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient’s body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Keytruda side effects

Get emergency medical help if you have signs of an allergic reaction to Keytruda: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, light-headed, itchy, hot, sweaty, chilled, or have trouble breathing.

Pembrolizumab affects your immune system, and can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine.

Call your doctor at once if you have:

sores in your mouth, throat, or nose, or on your genital area;
eye pain or vision problems;
numbness, tingling, burning pain, redness, rash, or blisters on your hands or feet;
severe muscle weakness, severe or ongoing muscle or joint pain;
fever, swollen glands, neck stiffness;
diarrhea or increased stools, severe stomach pain, bloody or tarry stools;
a change in the amount or color of your urine;
liver problems – loss of appetite, right-sided stomach pain, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
low levels of sodium in the body – confusion, slurred speech, severe weakness, loss of coordination, feeling unsteady; or
signs of a hormonal disorder – frequent or unusual headaches, feeling light-headed, rapid heartbeats, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation , hair loss , muscle pain, sweating, feeling cold, weight changes.

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.

Keytruda side effects (more detail)

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.

source :: https://www.drugs.com/keytruda.html

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