pembrolizumab
Trade Name:Keytruda®
Appearance:solution
mixed into larger bags of fluids
Monograph Name:pembrolizumab
Monograph Body:
Pembrolizumab is a humanized monoclonal antibody that binds to the programmed death receptor-1 (PD-1), preventing PD-1 pathway-mediated inhibition of tumour immune surveillance by active T-cells and reactivating anti-tumor responses.
AUC increases proportional to dose. Tmax occurs at the end of the IV infusion (30 min). Steady-state is reached by 16 weeks at q3w dosing.
For patients aged 2-6 years, exposure is approximately 1.3 fold higher than in adults. Patients aged < 2 years are predicted to have exposure ~2.2 fold higher than adults.
| Distribution Sites | Confined to extracellular fluid; does not bind to plasma proteins. |
Catabolized through non-specific pathways.
| Half-life | 22 days (terminal elimination) |
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma (RCC)
- Head and neck squamous cell carcinoma (HNSCC)
- Hodgkin lymphoma (HL)
- Primary mediastinal B-cell lymphoma (PMBCL)
- Urothelial / bladder carcinoma
- Colorectal cancer
- Gastric, esophageal or esophagogastric junction cancer
- Endometrial / cervical cancer
- Triple-negative breast cancer (TNBC)
- Malignant pleural mesothelioma (MPM)
- MSI-H or dMMR solid tumours
- Biliary tract carcinoma
(Includes conditional approvals)
Refer to the product monograph for a full list and details of approved indications.
Emetogenic Potential:
Extravasation Potential: None
The following drug related adverse effects were reported in ≥ 1% of patients in adjuvant melanoma who received pembrolizumab 200 mg q3 weeks. Incidences of some immune-related effects were based on pembrolizumab monotherapy clinical studies in various tumour types (marked with "^"). Rare, severe or life-threatening side effects from other trials or post-marketing are also included.
| ORGAN SITE | SIDE EFFECT* (%) | ONSET** | |||
|---|---|---|---|---|---|
| Cardiovascular | Myocarditis (rare) | E D | |||
| Pericarditis (<1%) | E D | ||||
| Dermatological | Dry skin (4%) | E | |||
| Rash, pruritus (17%) (may be severe) | E | ||||
| Skin hypopigmentation (5%) (including vitiligo) | E | ||||
| Stevens-Johnson syndrome (rare) | E | ||||
| Toxic epidermal necrolysis (rare) | E | ||||
| Gastrointestinal | Anorexia, weight loss (5%) | E | |||
| Diarrhea (19%) (1% severe colitis) | E | ||||
| Mucositis (3%) | E | ||||
| Nausea, vomiting (11%) | I E | ||||
| General | Fatigue (28%) | E | |||
| Flu-like symptoms (3%) | I E | ||||
| Sarcoidosis (<1%) | E | ||||
| Hematological | Anemia (6%) | E | |||
| Aplastic anemia (rare) | E | ||||
| Hemolytic anemia (<1%) | E | ||||
| Myelosuppression ± infection, bleeding (18%; in PMBCL) (<10% in other indications; rarely fungal and viral re-activation) | E | ||||
| Other – hemophagocytic lymphohistiocytosis (rare) | E | ||||
| Hepatobiliary | Cholangitis (rare) | E D | |||
| ↑ LFTs (5%) (<1% immune-mediated hepatitis^) | L | ||||
| Other – exocrine pancreatic insufficiency (rare) | E D | ||||
| Pancreatitis (<1%) | E | ||||
| Veno-occlusive disease (in HL patients who received allo HSCT after pembrolizumab) | D | ||||
| Hypersensitivity | Infusion related reaction (<1%) | I E | |||
| Immune | Cytokine release syndrome (2% in Hodgkin lymphoma; <1% in TNBC) | I E | |||
| Graft-versus-host disease (GVHD) (in HL patients who received allo HSCT before or after pembrolizumab) | D L | ||||
| Hemophagocytic lymphohistiocytosis (rare) | E | ||||
| Other (Graft loss - solid organ transplant recipients) (rare) | D | ||||
| Metabolic / Endocrine | Adrenal insufficiency (<1%) ^ | E | |||
| Hyperglycemia (2%) (including type 1 DM <1%^) | E | ||||
| Hyperthyroidism (3%) ^ | E | ||||
| Hypoparathyroidism (<1%) | E | ||||
| Hypopituitarism (<1%) (immune-mediated hypophysitis 1%^) | E | ||||
| Hypothyroidism (9%) ^ | E | ||||
| ↑ Triglycerides (2%) | E | ||||
| Musculoskeletal | Musculoskeletal pain (10%) (rarely myositis, myasthenia) | E | |||
| Nervous System | Encephalitis (<1%) | E | |||
| Guillain-Barre syndrome (<1%) | E | ||||
| Myelitis (<1%) | E | ||||
| Ophthalmic | Eye disorders (2%) (includes visual impairment; rarely uveitis) | E | |||
| Vogt-Koyanagi-Harada syndrome (rare) | E D | ||||
| Renal | Nephritis (<1%) (autoimmune)^ | E | |||
| Nephrotoxicity (<1%) | D | ||||
| Respiratory | Cough, dyspnea (5%) | E | |||
| Pneumonitis (3%) ^ | E D | ||||
| Vascular | Vasculitis (<1%) | E | |||
* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.
** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.
The most common side effects for pembrolizumab include fatigue, diarrhea, rash/pruritus, nausea/vomiting, and musculoskeletal pain.
Immune-mediated pneumonitis, colitis, hepatitis, hypophysitis, other endocrinopathies and nephritis were reported, may be severe and affect more than one body system simultaneously. Onset of immune-mediated reactions is variable and may occur after treatment has ended. Pneumonitis, including fatal cases had a median time to onset of 3.3 months and the median duration was 1.5 months. Pneumonitis occurred more frequently in patients with a history of prior thoracic radiation. Colitis occurred in 1-2% of patients with a median onset of 3.5 months and a median duration of 1.3 months. The median onset for hepatitis was 1.3 months with a median duration of 1.8 months. For nephritis, median onset was 5.1 months and the median duration was 3.3 months. The median onset of hypophysitis was 3.7 months.
Type 1 diabetes mellitus, including ketoacidosis has been reported.
Hyper or hypothyroidism has been reported at any time during treatment. The median onset for hyperthyroidism was 1.4 months and hypothyroidism was 3.5 months.
Severe infusion-related reactions are rare.
Severe skin rashes, including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis have been reported, including fatal reactions.
Graft vs. host disease (GVHD) cases have been reported in patients who received pembrolizumab before or after an allogeneic HSCT. Cases of veno-occlusive disease (VOD) have been observed in patients undergoing allogeneic HSCT after previous pembrolizumab exposure. The benefit-risk of allogeneic HSCT before or after pembrolizumab should be carefully considered.
Atypical treatment responses, including a transient increase in tumour size, followed by shrinkage have been observed.
Higher than expected frequencies of severe ALT and AST elevations have been observed in treatment with pembrolizumab in combination with axitinib, in patients with advanced RCC.
Refer to protocol by which patient is being treated.
Screen for hepatitis B virus in all cancer patients starting systemic treatment. Refer to the hepatitis B virus screening and management guideline.
Avoid the use of corticosteroids or immunosuppressants before starting treatment.
Some treatment indications require a validated test to determine PD-L1 tumour status or MSI-H/dMMR status. Refer to the product monograph for details.
Premedication (prophylaxis for infusion reactions):
- Routine pre-medication is not recommended.
- May consider antipyretic and H1-receptor antagonist in patients who experienced a grade 1-2 infusion reaction.
200 mg† IV every 3 weeks
OR
400 mg† IV every 6 weeks
Note: As atypical responses have been reported, clinically stable patients should continue on treatment until progression is confirmed.
†Health Canada approved dosing. Pembrolizumab weight-based and corresponding fixed dosing have been studied in various cancers, and have been suggested to have similar effects. NDFP funding is available for weight-based dosing (refer to NDFP forms).
Healthcare professionals should also consult the most recent pembrolizumab product monograph for additional information.
There are no dose reductions for pembrolizumab. Doses are either delayed or discontinued with toxicity.
Summary of Principles of Management or immune-related adverse effects (iRAEs)
Immune-related adverse effects (irAEs) are different in their presentation, onset and duration compared to conventional chemotherapy. Patient and provider education is essential.
Initial irAE presentation can occur months after completion of treatment and affect multiple organs.
Dose escalation or reduction is not recommended.
If no other cause can be identified (such as infection), any new symptom should be considered immune-related and prompt treatment initiated.
Organ-specific system-based toxicity management is recommended.
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions of Immune-related toxicities and their management.
HL and PMBCL specific dose modifications:
| Toxicity | Action |
| Grade 4 Hematologic | Hold until resolved to ≤ grade 1. |
RCC specific dose modifications (during treatment in combination with axitinib):
ALT or AST |
| Bilirubin | Action |
≥ 3 to < 10 x ULN | And | < 2 X ULN | Hold pembrolizumab and axitinib until ≤ grade 1. Consider corticosteroids. After recovery, consider re-challenge with a single drug or sequentially with both drugs. |
| > 3 x ULN | And | ≥ 2 x ULN | Discontinue both. Consider corticosteroids. |
≥ 10 x ULN | And | Any |
Management of Infusion-related Reactions:
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
| Grade | Management | Re-challenge |
| 1 or 2 |
Restart:
|
|
| 3 or 4 |
|
|
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions for immune-related hepatitis management.
| Hepatic Impairment | Pembrolizumab Dose |
| Mild (bilirubin 1 - 1.5 x ULN or AST > ULN) | No dose adjustment necessary |
| Moderate (bilirubin >1.5 - 3 x ULN and any AST) | No dose adjustment necessary; limited data |
| Severe (bilirubin > 3 x ULN and any AST) | Caution; no data |
Refer to CCO's Immune Checkpoint Inhibitor Toxicity Management Guideline for detailed descriptions for immune-related nephritis management.
| CrCl (mL/min) | Pembrolizumab Dose |
| ≥ 60 | No dose adjustment necessary |
| 30 to 59 | No dose adjustment necessary |
| < 30 | Caution; no data |
No dosage adjustment is required. No overall differences in safety or efficacy were reported between patients aged 65 and older and younger patients (very limited data for Hodgkin lymphoma).
Refer to the product monograph for comprehensive indications, pre-medication, and dosing information in this population. The safety and efficacy of pembrolizumab has not been established in pediatric patients with conditions other than the approved pediatric indications.
Efficacy in pediatric indications was extrapolated from the results in the respective adult populations and KEYNOTE-051. The developmental effects of pembrolizumab on pediatric patients have not been established.
In a single phase I/II trial that enrolled pediatric patients, immune mediated reactions were similar to those seen in adult patients including pneumonitis, colitis, thyroid disorders (hyperthyroidism, hypothyroidism and thyroiditis) and skin reactions. Infusion reactions were also observed.
Adverse reactions that occurred more frequently among pediatric patients (> 10% increased) in comparison to adult patients include pyrexia, vomiting, abdominal pain, ↓ lymphocyte count, and ↓WBC count.
Dilute in 0.9% sodium chloride or D5W to final concentration of 1 to 10 mg/mL; mix by gentle inversion.
Administer over 30 minutes using sterile, non-pyrogenic, low protein-binding 0.2 to 5 micron in-line or add-on filter.
If given with chemotherapy on the same day, administer pembrolizumab before chemotherapy. (EXCEPTION: Administer enfortumab vedotin before pembrolizumab when both drugs are given on the same day.)
Do not co-administer other drugs through the same infusion line.
If a planned dose is missed, administer as soon as possible. Adjust the schedule to maintain the prescribed dosing interval.
Unopened vials should be stored under refrigeration (2 to 8oC). Protect from light. Do not freeze.
Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
- Patients who have a hypersensitivity to this drug or any of its components.
Other Warnings/Precautions:
- Patients with conditions such as an active infection, autoimmune disease or require systemic immunosuppressive therapy (i.e. transplant patients), a history of pneumonitis, severe immune-mediated adverse reactions with ipilimumab, or severe hypersensitivity to other monoclonal antibodies were excluded from clinical studies.
Pembrolizumab may cause serious immune-mediated reactions affecting multiple organ systems, including GI, hepatic, renal, respiratory, endocrine and others. Use with caution and monitor closely in patients with pre-existing conditions such as colitis, hepatic impairment, respiratory or endocrine disorders, such as hypo or hyperthyroidism or diabetes mellitus.
Patients with ECOG performance status ≥ 2 were excluded from clinical trials.
Use of a PD-1 or PD-L1 blocking antibody with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials, due to increased mortality reported.
Other Drug Properties:
- Carcinogenicity: Unknown
Pregnancy and Lactation:
- Genotoxicity: Unknown
- Fetotoxicity: Probable
- Embryotoxicity: Probable
- Pregnancy:
Pembrolizumab is not recommended for use in pregnancy. Adequate contraception should be used by both sexes during treatment, and for at least 4 months after the last dose.
- Breastfeeding:
Breastfeeding is not recommended during treatment, and for at least 4 months after the last dose.
- Fertility effects: Unknown
Pembrolizumab is not expected to have pharmacokinetic drug-drug interactions as it is not metabolized by drug metabolizing enzymes. No pharmacokinetic drug interaction studies have been performed.
Acetaminophen may affect the response to immune checkpoint inhibitors. Further clinical studies are needed to determine the exact mechanism and the appropriate clinical management (Bessede et al, 2022).
| AGENT | EFFECT | MECHANISM | MANAGEMENT |
|---|---|---|---|
| Systemic corticosteroids / immunosuppressants (e.g. mycophenolate, cyclosporine) | Possible ↓ in anti-tumour effect | ↓ T-cell activation and T-cell mediated immune responses | Avoid, especially at baseline before starting pembrolizumab. Corticosteroids or other immunosuppressants may be used to treat immune reactions after starting pembrolizumab. Corticosteroids may be used as premedication (e.g. antiemetic) when given with chemotherapy. |
| Thalidomide Analogues | ↑ mortality | Unknown | Avoid combination with thalidomide analogues and dexamethasone. |
Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.
Refer to the hepatitis B virus screening and management guideline for monitoring during and after treatment.
| Monitor Type | Monitor Frequency |
|---|---|
CBC | Baseline and Q3-6 weeks, or as clinically indicated |
Liver function tests | Baseline and Q3-6 weeks, or as clinically indicated |
Serum creatinine, urine protein | Baseline and Q3-6 weeks, or as clinically indicated |
Electrolytes | Baseline and as clinically indicated |
Blood glucose | Baseline and as clinically indicated |
Thyroid function tests | Baseline and as clinically indicated |
Blood cortisol (for TNBC in neoadjuvant setting) | Baseline, prior to surgery, and as clinically indicated |
Clinical toxicity assessment for infusion-related and immune-mediated reactions, fatigue, ocular, endocrine, skin, GI, neurologic, musculoskeletal, cardiac and respiratory effects | At each visit |
Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version
New Drug Funding Program (NDFP Website )
- Pembrolizumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) and Prior Ipilimumab
- Pembrolizumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) and No Prior Ipilimumab
- Pembrolizumab - Advanced or Metastatic Non-Small Cell Lung Cancer (Second or Subsequent Line)
- Pembrolizumab - Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Pembrolizumab - In Combination with Platinum and Pemetrexed for First Line Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Pembrolizumab - In Combination with Carboplatin and Paclitaxel for First-Line Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
- Pembrolizumab - In Combination with Axitinib for First Line Advanced or Metastatic Renal Cell Carcinoma
- Pembrolizumab - Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Pembrolizumab - Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
- Pembrolizumab - First Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
- Pembrolizumab (Adult Who Failed Prior Brentuximab Vedotin) - Relapsed Classical Hodgkin Lymphoma Post-Autologous Stem Cell Transplant or ASCT Ineligible
- Pembrolizumab (Adult and Pediatric) - Relapsed Classical Hodgkin Lymphoma Post-Autologous Stem Cell Transplant or ASCT Ineligible
- Pembrolizumab - Previously Untreated High-Risk Early-Stage Triple Negative Breast Cancer
- Pembrolizumab - Adjuvant Treatment for Renal Cell Carcinoma
- Pembrolizumab - Metastatic, Persistent, or Recurrent Carcinoma of the Cervix
- Pembrolizumab - Locally Recurrent Unresectable or Metastatic Triple Negative Breast Cancer
- Pembrolizumab - Previously Treated MSI-H/dMMR Advanced Endometrial Cancer
- Pembrolizumab - In Combination with Lenvatinib for First-Line Advanced or Metastatic Renal Cell Carcinoma
- Pembrolizumab - In Combination with Lenvatinib for Advanced Endometrial Cancer
- Pembrolizumab (Adult and Pediatric) - Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma
- Pembrolizumab - (Neo)adjuvant Treatment for Completely Resectable Stage III or IV Melanoma
- Pembrolizumab and Trastuzumab (Biosimilar) - First-line Treatment of Advanced HER2-Positive Gastric or Esophagogastric Junction Adenocarcinoma
- Pembrolizumab - Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
- Pembrolizumab - First-line Treatment of Advanced HER2-negative Esophageal, Gastric, and Esophagogastric Junction Carcinoma
- Pembrolizumab - Adjuvant Treatment for Non-Small Cell Lung Cancer
- Pembrolizumab (Adult and Pediatric) - Unresectable or Metastatic MSI-H or dMMR Advanced Solid Tumours
- Pembrolizumab - (Neo)adjuvant Therapy for Resectable Non-Small Cell Lung Cancer
- Enfortumab Vedotin with Pembrolizumab - Previously Untreated Locally Advanced Unresectable or Metastatic Urothelial Cancer
- Pembrolizumab - Primary Advanced or Recurrent Endometrial Carcinoma
- Pembrolizumab - Previously Untreated Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
Bessede A, Marabelle A, Guegan JP, et al. Impact of acetaminophen on the efficacy of immunotherapy in cancer patients. Ann Oncol 2022;33(9):909-15.
CADTH technology review: Dosing and timing of immune-oncology drugs. November 2019.
Fay AP, Brandao Moreira R, Nunes Filho PRS, et al. The management of immune-related adverse events associated with immune checkpoint blockade. Expert Rev of Qual Life Cancer Care 2016;1(1):89-97.
Friedman CF, Proverbs-Singh TA, Postow MA. Treatment of the immune-related adverse effects of immune checkpoint inhibitors: a review. JAMA Oncol 2016;2(10):1346-53.
Haanen JBAG, Carbonnel F, Robert C, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142.
Herbst RS, Baas P, Kim DW et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016 Apr 9;387(10027):1540-1550.
Pembrolizumab (Keytruda) product monograph, Merck Canada, April 11, 2025.
Pembrolizumab (Keytruda) prescribing information (U.S.), January 2015.
Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med 2016;375(19):1823-33.
Robert C, Schachter J, Long GV, et al; KEYNOTE-006 investigators. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015 Jun 25;372(26):2521-32.
Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomized dose-comparison cohort of a phase 1 trial. Lancet. 2014 Sep 20;384(9948):1109-17.
Villadolid J and Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Transl Lung Cancer Res 2015;4(5):560-75.
September 2025 Added NDFP forms; Updated Indications, Adverse effects, Dosage with hepatic impairment, Dosing-Children, Administration Guidelines, and Monitoring sections
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.
Bessede A, Marabelle A, Guegan JP, et al. Impact of acetaminophen on the efficacy of immunotherapy in cancer patients. Ann Oncol 2022;33(9):909-15.CADTH technology review: Dosing and timing of immune-oncology drugs. November 2019.Fay AP, Brandao Moreira R, Nunes Filho PRS, et al. The management of immune-related adverse events associated with immune checkpoint blockade. Expert Rev of Qual Life Cancer Care 2016;1(1):89-97.Friedman CF, Proverbs-Singh TA, Postow MA. Treatment of the immune-related adverse effects of immune checkpoint inhibitors: a review. JAMA Oncol 2016;2(10):1346-53.Haanen JBAG, Carbonnel F, Robert C, et al. Management of toxicities from immunotherapy: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2017 Jul 1;28(suppl_4):iv119-iv142.Herbst RS, Baas P, Kim DW et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet. 2016 Apr 9;387(10027):1540-1550.Pembrolizumab (Keytruda) product monograph, Merck Canada, April 11, 2025.Pembrolizumab (Keytruda) prescribing information (U.S.), January 2015.Reck M, Rodríguez-Abreu D, Robinson AG, et al. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med 2016;375(19):1823-33.Robert C, Schachter J, Long GV, et al; KEYNOTE-006 investigators. Pembrolizumab versus Ipilimumab in Advanced Melanoma. N Engl J Med. 2015 Jun 25;372(26):2521-32.Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor-1 treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomized dose-comparison cohort of a phase 1 trial. Lancet. 2014 Sep 20;384(9948):1109-17.Villadolid J and Amin A. Immune checkpoint inhibitors in clinical practice: update on management of immune-related toxicities. Transl Lung Cancer Res 2015;4(5):560-75.
pembrolizumab (patient)
Info Sheet Introduction:- For treating certain types of cancers such as skin (called melanoma), non-small cell lung, head and neck, renal cell (kidney), colorectal, endometrial, cervical, bladder or urinary tract, breast, esophageal and others. It is also used to treat some types of lymphomas.
- Pembrolizumab is an immunotherapy drug. For more information on immunotherapy, click here.
Other Name: Keytruda®
mixed into larger bags of fluids
For treating certain types of cancers such as skin (called melanoma), non-small cell lung, head and neck, renal cell (kidney), colorectal, endometrial, cervical, bladder or urinary tract, breast, esophageal and others. It is also used to treat some types of lymphomas.
Pembrolizumab is an immunotherapy drug. For more information on immunotherapy, click here.
- Tell your health care team if you have or had significant medical condition(s), especially if you have / had:
an organ or stem cell transplant
immune conditions (such as ulcerative colitis or Crohn's, rheumatoid arthritis or lupus)
problems with your hormone producing glands (such as thyroid, pituitary, adrenal glands)
diabetes
liver, kidney or lung problems
active infections or
any allergies
Remember to:
- Tell your health care team about all of the other medications you are taking especially if you are taking corticosteroids (such as prednisone).
- Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.
You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.
Talk to your health care team about:
How this medication may affect your sexual health.
How this medication may affect your ability to have a baby, if this applies to you.
This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.
If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time until at least 4 months after your last dose. Talk to your health care team about which birth control options are best for you.
Do not breastfeed while on this medication and for at least 4 months after your last dose.
This drug is given through an IV (injected into a vein). Most people get pembrolizumab every 3 weeks. Talk to your health care team about your treatment schedule.
If you miss your treatment appointment, talk to your health care team to find out what to do.
Will this medication interact with other medications or natural health products?
Although this medication is unlikely to interact with other medications, vitamins, foods and natural health products, tell your health care team about all of your:
prescription and over-the-counter (non-prescription) medications and all other drugs, such as cannabis/marijuana (medical or recreational)
natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
Check with your health care team before starting or stopping any of them.
What should I do if I feel unwell, have pain, a headache or a fever?
Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol®) or ibuprofen (Advil®)).
Fever can be a sign of infection that may need treatment right away.
If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.
How to check for fever:
Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).
- You have a fever if your temperature taken in your mouth (oral temperature) is:
- 38.3°C (100.9°F) or higher at any time
OR
- 38.0°C (100.4°F) or higher for at least one hour.
- 38.3°C (100.9°F) or higher at any time
If you do have a fever:- Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
- Ask your health care team for the Fever pamphlet for more information.
If you do not have a fever but have mild symptoms such as headache or mild pain:
Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.
What to DO while on this medication:
- DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures.
- DO consider asking someone to drive you to and from the hospital on your treatment days. You may feel drowsy or dizzy after your treatment.
- DO tell your health care team about any serious infections that you have now or have had in the past.
- DO tell your healthcare team about ANY new symptom you may develop. You may need urgent medical treatment.
What NOT to DO while on this medication:
- DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.
- Pembrolizumab makes your immune system work harder. Your immune system is what fights infections and your cancer.
When your immune system is working harder, you may have side effects in your bowels, liver, lungs, skin, kidneys, hormones and other organs.
These side effects may be mild or may become serious or life-threatening in rare cases.
They may happen during your treatment or weeks to months after your treatment ends.
Some things to watch for are:
diarrhea
a new cough
problems with breathing
rash
any other new symptom
If you have side effects, you must talk to your health care team right away. You may need urgent treatment.
The following table lists side effects that you may have when getting pembrolizumab. The table is set up to list the most common side effects first and the least common last. It is unlikely that you will have all of the side effects listed and you may have some that are not listed.
Read over the side effect table so that you know what to look for and when to get help. Refer to this table if you experience any side effects while on pembrolizumab.
| Common Side Effects (25 to 49 out of 100 people) | |
| Side effects and what to do | When to contact health care team |
Fatigue What to look for?
What to do?
Ask your health care team for the Fatigue pamphlet for more information. | Talk to your health care team if it does not improve or if it is severe. |
| Less Common Side Effects (10 to 24 out of 100 people) | |
| Side effects and what to do | When to contact health care team |
Diarrhea What to look for?
What to do? If you have diarrhea:
Ask your health care team for the Diarrhea pamphlet for more information. In rare cases, your diarrhea may be severe due to inflammation of the intestines if:
If this happens, talk to your health care team or go to the emergency room right away.
| Talk to your health care team. for advice.
Talk to your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away. |
Rash What to look for?
What to do? To prevent and treat dry skin:
In rare cases, rash may be severe if:
If this happens, talk to your health care team or go to the emergency room right away. | Talk to your health care team for advice.
Talk to your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away. |
Nausea and vomiting (Generally mild) What to look for?
To help prevent nausea:
| Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe. |
Mild joint, muscle pain or cramps What to look for?
What to do?
Ask your health care team for the Pain pamphlet for more information. | Talk to your health care team if it does not improve or if it is severe. |
Other rare, but serious side effects are possible.
If you experience ANY of the following, talk to your cancer health care provider or get emergency medical help right away:
New cough, chest pain, trouble breathing, shortness of breath or coughing up blood
Peeing more than normal and feeling very thirsty
Signs of an allergy such as severe rash, swollen lips, face or tongue, chest and throat tightness, during or shortly after the drug is given
Bleeding from your gums, unusual nosebleeds, bruising easily or more than normal, or blood in urine or stools. If you have bleeding that doesn’t stop, you must get emergency help.
Rare immune problems after an organ or stem cell transplant (if this applies to you). Your doctor may discuss these with you.
Who do I contact if I have questions or need help?My cancer health care provider is: ________________________________________________ During the day I should contact:__________________________________________________ Evenings, weekends and holidays:________________________________________________
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Other Notes:
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April 2023 Updated info sheet
For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.
The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.
A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
pembrolizumab patient.pdf Info Sheet (French):
pembrolizumab pour le patient.pdf Monograph:
pembrolizumab.pdf Funding Program:
New Drug Funding Program Funding Instance:
- Pembrolizumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) and Prior Ipilimumab
- Pembrolizumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) and No Prior Ipilimumab
- Pembrolizumab - Advanced or Metastatic Non-Small Cell Lung Cancer (Second or Subsequent Line)
- Pembrolizumab - Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Pembrolizumab - In Combination with Platinum and Pemetrexed for First Line Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
- Pembrolizumab - In Combination with Carboplatin and Paclitaxel for First-Line Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)
- Pembrolizumab - In Combination with Axitinib for First Line Advanced or Metastatic Renal Cell Carcinoma
- Pembrolizumab - Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- Pembrolizumab - Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma
- Pembrolizumab - First Line Treatment of MSI-H/dMMR Metastatic Colorectal Cancer
- Pembrolizumab (Adult Who Failed Prior Brentuximab Vedotin) - Relapsed Classical Hodgkin Lymphoma Post-Autologous Stem Cell Transplant or ASCT Ineligible
- Pembrolizumab (Adult and Pediatric) - Relapsed Classical Hodgkin Lymphoma Post-Autologous Stem Cell Transplant or ASCT Ineligible
- Pembrolizumab - Previously Untreated High-Risk Early-Stage Triple Negative Breast Cancer
- Pembrolizumab - Adjuvant Treatment for Renal Cell Carcinoma
- Pembrolizumab - Metastatic, Persistent, or Recurrent Carcinoma of the Cervix
- Pembrolizumab - Locally Recurrent Unresectable or Metastatic Triple Negative Breast Cancer
- Pembrolizumab - Previously Treated MSI-H/dMMR Advanced Endometrial Cancer
- Pembrolizumab - In Combination with Lenvatinib for First-Line Advanced or Metastatic Renal Cell Carcinoma
- Pembrolizumab - In Combination with Lenvatinib for Advanced Endometrial Cancer
- Pembrolizumab (Adult and Pediatric) - Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma
- Pembrolizumab - (Neo)adjuvant Treatment for Completely Resectable Stage III or IV Melanoma
- Pembrolizumab and Trastuzumab (Biosimilar) - First-line Treatment of Advanced HER2-Positive Gastric or Esophagogastric Junction Adenocarcinoma
- Pembrolizumab - Locally Advanced Unresectable or Metastatic Biliary Tract Cancer
- Pembrolizumab - First-line Treatment of Advanced HER2-negative Esophageal, Gastric, and Esophagogastric Junction Carcinoma
- Pembrolizumab - Adjuvant Treatment for Non-Small Cell Lung Cancer
- Pembrolizumab (Adult and Pediatric) - Unresectable or Metastatic MSI-H or dMMR Advanced Solid Tumours
- Pembrolizumab - (Neo)adjuvant Therapy for Resectable Non-Small Cell Lung Cancer
- Enfortumab Vedotin with Pembrolizumab - Previously Untreated Locally Advanced Unresectable or Metastatic Urothelial Cancer
- Pembrolizumab - Primary Advanced or Recurrent Endometrial Carcinoma
- Pembrolizumab - Previously Untreated Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
PEM broe LIZ ue mab
Eligibility Form: Pembrolizumab - Advanced or Metastatic Non-Small Cell Lung Cancer (Second or Subsequent Line) Pembrolizumab - Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma Pembrolizumab - Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Pembrolizumab - Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck Pembrolizumab (Adult and Pediatric) - Relapsed cHL Post-Autologous Stem Cell Transplant or ASCT Ineligible Pembrolizumab (Adult Who Failed Prior Brentuximab Vedotin) - Relapsed cHL Post-ASCT or ASCT Ineligible Pembrolizumab - In Combination with Axitinib for First Line Advanced or Metastatic Renal Cell Carcinoma Pembrolizumab - First Line Treatment of MSI-H dMMR Metastatic Colorectal Cancer Pembrolizumab - Adjuvant Treatment for Renal Cell Carcinoma Pembrolizumab - Previously Treated MSI-H dMMR Advanced Endometrial Cancer Pembrolizumab - In Combination with Lenvatinib for Advanced Endometrial Cancer Pembrolizumab - In Combination with Lenvatinib for First-Line Advanced or Metastatic Renal Cell Carcinoma Pembrolizumab - Locally Recurrent Unresectable or Metastatic Triple Negative Breast Cancer Pembrolizumab - Previously Untreated High-Risk Early-Stage Triple Negative Breast Cancer Pembrolizumab and Trastuzumab (Biosimilar) - First-line Treatment of Advanced HER2-Positive Gastric or Esophagogastric Junction Pembrolizumab - Locally Advanced Unresectable or Metastatic Biliary Tract Cancer Pembrolizumab - Metastatic Persistent or Recurrent Carcinoma of the Cervix Pembrolizumab - First-line Treatment of Advanced HER2-negative Esophageal, Gastric, and Esophagogastric Junction Carcinoma Pembrolizumab - In Combo w Platinum and Pemetrexed for First Line Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Pembrolizumab - In Combo w Carboplatin and Paclitaxel for First-Line Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) Pembrolizumab (Adult and Pediatric) - Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma Pembrolizumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) and Prior Ipilimumab Pembrolizumab - Advanced Melanoma (Unresectable or Metastatic Melanoma) and No Prior Ipilimumab Pembrolizumab - Adjuvant Treatment for Non-Small Cell Lung Cancer Pembrolizumab (Adult and Pediatric) - Unresectable or Metastatic MSI-H or dMMR Advanced Solid Tumours Pembrolizumab - (Neo)Adjuvant Therapy for Resectable Non-Small Cell Lung Cancer Enfortumab Vedotin with Pembrolizumab - Previously Untreated Locally Advanced Unresectable or Metastatic Urothelial Cancer Pembrolizumab - Previously Untreated Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma Pembrolizumab - Primary Advanced or Recurrent Endometrial Carcinoma Pembrolizumab (Adult and Pediatric) - Adjuvant Treatment for Completely Resected Stage IIB or IIC Melanoma Pembrolizumab - (Neo)adjuvant Treatment for Completely Resectable Stage III or IV Melanoma Cancer Type:
Breast Central Nervous System Endocrine Adrenal Neuroendocrine Pancreatic Neuroendocrine Parathyroid Thymoma Thyroid Gastrointestinal Anus Colorectal Esophagus Gastric / Stomach Gastrointestinal Stromal Tumours Hepatobiliary / Liver / Bile Duct Mesothelioma (Peritoneal) Neuroendocrine (GI) Pancreas Rectal Small bowel and appendix Genitourinary Bladder / Urothelial Penile Prostate Renal cell / Kidney Testis Gynecologic Cervix Endometrial Germ Cell Gestational Trophoblastic Disease Ovary Uterine Sarcoma Vagina Vulva Head and Neck Larynx Nasopharynx Oral Paranasal Sinus Pharynx Salivary Gland Squamous Cell Hematologic Lymphoma - Hodgkin Kaposi's Sarcoma Lung Mesothelioma (Pleural) Neuroendocrine (Lung) Non-Small Cell Small Cell Mesothelioma Ocular / Eye Sarcoma Desmoid Tumour Ewing's Ewing's and Soft Tissue GIST Giant Cell Tumour Kaposi's Sarcoma Osteogenic / Bone Soft Tissue Uterine Wilm's Tumour Skin Basal Cell Melanoma Merkel Cell Squamous Cell Unknown Primary Type of Content:
Drug Monograph Status:
Null Info Sheet Status:
Null Global Date:
Jeudi, septembre 11, 2025 Universal Date:
2025-09-11 00:00:00 AddThis:
Title URL:
pembrolizumab Drug Display Status:
Active Revision Summary:
Drug Monograph: Added NDFP forms; Updated Indications, Adverse effects, Dosage with hepatic impairment, Dosing-Children, Administration Guidelines, and Monitoring sections