Pembrolizumab

Name: Pembrolizumab

Pembrolizumab Interactions

This medicine 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.

Other drugs may interact with pembrolizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Pembrolizumab and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if pembrolizumab crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using pembrolizumab.

Pembrolizumab Usage

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Your doctor may reduce the dose of pembrolizumab or even discontinue the medication if you experience certain adverse drug reactions.

If you miss a dose, be sure to make a follow up appointment.

 

Pembrolizumab Overdose

If pembrolizumab is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Other Requirements

It is important you keep all scheduled appointments for blood work or other laboratory tests.

What should I avoid while receiving pembrolizumab?

This medicine 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.

Pembrolizumab dosing information

Usual Adult Dose for Melanoma - Metastatic:

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

Use: Treatment of patients with unresectable or metastatic melanoma

Usual Adult Dose 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.

Uses:
-As a single agent for the first-line treatment of patients with metastatic NSCLC whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] 50% or greater) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations
-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 carboplatin, as first-line treatment of patients with metastatic nonsquamous NSCLC

Usual Adult Dose 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

Use: For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy

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

Use: For the treatment of patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy

Usual Adult Dose 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

Use: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy

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

Uses: For the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Usual Adult Dose 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

Uses: For the treatment of patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Usual Pediatric Dose for Hodgkin's Disease:

2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression

Use: For the treatment of pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy

Usual Pediatric Dose for Colorectal Cancer:

2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression

Uses: For the treatment of pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Usual Pediatric Dose for Solid Tumors:

2 years and older:
2 mg/kg (up to a maximum of 200 mg) IV 30 minutes every 3 weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression

Uses: For the treatment of pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options OR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan

Uses for Pembrolizumab

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Melanoma

Treatment of unresectable or metastatic melanoma following failure of ipilimumab and, in patients with tumors bearing the b-Raf serine-threonine kinase (BRAF) V600 mutation, therapy with a BRAF inhibitor1 3 5 (designated an orphan drug by FDA for this use).4

Efficacy based on overall response rate and response duration; improvement in patient-reported outcomes and overall survival not demonstrated.1

What are some other side effects of Pembrolizumab?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling tired or weak.
  • Muscle or joint pain.
  • Bone pain.
  • Upset stomach or throwing up.
  • Not hungry.
  • Hard stools (constipation).
  • Loose stools (diarrhea).
  • Belly pain.
  • Headache.
  • Back pain.
  • Weight loss.
  • Hair loss.
  • Change in taste.
  • Not able to sleep.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Index Terms

  • Anti-PD-1 Monoclonal Antibody MK-3475
  • Lambrolizumab
  • MK-3475
  • SCH 90045

Brand Names U.S.

  • Keytruda

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to pembrolizumab or any component of the formulation.

Dosing Adult

Head and neck cancer, squamous cell, (recurrent or metastatic): IV: 200 mg once every 3 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to 24 months.

Hodgkin lymphoma, classical (relapsed or refractory): IV: 200 mg once every 3 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) up to 24 months.

Melanoma (unresectable or metastatic): IV: 200 mg once every 3 weeks until disease progression or unacceptable toxicity.

Off-label dosing: 2 mg/kg once every 3 weeks until disease progression or unacceptable toxicity (Ribas 2015).

Microsatellite instability-high cancer (unresectable or metastatic): IV: 200 mg once every 3 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to 24 months.

Non-small cell lung cancer (metastatic), single-agent therapy: IV: 200 mg once every 3 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) up to 24 months.

Off-label dosing (in patients with disease progression following platinum-containing chemotherapy): 2 mg/kg once every 3 weeks for 24 months or until disease progression or unacceptable toxicity (Herbst 2016).

Non-small cell lung cancer (metastatic, nonsquamous), combination therapy: IV: 200 mg once every 3 weeks (in combination with pemetrexed and carboplatin) for 4 cycles, followed by pembrolizumab monotherapy of 200 mg once every 3 weeks (with or without optional indefinite pemetrexed maintenance therapy) until disease progression, unacceptable toxicity, or (in patients without disease progression) up to 24 months (Langer 2016).

Urothelial carcinoma (locally advanced or metastatic): IV: 200 mg once every 3 weeks until disease progression, unacceptable toxicity, or (in patients without disease progression) for up to 24 months (Belmunt 2017).

Merkel cell carcinoma, advanced (off-label use): IV: 2 mg/kg once every 3 weeks for up to 2 years or until complete response, or until disease progression or unacceptable toxicity (Nghiem 2016).

Dosing Hepatic Impairment

Hepatic impairment prior to treatment initiation:

Mild impairment (total bilirubin ≤ ULN and AST > ULN or total bilirubin >1 to 1.5 times ULN and any AST): No dosage adjustment necessary.

Moderate (total bilirubin >1.5 to 3 times ULN and any AST) to severe (total bilirubin >3 times ULN and any AST) impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Hepatotoxicity during treatment: Note: For patients with baseline grade 2 ALT or AST abnormalities due to liver metastases, permanently discontinue if AST or ALT increases by ≥50% (relative to baseline) and persists at least 1 week.

AST or ALT >3 to 5 times ULN or total bilirubin >1.5 to 3 times ULN: Withhold treatment; may resume therapy upon recovery to grade 0 or 1 toxicity. Also administer corticosteroids (prednisone 0.5 to 1 mg/kg/day [or equivalent] followed by a taper).

AST or ALT >5 times ULN or total bilirubin >3 times ULN: Permanently discontinue. Also administer corticosteroids (prednisone 1 to 2 mg/kg/day [or equivalent] followed a taper).

Usual Adult Dose 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

Use: For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy

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