.launch-header{position:relative!important}.launch-desktop-nav button,.launch-mobile-toggle,.experience-region-trigger{display:none!important}.experience-noscript-nav{display:flex;flex-wrap:wrap;justify-content:center;gap:16px;padding:16px;background:#f8fafc;font-size:13px}.experience-noscript-nav a{min-height:44px;display:inline-flex;align-items:center}Prognia Ward Suture Osler Medical library Learning resources Pricing Crowdfunding Founders Wall English Nederlands Español Français Deutsch

Loading your page…

American Society of Clinical OncologyOncology2020advanced

Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer

Published by Merck Sharp & Dohme Corp.

25Tables

5Figures

Summary

AI-generated

KEYTRUDA (pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody. The prescribing information outlines its indications for various advanced cancers, recommended dosage, contraindications, and comprehensive warnings regarding immune-mediated adverse reactions.

ovarian cancerpembrolizumabKEYTRUDAMSDoncologyguidelinesmelanomaNSCLC

Key Takeaways

1
KEYTRUDA (pembrolizumab) is a PD-1-blocking antibody indicated for multiple advanced cancers, including melanoma, NSCLC, HNSCC, cHL, urothelial carcinoma, and MSI-H cancer.
2
The recommended dosage for adults in most indications is 200 mg as a 30-minute IV infusion every 3 weeks.
3
Treatment can cause severe and fatal immune-mediated adverse reactions affecting multiple organ systems (e.g., pneumonitis, colitis, hepatitis, endocrinopathies, nephritis).
4
Management of immune-mediated toxicities often requires withholding or permanently discontinuing KEYTRUDA and administering systemic corticosteroids.
5
KEYTRUDA can cause fetal harm; female patients of reproductive potential should be advised to use highly effective contraception during treatment and for 4 months post-treatment.

What's New in This Version

Recent major changes in 05/2017 include updates to Indications and Usage (1), Dosage and Administration (2), and Warnings and Precautions (5).

Key Recommendations

2.2 Recommended Dosage for Melanoma

REC-01
The recommended dose of KEYTRUDA is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.
Treatment

2.1 Patient Selection for Treatment of NSCLC

REC-02
Select patients for treatment of metastatic NSCLC with KEYTRUDA as a single agent based on the presence of positive PD-L1 expression as determined by an FDA-approved test.
Screening/Patient Selection

5.1 Immune-Mediated Pneumonitis

REC-03
Evaluate patients with suspected pneumonitis with radiographic imaging and administer corticosteroids (initial dose of 1 to 2 mg/kg/day prednisone or equivalent followed by a taper) for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for moderate (Grade 2) pneumonitis, and permanently discontinue KEYTRUDA for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis.
Safety/Adverse Event Management

8.3 Females and Males of Reproductive Potential

REC-04
Advise females of reproductive potential to use effective contraception during treatment with KEYTRUDA and for at least 4 months following the final dose.
Safety/Counseling

Scope & Objectives

Clinical Topic

Oncology

Objectives

Provide prescribing information, dosage, administration, warnings, and safety data for the use of KEYTRUDA (pembrolizumab).

Target Patient Population

Patients with melanoma, NSCLC, HNSCC, cHL, urothelial carcinoma, or MSI-H cancer.

Diagnostic Criteria

FDA-approved tests for PD-L1 expression (e.g., in NSCLC) and PCR or IHC testing for MSI-H/dMMR tumor status.

Target Providers

OncologistsPhysiciansHealthcare Providers

Patient Criteria & Setting

Therapeutic Area

Oncology

Guideline Scope

TreatmentPrescribingSafety Guidelines

Care Settings

HospitalClinic

Special Populations

PregnancyLactationFemales and Males of Reproductive PotentialPediatric UseGeriatric Use

Safety & Contraindications

Contraindications

None

Monitoring Guidance

Monitor for immune-mediated adverse reactions. Check hepatic function, renal function, and thyroid function. Monitor for hyperglycemia and infusion-related reactions.

Authors & Contributors

FDA

Guideline Features

Dosing information

Learning Context

Difficulty

advanced

Learning Paths

OncologyImmunotherapyPD-1 BlockadePembrolizumab PrescribingImmune-Mediated Adverse ReactionsTargeted Therapy