Germline and Somatic Tumor Testing in Epithelial Ovarian Cancer
Published by Merck Sharp & Dohme Corp.
Summary
AI-generatedKEYTRUDA (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.
Key Takeaways
- 1KEYTRUDA (pembrolizumab) is a PD-1-blocking antibody indicated for multiple advanced cancers, including melanoma, NSCLC, HNSCC, cHL, urothelial carcinoma, and MSI-H cancer.
- 2The recommended dosage for adults in most indications is 200 mg as a 30-minute IV infusion every 3 weeks.
- 3Treatment can cause severe and fatal immune-mediated adverse reactions affecting multiple organ systems (e.g., pneumonitis, colitis, hepatitis, endocrinopathies, nephritis).
- 4Management of immune-mediated toxicities often requires withholding or permanently discontinuing KEYTRUDA and administering systemic corticosteroids.
- 5KEYTRUDA 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
Patient Criteria & Setting
Therapeutic Area
OncologyGuideline Scope
Care Settings
Special Populations
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
Guideline Features
Learning Context
Difficulty
advanced
Learning Paths