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Zynyz

retifanlimab-dlwr
PD-1 Inhibitor FDA Approved 2023 Incyte
Route
IV
Half-Life
~25 days
FDA Approved
2023
Manufacturer
Incyte
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1. Indications and Usage

Merkel cell carcinoma.

2. Dosage and Administration

500 mg IV Q4W.

3. Dosage Forms and Strengths

500 mg/10 mL vial

4. Contraindications

None listed.

5. Warnings and Precautions
  • Immune-Mediated Reactions: Standard management.
  • Infusion Reactions: Monitor.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Fatigue (33%), MSK Pain (22%), Constipation (18%), Rash (18%), Diarrhea (16%), Pruritus (15%)

Fatigue
33%
MSK Pain
22%
Constipation
18%
Rash
18%
Diarrhea
16%
Pruritus
15%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

No CYP interactions.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Anti-PD-1 mAb releasing T-cell anti-tumor immunity.

Pharmacokinetics

t1/2: ~23 days.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Zynyz Trials on ClinicalTrials.gov ↗ 📚 PubMed: Zynyz Clinical Trials ↗
FDA-Approved Tumor Types

Zynyz has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Merkel Cell Carcinoma
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Zynyz. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Zynyz (retifanlimab-dlwr) approved for?

Zynyz (retifanlimab-dlwr) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Zynyz (retifanlimab-dlwr) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Zynyz (retifanlimab-dlwr) work?

Anti-PD-1 mAb releasing T-cell anti-tumor immunity.

What are the most common side effects?

Fatigue (33%), MSK Pain (22%), Constipation (18%), Rash (18%), Diarrhea (16%), Pruritus (15%) Fatigue 33% MSK Pain 22% Constipation 18% Rash 18% Diarrhea 16% Pruritus 15%

← All Therapies Full Prescribing Information ↗