Zynyz

About Zynyz 

• The US FDA administration granted approval to ZYNYZ on March 22, 2023.
• ZYNYZ is an antibody that blocks programmed death receptor-1 (PD-1) and is used to treat adults with metastatic or recurrent locally advanced Merkel cell carcinoma in adult.
• Merkel cell carcinoma (MCC) is an uncommon and aggressive form of skin cancer. It typically manifests as a painless, reddish-purple nodule on sun-exposed areas of the head, neck, and arms. 
• MCC is known for its rapid growth and a tendency to quickly spread to other parts of the body, making it a particularly challenging cancer to manage.
• Metastatic or recurrent locally advanced Merkel cell carcinoma can present with various symptoms, including painless, firm, shiny, or reddish skin nodules or lesions, often on sun-exposed areas. 
• These nodules can grow quickly and may be associated with pain, tenderness, or itching.
• Other symptoms may include fatigue, weakness, and swollen lymph nodes. It’s important to consult a healthcare professional for a proper evaluation and diagnosis if you experience symptoms or changes in your skin.

Strength

Injection: 500 mg/20 mL (25 mg/mL) solution in a single-dose vial

Recommended Dosage

Administering intravenous (IV) injections is a medical procedure that should be performed by trained healthcare professionals. Use proper aseptic technique when handling equipment and performing the injection. This includes washing hands, wearing gloves, and cleaning the injection site. Continuously monitor the patient during and after the injection for any adverse reactions. Properly dispose of all used equipment and materials according to medical waste disposal guidelines.

• ZYNYZ is typically administered as an intravenous infusion of 500 mg over 30 minutes every 4 weeks. This treatment continues until disease progression, unacceptable side effects, or for a maximum duration of 24 months. The infusion is prepared after dilution.

Important

There is no recommended dose reduction for ZYNYZ. In the case of severe (Grade 3) immune-related adverse reactions, ZYNYZ should be temporarily withheld. ZYNYZ should be permanently discontinued for life-threatening (Grade 4) immune-related adverse reactions, recurrent severe (Grade 3) immune-related reactions requiring systemic immunosuppressive treatment, or if corticosteroid dose cannot be reduced to 10 mg or less of prednisone equivalent per day within 12 weeks of starting steroids.

Warnings & Precautions

• Zynyz is not suitable for individuals with known hypersensitivity to Retifanlimab-dlwr.
• Immune-mediated adverse reactions, including severe and life-threatening conditions affecting various organs, may occur with ZYNYZ treatment. 
• These reactions encompass pneumonitis, colitis, hepatitis, endocrine issues, kidney problems, skin reactions, and transplant rejection. 
• Close monitoring and regular assessments of liver enzymes, kidney function, and thyroid health are essential. ZYNYZ may need to be temporarily halted or discontinued with corticosteroid treatment depending on reaction severity. It’s vital to monitor and manage infusion-related reactions. 
• Additionally, complications can arise in patients undergoing allogeneic hematopoietic stem cell transplant (HSCT) when receiving PD-1/PD-L1 antibody therapy. 

Common Zynyz Side Effects:

• Fatigue (tiredness)
• Musculoskeletal pain (muscle and bone pain)
• Pruritus (itching)
• Diarrhea
• Rash
• Pyrexia (fever)
• Nausea (feeling sick)

Use in Specific Population

• ZYNYZ can potentially harm a developing fetus when given to a pregnant woman due to its mechanism of action. There is no available data on ZYNYZ use in pregnant women. Inform your doctor if you experience these issues during treatment. 
• Additionally, there is no information regarding the presence of retifanlimab-dlwr in human milk or its effects on breastfed children or milk production. As there is a risk of severe adverse reactions in breastfed children, it’s advised that women do not breastfeed during ZYNYZ treatment and for 4 months after the last dose. 
• To ensure safe use, verify the pregnancy status of females capable of reproduction before starting ZYNYZ and advise them to use effective contraception during treatment and for 4 months following the final dose.
• The safety and efficacy of Zynyz have not been confirmed in pediatric patients.
• Clinical trials with Zynyz did not involve an adequate number of older adult participants to determine potential differences in treatment response compared to younger adults.

Storage and Handling

• Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. 
• Do not freeze or shake.