Zynyz: FDA-Approved Treatment For Merkel Cell Carcinoma In Adult Patient 

Zynyz (retifanlimab-dlwr) received accelerated approval from the FDA On March 22, 2023. The drug is manufactured by Incyte Corporation and is a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1). 

Indication 

Zynyz is an antibody that blocks the programmed death receptor-1 (PD-1), and it is approved for treating metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adult patients.

What Is Merkel Cell Carcinoma

Merkel cell carcinoma (MCC) is a rare and aggressive type of skin cancer that arises from Merkel cells, which are found in the skin’s top layer. Merkel cells are associated with the sense of touch. 

MCC typically appears as firm, painless nodules or lumps on the skin and can be fast-growing. Due to its aggressive nature, early detection and prompt treatment are crucial for managing Merkel cell carcinoma. 

Causes 

Merkel cell carcinoma is primarily caused by exposure to ultraviolet (UV) rays, originating from sunlight or artificial sources like tanning beds. Additionally, around 80% of cases involve the Merkel cell polyomavirus (MCP).  

Although most individuals with Merkel cell polyomavirus (MCPyV) infection do not develop Merkel cell carcinoma, a weakened immune system may be unable to effectively control the virus. This can result in the production of proteins that turn off genes responsible for suppressing tumor growth, potentially contributing to the development of Merkel cell carcinoma.

Mechanism Of Zynyz

Zynyz is a PD-1-blocking antibody that functions by binding to the PD-1 protein on immune T-cells to prevent their interaction with the PD-L1 protein on cancer cells, thereby enabling the immune system to attack cancer cells more effectively.

Dosage Information 

The suggested dose for Zynyz is 500 mg, given through intravenous infusion over a 30-minute period every four weeks until either disease progression or the occurrence of unacceptable toxicity.

The number of treatments required will be determined by your healthcare provider. Blood tests will be conducted to monitor potential side effects. In the event of missed appointments, promptly contact your healthcare provider to reschedule.

Drug Interactions

There are no specific drug interaction studies with Zynyz injection. However, as it is a monoclonal antibody, it may interfere with the activity of other monoclonal antibodies.

Warning And Precaution

Immune-Mediated Adverse Reactions: Immune-mediated adverse reactions, which may manifest as severe or life-threatening, can affect various organ systems, including immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis leading to renal dysfunction, dermatologic adverse reactions, and solid organ transplant rejection. 

Vigilant monitoring is crucial for early identification and effective management. Baseline assessments and periodic evaluations of liver enzymes, creatinine, and thyroid function are recommended during treatment. In response to the severity of reactions, Zynyz administration may need to be temporarily withheld or permanently discontinued, with corticosteroids administered as deemed necessary.

Embryo-Fetal Risk: Zynyz carries the risk of causing fetal harm. Women of reproductive potential should be informed about this risk, and the use of effective contraception is strongly recommended to mitigate potential harm to a fetus.

Infusion-Related Reactions: For infusion-related reactions, interventions such as interrupting, slowing the infusion rate, or permanent discontinuation of Zynyz should be based on the severity of the reaction.

Complications of Allogeneic HSCT: Patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) may experience fatal or serious complications when treated with a PD-1/PD-L1–blocking antibody, either before or after the transplant. Close monitoring and careful consideration of potential risks are advised.

Before Consuming Zynyz

Prior to receiving Zynyz, it is crucial to inform your healthcare provider about your complete medical history, including whether you:

• Experience immune system issues like Crohn’s disease, ulcerative colitis, or lupus
• Have undergone organ transplantation.
• Have undergone or plan to undergo a stem cell transplant utilizing donor stem cells (allogeneic).
• Have undergone radiation treatment in the chest area.
• Have a condition impacting your nervous system, such as myasthenia gravis or Guillain-Barre syndrome.

Usage In Specific Populations

• Pregnancy: Zynyz can cause fetal harm when administered to a pregnant woman. Patients should be advised of the potential risk to a fetus and to use effective contraception during treatment and for at least 4 months after the last dose.
• Lactation: It is unknown whether Zynyz is present in human milk or its effects on the breastfed infant or milk production. Women should be advised not to breastfeed during treatment and for at least 4 months after the last dose.
• Pediatric: The safety and effectiveness of Zynyz in pediatric patients have not been established.
• Geriatric: Clinical studies of Zynyz did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Side Effects

Common adverse reactions in patients receiving Zynyz are

1. Fatigue
2. Musculoskeletal pain
3. Rash
4. Diarrhea
5. Nausea
6. Asthenia
7. Cough
8. Dyspnea
9. Pruritus
10. Constipation
11. Decreased appetite

If you notice any of these side effects, it is advised to contact your healthcare provider immediately. 

How To Buy Zynyz Online?

If Zynyz is unavailable in your location, alternatives are accessible in the USA and Europe. Sansfro Health, a trusted medication import service, provides a streamlined four-step process for obtaining prescriptions. This includes Medication Verification, Procurement, and Safe Delivery. To initiate the medication import, a valid prescription and identification verification are required. For information on Zynyz price and more, contact Sansfro’s Patient Support Team at (91) 9315705373 or email help@sansfro.com. Simplifying the process, approved platforms connect patients with reliable vendors for convenient access to Zynyz.

Conclusion 

Merkel cell carcinoma is a very rare type of skin cancer, affecting approximately 3,000 Americans every year. Zynyz (retifanlimab) is an FDA-approved treatment for metastatic or recurrent locally advanced merkel cell carcinoma. It is a PD-1-blocking antibody administered via intravenous infusion. It has specific usage considerations in pregnancy, lactation, pediatric, and geriatric populations, and its most common side effects include fatigue, musculoskeletal pain, and rash. Contact your doctor to learn more information on Zynyz.

Reference:

1. https://everyone.org/Zynyz-retifanlimab-dlwr 
2. https://blog.zoomrx.com/Zynyz-for-merkel-cell-carcinoma-a-highly-effective-but-little-known-treatment-option/ 
3. https://www.patsnap.com/resources/blog/fda-approves-incytes-zynzy-for-metastatic-mcc/ 
4. https://www.cmaxinsight.com/blog/fda-approved-drugs-march-april-2023/ 
5. https://www.pharmacytimes.com/view/fda-approves-retifanlimab-dlwr-for-the-treatment-of-merkel-cell-carcinoma