Retifanlimab

What is Retifanlimab?

• Retifanlimab (Zynyz), is a programmed death receptor-1 (PD-1)–blocking antibody. Retifanlimab‑dlwr is a humanized IgG4 kappa monoclonal antibody produced in Chinese hamster ovary cells.

What are the uses of this medicine?

• Retifanlimab (Zynyz), is a prescription medicine used to treat a type of skin cancer called Merkel cell carcinoma in adults. Zynyz may be used to treat your skin cancer when it has spread or returned.

How does this medicine work?

• Upon administration, retifanlimab binds to and inhibits PD-1 and its downstream signaling pathways.
• This may restore immune function through the activation of T-cells and cell-mediated immune responses against tumor cells.
• PD-1, a transmembrane protein in the immunoglobulin superfamily (IgSF) expressed on T-cells, functions as an immune checkpoint that negatively regulates T-cell activation and effector function when activated by its ligands programmed cell death ligand 1 (PD-L1) or 2 (PD-L2);
• It plays an important role in tumor evasion from host immunity.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, you are taking or plan to take.

Is this medicine FDA approved?

• It was approved for medical use in the United States in March 2023.

How should this medicine be used?

Recommended dosage: The recommended dosage of Zynyz is 500 mg administered as an intravenous infusion over 30 minutes every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.

Administration:

• Retifanlimab-dlwr comes as a solution (liquid) to be injected slowly into a vein.
• Your healthcare provider will give you Zynyz into your vein through an intravenous (IV) line over 30 minutes.
• Zynyz is usually given every 4 weeks.
• Your healthcare provider will decide how many treatments you will need.
• Your healthcare provider will do blood tests to check you for side effects.
• If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

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

This medicine is available in fallowing brand namesː

• Zynyz

What side effects can this medication cause?

The most common side effects of this medicine may include:

• tiredness
• muscle and bone pain
• itching
• diarrhea
• rash
• fever
• nausea

Less common, but serious side effects may include:

• Lung problems
• Intestinal problems
• Liver problems
• Hormone gland problems
• Kidney problems
• Skin problems
• Rejection of a transplanted organ
• Infusion reactions
• Complications, including graft-versus-host disease

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune‑mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, and immune‑mediated dermatologic adverse reactions, and solid organ transplant rejection.
• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. Withhold or permanently discontinue Zynyz and administer corticosteroids based on the severity of reaction.
• A severe infusion-related reaction occurred in patients receiving Zynyz. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions.
• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1–blocking antibody. Advise patients to contact their healthcare provider immediately if they develop signs or symptoms of post-allogeneic HSCT complications or of solid organ transplant rejection.
• Based on its mechanism of action, Zynyz can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential that Zynyz can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females of reproductive potential to use effective contraception during treatment and for 4 months after the last dose of Zynyz.
• Advise female patients not to breastfeed while taking Zynyz and for 4 months after the last dose.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Zynyz can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Zynyz.
• You should use an effective method of birth control during your treatment and for 4 months after your last dose of Zynyz. Talk to your healthcare provider about birth control methods that you can use during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Zynyz.

Can this medicine be used in children?

• It is not known if Zynyz is safe and effective in children.

What are the active and inactive ingredients in this medicine?

• Active ingredient: retifanlimab-dlwr
• Inactive ingredients: glacial acetic acid, polysorbate 80, sodium acetate, sucrose, and Water for Injection.

Who manufactures and distributes this medicine?

• Manufactured by: Incyte Corporation, Wilmington, DE
• Zynyz and the Zynyz logo are trademarks of Incyte.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Retifanlimab
• FDA Retifanlimab

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