Zynyz

Generic name: Retifanlimab-dlwr
Dosage form: injection
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)

Usage of Zynyz

Zynyz is a prescription medicine used to treat a type of skin cancer called Merkel cell carcinoma in adults.

Zynyz is a programmed death receptor-1 (PD-1)–blocking antibody (also called an immune checkpoint inhibitor) that works by binding to the PD-1 protein on immune T-cells to prevent the interaction with PD-L1, a protein that is often found on some cancer cells.

When the PD-1 protein on an immune cell interacts with the PD-L1 protein on a cancer cell, the cancer cell is considered healthy and is left alone. By blocking the interaction with PD-1, Zynyz works to remove the "brakes" on the immune system, allowing it to attack cancer cells more effectively.

Zynyz side effects

Zynyz can cause serious side effects. See Important information.

The most common side effects include:

tiredness

muscle and bone pain

itching

diarrhea

rash

fever

nausea

These are not all the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Zynyz

Before you start treatment, tell your healthcare provider about all of your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus

have received an organ transplant

have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)

have received radiation treatment to your chest area

have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome

Pregnancy

Tell your healthcare provider if you are pregnant or plan to become pregnant. 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.

You should use an effective method of birth control during your treatment, and for 4 months after your last dose. 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.

Breastfeeding

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Zynyz passes into your breast milk.

Do not breastfeed during treatment, and for 4 months after your last dose.

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How to use Zynyz

Usual Adult Dose for Merkel Cell Carcinoma

500 mg as an intravenous infusion over 30 minutes every 4 weeks until disease progression, unacceptable toxicity, or up to 24 months.

Use: For the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

Warnings

Zynyz is a medicine that may treat Merkel cell carcinoma by working with your immune system. It can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems.

cough

shortness of breath

chest pain

Intestinal problems.

diarrhea (loose stools) or more frequent bowel movements than usual

stools that are black, tarry, sticky, or have blood or mucus

severe stomach-area (abdomen) pain or tenderness

Liver problems.

yellowing of your skin or the whites of your eyes

severe nausea or vomiting

pain on the right side of your stomach area (abdomen)

dark urine (tea colored)

bleeding or bruising more easily than normal

Hormone gland problems.

headaches that will not go away or unusual headaches

eye sensitivity to light

eye problems

rapid heartbeat

increased sweating

extreme tiredness

weight gain or weight loss

feeling more hungry or thirsty than usual

urinating more often than usual

hair loss

feeling cold

constipation

your voice gets deeper

dizziness or fainting

changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems.

decrease in your amount of urine

blood in your urine

swelling of your ankles

loss of appetite

Skin problems.

rash

itching

skin blistering or peeling

painful sores or ulcers in your mouth or nose, throat, or genital area

fever or flu-like symptoms

swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen during treatment with this medicine. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:

chest pain, irregular heartbeat, shortness of breath, or swelling of ankles

confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs

double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight

persistent or severe muscle pain or weakness, muscle cramps

low red blood cells, bruising

Infusion reactions that can sometimes be severe. Signs and symptoms of infusion reactions may include:

chills or shaking

itching or rash

flushing

shortness of breath or wheezing

dizziness

feel like passing out

fever

back or neck pain

Rejection of a transplanted organ. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host disease, in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Zynyz. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment if you have severe side effects.

What other drugs will affect Zynyz

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Disclaimer

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