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Overview: Zynyz is used to treat certain types of anal and skin cancers. It works by helping your immune system find and attack cancer cells. Common side effects may include tiredness, pain in your muscles or joints, diarrhea, skin rash or itching, fever, or nausea. Zynyz may cause your immune system to attack healthy tissues or organs. This can lead to serious or even life-threatening problems. Keep all appointments to check your blood work and tell your health care provider right away if you have any new or worsening symptoms. Zynyz given as an infusion into a vein (IV) by a health care provider.

Uses

What is Zynyz used for?

Zynyz (retifanlimab-dlwr) is commonly used for certain people with the following types of cancer.

Zynyz may also be used for other conditions as determined by your health care provider.

How does Zynyz work (mechanism of action)?

Some cancers have higher-than-normal amounts of proteins, called PD-L1 and PD-L2, that attach to certain immune cells and slow them down. This helps the cancer hide from your immune system. Zynyz works by blocking these proteins, which helps these immune cells stay active and free to attack the cancer cells. 

How is Zynyz supplied (dosage forms)?

Zynyz is available in an injectable form that is given by a health care provider.

How should I store Zynyz?

Zynyz is given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Zynyz?

The most common side effects of Zynyz are listed below. These side effects may vary depending on the condition that is being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Tiredness
  • Muscle or joint pain
  • Diarrhea or constipation
  • Infections
  • Itching or rash
  • Fever
  • Nausea or vomiting
  • Stomach pain
  • Decreased appetite or weight loss
  • Bleeding
  • Shortness of breath
  • Cough
  • Headache

There may be other side effects of Zynyz that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Zynyz?

While less common, the most serious side effects of Zynyz are described below, along with what to do if they happen.

Severe Allergic Reactions. Zynyz may cause allergic reactions, which can be serious. Get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Infusion Reactions. Zynyz is given as an infusion into a vein. Some people may have reactions during an infusion that can be serious. If you have these reactions, your infusion may need to be paused, slowed, or stopped. Tell your health care provider right away if you have any of the following symptoms when you get your infusion.

  • Fever, chills, or shaking
  • Itching or skin rash
  • Flushing
  • Wheezing or trouble breathing
  • Dizziness or fainting
  • Pain in your neck or back

Immune System Reactions. Zynyz may cause your immune system to attack healthy tissues or organs, causing inflammation. When tissues or organs become inflamed, they may not work as well as they should. These side effects of immunotherapy can lead to serious or even life-threatening problems. You may be able to prevent these problems from getting more serious if you get medical help right away. Keep all appointments to check your blood work. Tell your health care provider right away if you have any of the following signs or symptoms, even if you are no longer using Zynyz.

  • Inflamed lungs (pneumonitis): Chest pain, shortness of breath, or new or worsening cough
  • Inflamed intestines (colitis): Severe stomach pain, diarrhea, blood or mucus in your poop, or black, tarry poop
  • Inflamed liver (hepatitis): Severe nausea or vomiting, stomach pain on your right side, yellowish eyes or skin, dark urine (pee), or easy bleeding or bruising
  • Inflamed hormone glands (adrenal insufficiency, thyroiditis, type 1 diabetes): Headache, fast or irregular heartbeat, sweating, tiredness, weight gain or loss, hair loss, changes in mood, behavior, or voice, peeing or feeling more hungry or thirsty than usual, feeling cold, constipation
  • Inflamed kidneys (nephritis): Peeing less than usual, bloody pee, loss of appetite, or swelling in your ankles
  • Skin inflammation (dermatitis): Rash, itching, blistering, or peeling or painful sores in your mouth, nose, throat, or genitals
  • Heart or blood vessel inflammation: Chest pain, fast or irregular heartbeat
  • Inflamed nerves: Weakness, numbness, or tingling in your arms or legs
  • Inflamed muscles or joints: Pain, swelling, or stiffness in your muscles or joints, or muscle cramps or weakness
  • Inflamed eye (such as uveitis): Blurred or double vision, eye pain or redness, sensitivity to light, vision loss
  • Inflamed brain (encephalitis): Stiff neck, balance or memory problems, or confusion

Warnings & Precautions

Who should not use Zynyz?

Allergies to Ingredients. People who are allergic to any of the following should not use Zynyz.

  • Retifanlimab-dlwr
  • Zynyz
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Zynyz.

What should I know about Zynyz before using it?

Zynyz is usually given as an infusion into a vein (IV) by a health care provider in a hospital or clinic.

Tell your health care provider right away if you have new or unusual symptoms during or after Zynyz treatment. Zynyz may cause your immune system to attack healthy parts of your body, such as the lungs, digestive tract, liver, or kidneys. This can happen at any time while you are using Zynyz or after treatment ends. Catching and treating these side effects early may help prevent serious problems. See the Side Effects section for more details. 

What should I tell my health care provider before using Zynyz?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Zynyz is right for you.

In particular, make sure that you discuss any of the following.

Stem Cell Transplant. Tell your health care provider if you have had a stem cell transplant or plan to have one. Zynyz may raise the risk of serious problems after a stem cell transplant, including a risk of your immune system attacking the donor cells.

Chest Radiation. The risk of certain side effects, including inflamed lungs, may be higher in people who have received radiation treatments in the chest area. Tell your health care provider if you had radiation treatments in your chest area in the past. They can help decide if Zynyz is safe for you.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Pregnancy. Zynyz may cause harm to an unborn baby. Tell your health care provider right away if you are pregnant, think you might be pregnant, or plan to become pregnant. Your health care provider may give you a pregnancy test to make sure you are not pregnant before starting Zynyz. If you can become pregnant, you should use effective birth control while using Zynyz and for 4 months after your last dose. 

Breastfeeding. Do not breastfeed while using Zynyz and for 4 months after your last dose. It is not known if Zynyz passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Zynyz?

For more information about Zynyz, you can visit the drugmaker’s website at www.zynyz.com or call them at 855-463-3463.

Interactions

Does Zynyz interact with foods or drinks?

There are no known interactions between Zynyz and foods or drinks.

It is unknown if drinking alcohol will affect Zynyz.

Does Zynyz interact with other medicines (drug interactions)?

There are no known interactions between Zynyz and other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Zynyz?

If you or someone else has used too much Zynyz, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Zynyz?

Zynyz is usually given by a health care provider in a hospital or clinic. If you miss an appointment to get your Zynyz dose, call to make another appointment as soon as possible.