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Overview: Papzimeos is used to treat recurrent respiratory papillomatosis. It is a condition caused by a virus where wart-like tumors (papillomas) grow in the airways. Papzimeos helps your immune system target the infected cells, which can slow or stop the growths from coming back. Common side effects are discomfort at the injection site, tiredness, fever, chills, and muscle aches. Get medical help right away if you have a rash, trouble breathing, face swelling, chest pain, or swelling in your leg. Papzimeos is given as an injection under the skin by a health care professional.

Uses

What is Papzimeos used for?

Papzimeos (zopapogene imadenovec-drba) is commonly used for recurrent respiratory papillomatosis (RRP). RRP is a condition where wart-like tumors (papillomas) grow in the airways and keep coming back. RRP is caused by certain types of human papillomavirus (HPV) and mainly affects the voice box (larynx). 

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

How does Papzimeos work (mechanism of action)?

Papzimeos works by training the immune system to recognize and attack cells infected with HPV types 6 and 11, the viruses that can cause recurrent respiratory papillomatosis (RRP). This can delay or stop the growths in the airways (papillomas) from coming back.

How is Papzimeos supplied (dosage forms)?

Papzimeos is available as an injection that is given under the skin by a health care provider.

How should I store Papzimeos?

Papzimeos is usually 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 Papzimeos?

The most common side effects of Papzimeos are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Injection site reactions (see below)
  • Tiredness
  • Fever and chills
  • Muscle aches
  • Nausea 

There may be other side effects of Papzimeos 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 Papzimeos?

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

Severe Allergic Reactions. Papzimeos 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

Risk of Blood Clots. Papzimeos may increase the risk of blood clots. A blood clot can form in your arteries or veins and could cause a stroke, heart attack, or venous thromboembolism, including a blood clot in the lungs (pulmonary embolism) or deep vein thrombosis (DVT). Get emergency help if you have any of the following signs of blood clots.

  • Chest pain or pressure
  • Fast or abnormal heartbeat
  • Trouble breathing
  • Pain in your back, jaw, throat, or arm
  • Sweating, upset stomach, vomiting, or dizziness
  • Sudden weakness on one side of your body
  • Sudden and severe headache
  • Slurred speech or trouble understanding speech
  • Pain, swelling, or tenderness in your arm or leg
  • Vision loss
  • Bulging eyes
  • Double vision

Warnings & Precautions

Who should not use Papzimeos?

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

  • Papzimeos
  • Zopapogene imadenovec-drba
  • Any of the ingredients in the specific product dispensed

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

What should I know about Papzimeos before using it?

Papzimeos is usually given by a health care provider in a hospital or clinic. Plan to have someone drive you home after you receive Papzimeos. This medicine may cause tiredness, blurry vision, or dizziness. 

Papzimeos is usually given as four doses over the course of 3 months. Before your first dose, you  may have surgery to remove any growths (papillomas) in your airway. You may also need to have growths removed between doses of Papzimeos. Talk with your health care provider for details about your treatment schedule, including when surgery may be needed.

Do not touch or scratch the area or remove any dressings or bandages for about 24 hours after each injection. 

Keep in mind that any dressings used at the injection site may contain small amounts of body fluid for one to two weeks after each injection. To avoid spreading germs, any dressings should be sealed in a bag before being thrown away. Always wash your hands after handling. Be sure to follow the instructions given by your health care provider.

It is common to have redness, pain, swelling, warmth, or itching near where Papzimeos was injected. To watch for these reactions, a health care provider may monitor you for at least 30 minutes after you receive your first dose of Papzimeos. Your health care provider may suggest a cold compress or over-the-counter pain relievers or antihistamines to ease discomfort, if needed. Contact your health care provider right away if your symptoms feel severe, get worse, do not go away, or if you have signs of an infection. Get emergency help if you have trouble breathing, a widespread rash, or face swelling.

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

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 Papzimeos is right for you.

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

Pregnancy. It is not known if or how Papzimeos could affect pregnancy or an unborn baby. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if Papzimeos passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. 

How can I get more information about Papzimeos?

For more information about Papzimeos, you can visit the drugmaker’s website at www.papzimeos.com or call them at 866-827-8180.

Interactions

Does Papzimeos interact with foods or drinks?

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

It is unknown if drinking alcohol will affect Papzimeos.

Does Papzimeos interact with other medicines (drug interactions)?

There are no known interactions between Papzimeos 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 Papzimeos?

If you or someone else has used too much Papzimeos, 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 Papzimeos?

Papzimeos is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Papzimeos as scheduled. If you miss an appointment to get your Papzimeos dose, call to make another appointment as soon as possible.