Zopapogene imadenovec-dbra Injection

Zopapogene imadenovec-dbra injection is used with surgery to treat recurrent respiratory papillomatosis (RRP; a chronic viral infection that causes wart-like tumors to grow in air passages from the nose and mouth to the lungs). Zopapogene imadenovec-dbra is in a class of medications called immune therapy. It works by helping the body's immune system fight the virus that causes RRP. It also helps to decrease the number of surgeries needed for RRP.

Zopapogene imadenovec-dbra comes as a suspension (liquid) to be injected subcutaneously (under the skin) by a healthcare provider into the front of your thighs or upper arm. It is given as 4 doses over 12 weeks. Your doctor will tell you how often you will receive zopapogene imadenovec-dbra injection.

Zopapogene imadenovec-dbra injection can cause reactions at the injection site. A doctor or nurse will watch you for at least 30 minutes after you receive your first dose. If you experience any of the following symptoms, tell your doctor or nurse immediately: redness, itching, bruising, pain, or swelling at the injection site; or fever and pus-filled, blister-like sores, redness, and swelling of the skin.

Avoid touching or scratching the injection site and dressings for about 24 hours after you receive zopapogene imadenovec-dbra injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving zopapogene imadenovec-dbra injection,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have ever had blood clots in your legs or lungs.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving zopapogene imadenovec-dbra injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

If you miss an appointment to receive zopapogene imadenovec-dbra injection, call your doctor immediately.

Zopapogene imadenovec-dbra injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• fatigue
• fever or chills
• muscle pain
• nausea
• vomiting
• diarrhea
• headache
• sweating
• dizziness

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• shortness of breath, rapid breathing, chest pain, fast heartbeat, or coughing up blood
• leg pain; feeling of warmth in the lower leg; or swelling of the feet, ankles, or lower legs
• stomach pain that doesn't go away
• sudden severe headache that doesn't go away or blurred vision
• rash; swelling of the face, eyelids, tongue, or throat; shortness of breath; or difficulty breathing or swallowing

Zopapogene imadenovec-dbra injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Papzimeos ^®