Zopapogene Imadenovec

Zopapogene Imadenovec is an immunotherapy indicated for the treatment of adults with recurrent respiratory papillomatosis. 

• Zopapogene Imadenovec is available under the following different brand names: Papzimeos, Zopapogene Imadenovec-drba

Common side effects of Zopapogene Imadenovec include:

• injection site reactions 
• fatigue 
• chills
• fever 
• muscle pain
• nausea 

Serious side effects of Zopapogene Imadenovec include:

• symptoms of injection site reactions may include redness, pain, swelling, itching, or warmth at the injection site
• symptoms of thrombotic events may include  shortness of breath, chest pain, leg swelling, persistent abdominal pain, or neurological symptoms (including severe or persistent headaches or blurred vision) 

Rare side effects of Zopapogene Imadenovec include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, SC suspension

• 5x 10^11 particle units/mL single-dose vial

Recurrent Respiratory Papillomatosis

Adult dosage

• 5x 10^11 particle units SC x 4 doses over 12 weeks
• Recommended treatment schedule
  • Initial dose (dose 1): Day 1
  • Dose 2: Administer 2 weeks after initial dose
  • Dose 3: Administer 6 weeks after initial dose
  • Dose 4: Administer 12 weeks after initial dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zopapogene Imadenovec?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zopapogene Imadenovec?”

Cautions

• Injection site reactions
  • Injection site reactions reported
  • Monitor for local site reactions for at least 30 minutes after initial treatment and manage accordingly
• Thrombotic events
  • Thrombotic events may occur following administration of adenoviral vector-based therapies owing to the potential to induce prothrombotic antibody development
  • Monitor for signs and symptoms of thrombotic events and treatment as clinically indicated

Pregnancy and Lactation

• Data are unavailable regarding use during pregnancy
• Animal reproductive and developmental toxicity studies have not been conducted
• Lactation
  • No information is available regarding the presence of the drug in human milk, its effects on breastfed infants, or milk production