Papzimeos
Pronunciation: Pap-zim-e-os
Generic name: zopapogene imadenovec-drba
Dosage form: suspension for subcutaneous injection (5 x 10¹¹ PU/1 mL)
What is Papzimeos?
Papzimeos is used to treat recurrent respiratory papillomatosis (RRP) in adults. This gene therapy is the first non-replicating adenoviral vector-based immunotherapy approved for RRP treatment. Papzimeos is given by subcutaneous injection 4 times over a 12-week interval.
RRP is a rare, life-threatening infection caused by human papillomavirus (HPV) types 6 and 11, resulting in voice problems, airway obstruction, and pneumonia.
Papzimeos (zopapogene imadenovec-drba) gained FDA approval on August 14, 2025.
How does Papzimeos work?
Mechanism
Papzimeos works in RRP by using selected parts of HPV 6 and HPV 11 proteins as a fusion antigen, training the immune system to recognize and attack cells infected with these viruses.
Side effects
Common side effects
The most common side effects of Papzimeos are:
- Injection site reactions
- Fatigue
- Chills
- Pyrexia (fever)
- Myalgia (muscle aches)
- Nausea.
Serious side effects and warnings
Papzimeos may cause the following serious side effects:
Injection site reactions. These have occurred after an injection of Papzimeos, and some may be severe. Signs and symptoms may include redness, pain, swelling, itching, or warmth at the injection site. Your healthcare provider will monitor you for these for at least 30 minutes after the initial treatment. Manage symptoms with a cold compress, over-the-counter pain relievers, or antihistamines if needed. Seek urgent medical attention if symptoms worsen or are accompanied by signs of a systemic allergic reaction (such as difficulty breathing, widespread rash, or facial swelling) or an infection
Thrombotic events. These may occur after a Papzimeos injection and symptoms may include shortness of breath, chest pain, leg swelling, persistent abdominal pain, or neurological symptoms (including severe or persistent headaches or blurred vision). Seek urgent medical attention if you develop any of these symptoms.
These are not all the side effects of Papzimeos. See the Papzimeos Prescribing Information for a list of side effects. To report suspected adverse reactions, contact Precigen Inc. at 855-743-6777, and medinfo@precigen.com or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
How is Papzimeos administered?
Papzimeos is administered by a health professional by subcutaneous (under the skin) injection, into the outer, upper arm or outer, upper thigh.
- Before administering Papzimeos, your healthcare provider will remove as much of the visible papilloma as possible. This is called surgical debulking.
- This may be repeated before the third and fourth treatment of Papzimeos if necessary.
- Avoid direct contact with the injection site (such as touching or scratching) and dressings for at least 24 hours following treatment.
You and your healthcare provider should treat any material associated with the Papzimeos injection as contaminated.
- This includes the needle and syringe containing Papzimeos and any dressings.
- Place these in a sealable bag and dispose of them in your regular trash.
- Follow these precautions for 1-2 weeks after the injection.
- All caregivers should practice proper hand hygiene, such as hand washing when coming into direct contact with a patient's body waste.
Dosing information
Dose of Papzimeos for Recurrent Respiratory Papillomatosis (RRP) in Adults
- 5 x 1011 particle units (PU) subcutaneously (SC).
- Administer four times over a 12-week interval (at 0, 2, 6, and 12 weeks)
Storage
Papzimeos requires storage at -60°C (-76°F) or less.
When ready to administer, remove Papzimeos from the freezer and thaw immediately in a 37°C (98.6°F) water bath or dry bead bath until there are no visible ice crystals in the vial, for a time of less than or equal to 5 minutes.
- Do not hold Papzimeos at room temperature for more than 60 minutes after thawing. Do not store thawed Papzimeos.
Treat any Papzimeos spills with a virucidal agent (eg, sodium hypochlorite with 0.5% active chlorine or 6% hydrogen peroxide) for 15 minutes.
Dispose of any unused product or waste materials as per facility biohazard waste disposal procedure.
Ingredients
Active ingredient: zopapogene imadenovec-drba 5 x 1011 PU/1 mL
Excipients: Tris base (10 mM), sodium chloride (75 mM), magnesium chloride hexahydrate (1 mM), polysorbate 80 (0.019 mM), and trehalose dihydrate (146 mM).
Supplied as a sterile, frozen suspension that has been aseptically filled into single-dose vials fitted with a rubber stopper and aluminum flip-cap seal.
Manufacturer
Papzimeos is manufactured by Precigen Inc., 20358 Senecca Meadows Parkway, Germantown, MD 20876 USA. U.S. Licence No. 2364.
References
More about Papzimeos (zopapogene imadenovec)
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.