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Drug overview for PAPZIMEOS (zopapogene imadenovec-drba):
Generic name: ZOPAPOGENE IMADENOVEC-DRBA
Drug class:
Therapeutic class: Respiratory Therapy Agents
Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy.
No enhanced Uses information available for this drug.
Generic name: ZOPAPOGENE IMADENOVEC-DRBA
Drug class:
Therapeutic class: Respiratory Therapy Agents
Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy.
No enhanced Uses information available for this drug.
DRUG IMAGES
PAPZIMEOS VIAL
The following indications for PAPZIMEOS (zopapogene imadenovec-drba) have been approved by the FDA:
Indications:
Recurrent respiratory papillomatosis
Professional Synonyms:
None.
Indications:
Recurrent respiratory papillomatosis
Professional Synonyms:
None.
The following dosing information is available for PAPZIMEOS (zopapogene imadenovec-drba):
It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:
Zopapogene imadenovec-drba is for subcutaneous injection only.
The recommended dose of zopapogene imadenovec-drba is 5x1011 particle units (PU) per injection administered by subcutaneous injection 4 times over a 12-week interval. The second dose should be administered 2 weeks (no less than 11 days) after initial administration. The third dose should be administered 6 weeks after initial administration, and the fourth dose should be administered 12 weeks after initial administration.
Prior to the initial administration of zopapogene imadenovec-drba, perform a surgical debulking of visible papilloma to establish minimal residual disease. To maintain minimal residual disease during treatment with zopapogene imadenovec-drba, remove visible papilloma, if present, prior to the third and fourth administration of zopapogene imadenovec-drba.
Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy. Follow universal biosafety precautions for handling.
Zopapogene imadenovec-drba is provided as a single-dose vial of sterile frozen suspension that MUST BE RAPIDLY thawed before use and prepared for immediate administration. See Full Prescribing Information for additional preparation, handling, and administration instructions.
Zopapogene imadenovec-drba is for subcutaneous injection only.
The recommended dose of zopapogene imadenovec-drba is 5x1011 particle units (PU) per injection administered by subcutaneous injection 4 times over a 12-week interval. The second dose should be administered 2 weeks (no less than 11 days) after initial administration. The third dose should be administered 6 weeks after initial administration, and the fourth dose should be administered 12 weeks after initial administration.
Prior to the initial administration of zopapogene imadenovec-drba, perform a surgical debulking of visible papilloma to establish minimal residual disease. To maintain minimal residual disease during treatment with zopapogene imadenovec-drba, remove visible papilloma, if present, prior to the third and fourth administration of zopapogene imadenovec-drba.
Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy. Follow universal biosafety precautions for handling.
Zopapogene imadenovec-drba is provided as a single-dose vial of sterile frozen suspension that MUST BE RAPIDLY thawed before use and prepared for immediate administration. See Full Prescribing Information for additional preparation, handling, and administration instructions.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for PAPZIMEOS (zopapogene imadenovec-drba):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for PAPZIMEOS (zopapogene imadenovec-drba):
Drug contraindication overview.
None.
None.
There are 0 contraindications.
There are 0 severe contraindications.
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Thromboembolic disorder |
| Thrombotic disorder |
The following adverse reaction information is available for PAPZIMEOS (zopapogene imadenovec-drba):
Adverse reaction overview.
The most common adverse reactions (incidence >=5%) were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
The most common adverse reactions (incidence >=5%) were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.
There are 0 severe adverse reactions.
There are 15 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Chills Fatigue Fever Headache disorder Injection site sequelae Myalgia Nausea |
Blurred vision Diarrhea Dizziness Dyspnea Hyperhidrosis Pruritus of skin Tachycardia Vomiting |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for PAPZIMEOS (zopapogene imadenovec-drba):
The safety and effectiveness of zopapogene imadenovec-drba have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data with zopapogene imadenovec-drba in pregnant women. Animal reproductive and developmental toxicity studies have not been conducted with zopapogene imadenovec-drba. In the PRGN-2012-201 study, one patient reported pregnancy at 6 months following completion of treatment with zopapogene imadenovec-drba.
The patient delivered at 40 weeks without any reported birth complications or neonatal concerns. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
The patient delivered at 40 weeks without any reported birth complications or neonatal concerns. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
There is no information available on the presence of zopapogene imadenovec-drba in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zopapogene imadenovec-drba and any potential adverse effects on the breastfed child from zopapogene imadenovec-drba or from the underlying maternal condition.
There were 9 patients (24%) 65 years of age and older and 1 patient (3%) 75 years of age and older in Study PRGN-2012-201. Clinical studies of zopapogene imadenovec-drba did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients.
The following prioritized warning is available for PAPZIMEOS (zopapogene imadenovec-drba):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for PAPZIMEOS (zopapogene imadenovec-drba)'s list of indications:
| Recurrent respiratory papillomatosis | |
| D14.1 | Benign neoplasm of larynx |
| D14.2 | Benign neoplasm of trachea |
| D14.3 | Benign neoplasm of bronchus and lung |
| D14.30 | Benign neoplasm of unspecified bronchus and lung |
| D14.31 | Benign neoplasm of right bronchus and lung |
| D14.32 | Benign neoplasm of left bronchus and lung |
| D14.4 | Benign neoplasm of respiratory system, unspecified |
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