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.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

None.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Thromboembolic disorder
• Thrombotic disorder

The most common adverse reactions (incidence >=5%) were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.

There are no severe adverse reactions for this drug.

More Frequent

• Chills
• Fatigue
• Fever
• Headache disorder
• Injection site sequelae
• Myalgia
• Nausea

Less Frequent

• Blurred vision
• Diarrhea
• Dizziness
• Dyspnea
• Hyperhidrosis
• Pruritus of skin
• Tachycardia
• Vomiting

No enhanced messaging available.

The safety and effectiveness of zopapogene imadenovec-drba have not been established in pediatric patients.

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.

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.