Prescribing guide
Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd)Dosing schedule, CELLECTRA 5PSP administration, debulking timing and coverage for recurrent respiratory papillomatosisFor prescribers and their offices treating recurrent respiratory papillomatosis: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS, boxed warning or contraindications; surgical debulking of visible papilloma before dose 1; a CELLECTRA 5PSP device, requested from INOVIO at 1-855-INOVIO1, and a provider trained in its use; current height and weight for needle depth; a deltoid or anterolateral quadriceps site clear of an ipsilateral ICD or pacemaker, metal implants and skin abnormalities.
Example PA threshold
No public payer policy found as of November 9, 2026; label indication is adults with RRP, with no surgery-count or prior-therapy criterion; RRP-001 enrolled 2 or more surgeries in the prior 12 months, and the efficacy population had 3 or more.
Monitoring
At least 30 minutes of observation after each dose for injection-site reactions; electroporation effects including vasovagal reactions and transient CPK changes; no laboratory monitoring specified; efficacy in the label judged by surgical need over 12 months.
Support line
No INOVIO patient support program published as of November 9, 2026; 1-855-INOVIO1 for a representative, adverse reaction reports and the CELLECTRA 5PSP; ordering expected about 60 days after the October 30, 2026 approval, full launch in the first quarter of 2027.
Give your patient their plan
A one-page handout for starting Voceryq, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/voceryqBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Confirm the indication | To reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis, under accelerated approval. Safety and effectiveness in pediatric patients are not established. | FDA label |
| Debulk first | Perform surgical debulking of visible papilloma before the initial dose to establish minimal residual disease. The label sets no interval between the surgery and dose 1. | FDA label |
| Debulking timing in RRP-001 | Every patient had a clinically necessary procedure, predominantly laser-based or microdebridement, within 14 days of the first dose (day 0), to standardize baseline disease burden. | Nature Communications |
| Device and training | Administer only with the CELLECTRA 5PSP and by a healthcare provider trained in its use. The device is not supplied with the cartridges and is provided to healthcare providers by calling 1-855-INOVIO1. | FDA label |
| Supplies per visit | CELLECTRA 5PSP base station and handset, set up and charged; a sterile CELLECTRA 5PSP Array; the Voceryq carton with its single-dose cartridge; alcohol wipes; gauze and bandage; a sharps container; the User Manual. | FDA label |
| Height and weight | Current height and weight are entered in the base station, which recommends needle depth; set depth on the handset from that recommendation and clinical judgment for the chosen site. | FDA label |
| Screen the site | No ICD or pacemaker ipsilateral to the intended deltoid, no metal implants or implantable devices within the treatment site, and no tender, bruised, erythematous or indurated skin or lesions. Stay at least 2cm from a tattoo, keloid or hypertrophic scar. | FDA label |
| Clinical judgment | Do not administer to patients with any medical condition, laboratory abnormality or clinical circumstance that in the treating provider's judgment may increase the risk of complications with electroporation. | FDA label |
| Ordering | INOVIO expected Voceryq to be available to order and ship in about 60 days from October 30, 2026, with full field deployment in the first quarter of 2027. | INOVIO announcement |
| Distribution partners | In August 2026 INOVIO said it had engaged or identified a third-party logistics provider, specialty distributor, specialty pharmacy and patient hub, without naming them. | INOVIO, Q2 2026 |
Prior authorization criteria and what to document
No public payer policy with Voceryq criteria was found as of November 9, 2026. We searched the web for public policies on November 9, 2026. We looked for Express Scripts, FEP Blue, Aetna, Cigna, UnitedHealthcare, Optum Rx, CVS Caremark and Blue Cross Blue Shield plans. None of them had published criteria for Voceryq by that date. Until plans publish their own, the label is the only written standard, and it covers adults with recurrent respiratory papillomatosis.
| Element | What the checklist lists | In the chart | Source |
|---|---|---|---|
| Indication | Adults with recurrent respiratory papillomatosis; no surgery-count or prior-therapy criterion in the label | No public payer criteria found on November 9, 2026, so the rows below are label and trial facts an office may document, not payer rules | FDA label |
| Diagnosis in the trial | The registry lists histologically documented HPV-6 or HPV-11 positive respiratory papilloma, or a low-risk positive HPV result on a sponsor-approved HPV-6/11 type-specific assay | Pathology report and HPV typing, where done | ClinicalTrials.gov |
| Surgical burden | RRP-001 enrolled 2 or more laryngotracheal papilloma surgeries in the prior 12 months; the label's efficacy population had 3 or more, median 4.5 (range 3 to 8), counting the pre-treatment excision | Dated operative notes for the prior 12 months | FDA label |
| Debulking | Surgical debulking of visible papilloma before the first dose | Operative note with date | FDA label |
| Prior RRP-directed therapy | RRP-001 excluded cidofovir and other antivirals, bevacizumab, radiation, chemotherapy, Gardasil given as therapy and experimental agents within 3 months before day 0 | Medication history with dates; a trial exclusion, not a label rule | ClinicalTrials.gov |
| Site and device | Implanted cardiac device side, metal implants and skin at the planned site | Exam note naming the site used | FDA label |
Voceryq dosing and titration
| When | Label | Source |
|---|---|---|
| Before day 1 | Debulk visible papilloma to minimal residual disease; the label gives no interval. | FDA label |
| Day 0 (dose 1), weeks 3, 6 and 9 | 1mL (6.25mg/mL) IM with electroporation via CELLECTRA 5PSP every 3 weeks for a total of 4 doses. Each cartridge delivers 6mg doruxapapogene ralaplasmid and 0.25mg lalikinogene sifuplasmid. | FDA label |
| Site | Thickest part of the deltoid; anterolateral quadriceps if neither deltoid is suitable. No need to rotate sites during the course. | FDA label |
| Preparation | Warm in the carton about 30 minutes; use within 24 hours of leaving the refrigerator, re-refrigeration allowed; use within 8 hours once out of the carton. Clear to slightly opalescent and colorless; discard if particles, discoloration or cloudiness. | FDA label |
| Delivery | Insert the Array fully, press and release the trigger, and hold until the confirmation sound, about 10 seconds. Withdrawing after the trigger aborts treatment; remove only when the handset reads TREATMENT COMPLETE. | FDA label |
| Incomplete treatment | Follow the device prompts; reschedule if a new Array and cartridge are needed. If all steps were done and the handset does not show Treatment Complete, contact Inovio. The label has no missed-dose instruction. | FDA label |
| Supply | One single-dose prefilled glass cartridge per carton; package NDC 84348-3107-1, cartridge NDC 84348-3107-0. | FDA label |
| Storage | 2°C to 8°C (36°F to 46°F) in the original carton; do not freeze; total room temperature exposure no more than 24 hours. | FDA label |
| Dating period | 36 months from manufacture at 2°C to 8°C; the CELLECTRA 5PSP Array has a 12-month shelf life from device manufacture. | FDA letter |
Monitoring the Voceryq label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| After each dose | Local injection-site reactions | Observe at least 30 minutes and manage accordingly | FDA label |
| During and after electroporation | Brief muscle contractions or tetany, temporary bleeding, anxiety, vasovagal reactions including lightheadedness and dizziness, transient CPK changes, site erythema and pain | Position and stabilize the patient for administration, per the label and User Manual | FDA label |
| Adverse reactions in RRP-001 | Injection site reaction 34%, headache 19%, fatigue 16%, hypertension 13%, nausea 6%, dizziness 6% (N=32) | Under 5%, each 3%: localized edema, malaise, lethargy, flank pain, jaw pain, procedural anxiety, flushing, neutropenia, cholecystitis, myalgia | FDA label |
| Laboratory | None specified | The label lists no baseline or on-treatment laboratory tests | FDA label |
| 12 months after treatment | Need for surgical excision | Complete response, no surgery in 12 months, in 7 of 26 (27%, 95% CI 12 to 48%) of the efficacy population | FDA label |
| Immune response | HPV-6 and HPV-11 specific T cells at week 11 and week 52 in RRP-001 | Median 4,195 papilloma T cell clones in responders against 1,218 in non-responders at week 52; a pharmacodynamic finding, not a test to order | FDA label |
| Trial record | RRP-001 is NCT04398433, listed as completed | The registry names the CELLECTRA 2000 for the trial; the label approves administration with the CELLECTRA 5PSP | ClinicalTrials.gov |
| Confirmatory study | At least 50 adult and pediatric patients with 3 or more surgeries in the prior 12 months, surgery counts over at least 3 years after treatment | Draft protocol due December 30, 2026; final report due August 30, 2032 | FDA letter |
Voceryq drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Drug interactions | The label has no drug interactions section and lists none | FDA label |
| Implanted devices | Avoid an ICD or pacemaker ipsilateral to the deltoid site and metal implants or implantable devices within the site; use an alternate site | FDA label |
| Trial exclusions, not label rules | RRP-001 excluded systemic immunosuppressive therapy, including systemic corticosteroids, within 28 days, a live vaccine within 4 weeks or a non-live vaccine within 2 weeks before the first dose, and a high bleeding risk or anticoagulants for a known bleeding diathesis | ClinicalTrials.gov |
| Kanamycin | Used in fermentation, cleared in manufacturing and not detectable in the final product | FDA label |
| Pregnancy and lactation | No human data; a rabbit fertility and development study showed no significant maternal, fetal or developmental toxicity; no data on human milk | FDA label |
| Age 65 and older | Too few subjects to determine whether response differs; trial ages ranged from 25 to 82 | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedWe found no public insurer policy for Voceryq as of November 9, 2026, so each plan sets its own rules. The label covers adults with recurrent respiratory papillomatosis and names no required number of past surgeries. The trial enrolled adults with 2 or more surgeries in the prior 12 months.
- The clinic cannot order it yetINOVIO said on October 30, 2026 that it expected Voceryq to be available to order and ship in about 60 days. It expected full commercial launch in the first quarter of 2027.
- The clinic has no CELLECTRA 5PSP deviceThe label says Voceryq is given only with this device, by a provider trained in its use. The device does not come with the medicine, and clinics request it from INOVIO at 1-855-INOVIO1.
- An implant or skin problem at the planned siteThe label moves the injection to another site for a pacemaker or defibrillator on the same side, a metal implant, or damaged skin. The thigh is the label's other choice when neither upper arm is suitable.
- A cost questionINOVIO had not published a copay or patient assistance program by November 9, 2026. INOVIO said in August 2026 that it had engaged or identified a specialty pharmacy, a specialty distributor and a patient hub, without naming them. Our help paying page lists assistance funds for this condition as they open.
INOVIO, no patient support program published yet
- INOVIO's prescriber site says to call 1-855-INOVIO1 to speak with a representative about Voceryq
- The label gives the same number for reporting side effects and for clinics to get the CELLECTRA 5PSP device FDA label
- INOVIO expected Voceryq to be available to order and ship about 60 days after the October 30, 2026 approval INOVIO announcement
- In August 2026, INOVIO said it had engaged or identified a patient hub and a specialty pharmacy, without naming either INOVIO, Q2 2026
- No copay, free drug or bridge program had been published by November 9, 2026
Questions prescribers' offices ask about Voceryq
What is the Voceryq dosing schedule?
Four doses of 1mL (6.25mg/mL) given IM with electroporation via CELLECTRA 5PSP, every 3 weeks, per the October 2026 label; in RRP-001 that was day 0 and weeks 3, 6 and 9. The label describes no retreatment course.
When is debulking done relative to the first Voceryq dose?
Before dose 1, with no fixed interval in the October 2026 label, which says to debulk visible papilloma to establish minimal residual disease. RRP-001 required the surgery within 14 days before day 0, and the protocol required no further excisions during the 9-week dosing window.
How is Voceryq administered with the CELLECTRA 5PSP?
One single-dose 1mL cartridge per visit, loaded into a sterile Array on the handset, injected into the thickest part of the deltoid, per the October 2026 label; the anterolateral quadriceps is used if neither deltoid is suitable. The device recommends needle depth from current height and weight, delivery takes about 10 seconds, and the patient is observed for at least 30 minutes.
Does Voceryq have a REMS, boxed warning or contraindications?
None of the 3, per the October 2026 label and the October 30, 2026 approval letter. Warnings cover injection-site reactions and electroporation effects; avoid an ipsilateral ICD or pacemaker, metal implants or implanted devices at the site, and irritated, damaged, bruised, scarred or tattooed skin.
What do insurers ask for to approve Voceryq?
As of November 9, 2026 we found 0 public payer policies with Voceryq criteria, and the October 2026 label indication, adults with RRP, names no surgery count. INOVIO had published no patient support program by that date; RRP-001 enrolled patients with 2 or more surgeries in the prior 12 months, and the efficacy population had 3 or more.
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Sources
- Package Insert - VOCERYQ (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) solution for intramuscular injection, Revised 10/2026, FDA, Center for Biologics Evaluation and Research, 2026-10-30.
- VOCERYQ, FDA, Center for Biologics Evaluation and Research, 2026-10-30.
- October 30, 2026 Approval Letter - VOCERYQ, FDA, Center for Biologics Evaluation and Research, 2026-10-30.
- FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis, FDA, 2026-10-30.
- INOVIO Announces FDA Accelerated Approval of VOCERYQ, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP), INOVIO, 2026-10-30.
- Official HCP Website | VOCERYQ, INOVIO, 2026-11-09.
- INOVIO Reports Second Quarter 2026 Financial Results and Recent Business Highlights, INOVIO via PR Newswire, 2026-08-12.
- DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107, Nature Communications, 2025-02-12.
- INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomatosis (RRP), NCT04398433, ClinicalTrials.gov, record verified March 2026, 2026-11-09.
A reference drawn from the October 30, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 9, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.