Your first 90 days
Your first 90 days on Voceryq for recurrent respiratory papillomatosis
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Voceryq works differently from the surgery that has long been the main treatment for recurrent respiratory papillomatosis. It starts with one more operation to clear the visible papillomas, then 4 injections into muscle over 9 weeks. Each injection comes with a brief electrical pulse that helps the DNA get into cells, and the goal is fewer operations afterward. This page lays out those first 3 months from the FDA label, the approval letter and what INOVIO has published so far.
What has to happen before the first bottle ships
Voceryq has no REMS and is given by a trained provider, never taken at home. The first dose waits on surgery, a clinic with the right device and an insurance decision. These are the 7 things in the way, in order.
Surgery to clear the visible papillomas
The label says to remove the papillomas that can be seen before the first dose, leaving as little disease as possible.
- Doctors call this operation surgical debulking, the first step in the Voceryq plan.
- The label does not set how many days before dose 1 it should happen, so the otolaryngologist decides the timing.FDA label
A clinic with the CELLECTRA 5PSP device
The label says Voceryq is given only with the CELLECTRA 5PSP device, by a healthcare provider trained to use it.
- The device is not shipped with the medicine, so the clinic needs its own.
- Clinics get it from INOVIO by calling 1-855-INOVIO1, according to the label.FDA label
Your height and weight on file
The device uses your current height and weight to suggest how deep the needles go.
- The label asks the care team to have both up to date before each dose begins.FDA label
A safe place on the arm or thigh
The label uses the thickest part of the upper arm muscle, or the front and outer thigh when neither arm is suitable.
- It avoids skin that is bruised, red, tender, hardened or affected by lesions.
- It also avoids anywhere within 2cm of a tattoo, keloid or raised scar.FDA label
Pacemakers, defibrillators and metal implants
The label says not to give the electrical pulse in an arm on the same side as a pacemaker or implanted defibrillator.
- It also avoids sites with metal implants or other implanted devices.
- Tell the otolaryngologist about any implant, including where it sits, before day 1.FDA label
Your health history
The label lets the treating provider decide against Voceryq for any condition, lab result or situation that could make the electrical pulse riskier.
- It has no data on pregnancy or breastfeeding, so mention either one at the first visit.FDA label
Ordering and insurance
INOVIO said on October 30, 2026 that it expected Voceryq to be available to order and ship in about 60 days.
- It also said the full launch would come in the first quarter of 2027.
- We found no published insurer rules for Voceryq on November 9, 2026.INOVIO announcement
The days that matter
Counted from the first dose, with the surgery before it and a dose every 3 weeks to day 64. The label judges the result over the year after treatment. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Ordering and the insurance review
INOVIO expected ordering to open about 60 days after the October 30, 2026 approval.
- It expected the full commercial launch in the first quarter of 2027.
Surgery to clear the visible papillomas
In the trial, every patient had surgery to remove papillomas within 14 days before the first dose.
- Your otolaryngologist sets the timing for you, because the label gives no fixed number of days.
Dose 1, an injection with a short electrical pulse
A trained provider gives 1mL into the upper arm muscle, usually, with the CELLECTRA 5PSP device.
- The label says the treatment takes about 10 seconds, and you are watched for at least 30 minutes afterward.
The injection site
Redness, pain, swelling, itching or warmth where the shot went in are the reactions the label describes.
- It says to seek care if they get worse or come with trouble breathing, a widespread rash or facial swelling.
Dose 2, 3 weeks later
The second dose follows the same steps as the first.
- The label says there is no need to switch to a different arm or leg between doses.
Dose 3
Another dose with the device, 3 weeks after dose 2, followed by at least 30 minutes of observation in the clinic.
Dose 4, the last one
This dose completes the label course of 4 doses in total.
- In the trial, no extra surgery to remove papillomas was required during the 9 weeks of dosing.
Follow-up and the 12-month mark
The label judged Voceryq by whether people needed any papilloma surgery in the 12 months after treatment.
- Your otolaryngologist sets the schedule of follow-up visits during that year.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Voceryq label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Label dated October 30, 2026, read from the FDA's website. FDA label
- November 2026
DailyMed, the usual home of FDA labels, did not list Voceryq on November 9, 2026. This page was read from the package insert on the FDA's Voceryq product page instead.FDA product page
- October 2026
The FDA said this was the first approval of a plasmid DNA-based immunotherapy in the US. Voceryq also holds Breakthrough Therapy and Orphan Drug designations from the FDA.FDA announcement
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Given only in a clinic, with the device
Voceryq is not a medicine you take at home, and the label names who gives it.
- The label says only a provider trained on the CELLECTRA 5PSP device gives it, using that device.FDA label
- Four doses, 3 weeks apart
The label dose is 1mL, at 6.25mg per mL, injected into muscle with the electrical pulse every 3 weeks, for 4 doses in total.FDA label
- No surgery planned during dosing
INOVIO's prescriber site says no planned surgery is required as part of the 9-week dosing schedule.
- The surgery to clear the visible papillomas comes before dose 1, by the same page.INOVIO prescriber site
- If a dose is missed or stops partway
The label gives no instruction for what to do after a missed dose.
- For a dose the device did not finish, it says to follow the device prompts or reschedule the visit.
- Ask the clinic what its plan is before day 1.FDA label
- Implants and skin at the injection site
The label avoids the arm on the same side as a pacemaker or defibrillator, and any site with metal implants.
- It also avoids skin with bruises, scars or tattoos, and a different site is used instead.FDA label
- Pregnancy and breastfeeding
The label says there are no data on Voceryq in pregnancy or in human milk.
- In a rabbit study, it showed no significant harm to fertility, the mothers or their offspring.
- Any decision about Voceryq in pregnancy rests with you and the otolaryngologist.FDA label
- Age limits in the label
Voceryq is approved for adults with recurrent respiratory papillomatosis, not for children.
- The label says safety and effectiveness in children have not been established, and the trial had too few people aged 65 or older to compare.FDA label
- Storage is the clinic's job
The clinic keeps Voceryq in the refrigerator at 36 to 46 degrees Fahrenheit and never freezes it.
- The label says to use it within 8 hours once the cartridge leaves its carton.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Injection site reactions
Redness, pain, swelling, itching or warmth where the shot went in.
- The label says to seek medical care if these get worse, or come with trouble breathing, a widespread rash, facial swelling or signs of infection.FDA label
During and right after the pulse
The label lists brief muscle contractions, temporary bleeding at the site, anxiety, lightheadedness and dizziness.
- The label groups lightheadedness and dizziness together under what it calls vasovagal reactions.
- Tell the care team at once if you feel faint.FDA label
The most common side effects
In the trial of 32 adults, injection site reactions affected 34% and headache 19%.
- Tiredness affected 16%, high blood pressure 13%, and nausea and dizziness 6% each.FDA label
Less common reactions
The label lists swelling in one spot, feeling unwell, low energy, flank or jaw pain, procedure anxiety, flushing and muscle aches.
- It also lists a low white cell count and gallbladder inflammation.
- Each of these affected 3% of trial patients, about 1 in 32 people.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.FDA label
- 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.INOVIO announcement
- 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.FDA label
- 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.FDA label
- 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, Q2 2026
Checked 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. FDA label
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. INOVIO prescriber site
Five questions for the pharmacist or the support line
- Does this clinic have the CELLECTRA 5PSP device and a provider trained to use it?
- When will my debulking surgery be, and how long after it will dose 1 be given?
- If I have a pacemaker, defibrillator or metal implant, which arm or leg will you use?
- What happens if a dose is missed or the device stops before the treatment is complete?
- Has my plan approved Voceryq, and what will I owe for each of the 4 visits?
- Who do I call if the injection site gets worse after I go home?
Questions people ask in the first weeks
How is Voceryq given?
Voceryq is a 1mL injection into the upper arm muscle, or the thigh if needed, given by a trained provider with the CELLECTRA 5PSP device. Right after the injection, the device sends a short electrical pulse that helps the DNA get into cells. The label says the injection and pulse take about 10 seconds in all.
How many doses of Voceryq are there?
The label schedule is 4 doses, 1 every 3 weeks, so the course ends around week 9. The label does not describe a second course after the fourth dose.
Do I need surgery before Voceryq?
Yes, the label says to remove the visible papillomas before the first dose. In the trial, that surgery happened within 14 days before dose 1. No extra surgery was required during the 9 weeks of dosing.
Does Voceryq have a boxed warning?
No, the October 2026 label has no boxed warning and lists no contraindications. Its warnings cover injection site reactions and reactions to the electrical pulse, such as muscle contractions, bleeding at the site, lightheadedness and dizziness.
What are the side effects of Voceryq?
In the trial of 32 adults, the most common were injection site reactions in 34% and headache in 19%. Tiredness affected 16%, high blood pressure 13%, and nausea and dizziness 6% each.
How well did Voceryq work in the trial?
The label counted 26 adults who had needed 3 or more surgeries in the year before treatment. Seven of them, 27%, needed no papilloma surgery in the 12 months after treatment. The approval is accelerated, so INOVIO must run another study to confirm the benefit.
Can I take Voceryq at home?
No, the label says a healthcare provider trained on the CELLECTRA 5PSP device gives every dose. INOVIO said on October 30, 2026 that it expected ordering to open in about 60 days.
Will my insurance cover Voceryq?
We found no public insurer policy for Voceryq as of November 9, 2026, so each plan decides case by case for now. The otolaryngologist's office can ask your plan what it needs.
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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, October 30, 2026.
- VOCERYQ, FDA, Center for Biologics Evaluation and Research, October 30, 2026.
- October 30, 2026 Approval Letter - VOCERYQ, FDA, Center for Biologics Evaluation and Research, October 30, 2026.
- FDA Approves First Plasmid DNA-based Immunotherapy for Adults with Recurrent Respiratory Papillomatosis, FDA, October 30, 2026.
- INOVIO Announces FDA Accelerated Approval of VOCERYQ, an Immunotherapy to Reduce the Frequency of Surgery in Adults with Recurrent Respiratory Papillomatosis (RRP), INOVIO, October 30, 2026.
- Official HCP Website | VOCERYQ, INOVIO, November 9, 2026.
- INOVIO Reports Second Quarter 2026 Financial Results and Recent Business Highlights, INOVIO via PR Newswire, August 12, 2026.
- DNA immunotherapy for recurrent respiratory papillomatosis (RRP): phase 1/2 study assessing efficacy, safety, and immunogenicity of INO-3107, Nature Communications, February 12, 2025.
- 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, November 9, 2026.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing otolaryngologist. Found an error? Use the report link in the footer and it will be checked against the source.