Your first 90 days
Your first 90 days on Voyxact for IgA nephropathy
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.
Voyxact is the IgA nephropathy drug you inject once every 4 weeks, at home, from a prefilled syringe. It needs no REMS, no pregnancy test and no monthly lab before the pharmacy ships. The first fill waits on a few ordinary steps instead, an infection check, a signed start form, an insurance approval and a call from PANTHERx Rare. This page lays out those first 3 months from the FDA label, Otsuka's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Voyxact has no REMS, so the first fill waits on an infection check, a start form, an insurance approval and a call from the pharmacy. These are the 6 things in the way, in order.
A check for active infection
Voyxact lowers the antibodies your immune system makes, and the label says this may raise the risk of infection.
- It tells prescribers to check for an active infection before the first dose.
- The label adds that chronic or recurring infections may raise the risk of a serious one.FDA label
Live vaccines at least 30 days ahead
The label does not recommend live vaccines within 30 days before the first dose or at any time during treatment.
- It also says Voyxact may weaken the response to other vaccines.
- Tell the nephrologist about any vaccine you recently had or have scheduled.FDA label
No REMS to enroll in
The FDA's risk review, completed on November 19, 2025, concluded that Voyxact did not need a REMS.
- The reviewers said the infection risk did not rise to the level of a boxed warning.
- The safety rules live in the label and Patient Information instead.FDA REMS review
The Prescription Start Form, signed by you too
Otsuka's Prescription Start Form doubles as the prescription and the enrollment in Otsuka Patient Services.
- The office sends it to PANTHERx Rare by fax or e-prescription, with the biopsy, protein and kidney function results.
- You sign the consent and HIPAA pages to join the program and the copay program.Start Form
The insurance approval
Plans often require prior authorization, which your nephrologist's office prepares and submits.
- Otsuka Patient Services can run a benefits check to learn whether your plan needs one and what it asks for.
- Otsuka's checklist lists the records plans may want, such as the biopsy, protein and kidney function results.PA checklist
The call from PANTHERx Rare
Otsuka says Voyxact is only available from a specialty pharmacy, and the one it names is PANTHERx Rare.
- After your nephrologist prescribes it, PANTHERx Rare calls you to set up shipments to your home.
- Answer calls from numbers you do not know that week.Voyxact FAQs
The days that matter
Counted from the first injection, with the live vaccine window before it, one shot every 4 weeks, and one new carton for each dose. 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.Vaccines reviewed, live ones done
The label does not recommend live vaccines in the 30 days before the first dose.
- Any live vaccine you need goes before this point, after a talk with the nephrologist.
Start Form and prior authorization
The office sends the Prescription Start Form with your signed consents, and the prior authorization goes to your plan.
- If a commercial plan is slow, the Bridge Program may cover a 28-day supply.
PANTHERx Rare calls
The specialty pharmacy calls you to set up the shipment to your home.
- Otsuka says you can also reach PANTHERx Rare through its app or at 833-869-9228.
First injection, 400mg
Take the carton out of the refrigerator and let the syringe sit 15 to 30 minutes first.
- Inject into the front of the thigh or the belly, as your care team showed you.
- Each carton holds one syringe, and that one syringe is a full dose.
Next dose and refill, every 4 weeks
One syringe every 4 weeks means a new carton for each dose.
- Otsuka's start form writes the prescription with 12 refills unless the prescriber changes it, and PANTHERx Rare ships each one.
Next dose and refill, number 2
Three months in
The label sets no scheduled blood test of any kind for Voyxact.
- The main trial measured urine protein from a 24-hour collection at month 9.
- When to recheck protein and kidney function is the nephrologist's call.
Next dose and refill, number 3
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Voyxact 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.
Current label dated March 17, 2026, read from the FDA's label database today. FDA label
- March 2026
The current DailyMed version of the label carries this date. Its prescribing information still reads Revised 11/2025, so the dose, warnings and tests are those approved in November 2025.FDA label
- November 2025
Accelerated approval to reduce protein in the urine in adults with primary IgA nephropathy at risk of getting worse. The FDA requires a trial to confirm its clinical benefit, with a final report due in April 2027. The FDA also required studies in children aged 2 to 17, in breastfeeding and in pregnancy.FDA letter
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.
- Every 4 weeks, 400mg, under the skin
The label dose is 400mg once every 4 weeks, one single-dose prefilled syringe each time.
- There is no lower starting dose and no step up over the first weeks.
- Use a different spot from the last injection each time.FDA label
- Where it goes
The front of the thigh, or the belly at least 2 inches from the navel.
- A caregiver may also use the back of the upper arm.
- The label says to avoid moles, scars, bruises and tender, red, hard or damaged skin.FDA label
- Warm it up naturally
Let the syringe come to room temperature for 15 to 30 minutes before the shot.
- The Instructions for Use say never to warm it any other way or leave it in direct sunlight.FDA label
- How the shot goes
Pinch the skin, insert the whole needle at a 45 degree angle, and push the plunger as far as it goes.
- Lift your thumb, and a guard slides over the needle on its own.
- Air bubbles are normal, and the label says not to remove them.FDA label
- If you miss a dose
The label says to inject the missed dose as soon as possible.
- Your next dose then comes 4 weeks later, so your injection day may move.FDA label
- Refrigerator, original carton
Store it at 36 to 46°F (2 to 8°C) in its carton to protect it from light.
- Once it reaches room temperature it never goes back in the refrigerator.
- The label says not to use it once it has been at room temperature for 7 days or longer, and never to freeze or shake it.FDA label
- A syringe you cannot use
Otsuka says not to use a syringe that is cloudy, discolored, past its date, damaged or out for 7 days or longer.
- In that case it says to call PANTHERx Rare at 833-869-9228 or use its app, and the pharmacy will send another syringe.Voyxact FAQs
- Vaccines and immune medicines
Live vaccines are not recommended at any point during treatment.
- The label says data with other immunosuppressants are limited, and the prescriber should weigh the added effect.
- Tell the nephrologist and pharmacist about every medicine, vitamin and supplement you take.FDA label
- Pregnancy and breastfeeding
The label says there are no data on Voyxact in pregnancy, and antibodies like it cross the placenta more later in pregnancy.
- If you are exposed during pregnancy, the label asks you or your doctor to call 1-833-869-9228.
- It is not known whether Voyxact passes into breast milk.FDA label
- Throwing away used syringes
Put each used syringe straight into an FDA-cleared sharps container.
- A heavy plastic household container with a tight, puncture-resistant lid can stand in.
- Follow your community's rules for the full container, and never recycle it.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.
Signs of infection
The Patient Information lists fever, chills, feeling tired, cough, flu-like symptoms, aches and pain, and warm, red or painful skin.
- It says to tell your healthcare provider about any of these right away.
- The label lets the prescriber pause Voyxact until a serious infection is under control.FDA label
Infections in the trial
In VISIONARY, infections were reported in 49% of patients on Voyxact against 45% on placebo.
- Upper respiratory infections such as colds were the most common, at 15% against 14%.
- Otsuka reported on October 22, 2026 that serious infections over 2 years were 1.9% on Voyxact and 4.0% on placebo.Otsuka, Oct 2026
Reactions where you inject
Injection site reactions occurred in 24% of patients on Voyxact against 23% on placebo.
- Redness at the site was the most common, at 13% against 12%.
- The label says most side effects were mild or moderate and cleared without stopping treatment.FDA label
Signs of an allergic reaction
Breathing problems, swelling of the face, lips, mouth, tongue or throat, dizziness or lightheadedness, itching, hives or a skin rash.
- The Patient Information says to stop using Voyxact and get emergency help for any of these.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.
- The prescription went to a retail pharmacyOtsuka says Voyxact is only available from a specialty pharmacy, PANTHERx Rare. The office resends the Start Form by fax to 1-877-875-1264 or e-prescribes to PANTHERx Rare. This is a routing problem for the office to fix, not a denial.Start Form
- The pharmacy has not reached youOtsuka says PANTHERx Rare will call you to set up your shipments of Voyxact. A missed call from the pharmacy can hold up the first carton. Call 833-869-9228, Monday to Friday, 8 AM to 8 PM Eastern, or use the PANTHERx Rare app.Voyxact FAQs
- The Start Form is missing your signature or recordsThe form asks for the biopsy, current and past treatments with dates, urine protein, kidney function and a copy of the insurance card. Your own signature goes on the consent and HIPAA pages. Ask the office whether every page went in with the form.Start Form
- Prior authorization pending or deniedCigna, for example, asks for the biopsy, a protein level, 12 weeks on an ACE inhibitor or ARB, and a nephrologist. The full list is below, and the nephrologist's records usually answer it.Cigna policy
- A commercial plan is slow to decideThe Bridge Program may supply Voyxact at no cost after coverage has been attempted and is delayed. It allows up to three 28-day supplies while you actively pursue coverage.Bridge terms
- A copay you cannot payCommercial insurance may qualify for the Voyxact Copay Program, as little as $0 up to a yearly maximum of up to $10,600. Medicare Part D, Medicaid, Medigap, VA, DoD and TRICARE are excluded by its terms. Our help paying page lists the charity funds that are open.Copay terms
Cigna prior authorization policy, July 15, 2026
- Age 18 or older, with primary IgA nephropathy confirmed by biopsy
- Protein in the urine of 0.5g a day or more, or a urine protein-to-creatinine ratio of 0.5g/g or more
- At least 12 weeks on the highest or highest tolerated dose of an ACE inhibitor or an ARB before starting
- At least 3 months of supportive care, meaning blood pressure control, lifestyle and heart risk measures
- Kidney function (eGFR) of 30 or higher
- Prescribed by or with a nephrologist
Approval length. A year at a time, renewed if the prescriber reports a response such as lower urine protein and the eGFR is still 30 or higher.
Cigna posts this version under a file name marked for individual and family plans, effective July 15, 2026. That revision lowered its urine protein-to-creatinine ratio bar from 0.8g/g to 0.5g/g. It cites the November 2025 prescribing information, which is the text still in the current label. Other plans set their own thresholds, and a full approval may change them. It is here as an example of what a plan asks for, not as a rule. Cigna policy
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.
- An Otsuka Care Navigator who gives education about IgA nephropathy and Voyxact and help with the prefilled syringe, without replacing your nephrologist
- The Voyxact Copay Program for commercial insurance, as little as $0, with no copay card needed
- Copay benefits that may apply to copays, coinsurance and pharmacy deductibles, with a maximum yearly benefit and other limits
- The Bridge Program, temporary access for commercially insured patients facing insurance coverage challenges, so they may start while coverage is being determined
- Calls from Otsuka Patient Services to help you get started, which you can change at any time at 833-869-9228
Details as the drugmaker publishes them. Otsuka Patient Services
Five questions for the pharmacist or the support line
- Is this PANTHERx Rare, and what number will your calls come from?
- How will the carton be packed to stay cold, and what should I do if it arrives warm?
- When will each carton ship, and how early do you call before my next dose is due?
- I take these other medicines, including any steroid. Does anything here raise my infection risk?
- Where can I get a sharps container, and is one covered by my plan?
Questions people ask in the first weeks
How long does it take to get Voyxact after it is prescribed?
There is no fixed number of days between the prescription and the first shot. The Start Form, the prior authorization and the call from PANTHERx Rare each take their own time. The label also does not recommend live vaccines in the 30 days before the first dose. The Bridge Program exists for commercial plans that are slow to decide.
Does Voyxact have a REMS?
No. The FDA's risk review, completed on November 19, 2025, concluded that a REMS was not needed. The infection and vaccine rules sit in the label and Patient Information instead. There is no program enrollment and no test that gates each refill.
Can I pick up Voyxact at my regular pharmacy?
No. Otsuka says Voyxact is only available from a specialty pharmacy, PANTHERx Rare, which ships it to your home. Otsuka says PANTHERx Rare will call you to set up your shipments.
What if I miss a dose of Voyxact?
The label says to inject the missed dose as soon as possible. Your next dose then comes 4 weeks after that one.
Can Voyxact be left out of the refrigerator?
The label says not to use a syringe that has been at room temperature for 7 days or longer. Once it has reached room temperature, it does not go back in the refrigerator.
Does Voyxact require blood tests?
The label sets no scheduled blood test and has no REMS. It asks prescribers to check for active infection before starting and to watch for infection during treatment. How often to recheck urine protein and kidney function is the nephrologist's call.
Is Voyxact fully approved?
Not yet. The FDA granted accelerated approval on November 25, 2025, based on lower urine protein. Otsuka said on October 22, 2026 that it had completed its application for full approval. No FDA decision date had been announced when this page was checked.
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Sources
- VOYXACT (sibeprenlimab-szsi) injection, prescribing information, Patient Information and Instructions for Use, revised November 2025, Otsuka, via DailyMed and openFDA, March 17, 2026.
- BLA 761434 accelerated approval letter, Voyxact (sibeprenlimab-szsi), FDA, November 25, 2025.
- BLA 761434 Risk Assessment and Risk Mitigation Review, Evaluation of Need for a REMS, FDA, November 19, 2025.
- Otsuka Presents Landmark Final Phase 3 VISIONARY Results at ASN Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilized Kidney Function and Reduced Risk of Disease Progression and Kidney Failure, Redefining Treatment Paradigm in IgA Nephropathy, Otsuka, October 22, 2026.
- Patient Support | VOYXACT® (sibeprenlimab-szsi), Otsuka, November 9, 2026.
- VOYXACT Copay Program Terms and Conditions, Otsuka, November 9, 2026.
- VOYXACT Bridge Program Terms and Conditions, Otsuka, November 9, 2026.
- Resources & FAQs | VOYXACT® (sibeprenlimab-szsi), Otsuka, November 9, 2026.
- Support | VOYXACT® (sibeprenlimab-szsi) HCP, Otsuka, November 9, 2026.
- VOYXACT Prescription Start Form (21US26EBP0020, May 2026), Otsuka, November 9, 2026.
- VOYXACT Prior Authorization Checklist (21US25EBP0022, September 2025), Otsuka, November 9, 2026.
- Drug Coverage Policy IP0788, Nephrology, Voyxact, Cigna, July 15, 2026.
- Otsuka Patient Assistance Foundation | No-Cost Treatment Support & Coverage, Otsuka Patient Assistance Foundation, 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 nephrologist. Found an error? Use the report link in the footer and it will be checked against the source.