Your first 90 days
Your first 90 days on Altuviiio for hemophilia A
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.
Altuviiio replaces the factor VIII your body is missing with one infusion into a vein each week. The first weeks bring a training visit, a home supply of kits, and a written plan for treating any bleed. This page lays out that stretch from the FDA label, Sanofi's HemAssist program and one insurer's written rules.
What has to happen before the first bottle ships
Altuviiio has no REMS, so the first infusion waits on an insurance approval, a delivery of kits and infusion training. These are the 6 things in the way, in order.
Infusion training
The Patient Information says not to inject Altuviiio until a healthcare provider or hemophilia center has taught you how.
- Your provider may watch you give yourself the first dose.FDA label
Your weight, for the dose
Every Altuviiio dose is set in international units per kilogram of body weight.
- Your hematologist uses your current weight, which matters most for growing children.FDA label
A plan for treating bleeds
The label gives separate doses for minor bleeds, major bleeds and surgery.
- Ask your hematologist to write down your bleed plan, including when to call before treating at home.FDA label
HemAssist enrollment
Your doctor's office can enroll you online or fax an enrollment form to 1-855-398-7634.
- A HemAssist Case Manager then calls to welcome you and check your insurance.HemAssist enrollment
The insurance approval
Sanofi's checklist says your plan will likely need a prior authorization.
- The office may send bleed logs, lab results, inhibitor test results and a letter of medical necessity.PA checklist
A delivery of kits
HemAssist helps coordinate delivery and can send the prescription to the specialty pharmacy if the office prefers.
- Each kit holds one vial, a prefilled syringe of water and a vial adapter.HemAssist enrollment
The days that matter
Counted from the first weekly infusion, with the shipment checks and the switch from any free starter supply to insurance. 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.Enrollment, then the insurance check
The office enrolls you online or by fax, and a HemAssist Case Manager calls within 24 hours.
- No source sets how long insurance approval takes.
Free first month, if you qualify
First-time patients can get a 30-day supply through the Free Trial Program, generally within 24 to 48 hours of a valid prescription.
- It is a one-time offer.
Training at the hemophilia center
You or a caregiver learn to mix the powder and infuse it into a vein.
- The Patient Information says your provider may watch the first dose you give yourself.
First weekly infusion
The label's prevention dose is 50IU/kg, pushed slowly into a vein over 1 to 10 minutes.
- Mixed medicine must be used within 3 hours.
Second weekly infusion
The label gives the prevention dose once a week.
- Doses then fall on days 15, 22, 29 and every 7 days after that, through day 85.
Third weekly infusion
Headache occurred in 15% of trial patients and joint pain in 13%.
- Tell your doctor about any side effect that bothers you or does not go away.
Check the next shipment
The free starter supply covers 30 days.
- Ask the specialty pharmacy when the next kits ship, and whether extra doses for bleeds are included.
Insurance takes over
If you started on the Free Trial, the next supply runs through your insurance.
- HemAssist's Case Manager can help if the approval is not in place yet.
Three months in
If a bleed does not stop after a dose, call your hematologist right away.
- The label says this can be a sign of inhibitors, which a blood test checks.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Altuviiio 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 20, 2026, read on DailyMed. FDA label
- December 2025
The FDA approved new warning and side effect text on December 29th, based on reports of inhibitors since approval.FDA letter
- March 2025
The allergic reaction warning and the list of side effects reported since approval were updated on March 7th.FDA letter
- May 2024
Results from the completed study in children under 12 were added to the label on May 10th.FDA letter
- February 2023
The FDA first approved Altuviiio on February 22nd for adults and children with hemophilia A.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.
- The weekly prevention dose
The label gives 50IU/kg once a week for adults and children, with no dose change for age.
- Your hematologist sets your exact dose and day.FDA label
- Treating a bleed
The label lists a single 50IU/kg dose for a minor, moderate or major bleed.
- For a minor or moderate bleed within 2 to 3 days after a prevention dose, a lower 30IU/kg dose may be used.
- Your hematologist decides your bleed plan.FDA label
- Going back to weekly doses after a bleed
The label recommends at least 72 hours between the last 50IU/kg bleed dose and the next prevention dose.
- After that, the usual weekly schedule continues.FDA label
- Surgery and dental work
The label gives a single 50IU/kg dose before minor or major surgery, with more doses every 2 to 3 days if needed.
- Tell every surgeon and dentist that you use Altuviiio.FDA label
- A missed dose
The label does not give a rule for a missed weekly dose.
- Ask your hematologist what to do before it happens.FDA label
- Mixing and infusing
Let the kit reach room temperature, then swirl the vial gently and never shake it.
- Use the mixed medicine within 3 hours, and never put it back in the fridge.FDA label
- More than one vial
Doses that need more than one vial are pooled into a larger luer lock syringe, which is not in the carton.
- The label says not to give Altuviiio in the same tubing as other medicines.FDA label
- Storage
Keep kits in the fridge at 36°F to 46°F (2°C to 8°C), in the carton, never frozen.
- A kit may stay at room temperature up to 86°F (30°C) for one stretch of up to 6 months.FDA label
- Room temperature kits
Write the date you took a kit out of the fridge on the carton.
- Do not put it back in the fridge, and use it within 6 months or by the expiration date.FDA label
- Factor level blood tests
Some factor VIII tests read Altuviiio about 2.5 times too high.
- The label recommends a one-stage clotting test, so tell every lab that you use Altuviiio.FDA label
- Pregnancy and breastfeeding
There are no data on Altuviiio in pregnancy, and it is not known whether it passes into breast milk.
- Tell your hematologist if you are pregnant, planning a pregnancy or breastfeeding.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 an allergic reaction
Trouble breathing, chest tightness, swelling of the face, rash or hives.
- The Patient Information says to call your healthcare provider or go to the emergency department right away.FDA label
A bleed that will not stop
Contact your healthcare provider right away if bleeding is not controlled after a dose.
- Inhibitors have been reported since approval, and the label updated this warning in December 2025.FDA label
Common side effects
In the trials, headache occurred in 15% and joint pain in 13% across all ages.
- In children under 12, fever was the most common side effect, at 12.2%.FDA label
Blood clots in the extension study
Blood clots occurred in 3 of 261 people, about 1%, in the long-term extension study.
- All 3 already had risk factors for clots, according to the label.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 deniedSanofi lists incomplete paperwork, plan exclusions and missed step rules as common reasons. The office can call 1-833-723-5463 and ask for a local Field Reimbursement Manager.PA checklist
- No recent inhibitor testCigna's policy below asks for an inhibitor test in the past 30 days for a first approval, under 1.0 Bethesda units/mL. People who never had factor VIII before are exempt from that test.Cigna policy
- The plan wants a hemophilia specialistCigna covers Altuviiio only when a hemophilia specialist prescribes it or is consulted. A note from your hemophilia treatment center can show this.Cigna policy
- The doses asked for are above the plan's limitCigna approves up to 50IU/kg no more than once a week for prevention. Bleed and surgery doses are approved every 2 to 3 days, for up to 10 days each time.Cigna policy
- The request went to the wrong benefitFactor products can be covered under a medical or a pharmacy benefit. Sanofi's checklist says a benefit check can find the right path to coverage.PA checklist
- The prescription went to the wrong pharmacyHemAssist helps coordinate delivery, and it can send the prescription to the specialty pharmacy if the office prefers.HemAssist enrollment
- A copay you cannot payWith commercial insurance, the Copay Assistance Program offers as little as $0. Medicare, Medicaid, Medigap, VA, DoD, TRICARE and state programs are excluded by its terms.HemAssist
- No insurance, or a gap in coverageHemAssist's Patient Assistance Program may help people who are uninsured, underinsured or between plans. A Case Manager checks whether you qualify.HemAssist
Cigna prior authorization policy, May 1, 2026
- Used for routine prophylaxis, on-demand treatment of bleeds, or bleeding control around surgery
- First approval: a factor VIII inhibitor test in the past 30 days, under 1.0 Bethesda units/mL, or no past factor VIII treatment
- Already on Altuviiio: an inhibitor test in the past 365 days under 1.0 Bethesda units/mL, or no signs of inhibitors according to the prescriber
- Prescribed by, or in consultation with, a hemophilia specialist
- Prophylaxis up to 50IU/kg no more often than once a week
- Bleeds and surgery up to 50IU/kg, with more doses every 2 to 3 days for up to 10 days each time
Approval length. One year at a time; renewal asks for an inhibitor test in the past 365 days or the prescriber's word that there are no signs of inhibitors.
This policy took effect on May 1, 2026 and cites the December 2025 Altuviiio label, which is still the current text. It covers Altuviiio under the medical benefit. Citing MASAC guidance, it allows prevention doses plus 3 days of bleed or surgery doses per 28 days, and larger amounts get a case review. 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.
- A Case Manager who calls within 24 hours of enrollment, checks your insurance and helps coordinate shipments
- A Copay Assistance Program for commercial insurance, as little as $0
- No copay help for Medicare, Medicaid, Medigap, VA, DoD, TRICARE or state programs
- A Free Trial Program with the first 30-day supply for first-time patients, once per lifetime, not valid in Vermont
- A Patient Assistance Program for people who are uninsured, underinsured or between plans
- A Clinical Educator for extra infusion training and tips during the first months
- Enrollment online, or by fax at 1-855-398-7634
Details as the drugmaker publishes them. HemAssist
Five questions for the pharmacist or the support line
- Which kit strengths make up my weekly dose, and how many kits come in each shipment?
- Do I have extra doses at home for a bleed, and how many?
- Does my order include a larger syringe for pooling vials, and infusion sets?
- What do I do if the kits arrive warm or were left out during delivery?
- How do I track the 6-month room temperature limit on each carton?
- How do I get a sharps container and get rid of used needles?
Questions people ask in the first weeks
How long does it take to start Altuviiio after it is prescribed?
No source sets a fixed number of days. A HemAssist Case Manager calls within 24 hours of enrollment to check insurance. First-time patients may get a free 30-day supply, generally within 24 to 48 hours of a valid prescription.
How often is Altuviiio given?
For bleed prevention, the label gives 50IU/kg once a week, infused into a vein. The same dose is the starting point for treating a bleed or covering surgery.
Can my child use Altuviiio?
Yes, the label covers adults and children with hemophilia A, with no dose change for age. Children under 12 had fever as their most common side effect in the trial.
What if I miss a weekly dose?
The label does not give a missed-dose rule for Altuviiio. Ask your hematologist ahead of time, and write the answer into your treatment plan.
Why does my factor VIII level look high on Altuviiio?
Some lab tests read Altuviiio about 2.5 times too high, including chromogenic tests. The label recommends a one-stage clotting test, so tell the lab you use Altuviiio.
Can people with inhibitors use Altuviiio?
The trials found no inhibitors, but inhibitors have been reported since approval. If bleeding is not controlled, the label says to test for inhibitors. Your hematologist decides whether Altuviiio fits.
Does Medicare cover the Altuviiio copay program?
No, the Copay Assistance Program excludes Medicare, Medicaid, Medigap, VA, DoD, TRICARE and state programs. HemAssist's Patient Assistance Program may help people who are uninsured or underinsured.
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Sources
- DailyMed - ALTUVIIIO (antihemophilic factor- recombinant, fc-vwf-xten fusion protein-ehtl kit (prescribing information revised December 2025, Patient Information and Instructions for Use), Bioverativ Therapeutics Inc. (Sanofi), via DailyMed, October 20, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS), FDA, November 8, 2026.
- ALTUVIIIO | FDA, FDA, Center for Biologics Evaluation and Research, December 31, 2025.
- Patient Support for ALTUVIIIO | Sanofi HemAssist, Sanofi, November 8, 2026.
- Enroll in Rare Blood Disorder Support | Sanofi HemAssist, Sanofi, November 8, 2026.
- Insurance and Financial aid for Rare Blood Disorder | Sanofi HemAssist, Sanofi, November 8, 2026.
- Prior Authorization Checklist, Sanofi, October 1, 2024.
- Hemophilia - Altuviiio, Drug Coverage Policy IP0564, Cigna, May 1, 2026.
- December 29, 2025 Approval Letter - ALTUVIIIO (STN BL 125771/643, inhibitor development, sections 5 and 6), FDA, December 29, 2025.
- March 7, 2025 Approval Letter - ALTUVIIIO (STN BL 125771/437, sections 5.1 and 6.2), FDA, March 7, 2025.
- May 10, 2024 Approval Letter - ALTUVIIIO (STN BL 125771/136, completed pediatric study results), FDA, May 10, 2024.
- February 22, 2023 Approval Letter - ALTUVIIIO (STN BL 125771/0), FDA, February 22, 2023.
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 hematologist. Found an error? Use the report link in the footer and it will be checked against the source.