Prescribing guide
Ultomiris (ravulizumab-cwvz)Meningococcal vaccine requirements, REMS, weight-based dosing and prior authorization for IgA nephropathyFor prescribers and their offices treating IgA nephropathy: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
REMS-certified prescriber, MenACWY and MenB vaccination completed or updated at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, counseling with the Patient Safety Card, and a REMS-certified healthcare setting or pharmacy that verifies prescriber certification.
Example PA threshold
Label: adults with primary IgAN at risk for disease progression, 40kg or more. FEP example, July 2026, predates the IgAN approval and treats unlisted uses as investigational. I CAN main cohort: biopsy-proven IgAN, eGFR 30 or higher, UPCR 0.75g/g or higher or protein 1g a day or more, on maximally tolerated RAASi.
Monitoring
Meningococcal infection at any time, at least 1 hour of observation after each infusion, revaccination per ACIP for the duration of therapy; no scheduled laboratory test is written into the label for IgAN.
Support line
Alexion OneSource, 1-888-765-4747, Monday to Friday 8:30 AM to 8 PM ET, insurance navigation, vaccination support, CoPay Program as little as $0 for commercial plans, annual maximums may apply, enrollment fax 1-800-420-5150; the label lists the same number for the REMS.
Give your patient their plan
A one-page handout for starting Ultomiris, 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/ultomirisBefore 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 |
|---|---|---|
| Certify in the ULTOMIRIS and SOLIRIS REMS | Prescribers must enroll, counsel on serious meningococcal infection, provide the REMS educational materials and hand over the Patient Safety Card. The card is carried at all times during treatment and for 8 months after. REMS line 1-888-765-4747, www.UltSolREMS.com. | FDA label |
| Vaccinate | Complete or update vaccination against Neisseria meningitidis serogroups A, C, W, Y and B at least 2 weeks before the first dose, per current ACIP recommendations for complement inhibitor recipients. ACIP's schedule for these patients differs from the vaccine prescribing information, so prior standard vaccination may not meet it. | FDA label |
| Or prophylaxis | If urgent therapy is indicated in a patient not up to date, give antibacterial prophylaxis and the vaccines as soon as possible; the REMS requires the prescriber to write the prophylaxis prescription. The label says optimal regimens and durations have not been studied. | FDA label |
| Pneumococcal and Hib | Section 5.3 notes increased susceptibility to S. pneumoniae and H. influenzae, higher risk in children, and says to vaccinate against S. pneumoniae and Hib per ACIP; the instruction is not age-limited. Not a REMS element. | FDA label |
| Book a certified site | Healthcare settings and pharmacies that dispense Ultomiris must be certified in the REMS and must verify the prescriber is certified. The FDA's REMS assessment plan tracks how certified sites obtain vaccination status from prescribers before the first dispense. | FDA letter |
| Contraindication | Do not initiate in a patient with unresolved serious Neisseria meningitidis infection. | FDA label |
| OneSource enrollment | Online portal, email to OneSource@Alexion.com or fax to 1-800-420-5150, with the patient's signed authorization. OneSource explains coverage, addresses gaps and identifies nearby infusion centers. | OneSource enrollment |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, July 1, 2026. Approval six months at first, then 12 months at a time on renewal. This policy was approved on June 11, 2026 and cites the September 2025 label, so it predates the October 2026 approval for IgA nephropathy. Under it, an IgAN request falls under other uses until a newer version adds it. It still uses the old program name, Ultomiris REMS, from before March 2024. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Indication on the policy | FEP 5.85.033, effective July 1, 2026, lists PNH, aHUS, gMG and NMOSD; IgAN is not listed and the policy says Ultomiris may be considered investigational for all other indications | The October 2026 label and the diagnosis records, for a medical exception or a newer policy version | FEP Blue policy |
| Vaccination | Neisseria meningitidis vaccination at least 2 weeks before initiation, unless treatment cannot be delayed | Vaccine names and dates, or the prophylaxis prescription | FEP Blue policy |
| REMS | Prescriber enrolled in the REMS; the policy still uses the old name Ultomiris REMS | Enrollment confirmation | FEP Blue policy |
| Approval duration | Six months initially, 12 months on renewal; the policy cites the September 2025 package insert | Calendar the renewal ahead of the next 8-week dose | FEP Blue policy |
| Labeled population | Adults with primary IgAN at risk for disease progression; IgAN dosing covers 40kg or more; pediatric safety and effectiveness not established | Diagnosis, current weight with date | FDA label |
| Trial population | I CAN main cohort: biopsy-proven IgAN, eGFR 30 or higher, UPCR 0.75g/g or higher or urine protein 1g a day or more, stable maximally tolerated RAASi, with or without SGLT2i, DEARA, MRA or ERA | Pathology report, eGFR, UPCR, RAASi agent and dose, for a letter of medical necessity | Ultomiris HCP site |
| Appeal tools | Alexion Access Navigator posts an IgAN sample letter of medical necessity, an IgAN sample appeal letter, a coding and billing guide and home infusion access considerations | Payer submission packet | Alexion Access Navigator |
Ultomiris dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1, loading | 40 to under 60kg: 2,400mg. 60 to under 100kg: 2,700mg. 100kg or more: 3,000mg. Diluted to 50mg/mL in 0.9% sodium chloride, through a 0.2 or 0.22 micron filter; minimum infusion 0.8, 0.6 and 0.4 hours respectively. | FDA label |
| Day 15, first maintenance | 3,000mg, 3,300mg or 3,600mg by the same weight bands; minimum infusion 0.9, 0.7 and 0.5 hours. The 7-day window does not apply to this dose. | FDA label |
| Every 8 weeks | Maintenance dose every 8 weeks from day 15. Occasional variation within 7 days of the scheduled day is allowed; subsequent doses return to the original schedule. | FDA label |
| Plasma exchange, plasmapheresis, IVIg | PE or PP: 1,200mg to 1,800mg by weight and most recent dose, within 4 hours after each intervention. IVIg: 600mg within 4 hours after completion of a cycle (Table 3). | FDA label |
| Missed dose | The patient should contact the healthcare provider immediately. | FDA label |
| Vials | 300mg/3mL and 1,100mg/11mL single-dose vials, one per carton; refrigerate at 2 to 8°C in the carton, do not freeze or shake. | openFDA label |
Monitoring the Ultomiris label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before day 1 | Meningococcal vaccination status against the ACIP complement inhibitor schedule | Required by the label and the REMS; prophylaxis prescription if urgent | FDA label |
| Each infusion | Infusion-related reactions: back or abdominal pain, muscle spasms, blood pressure change, rigors, limb discomfort, hypersensitivity, dysgeusia; anaphylaxis reported postmarketing | Observe at least 1 hour after completion; slow or stop for a reaction, interrupt for cardiovascular instability or respiratory compromise | FDA label |
| Any time | Meningococcal infection: fever, fever with tachycardia, headache with fever, confusion, myalgia with flu-like symptoms, fever with rash, headache with nausea or vomiting, headache with stiff neck or back, photophobia | Evaluate immediately; consider interrupting Ultomiris during treatment of serious meningococcal infection | FDA label |
| Per ACIP | Meningococcal revaccination | Revaccinate considering the duration of therapy; vaccination does not eliminate risk | FDA label |
| Ongoing | Other Neisseria and encapsulated bacterial infections, including disseminated gonococcal infection | Counsel on gonorrhea prevention and regular testing for patients at risk | FDA label |
| I CAN safety | Upper respiratory infection 11% against 10%, infusion-related reaction 8% against 5%, headache 7% against 5% | Serious adverse reactions 4.6% on Ultomiris and 9.0% on placebo; median exposure 35 weeks | FDA label |
| After stopping | Patient Safety Card carried for 8 months after the last dose; breastfeeding avoided for 8 months after the final dose | The label's discontinuation monitoring periods are written for PNH and aHUS, not IgAN | FDA label |
Ultomiris drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Supplemental dose | Plasma exchange, plasmapheresis and IVIg reduce ravulizumab levels and require a supplemental dose | FDA label |
| Monitor | Neonatal Fc receptor blockers such as efgartigimod may lower exposure; monitor closely for reduced effectiveness | FDA label |
| Anticoagulants | Treatment should not alter anticoagulant management | FDA label |
| Pregnancy and lactation | No human data; registry 1-833-793-0563; untreated IgAN carries maternal and fetal risk; discontinue breastfeeding during treatment and for 8 months after the final dose | FDA label |
Why a first fill stalls, and the fix
- Your vaccine dates are missingThe prescriber must check your meningococcal vaccines before the first dose, and certified sites collect vaccination status for the REMS. The fix is the office sending the vaccine dates, or the antibiotic prescription if treatment cannot wait.
- The infusion site is not certifiedOnly healthcare settings and pharmacies certified in the ULTOMIRIS and SOLIRIS REMS may dispense it. The office moves the booking to a certified site, which makes it a routing problem rather than a denial.
- Your plan's policy does not list IgA nephropathy yetThe FEP policy below was written before the October 2026 approval and says Ultomiris may be considered investigational for all other indications. Alexion Access Navigator posts an IgAN letter of medical necessity and a sample appeal letter for your nephrologist's office.
- A copay you cannot payWith commercial insurance, the OneSource CoPay Program can bring the cost as low as $0, and annual maximums may apply. Medicare, Medicaid and other government plans are excluded, and OneSource says it can connect those patients with third-party resources.
- You live in Massachusetts or Rhode IslandThe CoPay terms say residents of these 2 states can get help with medicine costs but not with infusion costs. The infusion site can tell you its fee before the first visit.
- The vaccines themselves cost moneyOneSource says it can help you find a vaccination site and share resources that may cover vaccine costs. You need to be enrolled and have the vaccines prescribed.
Alexion OneSource
- A support specialist who explains your insurance coverage, helps with gaps in coverage and points you to infusion centers nearby
- Vaccination support for enrolled patients, including help finding a vaccination site and resources that may cover vaccine costs
- The Alexion OneSource CoPay Program for commercial insurance, as little as $0 for Ultomiris and eligible infusion costs, and annual maximums may apply
- CoPay help is not open to Medicare, Medicaid or other federal- or state-funded plans, and OneSource can point those patients to third-party resources
- Enrollment online, by email to OneSource@Alexion.com or by fax at 1-800-420-5150, with interpreters available
Questions prescribers' offices ask about Ultomiris
Which vaccines are required before Ultomiris for IgAN?
Meningococcal vaccines against serogroups A, C, W, Y and B, completed or updated at least 2 weeks before the first dose, per the boxed warning and section 2.2 of the October 2026 label, on the ACIP schedule for complement inhibitor recipients. Section 5.3 notes higher pediatric risk and says to vaccinate against Streptococcus pneumoniae and Hib per ACIP, an instruction that is not age-limited; the REMS covers meningococcal status only.
Can Ultomiris start before the vaccines have had 2 weeks?
Yes, if urgent therapy is indicated and the patient is not up to date 2 weeks before the first dose, the October 2026 label says to give antibacterial prophylaxis and meningococcal vaccines as soon as possible. The REMS requires the prescriber to write that prescription, and the label notes that optimal prophylaxis regimens and durations have not been studied.
What is the Ultomiris dose for IgAN?
For adults weighing 40kg or more, the October 2026 label gives a weight-based IV loading dose of 2,400mg, 2,700mg or 3,000mg, then a maintenance dose of 3,000mg, 3,300mg or 3,600mg 2 weeks later and every 8 weeks. Later doses may vary by up to 7 days, but not the first maintenance dose.
What does the ULTOMIRIS and SOLIRIS REMS require?
Per section 5.2 of the October 2026 label, prescriber enrollment, counseling, the REMS educational materials, a meningococcal vaccination check 2 weeks before the first dose, a prophylaxis prescription when treatment is urgent, and a Patient Safety Card carried for 8 months after treatment. Dispensing healthcare settings and pharmacies must be certified and verify the prescriber. The REMS line is 1-888-765-4747 and the site is www.UltSolREMS.com.
Do insurers cover Ultomiris for IgAN yet?
Not in the FEP policy shown here, effective July 1, 2026, which predates the October 2026 label, lists PNH, aHUS, gMG and NMOSD, and says Ultomiris may be considered investigational for all other indications. A newer version may add IgAN. Alexion Access Navigator posts an IgAN sample letter of medical necessity and a sample appeal letter.
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Sources
- ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous use, prescribing information and Medication Guide, revised October 2026 (BLA 761108/S-046), Alexion Pharmaceuticals, via FDA, 2026-10-21.
- MEDICATION GUIDE, ULTOMIRIS (ravulizumab-cwvz) injection, for intravenous use, revised 10/2026, Alexion Pharmaceuticals, 2026-10-21.
- ULTOMIRIS (ravulizumab-cwvz) label, SPL version 19, section 16 How Supplied/Storage and Handling, Alexion Pharmaceuticals, via openFDA, 2025-10-09.
- IgAN Treatment Patient Website | ULTOMIRIS® (ravulizumab-cwvz), Alexion Pharmaceuticals, 2026-11-09.
- IgA Nephropathy Treatment | ULTOMIRIS® (ravulizumab-cwvz), Alexion Pharmaceuticals, 2026-11-09.
- Alexion OneSource™ | ULTOMIRIS | Financial Assistance, Alexion Pharmaceuticals, 2026-11-09.
- Alexion OneSource™ | ULTOMIRIS | About OneSource™, Alexion Pharmaceuticals, 2026-11-09.
- Alexion OneSource™ | ULTOMIRIS | Fill Out a Start Form, Alexion Pharmaceuticals, 2026-11-09.
- Alexion OneSource™ | ULTOMIRIS | Vaccination-Support, Alexion Pharmaceuticals, 2026-11-09.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, 2026-11-09.
- Alexion Access Navigator | Ultomiris IgAN, Alexion Pharmaceuticals, 2026-11-09.
- 5.85.033 Ultomiris (ravulizumab-cwvz), Blue Cross Blue Shield Federal Employee Program, 2026-07-01.
- Ultomiris received accelerated approval in the US as first and only C5 complement inhibitor to reduce proteinuria in adults with primary immunoglobulin A nephropathy, AstraZeneca, 2026-10-21.
- BLA 761108/S-046 and BLA 125166/S-455 accelerated approval letter, IgA nephropathy and REMS modification, FDA, 2026-10-21.
- BLA 761108/S-045 and BLA 125166/S-453 supplement approval letter, REMS modification, FDA, 2026-06-01.
- BLA 761108/S-026 and S-031 supplement approval letter, NMOSD and the combined Ultomiris and Soliris REMS, FDA, 2024-03-22.
A reference drawn from the October 21, 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.