Your first 90 days
Your first 90 days on Voydeya for PNH
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.
Voydeya is a pill added to the Ultomiris or Soliris infusions you already get. It treats extravascular hemolysis, the breakdown of red blood cells outside the blood vessels. Before the first carton ships, the label requires vaccines against 2 kinds of bacteria and a blood test of your liver enzymes. After that the routine is tablets 3 times a day, a card in your wallet and one rule about fever. This page lays out those first 3 months from the FDA label, the REMS, Alexion's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Voydeya is a specialty drug under a REMS, so the first carton waits on vaccines, a certified prescriber, a liver blood test and an insurance approval. These are the 8 things in the way, in order.
Already on Ultomiris or Soliris
The label approves Voydeya only as an add-on to ravulizumab (Ultomiris) or eculizumab (Soliris), for adults with PNH who have extravascular hemolysis.
- It says Voydeya has not been shown to work alone and should only be prescribed with one of them.
- Those infusions continue while you take Voydeya.FDA label
Vaccines, at least 2 weeks before the first dose
Voydeya is a complement inhibitor, and the label says it raises the risk of serious infections from encapsulated bacteria.
- The label requires vaccines against Neisseria meningitidis serogroups A, C, W, Y and B, the MenACWY and MenB shots.
- It also requires a vaccine against Streptococcus pneumoniae, a pneumococcal shot.
- They are due at least 2 weeks before day 1, on the ACIP schedule for people on a complement inhibitor.
- The Medication Guide says people vaccinated in the past might still need more shots, and your healthcare provider decides.FDA label
Or antibiotics, if treatment cannot wait
If you are not up to date and Voydeya has to start right away, the label says to give the vaccines as soon as possible along with antibiotics.
- The REMS requires the prescriber to write that antibiotic prescription.
- The Medication Guide says to take the antibiotics for as long as your healthcare provider tells you.FDA label
A liver blood test
The label says to check liver enzymes before the first dose and periodically during treatment.
- In the label's trial, 14% of people on Voydeya had a rise in ALT, a liver enzyme.
- The Medication Guide says to tell your healthcare provider if you have liver problems.
- The label says to avoid Voydeya in severe liver impairment, where it has not been studied.FDA label
No serious infection at the start
The label says Voydeya must not be started in anyone with an unresolved serious infection caused by encapsulated bacteria.
- The Medication Guide says to tell your healthcare provider if you have an infection or fever.FDA label
A certified prescriber, and the counseling the REMS requires
Your hematologist must be enrolled in the VOYDEYA REMS.
- The REMS requires them to check for an unresolved serious infection, review your vaccines, counsel you with the Patient Guide, and hand you the Patient Safety Card.
- The FDA's REMS page lists no patient enrollment form.
- The label gives the REMS phone line as 1-888-765-4747, the same number as Alexion OneSource.FDA REMS page
One specialty pharmacy, and its vaccine check
Alexion's guide for doctors' offices says Onco360 is the sole specialty pharmacy for Voydeya.
- The office sends the VOYDEYA prescription form there.
- The guide says Onco360 confirms with the prescriber that your vaccine requirements are met before it ships.Alexion office guide
Insurance approval, and help while you wait
The same guide says Onco360 checks your coverage and supports the office through prior authorization.
- It describes Alexion OneSource as a free, personalized patient support program.
- It also describes a Free Limited Supply Program for people with commercial insurance whose approval is delayed 5 days or more.Alexion office guide
The days that matter
Counted from the first dose, with the vaccine deadline 2 weeks before it, the hemoglobin check after 4 weeks and a refill about every 30 days. 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.Vaccine review, with help finding the shots
OneSource says it may help enrolled patients find a vaccination site and resources that may cover vaccine costs.
- It also offers tools to keep track of your shots.
- The vaccines must be prescribed by your healthcare provider.
Vaccines done, or scheduled
The meningococcal and pneumococcal shots are due at least 2 weeks before day 1.
- The label says people on Voydeya are revaccinated on the ACIP schedule, so later doses can follow.
- Your hematologist decides which doses you need now.
Liver enzyme blood test
The label says liver enzymes are checked before the first dose.
- The Medication Guide says your healthcare provider does this blood test before and during treatment.
Insurance approval, pharmacy check, delivery
Alexion's guide says Onco360 checks your coverage and supports the prior authorization.
- It confirms your vaccine requirements with the prescriber before shipping.
- The guide also says Onco360 schedules refills and follows up with patients by phone.
First dose, then 2 more that day
The starting dose is 150mg 3 times a day, taken as one 100mg tablet and one 50mg tablet together.
- Doses go at around the same time every day, with or without food.
- The label says to carry the Patient Safety Card at all times from here.
Hemoglobin check, and a possible dose increase
The label lets the prescriber raise the dose to 200mg 3 times a day.
- That applies if hemoglobin has not risen by more than 2g/dL after 4 weeks, or if you needed a transfusion in the previous 4 weeks.
- The prescriber can also raise it based on clinical judgment.
- The 200mg dose is two 100mg tablets each time.
Refill, then about every 30 days
A carton holds 2 bottles of 90 tablets, 180 in all.
- Both doses use 6 tablets a day, so a carton lasts 30 days.
- The label says to store the tablets in their original container at room temperature.
Refill, number 2
Where the trial measured results
The label's trial compared hemoglobin at 12 weeks.
- It rose by 2.9g/dL on average with Voydeya and 0.5g/dL with placebo, both added to ravulizumab or eculizumab.
- Your hematologist can tell you how your own numbers compare.
Liver and cholesterol blood tests
The label asks for liver enzymes and blood lipids to be checked periodically during treatment.
- It sets no fixed dates, so your hematologist chooses when.
- Voydeya raises total and LDL cholesterol, and some people in the trial needed cholesterol-lowering medicine.
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 Voydeya 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 May 12, 2026, read from the FDA's label database today. FDA label
- May 2026
DailyMed posted a label version marked revised in May 2026. Compared with the December 2024 version there, section 2.2 now says doses should be taken around the same time every day. The Medication Guide now says not to take 2 or more doses at the same time, and the 7-day blister card cartons are no longer listed. Its highlights list no recent major changes, and Drugs@FDA shows no labeling supplement for it.FDA label
- June 2025
The FDA approved a change to the REMS. Its summary says the Alexion REMS landing webpage was removed from the REMS document and the website screenshots.FDA REMS page
- August 2024
The FDA's REMS page records a revision that made editorial changes to the REMS.FDA REMS page
- March 2024
First FDA approval, on March 29, 2024. The FDA's REMS page shows the VOYDEYA REMS was approved the same day.Drugs@FDA
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.
- Three times a day, with or without food
The label's starting dose is 150mg 3 times a day by mouth, and the prescriber can raise it to 200mg 3 times a day.
- Doses are taken around the same time every day.
- The Medication Guide says not to change the dose or stop taking Voydeya unless your healthcare provider tells you.FDA label
- Always with Ultomiris or Soliris
Voydeya is approved only as an add-on to ravulizumab or eculizumab.
- The label says it has not been shown to be effective as the only treatment.FDA label
- If you miss a dose
The Medication Guide says to take it as soon as you remember.
- If the next dose is due within 3 hours, it says to skip the missed one and take the next dose at the regular time.
- It says not to take 2 or more doses at the same time.
- If you take too much, it says to call your healthcare provider or go to the nearest emergency room right away.FDA label
- Fever is a call, not a wait
The Medication Guide lists fever with or without chills, fever with a rash, and fever with chest pain and cough.
- It also lists fever with breathlessness or fast breathing, fever with a high heart rate, and headache with nausea or vomiting.
- Headache with a fever, headache with a stiff neck or back, and confusion are on the list.
- The list ends with body aches with flu-like symptoms, clammy skin and eyes sensitive to light.
- It says to call your healthcare provider or get emergency care right away, and to show the Patient Safety Card.FDA label
- The card stays for 1 week after
The label requires carrying the Patient Safety Card at all times during treatment and for 1 week after the last dose.
- The Medication Guide says the infection risk may continue for a few days after the last dose.FDA label
- Stopping has its own watch period
The label says anyone who stops Voydeya is monitored closely for at least 2 weeks after the last dose for signs of hemolysis.
- It names a sudden drop in hemoglobin and fatigue as signs.
- If Voydeya has to stop, the label says to continue ravulizumab or eculizumab, or to consider another therapy if necessary.
- Any change to treatment is a decision for your hematologist.FDA label
- Medicines that interact
The label says Voydeya can raise blood levels of some other medicines.
- It names rosuvastatin, a cholesterol medicine, and says its dose should not go above 10mg once a day with Voydeya.
- It also covers 2 groups of medicines, called BCRP substrates and P-gp substrates, whose doses may need to change.
- The Medication Guide says to tell your healthcare provider about all your medicines, vitamins and herbal supplements.FDA label
- Boosters
The label says to revaccinate on the ACIP schedule for as long as treatment lasts.
- It also says vaccination does not eliminate the risk of serious infection, which is why the fever rule stays.FDA label
- Pregnancy and breastfeeding
The label says there are no data on Voydeya in pregnancy, and that untreated PNH carries risks for mother and baby.
- It leaves use in pregnancy to an assessment of the risks and benefits.
- It says not to breastfeed during treatment and for 3 days after the last dose.FDA label
- Storage
The Medication Guide says to store Voydeya in the original container between 68 and 77 degrees Fahrenheit.
- It says to keep it out of the reach of children.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 the label ties to serious infection
Fever with or without chills, fever with a rash, fever with chest pain and cough, or fever with fast breathing or a high heart rate.
- Headache with nausea or vomiting, with a fever, or with a stiff neck or back.
- Confusion, body aches with flu-like symptoms, clammy skin, or eyes sensitive to light.
- The Medication Guide says these infections may quickly become life-threatening.
- It says to call your healthcare provider or get emergency care right away, card in hand.FDA label
Liver enzymes
In the label's trial, 14% of people on Voydeya had a rise in the liver enzyme ALT.
- It was between 3 and 5 times the upper limit of normal in 9%, and between 5 and 10 times in 5%.
- The Medication Guide says your healthcare provider may temporarily or permanently stop Voydeya if liver enzymes rise.
- This shows up on a blood test, which is why the liver test is on the timeline.FDA label
Cholesterol
The label says Voydeya raises total and LDL cholesterol.
- Of 50 people with normal total cholesterol at the start of the trial, 30% developed Grade 1 high cholesterol, the mildest grade.
- Some people needed cholesterol-lowering medicine.
- The label asks prescribers to check blood lipids periodically during treatment.FDA label
Side effects in the trial
Headache was the most common, in 11% of people on Voydeya against 10% on placebo.
- Vomiting and fever each occurred in 7% against none on placebo.
- Pain in the arms or legs was 5% against none, and high blood pressure was 5% against 3%.
- Serious side effects were reported in 5% of people on Voydeya, and they included pancreatitis, gallbladder inflammation and a rise in bilirubin.FDA label
Signs of hemolysis after stopping
The Medication Guide says stopping Voydeya may cause a breakdown of red blood cells due to PNH.
- It lists a decreased hemoglobin level and tiredness as symptoms or problems that can follow.
- It says your healthcare provider will need to monitor you closely for at least 2 weeks after the last dose.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 pharmacy cannot confirm the vaccinesThe REMS requires the pharmacy to assess and document your meningococcal and pneumococcal vaccine status, or the antibiotic plan, before the first dose. The fix is the office sending the vaccine dates or the antibiotic prescription. If you were not up to date at the start, the pharmacy keeps checking for up to 6 months.FDA REMS page
- The prescription went to the wrong pharmacyAlexion's guide says Onco360 is the sole specialty pharmacy for Voydeya, and the REMS allows only certified pharmacies to dispense it. A prescription sent to a local pharmacy is a routing problem, not a denial. The office resends the VOYDEYA prescription form to Onco360.Alexion office guide
- The prescriber is not certified in the REMSBefore each fill, the pharmacy must contact the REMS to verify that the prescriber is certified. A prescriber enrolls by reviewing the REMS materials and sending the Prescriber Enrollment Form to the REMS.FDA REMS page
- Prior authorization pending or deniedThe FEP policy below asks for a baseline hemoglobin, use together with Soliris or Ultomiris, proof of the vaccines and the prescriber's REMS enrollment. Your hematologist's office sends the records that show each point. Alexion's guide describes a Free Limited Supply Program for commercial insurance when approval is delayed 5 days or more.Alexion office guide
- The plan says no after reviewAlexion Access Navigator posts a sample letter of medical necessity and a sample appeal letter for Voydeya for your hematologist's office. It also posts a guide to peer-to-peer reviews, a step some offices use before a formal appeal.Alexion Access Navigator
- A copay you cannot payWith commercial insurance, the OneSource CoPay Program can bring the cost as low as $0 for eligible patients. Medicare, Medicaid and other federal- or state-funded plans are excluded, and OneSource says it can connect those patients with third-party resources. Our help paying page lists the charity funds that are open.OneSource
- The renewal after 6 monthsThe FEP policy approves 6 months at first, then 12 months at a time. Renewal asks for a rise in hemoglobin from the level before treatment, continued use with Soliris or Ultomiris, and no unacceptable toxicity.FEP Blue policy
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- Age 18 or older
- Extravascular hemolysis associated with PNH
- A documented baseline hemoglobin value
- Used in combination with Soliris (eculizumab) or Ultomiris (ravulizumab)
- Vaccinated against encapsulated bacteria, including pneumococcus, meningococcus and Hib, at least 2 weeks before starting, with an exception when treatment cannot wait
- The prescriber is enrolled in the Voydeya REMS program
Approval length. Six months at first, then 12 months at a time. Renewal asks for a rise in hemoglobin from the pretreatment level, continued use with Soliris or Ultomiris, no unacceptable toxicity and REMS enrollment. The limit is 600mg a day.
This policy was approved on June 11, 2026 and took effect July 1, 2026. Its reference list cites the March 2024 label, not the version revised in May 2026. It lists a Hib vaccine, while the label's vaccine requirement names only meningococcal and pneumococcal vaccines. It is here as an example of what a plan asks for, not as a rule. FEP Blue 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.
- The Alexion OneSource CoPay Program for commercial insurance, as little as $0 for Voydeya for eligible patients
- Annual maximums may apply to the CoPay Program, and the terms say they can vary from patient to patient CoPay terms
- 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
- A 30-day free trial for eligible people who have not yet tried Voydeya for extravascular hemolysis
- A Free Limited Supply Program for people with commercial insurance whose approval is delayed 5 days or more, started through OneSource or Onco360 Alexion office guide
- Help locating a vaccination site, information on resources that may cover vaccine costs, and tools to track your vaccines OneSource vaccines
- Enrollment online, by email to OneSource@Alexion.com or by fax at 1-800-420-5150, with interpreters available OneSource enrollment
- Questions answered by phone without enrolling OneSource enrollment
Details as the drugmaker publishes them. OneSource
Five questions for the pharmacist or the support line
- Have you confirmed my vaccine dates with my hematologist's office, and is my first carton set to ship?
- Which carton am I getting, the 150mg one with 2 tablet strengths or the 200mg one?
- I take these other medicines. Is any of them a BCRP or P-gp substrate, and is my rosuvastatin dose 10mg or less?
- Which number will Onco360 call me from to schedule refills?
- If my dose changes to 200mg, how does the new carton reach me before the old one runs out?
- Has my OneSource copay help been applied to this fill?
Questions people ask in the first weeks
How long does it take to get Voydeya after it is prescribed?
The vaccines set the floor, at least 2 weeks between the shots and the first dose by the label, unless the hematologist starts antibiotics too. The liver blood test, prior authorization and the pharmacy's REMS check run alongside. No public source sets a typical number of days for the whole process.
Do I keep taking Ultomiris or Soliris with Voydeya?
Yes. The label approves Voydeya only as an add-on to ravulizumab (Ultomiris) or eculizumab (Soliris). It says Voydeya has not been shown to be effective on its own.
Which vaccines do I need before Voydeya?
By the label, vaccines against Neisseria meningitidis serogroups A, C, W, Y and B and against Streptococcus pneumoniae, at least 2 weeks before the first dose. In plain terms, that is the MenACWY and MenB shots plus a pneumococcal shot. The Medication Guide says people vaccinated in the past might need more shots, and the healthcare provider decides.
How many Voydeya tablets do I take?
The Medication Guide says the 150mg dose is one 100mg tablet and one 50mg tablet together, 3 times a day. The 200mg dose is two 100mg tablets, 3 times a day. Your prescriber sets which dose you take.
What if I miss a dose of Voydeya?
The Medication Guide says to take it as soon as you remember. If it is within 3 hours of the next dose, it says to skip the missed dose and take the next one at the regular time. It says not to take 2 or more doses at the same time.
What is the Patient Safety Card?
A card from your prescriber about the risk of serious infections, to show any healthcare provider who treats you. The label requires carrying it at all times during treatment and for 1 week after the last dose.
Does Voydeya need regular blood tests?
Yes. The label asks for liver enzymes before the first dose and periodically during treatment, and for blood lipids periodically during treatment. It also ties the dose increase to hemoglobin after 4 weeks. The label sets no fixed dates for the liver and lipid tests.
Can I pick up Voydeya at my regular pharmacy?
No. Only pharmacies certified in the VOYDEYA REMS can dispense it. Alexion's guide for doctors' offices says Onco360 is the sole specialty pharmacy for Voydeya.
Why was Voydeya denied by my insurance?
One federal employee plan's policy asks for a baseline hemoglobin, use together with Soliris or Ultomiris, proof of the vaccines and the prescriber's REMS enrollment. A missing record for any of these can hold up approval. The hematologist's office sends the records.
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Sources
- VOYDEYA (danicopan) tablets, for oral use: prescribing information and Medication Guide, revised 05/2026 (DailyMed listing: VOYDEYA- danicopan tablet, film coated; VOYDEYA- danicopan kit; SPL version 5), Alexion Pharmaceuticals, via DailyMed and openFDA, May 12, 2026.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Voydeya (danicopan), NDA 218037, REMS last update 06/27/2025, FDA, June 27, 2025.
- Alexion OneSource™ | VOYDEYA | Financial Assistance, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | VOYDEYA | Fill Out a Start Form, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ | VOYDEYA | Vaccination Support, Alexion Pharmaceuticals, November 13, 2026.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, November 13, 2026.
- Alexion Access Navigator | VOYDEYA, Alexion Pharmaceuticals, November 13, 2026.
- Quick Start Guide to VOYDEYA: Help your patient get started on VOYDEYA (danicopan) with these 3 steps, US/VOY-PNH/0093 V2 05/2026, Alexion Pharmaceuticals, November 13, 2026.
- How to Access VOYDEYA, Alexion Pharmaceuticals, November 13, 2026.
- 5.85.060 Voydeya (danicopan), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- Drugs@FDA: FDA-Approved Drugs, VOYDEYA, NDA 218037, FDA, June 27, 2025.
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.