Prescribing guide
Voydeya (danicopan)Vaccine requirements, REMS, dose escalation, monitoring and prior authorization criteria for extravascular hemolysis in PNHFor prescribers and their offices treating paroxysmal nocturnal hemoglobinuria (PNH): 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, ongoing ravulizumab or eculizumab, meningococcal (ACWY and B) and pneumococcal vaccination at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, no unresolved encapsulated bacterial infection, baseline liver enzymes, counseling with the Patient Guide and Patient Safety Card, and the prescription form to Onco360, the sole specialty pharmacy.
Example PA threshold
FEP example: age 18 or older, EVH associated with PNH, documented baseline hemoglobin, combination with Soliris or Ultomiris, vaccination including Hib, prescriber REMS enrollment; 6 months then 12 months, 600mg a day.
Monitoring
Serious infection with encapsulated bacteria at any time; liver enzymes at baseline and periodically; hemoglobin at 4 weeks for the dose decision; serum lipids periodically; hemolysis for at least 2 weeks after any discontinuation; revaccination per ACIP.
Support line
Alexion OneSource, 1-888-765-4747, Monday to Friday 8:30 AM to 8 PM ET; Onco360 (sole specialty pharmacy) 1-877-662-6633; CoPay Program to $0 for commercial plans, 30-day free trial, Free Limited Supply on a coverage delay of 5 days or more; REMS line 1-888-765-4747.
Give your patient their plan
A one-page handout for starting Voydeya, 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/voydeyaBefore 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 VOYDEYA REMS | Review the Prescribing Information, the Healthcare Provider Safety Brochure, Patient Safety Card and Patient Guide, then submit the Prescriber Enrollment Form to the REMS. The pharmacy verifies certification before each dispense. | FDA REMS page |
| Confirm the add-on setting | Indicated only as add-on therapy to ravulizumab or eculizumab for EVH in adults with PNH. The label states it has not been shown to be effective as monotherapy. | FDA label |
| Rule out active infection | Initiation is contraindicated with an unresolved serious infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae type B. | FDA label |
| Vaccinate | Neisseria meningitidis serogroups A, C, W, Y and B and Streptococcus pneumoniae, at least 2 weeks before the first dose, on the ACIP complement inhibitor schedule, which differs from the vaccine prescribing information. Revaccinate per ACIP considering the duration of therapy. | FDA label |
| Or prophylaxis | If treatment is urgent and the patient is not up to date, give antibacterial prophylaxis and the vaccines as soon as possible. The REMS requires the prescriber to provide the prophylaxis prescription. The label notes the optimal regimens and durations have not been studied. | FDA label |
| Baseline liver enzymes | Assess liver enzyme test results before initiation. Avoid use in severe hepatic impairment (Child-Pugh C); no dose adjustment in mild to moderate impairment (Child-Pugh A and B). | FDA label |
| Counsel and hand over the card | Counsel with the Patient Safety Card and Patient Guide and give copies. The card is carried at all times during treatment and for 1 week after the last dose. | FDA REMS page |
| Prescription form to Onco360 | Send the completed and signed VOYDEYA Prescription Form directly to Onco360, the sole specialty pharmacy for Voydeya (phone 1-877-662-6633, fax 1-877-662-6355). Alexion's access guide says Onco360 conducts the benefit investigation once it has a complete, valid prescription and coordinates the PA documentation with the office. | Alexion access guide |
| Onco360 before shipping | Alexion's Quick Start Guide says Onco360 confirms with the prescriber that the patient's vaccination requirements have been met before shipping Voydeya, and schedules refills. | Alexion office guide |
| Expect the pharmacy's check | The certified outpatient pharmacy obtains authorization for each prescription by contacting the REMS to verify the prescriber, and assesses and documents vaccination status or prophylaxis before the first dose. For patients not up to date at the start, it repeats that check before dispensing for up to 6 months after the first dose. | FDA REMS page |
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. 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis and age | Extravascular hemolysis associated with PNH, age 18 or older | Diagnosis in the chart; Alexion's Quick Start Guide says certain laboratory tests related to EVH may be required by the plan as part of prior authorization | FEP Blue policy |
| Baseline hemoglobin | A documented baseline hemoglobin value; renewal requires an increase from the pretreatment baseline | Hemoglobin with date, before the first dose and at renewal | FEP Blue policy |
| Combination therapy | Used in combination with Soliris (eculizumab) or Ultomiris (ravulizumab), at initiation and renewal | Medication list and infusion records | FEP Blue policy |
| Vaccination | Vaccination against encapsulated bacteria, including Streptococcus pneumoniae, Neisseria meningitidis and Haemophilus influenzae type B, at least 2 weeks before initiation, with an exception when treatment cannot wait; the label's requirement names only the first 2 | Vaccine names and dates, or the prophylaxis prescription | FEP Blue policy |
| REMS | Prescriber enrolled in the Voydeya REMS program, at initiation and renewal | Enrollment confirmation | FEP Blue policy |
| Quantity and duration | 600mg per day; 6 months initially, 12 months on renewal; renewal also requires absence of unacceptable toxicity | The 600mg a day limit equals the label's maximum of 200mg 3 times a day | FEP Blue policy |
Voydeya dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | 150mg orally 3 times a day, with or without food, at around the same time every day, as one 100mg and one 50mg tablet per dose. Always with ravulizumab or eculizumab. | FDA label |
| After 4 weeks | May increase to 200mg 3 times a day (two 100mg tablets per dose) if hemoglobin has not increased by more than 2g/dL after 4 weeks, if the patient required a transfusion during the previous 4 weeks, or to achieve an appropriate hemoglobin response based on clinical judgment. | FDA label |
| Missed dose | Take as soon as remembered unless within 3 hours of the next dose; then skip and resume at the next scheduled time. Do not take 2 or more doses at the same time. | FDA label |
| Hepatic impairment | No adjustment for Child-Pugh A or B. Avoid in Child-Pugh C, which has not been studied. | FDA label |
| Supply | Cartons of 180 tablets in 2 bottles of 90: the 150mg-dose carton (NDC 25682-046-92) holds 90 x 50mg and 90 x 100mg; the 200mg-dose carton (NDC 25682-043-92) holds 180 x 100mg. Either is 30 days at 6 tablets a day. Store and dispense in the original container at 20 to 25 degrees C. | FDA label |
| Discontinuation | Continue background ravulizumab or eculizumab, or consider alternative therapy if necessary; monitor for hemolysis for at least 2 weeks after the last dose. | FDA label |
Monitoring the Voydeya label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before day 1 | Vaccination status against the ACIP complement inhibitor schedule; unresolved encapsulated bacterial infection; liver enzymes | Required by the label; vaccination status is also documented by the pharmacy under the REMS | FDA label |
| Any time | Serious infection: fever with or without chills, fever with rash, fever with chest pain and cough, fever with breathlessness or fast breathing, fever with high heart rate, headache with nausea or vomiting, headache with fever, headache with stiff neck or back, confusion, body aches with flu-like symptoms, clammy skin, photophobia | Evaluate immediately and treat promptly; consider interruption during treatment of a serious infection | FDA label |
| Week 4 | Hemoglobin and transfusion need over the previous 4 weeks | Basis for the increase to 200mg 3 times a day | FDA label |
| Periodically | Liver enzymes. In Study ALXN2040-PNH-301, ALT elevations occurred in 14%: above 3 and up to 5 times ULN in 9%, above 5 and up to 10 times ULN in 5% | Consider interruption or discontinuation if elevations are clinically significant or the patient becomes symptomatic | FDA label |
| Periodically | Serum lipids. Of 50 patients with normal baseline total cholesterol, 30% developed Grade 1 hypercholesterolemia; of 54 with LDL-C of 130mg/dL or less, 13% rose to above 130 to 160mg/dL and 9% to above 160 to 190mg/dL | Initiate cholesterol-lowering medication if indicated; rosuvastatin not above 10mg once daily | FDA label |
| After any discontinuation | Signs and symptoms of hemolysis, which may include a sudden decrease in hemoglobin or fatigue | Monitor closely for at least 2 weeks after the last dose; consider restarting if hemolysis occurs | FDA label |
| Per ACIP | Revaccination | Revaccinate in accordance with ACIP recommendations considering the duration of therapy | FDA label |
Voydeya drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| BCRP substrates | Danicopan inhibits BCRP and raises substrate concentrations; monitor more frequently for the substrate's adverse reactions and consider reducing its dose per its prescribing information | FDA label |
| Rosuvastatin | Exposure significantly increased; dose should not exceed 10mg once daily with Voydeya | FDA label |
| P-gp substrates | Danicopan inhibits P-gp and may raise substrate concentrations; dose adjustment might be necessary where minimal concentration changes may lead to serious adverse reactions | FDA label |
| C5 inhibitors | Required background therapy: ravulizumab or eculizumab continues throughout; if Voydeya is discontinued, continue it or consider alternative therapy if necessary | FDA label |
| Pregnancy and lactation | No available human data; no adverse developmental effects in rabbits or rats at 18 and 25 times the exposure at the maximum recommended human dose; use may be considered after a risk and benefit assessment. No breastfeeding during treatment and for 3 days after the last dose | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Alexion OneSource
- 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
Questions prescribers' offices ask about Voydeya
Which vaccines are required before Voydeya?
Neisseria meningitidis serogroups A, C, W, Y and B and Streptococcus pneumoniae, at least 2 weeks before the first dose, on the ACIP schedule for complement inhibitor recipients, per the label revised May 2026. The boxed warning also names Haemophilus influenzae type B among the organisms, but the vaccination requirement names only the first 2. If treatment is urgent, the label says to give antibacterial prophylaxis and the vaccines as soon as possible.
What is the Voydeya dose, and when is it increased?
The dose is 150mg orally 3 times a day, increased to 200mg 3 times a day if hemoglobin has not risen by more than 2g/dL after 4 weeks, per the label revised May 2026. The label also allows the increase if the patient needed a transfusion in the previous 4 weeks, or to achieve an appropriate hemoglobin response based on clinical judgment.
What does the Voydeya REMS require?
A certified prescriber, a certified pharmacy that verifies the prescriber before each dispense, and a Patient Safety Card carried during treatment and for 1 week after the last dose, per the REMS last updated June 27, 2025. The prescriber assesses for unresolved encapsulated bacterial infection, checks and completes vaccination, writes antibacterial prophylaxis if the start is urgent, and counsels with the Patient Guide and Patient Safety Card. The FDA page lists no patient enrollment form. The label lists the REMS line as 1-888-765-4747.
What monitoring does the Voydeya label require?
Liver enzymes before initiation and periodically, serum lipids periodically, and hemolysis monitoring for at least 2 weeks after the last dose, per the label revised May 2026. ALT rose in 14% of Voydeya patients in Study ALXN2040-PNH-301, and 30% of the 50 patients with normal baseline total cholesterol developed Grade 1 hypercholesterolemia.
What do insurers ask for to approve Voydeya?
The FEP policy shown on this page, effective July 1, 2026, asks for age 18 or older, extravascular hemolysis associated with PNH, a documented baseline hemoglobin, use in combination with Soliris or Ultomiris, vaccination including Hib at least 2 weeks before initiation, and REMS enrollment. It approves 6 months at first and 12 months on renewal, at 600mg a day, with renewal on a hemoglobin increase from baseline.
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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, 2026-05-12.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Voydeya (danicopan), NDA 218037, REMS last update 06/27/2025, FDA, 2025-06-27.
- Alexion OneSource™ | VOYDEYA | Financial Assistance, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ | VOYDEYA | Fill Out a Start Form, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ | VOYDEYA | Vaccination Support, Alexion Pharmaceuticals, 2026-11-13.
- Alexion OneSource™ CoPay Program Terms and Conditions, US/ALL/1223 V1 12/2024, Alexion Pharmaceuticals, 2026-11-13.
- Alexion Access Navigator | VOYDEYA, Alexion Pharmaceuticals, 2026-11-13.
- 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, 2026-11-13.
- How to Access VOYDEYA, Alexion Pharmaceuticals, 2026-11-13.
- 5.85.060 Voydeya (danicopan), Blue Cross Blue Shield Federal Employee Program, 2026-07-01.
- Drugs@FDA: FDA-Approved Drugs, VOYDEYA, NDA 218037, FDA, 2025-06-27.
A reference drawn from the May 12, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 13, 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.