Your first 90 days
Your first 90 days on Piasky 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.
Piasky is a PNH drug that a healthcare provider gives, first as 1 infusion and then as injections under the skin. After the first month, the doses come every 4 weeks. Before the first dose, the label requires meningococcal vaccines, and the pharmacy checks with your doctor that they happened. If you are coming from Soliris or Ultomiris, the label describes an immune reaction to watch for in the first 30 days. This page lays out those first 3 months from the FDA label, the REMS, Genentech's own support program and one insurer's written rules.
What has to happen before the first bottle ships
Piasky is a specialty drug under a REMS, so the first dose waits on vaccines, a certified prescriber, a certified pharmacy or clinic and an insurance approval. These are the 7 things in the way, in order.
Meningococcal vaccines, at least 2 weeks before the first dose
Piasky blocks C5, a protein in the part of the immune system called complement, and that raises the risk of serious meningococcal infections.
- The label requires meningococcal vaccines for serogroups A, C, W, Y and B at least 2 weeks before day 1.
- The schedule is the ACIP one for people on a complement inhibitor, which differs from the usual one.
- The Medication Guide says that if you had a meningococcal vaccine in the past, you might need more.
- Your healthcare provider decides which ones.FDA label
Or antibiotics, if treatment cannot wait
If Piasky has to start right away and the vaccines are not up to date, 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 to.FDA label
A pneumococcal vaccine too
The label also says to vaccinate against Streptococcus pneumoniae, a pneumococcal vaccine, according to ACIP recommendations.
- For children, it adds a vaccine against Haemophilus influenzae type b (Hib), and the Medication Guide says that depends on age.
- The 2-week rule in the boxed warning names only the meningococcal vaccines.FDA label
A certified prescriber, and the counseling the REMS requires
Your hematologist must be enrolled in the PIASKY REMS.
- The REMS requires them to check for an unresolved meningococcal infection, review your vaccines, counsel you with the Patient Guide, and give you the Patient Safety Card.
- The FDA's REMS page lists no enrollment form for patients.
- The label lists the REMS line as 1-866-469-7599.FDA REMS page
A certified pharmacy or clinic, and its check
The label says healthcare settings and pharmacies that dispense Piasky must be certified in the REMS.
- Before the first dose is dispensed, the pharmacy must confirm your prescriber is certified and contact the office to document your vaccines or the antibiotic plan.
- If you were not up to date at the start, it repeats that check before each dispense for up to 6 months after the first dose.FDA REMS page
Insurance approval, and PiaSky Access Solutions
Enrolling in PiaSky Access Solutions takes a Patient Consent Form from you and a Prescriber Service Form from the office.
- The program can then check whether your plan covers Piasky, whether prior authorization is needed and which specialty pharmacy the plan requires.
- Genentech lists Accredo, CVS Specialty, Onco360 and, in Puerto Rico, Alivia Specialty Pharmacy as its network.
- Genentech says those pharmacies can send the medicine to the doctor's office or directly to the patient.Genentech Pro
Who gives each dose
The label says only healthcare providers should administer Piasky, and the vial carton is printed 'Administered by Healthcare Professionals Only'.
- That covers the day 1 infusion and every injection after it.FDA label
The days that matter
Counted from the day 1 infusion, with the vaccine deadline 2 weeks before it. Five loading doses fall in the first 22 days, then a dose every 4 weeks from day 29. 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 done, or scheduled
The label calls for the meningococcal vaccines at least 2 weeks before day 1.
- The pharmacy will contact the office for your vaccine status before it dispenses the first dose.
Insurance approval and the pharmacy's check
The pharmacy confirms your prescriber's REMS certification and documents your vaccines, or the antibiotic plan, with the office.
- PiaSky Access Solutions can tell the office which specialty pharmacy your plan requires.
First dose, by infusion
A healthcare provider gives 1,000mg into a vein over about 60 minutes for people from 40kg to under 100kg (88 to about 220 pounds).
- At 100kg or more, the dose is 1,500mg over about 90 minutes.
- The label says to carry the Patient Safety Card at all times from the start of treatment.
First injection under the skin
One 340mg injection in the belly area, given by a healthcare provider the day after the infusion.
- The label's 2-day leeway for other doses does not apply to day 1 or day 2.
Three more weekly loading injections
One 340mg injection under the skin on each of days 8, 15 and 22.
- The label lets a dose occasionally move by up to 2 days, with the next dose back on the regular schedule.
Maintenance dose, then every 4 weeks
From day 29 the dose is 680mg, given as 2 injections, for people from 40kg to under 100kg.
- At 100kg (about 220 pounds) or more it is 1,020mg, given as 3 injections.
- Each carton holds 1 vial of 340mg, so each dose uses 2 or 3 vials.
If you switched from Soliris or Ultomiris, the 30-day watch ends
The label says people who switch C5 inhibitors should be monitored for the first 30 days for a Type III hypersensitivity reaction.
- In trials, these reactions started a median of 1.6 weeks after the switch, with a range of 0.7 to 4.4 weeks.
Maintenance dose, number 2
Blood levels settle
The label says Piasky reaches a steady level in the blood after about 12 weeks of dosing.
- The third every-4-week dose falls on day 85.
Maintenance dose, 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 Piasky 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 November 11, 2025, read from the FDA's label database today. FDA label
- May 2026
The FDA's REMS page records a revision of the PIASKY REMS for editorial changes on May 29, 2026. The REMS requirements described here did not change.FDA REMS page
- November 2025
DailyMed carries a label version dated November 11, 2025, with no recent major changes listed. Genentech's own prescribing information still reads Revised 06/2024, and the Medication Guide keeps its June 2024 issue date. Drugs@FDA lists no labeling supplement since the June 2024 approval.FDA label
- May 2025
The FDA approved a change to the hours of the REMS call center. The prescribing information was not part of that supplement.FDA letter
- June 2024
First approval, on June 20, 2024, for adults and children 13 and older with PNH who weigh at least 40kg (88 pounds). The FDA approved the PIASKY REMS in the same letter.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.
- Given by a healthcare provider, every time
The label says only healthcare providers should administer Piasky.
- The first dose goes into a vein, and every later dose goes under the skin of the belly area.
- The label says no data are available on injecting at other sites of the body.FDA label
- The dose follows your weight
Doses are set by actual body weight, with the line at 100kg (about 220 pounds).
- The label says the maintenance dose must change if your weight moves across that line and stays there.
- The Medication Guide says to tell your healthcare provider if your weight changes.FDA label
- If a dose is missed or late
The label says a missed dose, or the missed part of one, is given as soon as possible before the day of the next scheduled dose.
- The next dose then stays on its regular day.
- Two doses are never given on the same day to make up for a missed one.
- The Medication Guide says to talk to your healthcare provider if you miss a dose.FDA label
- Fever is a call, not a wait
The Medication Guide lists fever, fever with a rash, fever with a high heart rate, and fever with a headache.
- It also lists headache with nausea or vomiting, headache with a stiff neck or stiff back, confusion, muscle aches with flu-like symptoms, and eyes sensitive to light.
- It says to call your healthcare provider or get emergency medical care right away, and to show the Patient Safety Card.FDA label
- The card outlasts the drug
The label says to carry the Patient Safety Card at all times during treatment and for 11 months after the last dose.
- The Medication Guide says the risk of meningococcal infection may continue for several months after the last dose.FDA label
- Switching C5 inhibitors has its own rule
For people coming from eculizumab (Soliris) or ravulizumab (Ultomiris), the label says the first Piasky dose comes no sooner than the next scheduled dose of the old drug.
- Piasky and those drugs attach to different parts of the C5 protein, so complexes of C5 bound to both drugs can form.
- The label says the same risk applies when switching from Piasky to one of them.
- Your hematologist decides the timing.FDA label
- Stopping has its own watch period
The label says stopping Piasky can cause red blood cells to break down because of PNH.
- Anyone who stops without switching to another PNH treatment is monitored closely for at least 20 weeks.
- The Medication Guide lists anemia, blood in the urine or dark urine, shortness of breath, tiredness, stomach pain, blood clots, trouble swallowing, erectile dysfunction and kidney problems.
- Any change to treatment is a decision for your hematologist.FDA label
- Boosters
The label says to revaccinate against meningococcal infection according to ACIP recommendations while on Piasky.
- It also says vaccination does not remove the risk of meningococcal infection.FDA label
- Pregnancy and breastfeeding
The label says the data in pregnancy are not enough to know the risk, and that untreated PNH carries its own risks in pregnancy.
- It says breastfeeding is not recommended during treatment and for 9 months after the final dose.
- The Medication Guide says to tell your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.FDA label
- Storage
Piasky is kept in a refrigerator at 36 to 46 degrees Fahrenheit, in its outer carton to protect it from light, and never frozen or shaken.
- The label allows an unopened vial up to 7 days in total at room temperature, up to 86 degrees Fahrenheit.
- A vial kept out of the refrigerator longer than that is discarded.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 meningococcal infection
Fever, fever with a rash, fever with a high heart rate, or fever with a headache.
- Headache with nausea or vomiting, or headache with a stiff neck or stiff back.
- Confusion, muscle aches with flu-like symptoms, or eyes sensitive to light.
- The Medication Guide says these infections may quickly become life-threatening or cause death if not treated early.
- Call your healthcare provider or get emergency medical care right away, card in hand.FDA label
A Type III hypersensitivity reaction after a switch
Joint pain, muscle or bone pain, rash or skin problems, itching, headache, fever, weakness or tiredness, and stomach trouble or pain.
- Kidney problems, or numbness and tingling in the hands and feet.
- The Medication Guide says to call your healthcare provider or go to the nearest emergency room right away.
- In trials, 39 of 201 people (19%) who switched from eculizumab or ravulizumab to Piasky had one, and 8 had reactions counted as serious because of a hospital stay.
- Of 42 reactions, 37 resolved, and the median length was 1.9 weeks.FDA label
Nerve damage reported after a switch
The label reports 2 cases of serious nerve damage, called axonal neuropathy, in people who switched between Piasky and another C5 inhibitor.
- In both, a Type III reaction could not be ruled out as a cause, and neither had resolved at the last follow-up visit.
- Numbness, tingling or a feeling of pins and needles in the hands and feet is on the Medication Guide's list of signs to act on right away.FDA label
Reactions to the infusion or an injection
Headache, pain where the needle went in or in other parts of the body, swelling, bruising or bleeding, red skin, itching and rash.
- The Medication Guide also lists signs of a serious allergic reaction.
- Those are trouble breathing, chest pain or tightness, wheezing, feeling dizzy or lightheaded, swelling of the throat, lips, tongue or face, hives, and fever or chills.
- It says to call your healthcare provider right away or go to the nearest emergency room.
- The Medication Guide lists an allergy to crovalimab or any ingredient in Piasky as a reason not to receive it.
- In the COMMODORE 2 trial, infusion-related reactions occurred in 16% of people on Piasky and injection-related reactions in 6%.FDA label
Other infections
The Medication Guide says to call your healthcare provider right away for any new signs of infection.
- It lists a fever of 100.4 degrees Fahrenheit or higher, cough, chest pain, tiredness and shortness of breath.
- It also lists a painful rash, sore throat, burning pain when passing urine, and feeling weak or generally unwell.FDA label
Side effects in the 2 trials the label describes
In COMMODORE 2, in people new to complement inhibitors, respiratory tract infections occurred in 13% on Piasky against 20% on eculizumab.
- Viral infections were 11% against 7%, headache 8% against 6%, and diarrhea 7% against 1%.
- In COMMODORE 1, in people who switched from eculizumab, viral infections occurred in 23% on Piasky against 21% of those who stayed on eculizumab.
- Respiratory tract infections were 18% against 5%, Type III reactions 16% against none, and infusion-related reactions 14% against none.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 document the vaccinesThe REMS requires the pharmacy to check your meningococcal vaccine status, or the antibiotic plan, with the prescriber before the first dose is dispensed. The office sending the vaccine dates, or the antibiotic prescription, answers that check.FDA REMS page
- The prescriber, pharmacy or clinic is not certified in the REMSPrescribers must enroll in the PIASKY REMS, and pharmacies and healthcare settings that dispense Piasky must be certified. The pharmacy has to verify the prescriber's certification before each dispense. The label lists the REMS line as 1-866-469-7599.FDA REMS page
- Prior authorization pending or deniedThe FEP policy below asks for age, weight, a baseline LDH, the meningococcal vaccine and the prescriber's REMS enrollment. Genentech says a Case Manager or field reimbursement manager can give the office resources for an appeal. It also says PiaSky Access Solutions cannot complete or submit the appeal for the office.Genentech Pro
- The plan does not allow 2 PNH drugs at onceThe FEP policy below rules out dual therapy with Soliris, Ultomiris, Empaveli or Fabhalta. The label has people switching from eculizumab or ravulizumab start Piasky no sooner than the next scheduled dose of the old drug.FEP Blue policy
- A copay you cannot payCommercial insurance: the PiaSky Co-pay Program, as little as $0 per 30-day supply, up to $15,000 a calendar year. Medicare, Medicaid, TRICARE and other government plans are excluded. The Genentech Patient Foundation gives free Piasky to people who meet its insurance and income rules, at 888-941-3331. Our help paying page lists the charity funds that are open.PiaSky assistance options
Blue Cross Blue Shield Federal Employee Program prior authorization policy, July 1, 2026
- PNH, age 13 or older
- Weight of 40kg (88 pounds) or more
- A baseline LDH on record
- Vaccinated against Neisseria meningitidis at least 2 weeks before starting, unless treatment cannot be delayed
- The prescriber is enrolled in the Piasky REMS
- Not used together with another PNH drug that needs prior approval: Soliris, Ultomiris, Empaveli or Fabhalta
Approval length. Twelve months at a time, with 9 vials for the loading doses plus 9 vials every 84 days. Renewal asks that LDH has fallen from the starting level, with no unacceptable toxicity.
This policy was reviewed on June 11, 2026 and cites the June 2024 package insert. The label now on DailyMed is dated November 2025, lists no recent major changes and carries the same June 2024 Medication Guide. 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.
- A Case Manager who explains how your insurance can cover Piasky and works with your doctor's office or specialty pharmacy to help you get your medicine. Case Managers are not healthcare professionals and cannot give medical advice
- PiaSky Co-pay Program for commercial insurance, as little as $0 per 30-day supply, up to $15,000 in help per calendar year. It is not valid under Medicare, Medicaid, TRICARE or other government plans PiaSky assistance options
- Genentech Patient Foundation, which gives free Piasky to people without insurance, or with financial concerns, who meet its eligibility rules, at 888-941-3331 PiaSky assistance options
- Referrals to independent copay foundations, which have their own rules, for people with commercial or public insurance including Medicare and Medicaid PiaSky assistance options
- A financial assistance line at 866-422-2377 for talking through the options PiaSky assistance options
- A benefits investigation for the doctor's office, covering whether prior authorization is needed and which specialty pharmacy the plan requires Genentech Pro
Details as the drugmaker publishes them. PiaSky Case Managers
Five questions for the pharmacist or the support line
- Have you documented my meningococcal vaccine dates with my hematologist's office, and is anything still missing?
- Are you certified in the PIASKY REMS, and do you send the vials to my doctor's office or to me?
- Where will my day 1 infusion and my day 2 injection be given, and who gives the later injections?
- Which dose am I on for my weight, and how many vials is that each time?
- If I am switching from Soliris or Ultomiris, when was my last dose due, and who do I call about joint pain, rash or tingling in the first 30 days?
Questions people ask in the first weeks
How long does it take to get Piasky after it is prescribed?
The vaccines set the floor: at least 2 weeks between the meningococcal vaccines and the first dose, by the label, unless the hematologist starts antibiotics instead. The prior authorization and the pharmacy's REMS check run alongside. For people switching from Soliris or Ultomiris, the label also says the first dose comes no sooner than the next scheduled dose of the old drug.
Which vaccines do I need before Piasky?
By the label, meningococcal vaccines for serogroups A, C, W, Y and B, at least 2 weeks before the first dose. The schedule is the ACIP one for people on a complement inhibitor. The label also says to vaccinate against Streptococcus pneumoniae according to ACIP recommendations. The Medication Guide says a past meningococcal vaccine might not be enough, and your healthcare provider decides.
Can I inject Piasky myself at home?
The current US label says only healthcare providers should administer Piasky, and the carton is printed 'Administered by Healthcare Professionals Only'. That applies to the day 1 infusion and to every injection under the skin.
How often is Piasky given?
By the label, 1 infusion on day 1, then a 340mg injection under the skin on days 2, 8, 15 and 22. From day 29 the dose is 680mg or 1,020mg under the skin every 4 weeks, set by whether you weigh under 100kg (about 220 pounds) or 100kg or more.
How do I switch from Soliris or Ultomiris to Piasky?
The label says the first Piasky dose is given no sooner than the next scheduled dose of eculizumab (Soliris) or ravulizumab (Ultomiris). It says people who switch should be monitored for 30 days for a Type III hypersensitivity reaction, which occurred in 39 of 201 switchers (19%) in trials. Your hematologist weighs the timing.
What is the Patient Safety Card?
A card from your prescriber about the risk of serious meningococcal infection, which the Medication Guide says to show to any healthcare provider who treats you. The label says to carry it at all times during treatment and for 11 months after the last dose.
How did Piasky do in its main trial?
The label describes COMMODORE 2, which randomized 204 people with PNH who had never taken a complement inhibitor to Piasky or eculizumab for 24 weeks. Hemolysis control, measured by the blood marker LDH, averaged 79.3% on Piasky and 79.0% on eculizumab. Transfusions were avoided by 65.7% against 68.1%, and breakthrough hemolysis occurred in 10.4% against 14.5%. The label states that non-inferiority was demonstrated.
Why was Piasky denied by my insurance?
One federal employee plan's policy asks for age 13 or older, a weight of at least 40kg (88 pounds), a baseline LDH, the meningococcal vaccine, and the prescriber's REMS enrollment. It also rules out a second PNH drug at the same time.
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Sources
- PIASKY (crovalimab-akkz) injection, for intravenous or subcutaneous use: prescribing information and Medication Guide, DailyMed version effective November 11, 2025, Genentech, via openFDA and DailyMed, November 11, 2025.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Piasky (Crovalimab-akkz), BLA 761388, FDA, May 29, 2026.
- Case Managers | PiaSky (crovalimab-akkz), Genentech, November 13, 2026.
- Financial Assistance Options | PiaSky (crovalimab-akkz), Genentech, November 13, 2026.
- Genentech Pro | PiaSky (crovalimab-akkz), Genentech, December 11, 2025.
- Pharmacy Policy 5.85.064, Piasky (crovalimab-akkz), Blue Cross Blue Shield Federal Employee Program, July 1, 2026.
- BLA 761388 approval letter, Piasky (crovalimab-akkz), FDA, June 20, 2024.
- BLA 761388/S-001 supplement approval letter, REMS call center hours, FDA, May 14, 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.