Prescribing guide
Piasky (crovalimab-akkz)Meningococcal vaccination, REMS, weight-based dosing, C5 inhibitor switching, monitoring and prior authorization criteria for 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 and certified pharmacy or healthcare setting, meningococcal vaccination (serogroups A, C, W, Y and B) at least 2 weeks before day 1 or antibacterial prophylaxis with vaccines as soon as possible, no unresolved serious Neisseria meningitidis infection, counseling with the Patient Guide and Patient Safety Card, and the pharmacy's documentation of vaccination status with the office.
Example PA threshold
FEP example: PNH, age 13 or older, weight 40kg or more, documented baseline LDH, meningococcal vaccination, prescriber REMS enrollment, no dual therapy with another PA drug for PNH; 12 months, 9 vials for loading plus 9 vials per 84 days.
Monitoring
Meningococcal infection at any time and for 11 months after the last dose; Type III hypersensitivity for the first 30 days after a switch to or from another C5 inhibitor; infusion- and injection-related reactions; body weight against the 100kg dose line; hemolysis for at least 20 weeks after discontinuation without a switch.
Support line
PiaSky Access Solutions, 877-436-3683, Monday to Friday 6 AM to 5 PM Pacific; Prescriber Service Form plus Patient Consent Form; co-pay program enrollment (800) 888-8051; Genentech Patient Foundation (888) 941-3331; REMS line 1-866-469-7599.
Give your patient their plan
A one-page handout for starting Piasky, 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/piaskyBefore 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 PIASKY REMS | Review the Prescribing Information, the Patient Safety Card, Patient Guide and Healthcare Provider Safety Brochure, then submit the Prescriber Enrollment Form. The label gives www.PIASKYREMS.com and 1-866-469-7599. | FDA REMS page |
| Rule out active infection | Initiation is contraindicated with an unresolved serious Neisseria meningitidis infection, and the REMS requires the prescriber to assess for one before starting. Piasky is also contraindicated in patients with a known serious hypersensitivity reaction to crovalimab or any of the excipients. | FDA label |
| Vaccinate | Meningococcal vaccines for serogroups A, C, W, Y and B at least 2 weeks before the first dose, on the ACIP schedule for complement inhibitor recipients, which differs from the vaccine prescribing information. Revaccinate per ACIP considering the duration of therapy. Section 5.4 adds Streptococcus pneumoniae and Hib vaccination according to ACIP recommendations. | 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 regimen and duration have not been studied. | FDA label |
| Counsel and hand over the card | Counsel with the Patient Guide and Patient Safety Card and give copies. The card is carried at all times during treatment and for 11 months after the last dose. | FDA REMS page |
| Enroll in PiaSky Access Solutions | Both the Prescriber Service Form and the Patient Consent Form must be received before the program can act. It can run a benefits investigation, identify whether PA is required and which specialty pharmacy the plan requires. Forms go through My Patient Solutions or download. | Genentech Pro |
| Choose the specialty pharmacy | Genentech's network is Accredo (866-712-5200), CVS Specialty (800-237-2767), Onco360 (877-662-6633) and Alivia Specialty Pharmacy in Puerto Rico (787-979-2023). Genentech says they can dispense to the office or directly to the patient. The label says only healthcare providers should administer Piasky. | Genentech Pro |
| Expect the pharmacy's call | The certified pharmacy obtains REMS authorization for every dispense and contacts the office to document vaccination status or the prophylaxis plan before the first dose. For patients 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 |
Prior authorization criteria and what to document
One public policy as the example: Blue Cross Blue Shield Federal Employee Program, July 1, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis and age | PNH, age 13 or older; the label states safety and effectiveness are not established under 13 years or under 40kg | Diagnosis and date of birth in the chart note | FEP Blue policy |
| Weight | 40kg or more, at initial approval and at renewal | A dated weight; the same value sets the dose tier at 100kg | FEP Blue policy |
| Baseline LDH | A documented pretreatment serum LDH; renewal requires a decrease from it | LDH with date, before the first dose and at renewal | FEP Blue policy |
| Vaccination | Against Neisseria meningitidis 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 Piasky REMS, at initial approval and at renewal | Enrollment confirmation | FEP Blue policy |
| No dual therapy | Not used with another PNH drug requiring PA: eculizumab, ravulizumab, pegcetacoplan or iptacopan | Medication list; for a switch, the last dose date of the prior C5 inhibitor | FEP Blue policy |
| Quantity | 9 vials for loading doses plus 9 vials per 84 days; renewal 9 vials per 84 days; 12 months | Maintenance is 2 vials (680mg) or 3 vials (1,020mg) every 4 weeks, so 6 or 9 vials per 84 days. By the same arithmetic, loading takes 7 vials under 100kg (3 for the 1,000mg infusion plus 4) or 9 vials at 100kg or more (5 for the 1,500mg infusion plus 4) | FEP Blue policy |
Piasky dosing and titration
| When | Label | Source |
|---|---|---|
| Day 1 | IV loading dose by actual body weight: 1,000mg for 40kg to under 100kg, 1,500mg for 100kg or more. Dilute in 0.9% Sodium Chloride Injection to 4 to 15mg/mL and infuse over 60 minutes (1,000mg) or 90 minutes (1,500mg), each plus or minus 10 minutes, through a dedicated line with a 0.2 micron in-line filter. | FDA label |
| Days 2, 8, 15, 22 | 340mg SC, one 2mL injection, undiluted, in the abdomen. | FDA label |
| Day 29, then every 4 weeks | 680mg SC (2 consecutive 340mg injections) for 40kg to under 100kg; 1,020mg SC (3 consecutive injections) for 100kg or more. Rotate abdominal sites; consecutive injections at least 2 inches apart. No data on other injection sites. | FDA label |
| Schedule window | Doses may occasionally vary within 2 days of the scheduled day, except Day 1 and Day 2; the next dose follows the regular schedule. | FDA label |
| Weight change | Modify the maintenance dose if body weight becomes consistently greater than or lower than 100kg. | FDA label |
| From eculizumab or ravulizumab | Give the first IV loading dose no sooner than the time of the next scheduled dose of the prior C5 inhibitor, then follow the usual schedule. Weigh the timing against the Type III hypersensitivity risk. No dose adjustment for the transient increase in clearance. | FDA label |
| Missed dose | Give the missed dose, or the remainder, as soon as possible before the day of the next scheduled dose, then keep the regular day. Do not give 2 doses or more than the prescribed dose on the same day. | FDA label |
| Who administers | Only healthcare providers; the carton reads 'Administered by Healthcare Professionals Only'. Supplied as 1 single-dose 340mg/2mL vial per carton (NDC 50242-115-01). | FDA label |
| Storage | Refrigerate at 2 to 8 C (36 to 46 F) in the outer carton; do not freeze or shake. Unopened vials may spend a combined total of up to 7 days at up to 30 C (86 F). A filled syringe: up to 64 hours refrigerated and up to 5 hours at room temperature. | FDA label |
Monitoring the Piasky 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; unresolved serious Neisseria meningitidis infection; prior or current C5 inhibitor use and its last dose date | Vaccination is documented by the pharmacy with the office; initiation is contraindicated during unresolved serious meningococcal infection | FDA label |
| Any time, and 11 months after the last dose | Meningococcal infection: fever, fever with rash, fever with tachycardia, headache with fever, nausea or vomiting, or stiff neck or back, confusion, myalgia with flu-like symptoms, photophobia | Evaluate immediately and treat promptly; consider interruption during treatment of serious meningococcal infection | FDA label |
| First 30 days after a switch, either direction | Type III hypersensitivity: arthralgia, rash, pyrexia, myalgia, headache, fatigue, petechiae, abdominal pain; renal abnormalities; 2 cases of Grade 3 axonal neuropathy were reported in switchers | Mild or moderate: symptomatic treatment such as topical corticosteroids, antihistamines, antipyretics or analgesics. Severe: initiate and taper oral or systemic corticosteroids as clinically indicated | FDA label |
| During and after each dose | Infusion- and injection-related reactions, including hypersensitivity and anaphylaxis | Slow or interrupt the infusion for a reaction; for serious hypersensitivity discontinue Piasky immediately and treat per standard of care | FDA label |
| Other infections | Encapsulated bacteria including Streptococcus pneumoniae, Haemophilus influenzae and Neisseria gonorrhoeae | With an active systemic infection, monitor closely; if it worsens, consider whether to discontinue | FDA label |
| Body weight | Against the 100kg line | Change the maintenance dose if weight is consistently above or below it | FDA label |
| After discontinuation without a switch | LDH, hemoglobin, and fatigue, hemoglobinuria, abdominal pain, dyspnea, major adverse vascular events including thrombosis, dysphagia, erectile dysfunction, renal impairment | Monitor closely for at least 20 weeks; consider restarting Piasky or another PNH treatment if hemolysis occurs | FDA label |
| Per ACIP | Meningococcal revaccination | Revaccinate according to ACIP recommendations considering the duration of therapy; the REMS includes a Vaccination Reminder Letter to certified prescribers | FDA REMS page |
Piasky drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Eculizumab and ravulizumab | Piasky binds a different C5 epitope, so drug-target-drug complexes form on switching in either direction and can cause Type III hypersensitivity. The label expects them to clear within about 8 weeks after eculizumab and longer after ravulizumab. | FDA label |
| Timing between C5 inhibitors | Starting Piasky sooner than 5.5 half-lives after the last dose of another C5 inhibitor, or the reverse, increases the Type III risk. The label gives a mean terminal half-life of 53.1 days for crovalimab-akkz. | FDA label |
| Other drugs | Section 7 lists no other interactions; the Medication Guide asks patients to disclose all medicines, vitamins, supplements and vaccines | FDA label |
| Pregnancy and lactation | Human data are insufficient; no adverse developmental outcomes in monkeys at 14 times the exposure at the maximum recommended human dose; IgG crosses the placenta. Breastfeeding is not recommended during treatment and for 9 months after the final dose. | FDA label |
| Renal and hepatic impairment | No clinically significant pharmacokinetic differences with mild, moderate or severe renal impairment or mild hepatic impairment; not studied in moderate or severe hepatic impairment | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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 Access Solutions
- 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
Questions prescribers' offices ask about Piasky
What is the Piasky dosing schedule?
One IV loading dose on Day 1 (1,000mg for 40kg to under 100kg, 1,500mg for 100kg or more), then 340mg SC on Days 2, 8, 15 and 22, then 680mg or 1,020mg SC on Day 29 and every 4 weeks, per the label version dated November 11, 2025. Doses may occasionally vary within 2 days of the scheduled day, except Day 1 and Day 2. Only healthcare providers should administer it.
Which vaccines are required before Piasky?
Meningococcal vaccines for serogroups A, C, W, Y and B at least 2 weeks before the first dose, on the ACIP schedule for complement inhibitor recipients, per the label version dated November 11, 2025. If treatment is urgent, give antibacterial prophylaxis and vaccinate as soon as possible. Section 5.4 separately says to vaccinate against Streptococcus pneumoniae and Hib according to ACIP recommendations.
How common are Type III hypersensitivity reactions when switching to Piasky?
They were reported in 39 of 201 patients (19%) who switched from eculizumab or ravulizumab to Piasky, and in 2 of 8 who switched from Piasky to one of them, per the label version dated November 11, 2025. Median onset was 1.6 weeks (range 0.7 to 4.4) and median duration 1.9 weeks (range 0.4 to 34.1). Grade 3 reactions occurred in 8% of switchers. The label says to monitor for the first 30 days of the new therapy.
What does the Piasky REMS require?
A certified prescriber and a certified dispensing pharmacy, with no patient enrollment listed, per the FDA REMS page last updated May 29, 2026. The prescriber assesses for unresolved meningococcal infection, checks and completes vaccination for serogroups A, C, W, Y and B, writes antibacterial prophylaxis if treatment is urgent, and counsels with the Patient Guide and Patient Safety Card. The pharmacy verifies prescriber certification for every dispense and documents vaccination status with the office. The label lists the REMS line as 1-866-469-7599.
What do insurers ask for to approve Piasky for PNH?
Age 13 or older and weight of at least 40kg are the first 2 criteria in the FEP policy shown on this page, effective July 1, 2026. It also asks for a documented baseline LDH, meningococcal vaccination at least 2 weeks before starting, REMS enrollment, and no dual therapy with Soliris, Ultomiris, Empaveli or Fabhalta. It approves 12 months, with 9 vials for loading plus 9 vials per 84 days, renewed on a decrease in LDH from baseline.
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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, 2025-11-11.
- Approved Risk Evaluation and Mitigation Strategies (REMS): Piasky (Crovalimab-akkz), BLA 761388, FDA, 2026-05-29.
- Case Managers | PiaSky (crovalimab-akkz), Genentech, 2026-11-13.
- Financial Assistance Options | PiaSky (crovalimab-akkz), Genentech, 2026-11-13.
- Genentech Pro | PiaSky (crovalimab-akkz), Genentech, 2025-12-11.
- Pharmacy Policy 5.85.064, Piasky (crovalimab-akkz), Blue Cross Blue Shield Federal Employee Program, 2026-07-01.
- BLA 761388 approval letter, Piasky (crovalimab-akkz), FDA, 2024-06-20.
- BLA 761388/S-001 supplement approval letter, REMS call center hours, FDA, 2025-05-14.
A reference drawn from the November 11, 2025 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.