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PiaSky

Pronunciation: pea-UH-sky
Generic name: crovalimab
Dosage form: injection for intravenous or subcutaneous use
Drug class: Selective immunosuppressants

Medically reviewed by Carmen Pope, BPharm. Last updated on Aug 15, 2024.

What is PiaSky?

PiaSky (crovalimab-akkz) may be used to treat paroxysmal nocturnal hemoglobinuria (PNH) in adults and teenagers.

PiaSky works by targeting a specific part of the immune system called the complement system, which is overactive in PNH patients. It binds specifically to complement protein C5, preventing the formation of a complex that causes cell destruction. By preventing this overactive immune response, PiaSky's mechanism of action helps protect red blood cells from destruction.

PiaSky gained FDA approval on June 20, 2024.

PiaSky REMS

PiaSky is only available through a program called the PiaSky Risk Evaluation and Mitigation Strategy (PiaSky REMS). Before you can receive it your healthcare provider must:

PiaSky side effects

The most common side effects of PiaSky are:

Infusion-related reactions and Type III hypersensitivity reactions caused by PiaSky are explained in more detail below.

Serious side effects and warnings

PiaSky carries a Boxed Warning for serious meningococcal infections.

PiaSky increases your chance of getting meningitis and other serious infections caused by Neisseria meningitidis. Meningococcal infections can quickly become life-threatening or cause death if not recognized and treated early.

Immune system reactions called Type III hypersensitivity reactions are common during treatment with PiaSky and can also be serious. You are at increased risk if you are currently being treated with or have been treated with another C5 inhibitor medicine and you switch to PiaSky and vice versa, and your healthcare provider should monitor you for 30 days after you switch medicines. Call your healthcare provider or go to the nearest emergency room right away if you develop any signs and symptoms of Type III hypersensitivity reactions, including:

PiaSky may also increase the risk of other types of serious infections caused by encapsulated bacteria, including infections caused by Neisseria spp., Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.

Infusion- and injection-related reactions may happen during or after your PiaSky infusion or injection. Symptoms may include headache, pain at the infusion or injection site, pain in other parts of your body, swelling, bruising or bleeding, red skin, itching, and rash. PiaSky can also cause serious allergic reactions. If you react your healthcare provider may need to change the rate PiaSky is infused or stop infusing it. Call your healthcare provider right away or go to the nearest emergency room if you develop any signs or symptoms of a serious allergic reaction, including:

It is not known if PiaSky is safe and effective in children under 13 years of age or in people who weigh less than 88 pounds (40 kg).

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all of the possible side effects of PiaSky. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking

Do not receive PiaSky if you:

Before receiving PiaSky tell your healthcare provider about all of your medical conditions, including if you:

Pregnancy

It is not known if PiaSky will harm your unborn baby.

Breastfeeding

It is not known if PiaSky passes into your breast milk. You should not breastfeed during treatment and for 9 months after your final dose.

How will I receive PiaSky?

PiaSky is administered by a healthcare provider. The dose of PiaSky is based on your weight. If your weight changes, tell your healthcare provider.

If you are changing treatment from another C5 inhibitor such as eculizumab or ravulizumab to PiaSky, you should receive your first loading dose no sooner than the time you would have received your next scheduled dose of eculizumab or ravulizumab.

What happens if I miss a dose?

Talk to your healthcare provider if you miss receiving an entire dose or part of your dose of PiaSky.

If you stop taking PiaSky and do not switch to another treatment for your PNH, your healthcare provider will need to monitor you closely for at least 20 weeks after stopping it because stopping treatment may cause a breakdown of red blood cells due to PNH.

Symptoms or problems that can happen due to red blood cell breakdown include:

What other drugs will affect PiaSky?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PiaSky and other medicines can affect each other, causing side effects.

Especially tell your healthcare provider if you are currently being treated with or have ever been treated with any other complement C5 inhibitor (C5 inhibitor) medicine. PiaSky is a C5 inhibitor medicine.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Does PiaSky interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.

PiaSky ingredients

Active ingredient: crovalimab-akkz

Inactive ingredients: arginine hydrochloride, histidine, poloxamer 188, and Water for Injection. Aspartic acid may be added to adjust the pH.

PiaSky is available as crovalimab-akkz 340 mg/2 mL (170 mg/mL) in a single-dose vial.

Storage

Your healthcare provider will store PiaSky in the refrigerator at 2-8°C (36°F to 46°F) to protect it from light. It should not be frozen or shaken.

An unopened vial of PiaSky can be kept at room temperature (up to 30°C or 86°F) for up to 7 days but must be discarded if left out longer.

Once diluted the intravenous infusion should be used immediately because PiaSky does not contain any antimicrobial preservative. If immediate use is not possible, refer to the product information for detailed storage information which depends on the type of infusion bags used.

Who makes PiaSky?

Genentech, Inc., a member of the Roche group, manufactures Piasky.

Piasky Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for PiaSky.

Piasky (crovalimab-akkz) - Genentech, Inc.
Formulation type Strength
Single-Dose Vial 340 mg/2 mL (170 mg/mL)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.