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 is an injectable medication administered by a healthcare provider once every 4 weeks, after an initial loading dose period.
• It can be given by subcutaneous (under the skin) or intravenous (into a vein) injection.
• PiaSky prevents the destruction of red blood cells in people with PNH and is FDA-approved for adults and adolescents aged 13 years and older weighing at least 88 pounds (40kg).

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:

• enroll in the PiaSky REMS program
• counsel you about the risk of serious meningococcal infection
• give you information about the signs and symptoms of serious meningococcal infection
• make sure that you are vaccinated against serious infections caused by meningococcal bacteria and that you receive antibiotics if you need to start PiaSky right away and you are not up to date on your vaccines.

PiaSky side effects

The most common side effects of PiaSky are:

• infusion-related reactions
• respiratory tract infections including infections of the lungs
• cold symptoms, and pain or swelling of the nose or throat
• viral infections
• Type III hypersensitivity reactions.

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.

• You must complete or update your meningococcal vaccines at least 2 weeks before your first dose of PiaSky.
• If you have not completed your meningococcal vaccines and PiaSky must be started right away, you should receive the required vaccines as soon as possible and you should also receive antibiotics to take for as long as your healthcare provider tells you to.
• If you had a meningococcal vaccine in the past, your healthcare provider will tell you if you need additional vaccines before starting PiaSky.
• Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection:
  • fever with or without a rash, high heart rate, or headache
  • a headache with nausea or vomiting or a stiff neck or stiff back
  • confusion
  • muscle aches, with flu-like symptoms
  • eyes sensitive to light.
• Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 11 months after your last dose of PiaSky. Your risk of meningococcal infection may continue for several months after your last dose of PiaSky It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.

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:

• joint pain
• muscle or bone pain
• rash or skin problems
• itching
• headache
• kidney problems
• numbness and tingling or a feeling of pins and needles,
• especially of the hands and feet
• fever
• weakness, tiredness, or lack of energy
• stomach trouble or pain

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.

• Adults and children being treated with PiaSky should be vaccinated against S. pneumoniae, and children may also receive vaccinations against H. influenzae, depending on their age.
• Call your healthcare provider right away if you have any new signs or symptoms of infection such as:

• • fever of 100.4°F (38°C) or higher
  • cough
  • chest pain
  • tiredness
  • feeling short of breath
  • painful rash
  • sore throat
  • burning pain when passing urine
  • feeling weak or generally unwell.

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:

• shortness of breath or trouble breathing
• pain or tightness in your chest
• wheezing
• feeling dizzy or lightheaded
• swelling of the throat, lips, tongue, or face
• skin itching, hives, or rash
• fever or chills.

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.

Related/similar drugs

Before taking

Do not receive PiaSky if you:

• have a serious meningococcal infection caused by Neisseria meningitidis when you are starting treatment.
• are allergic to crovalimab, PiaSky, or any of the inactive ingredients in the injection.

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

• have an infection or fever
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

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.

• Your first dose will be given through a vein by intravenous (IV) infusion over 60 to 90 minutes on Day 1. This is the first loading dose.
• Another loading dose will be given as an injection under the skin (subcutaneous) on Days 2, 8, 15, and 22.
• Your maintenance doses will begin on Day 29 and then will be given every 4 weeks as a subcutaneous injection.

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:

• a lower number of red blood cells (anemia)
• blood in your urine or dark urine
• feeling short of breath
• feeling tired or low energy (fatigue)
• stomach pain
• blood clotting (thrombosis)
• difficulty swallowing
• difficulty getting or keeping an erection (erectile dysfunction)
• kidneys not working properly.

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.

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.

Further information

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

Medical Disclaimer