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Important Safety Information

What is PIASKY?

PIASKY is a prescription medicine used to treat a disease called paroxysmal nocturnal hemoglobinuria (PNH) in adults and children 13 years of age or older who weigh at least 88 pounds (40 kg).

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

 

What is the most important information I should know about PIASKY?

PIASKY is a medicine that can affect your immune system. PIASKY may lower the ability of your immune system to fight infections

  • PIASKY increases your chance of getting serious infections caused by Neisseria meningitidis. Meningococcal infections may 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 your healthcare provider decides that immediate treatment with PIASKY is needed and your meningococcal vaccination is not up to date, you should receive meningococcal vaccination as soon as possible, and receive antibiotics for as long as your healthcare provider tells you.
    • If you have been given a meningococcal vaccine in the past, you might need additional vaccines before starting PIASKY. Your healthcare provider will decide if you need additional meningococcal vaccine.
    • 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
      • fever and a rash
      • fever with a high heart rate
      • fever with a headache
      • headache with nausea or vomiting
        		•
      • headache with 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.
  • PIASKY is only available through a program called the PIASKY Risk Evaluation and Mitigation Strategy (PIASKY REMS). Before you can receive PIASKY, 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 with a meningococcal vaccine and that you receive antibiotics if you need to start PIASKY right away if you are not up to date on your vaccines.
    • give you a Patient Safety Card about your risk of meningococcal infection.
  • Immune system reactions called Type III hypersensitivity reactions are common during treatment with PIASKY and can be serious. If you are currently being treated with or have been treated with another C5 inhibitor medicine and you switch to PIASKY, PIASKY may cause Type III hypersensitivity reactions. People may also develop Type III hypersensitivity reactions when they switch from PIASKY to another C5 inhibitor medicine. If you have been treated with another C5 inhibitor medicine and you switch to PIASKY, or if you have been treated with PIASKY and you switch to another C5 inhibitor medicine, 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 have any signs or symptoms of Type III hypersensitivity reaction 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, including infections caused by Neisseria spp., Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.
    • If you receive treatment with PIASKY, you should receive vaccines against Streptococcus pneumoniae.
    • If your child receives treatment with PIASKY, your child should receive vaccines against Streptococcus pneumoniae and may receive vaccines against Haemophilus 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
      		•

Who should not receive PIASKY?
Do not receive PIASKY if you:

  • Have a serious meningococcal infection caused by Neisseria meningitidis when you are starting PIASKY treatment.
  • Are allergic to crovalimab or any of the ingredients in PIASKY.

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. It is not known if PIASKY may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if PIASKY passes into your breast milk.

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 complementary 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.

How should I receive PIASKY?

  • Your healthcare provider will give you your PIASKY treatment.
  • Your first dose will be given through a vein by intravenous (IV) infusion on Day 1 by your healthcare provider. 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.
  • Your healthcare provider will prescribe the dose based on your weight. If your weight changes, tell your healthcare provider.
  • Talk to your healthcare provider if you miss receiving your dose of PIASKY.
  • If you are changing treatment from another C5 inhibitor such as eculizumab or ravulizumab to PIASKY, you should receive your first loading dose of PIASKY no sooner than the time you would have received your next scheduled dose of eculizumab or ravulizumab.
  • 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 PIASKY. Stopping treatment with PIASKY 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 are the possible side effects of PIASKY?
PIASKY can cause serious side effects including:

  • Infusion- and injection-related reactions. Infusion- or injection-related reactions may happen during or after your PIASKY administration. Symptoms may include headache, pain at infusion or injection site or in other parts of your body, swelling, bruising or bleeding, red skin, itching and rash. PIASKY can also cause serious allergic reactions. Tell your healthcare provider right away or go to the nearest emergency room if you get any of the following symptoms or symptoms of a serious allergic reaction:
    • 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
      		•
  • 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
      		•

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of PIASKY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and Medication Guide for additional Important Safety Information, including Serious Side Effects.