Uses
What is Piasky used for?
Piasky (crovalimab-akkz) is commonly used to treat paroxysmal nocturnal hemoglobinuria (PNH). PNH is a rare blood disorder that may result in anemia and blood clots.
Piasky may also be used for other conditions as determined by your healthcare provider.
How does Piasky work (mechanism of action)?
Piasky prevents the immune system from forming a complex that destroys red blood cells.
How is Piasky supplied (dosage forms)?
Piasky is available as a 340 mg/2mL solution that is injected into a blood vessel or under the skin.
How should I store Piasky?
Piasky is given by a healthcare provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of Piasky?
The most common side effects of Piasky are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Infusion-related reactions (see below)
- Infection in the nose or throat, sore throat, or common cold symptoms (see below)
- Immune system reactions (see below)
There may be other side effects of Piasky that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Piasky?
While less common, the most serious side effects of Piasky are described below, along with what to do if they happen.
Severe Allergic Reactions. Piasky may cause allergic reactions, which can be serious. Stop taking Piasky and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Chest pain or tightness
- Racing heart
- Fever, chills, or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Meningococcal Infection. Piasky can increase the risk of meningococcal infections, which can quickly become life-threatening. Your meningococcal vaccines must be completed or updated at least 2 weeks before you start Piasky. If you have to start Piasky before completing or updating your meningococcal vaccine, your healthcare provider may prescribe antibiotics for a period of time. You can still get a meningococcal infection even if you have been vaccinated and the risk may continue for several months after stopping Piasky. Your healthcare provider will give you a Patient Safety Card about the risk of meningococcal infection that you should always carry with you during treatment and for 11 months after your last dose. Get emergency medical help if you have any of the following symptoms of a meningococcal infection.
- Fever or fever with a rash, high heart rate, or headache
- Headache with nausea or vomiting, or headache with a stiff neck or stiff back
- Confusion
- Muscle aches with flu-like symptoms
- Sensitivity to light
Infections. Piasky can also increase the risk of other infections. Make sure your vaccines are up to date before starting Piasky. Call your healthcare provider if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
Infusion and Injection-Related Reactions. Infusion or injection-related reactions may happen during or after you receive Piasky. If a reaction happens during the infusion, your healthcare provider may slow down the infusion, stop the infusion temporarily, or completely stop the infusion. Tell your healthcare provider if you are having any of the following symptoms of an infusion or injection-related reaction.
- Headache
- Pain at the infusion or injection site or other parts of your body
- Muscle pain
- Swelling
- Bruising or bleeding
- Red skin, or itching and rash
Immune System reactions. You are at risk of a serious immune system reaction called a Type III hypersensitivity reaction in the first 30 days after switching from another medicine known as a C5 inhibitor, like eculizumab or ravulizumab, to Piasky or if you are switching from Piasky to another C5 inhibitor. Your healthcare provider will monitor you for this reaction for 30 days after you switch medicines. Get emergency medical help right away if you have any of the following symptoms of a Type III hypersensitivity reaction.
- Joint, muscle, or bone pain
- Rash, itching, or other skin reactions
- Headache
- Fever
- Numbness, tingling, or burning in your arms, feet, or face
- Feeling unusually weak, tired, or lack of energy
- Stomach pain
Warnings & Precautions
Who should not use Piasky?
Allergies to Ingredients. People who are allergic to any of the following should not take Piasky.
- Crovalimab
- Piasky
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Piasky.
Infection. Do not receive Piasky if you have been diagnosed with a meningococcal infection caused by Neisseria meningitidis.
What should I know about Piasky before using it?
If you stop taking Piasky and do not switch to another medicine for PNH, your healthcare provider will monitor you closely for 20 weeks for signs that your red blood cells are breaking down due to PNH. Tell your healthcare provider if you notice any of the following symptoms after stopping Piasky.
- Blood in your urine or dark-colored urine
- Shortness of breath
- Feeling unusually weak or tired, or lack of energy
- Stomach pain
- Trouble swallowing
- Trouble getting or keeping an erection (erectile dysfunction)
- Blood clot symptoms
What should I tell my healthcare provider before using Piasky?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. Tell your healthcare provider about all the vaccines you have received. This will help them determine if Piasky is right for you.
In particular, make sure that you discuss any of the following.
Infection. Tell your healthcare provider if you have any signs or symptoms of an infection or a fever before receiving Piasky.
Other Medicines and Supplements. Piasky may interact with other medicines and supplements. Before using/taking Piasky, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Pregnancy. It is not known if or how Piasky could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should receive Piasky while you are pregnant or trying to get pregnant.
Breastfeeding. Do not breastfeed during treatment and for 9 months after your last dose of Piasky. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should stop breastfeeding or stop Piasky.
How can I get more information about Piasky?
For more information about Piasky, you can visit the manufacturer’s website at www.Piasky.com or call them at 877-436-3683.
Interactions
Does Piasky interact with foods or drinks?
There are no known interactions between Piasky and foods or drinks.
It is unknown if drinking alcohol will affect Piasky.
Does Piasky interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are switching from another C5 inhibitor, like eculizumab or ravulizumab, to Piasky or from Piasky to another C5 inhibitor.
This may not be a complete list of medicines that can interact with Piasky. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Piasky?
If you or someone else has used too much Piasky, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Piasky?
Talk to your healthcare provider if you miss part of or an entire dose of Piasky. Your healthcare provider will adjust your dosing schedule.