Patient Leaflet Updated 12-Aug-2024 | Roche Products Limited
Piasky 340 mg solution for injection/infusion
Piasky 340 mg solution for injection/infusion
crovalimab
▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
In addition to this leaflet, your doctor will give you a ‘Patient Card’ which lists the signs of meningococcal infection and sepsis:
1. What Piasky is and what it is used for
2. What you need to know before you use Piasky
3. How to use Piasky
4. Possible side effects
5. How to store Piasky
6. Contents of the pack and other information
7. Instructions for Use
Piasky contains the active substance crovalimab. It belongs to a class of medicines called ‘monoclonal antibodies’, which are proteins that are designed to attach to a specific target in the body.
Piasky is also called a complement component 5 (C5) inhibitor.
Piasky is used to treat a disease called paroxysmal nocturnal haemoglobinuria (PNH). It is used in adults and children aged 12 years and older who weigh 40 kg or more, including patients with haemolysis (the breakdown of red blood cells) and clinical symptoms indicating high disease activity and patients whose disease is stable after treatment with a C5 inhibitor for at least the past 6 months.
PNH can cause the immune system to attack the body’s red blood cells, causing haemolysis that can lead to:
Patients with PNH can require regular blood transfusions.
The active substance in Piasky, crovalimab, attaches to the complement 5 (C5) protein, which is a part of the body’s defence system called the ‘complement system’. By doing so, it blocks activation of C5, which prevents the immune system from attacking and damaging red blood cells, thereby reducing the breakdown of red blood cells. This helps to reduce the symptoms of PNH and the number of blood transfusions required.
Do not use Piasky if any of the above apply to you. If you are not sure, talk to your doctor, pharmacist or nurse before using Piasky.
Talk to your doctor, pharmacist or nurse before using Piasky.
Serious meningococcal infections
Piasky can increase your risk of meningococcal infections caused by Neisseria meningitidis bacteria as it blocks part of the immune system. This includes serious infections such as septicaemia (blood poisoning) and meningitis (inflammation of the membranes that surround the brain and spinal cord).
Talk to your doctor before you start Piasky to make sure that your vaccination against meningococcal infections is up to date – you need to be fully vaccinated at least 2 weeks before you start using Piasky. Even if you were vaccinated as a child, your doctor might decide that you need to be vaccinated again.
If you are not fully vaccinated but you need Piasky immediately, you should have the vaccine as soon as possible. Your doctor will prescribe you antibiotics from the time you start Piasky until 2 weeks after vaccination to reduce your risk of infection.
Vaccination may not always prevent this type of infection. Your doctor might decide that you need extra measures to prevent infection.
Your doctor will give you a ‘Patient Card’ which lists the signs of meningococcal infection and sepsis:
Other serious infections
Piasky may also increase your risk of other serious infections, such as infections caused by Streptococcus pneumoniae and Haemophilus influenzae.
Talk to your doctor before you start Piasky to make sure that your vaccination against infections caused by Streptococcus pneumoniae and Haemophilus influenzae are up to date – you need to be fully vaccinated at least 2 weeks before you start using Piasky. Even if you were vaccinated as a child, your doctor might decide that you need vaccination again.
If you are not fully vaccinated but you need Piasky immediately, you should have the vaccine as soon as possible. Your doctor will prescribe you antibiotics from the time you start Piasky until 2 weeks after vaccination to reduce your risk of infection.
Your doctor may recommend that you receive other vaccinations before treatment. Check with your doctor before treatment begins.
Reaction due to switching from another C5 inhibitor
Before you take Piasky, tell your doctor if you have ever been treated with any other C5 inhibitor. This is because you can have a type of temporary reaction, known as a Type III immune complex reaction, during the first 30 days after you switch from another C5 inhibitor to Piasky. This can also happen if you stop using Piasky and switch to a different C5 inhibitor.
Infusion and injection reactions
When Piasky is given as an intravenous infusion (drip into a vein) or subcutaneous injection (injection under the skin), you may have reactions to the infusion or injection. Tell your doctor or nurse straight away if you have any of the following, which may be signs of an infusion or injection reaction:
You may also have an allergic reaction to the infusion or injection. Tell your doctor or nurse straight away if you have any of the following signs of severe allergic reactions:
If you have had an infusion or injection reaction, including an allergic reaction, you should confirm with your doctor or nurse if Piasky treatment should continue or not.
Stopping treatment with Piasky
If you stop taking Piasky and do not switch to another treatment for PNH, tell your doctor immediately if you develop symptoms that are signs of intravascular haemolysis (breakdown of red blood cells in blood vessels) including:
Antibody formation (immunogenicity)
Your immune system may make antibodies (proteins made by the body against an unwanted substance) against crovalimab, potentially leading to reduced response or loss of response to Piasky. If you experience any of the following symptoms, you should tell your doctor immediately
Do not give Piasky to children under 12 years of age or children weighing less than 40 kg. This is because it has not yet been studied in this group.
Tell your doctor, pharmacist or nurse if you are using, have recently used, or might use any other medicines.
In particular, you must tell your doctor if you are currently being treated or have ever been treated with any other C5 inhibitor. This is because you can have a type of temporary reaction, known as a Type III immune complex reaction (see “Warnings and precautions”).
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
There is no information about the use of Piasky in pregnant women and the effects on an unborn baby are not known. Your doctor will discuss with you the potential risks of using Piasky during pregnancy.
If you are breast-feeding, it is not known whether Piasky passes into human milk but given its characteristics, it is expected to pass into the milk. Your doctor will discuss with you the potential risks of using Piasky during breast-feeding.
Piasky has no or little influence on the ability to drive and use machines.
Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
At least 2 weeks before you start treatment with Piasky, your doctor will give you a vaccine against meningococcal infections if you have not had one before, or if your vaccination is outdated.
If you start treatment with Piasky less than 2 weeks after receiving this vaccination, your doctor will prescribe antibiotics for at least 2 weeks after you have been vaccinated - to reduce the risk of infection.
Piasky is given as an intravenous infusion (drip into a vein) or as an injection under the skin (subcutaneous injection).
Only the first dose will be given as an intravenous infusion by a healthcare professional. The next doses are given as a subcutaneous injection. After training, you or your caregiver may do the subcutaneous injection of Piasky at home without medical supervision.
Your doctor or nurse will provide training to you or your caregiver on how to prepare this medicine and how to take or give the subcutaneous injections. Read carefully and follow the instructions provided in the ‘Instructions for Use’ at the end of this leaflet.
Your first dose will be given on Day 1 by a healthcare professional. This is the first loading dose, which is higher than the doses given later in your treatment. Additional loading doses will be given on Days 2, 8, 15, and 22.
After this, Piasky will be given on Day 29 and then every 4 weeks as a subcutaneous injection. These are the maintenance doses.
If you were previously receiving another medicine for PNH known as a ‘complement inhibitor’, the first loading dose of Piasky should be given when you were scheduled to receive the next dose of that medicine.
Your doctor will prescribe a dose and treatment plan based on how much you weigh.
If you weigh 40 kg or more, but less than 100 kg:
If you weigh 100 kg or more:
Your maintenance dose may change if your body weight changes during treatment with Piasky. Talk to your doctor if your weight goes above, or falls below 100 kg. Your doctor or nurse should monitor your weight on an ongoing basis.
If you think that you have used more Piasky than prescribed, please contact your doctor, pharmacist or nurse for advice.
For the treatment to be fully effective, it is very important to take Piasky as prescribed.
Do not stop treatment with Piasky unless you have discussed this with your doctor first. This is because stopping treatment will stop the effect of the medicine. This may make your PNH symptoms come back or get worse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Your doctor will discuss the possible side effects with you and explain the risks and benefits of Piasky with you before treatment.
Piasky can cause some side effects that you need to tell your doctor about straight away.
The most serious side effects are meningococcal infection and severe allergic reaction.
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people)
Tell your doctor, pharmacist or nurse if you notice any of the other side effects listed above. If you are not sure what the side effects above are, ask your doctor to explain them to you.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and the vial label after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C - 8 °C). Once removed from the refrigerator, unopened vials in their original carton may be kept at room temperature (up to 30 °C) for no longer than 7 days. Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Do not store syringes filled with this medicine. Syringes filled with Piasky must be used right away.
Do not use this medicine if you notice it is cloudy, discoloured or contains particles.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
More details are provided in the Instructions for Use. Please read carefully before using Piasky vial.
Piasky is a clear to strongly opalescent and almost colourless to brownish-yellow solution for injection/infusion.
Each pack of Piasky contains 1 glass vial of 2 ml.
This leaflet was last revised in July 2024.
Before you use the vial
Read this entire Instructions for Use before you or your caregiver start using Piasky vial and each time you get a new prescription. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
Your doctor may decide that you or your caregiver can take or give the Piasky injections.
Storage and handling
Full dose and number of injections
Your Piasky dose may require up to 3 injections, one after the other. You may need up to 3 Piasky vials to receive your full dose.
Supplies needed for 1 injection
This list is for a single injection. Change the number of the supplies according to the number of injections needed (see the “Full dose and number of injections” section above).
Included in the carton:
Not included in the carton:
Open the carton
1 Take the Piasky vial carton(s) you need out of the refrigerator.
Open the carton(s) and remove the vial(s).
Check the dose your doctor has prescribed. The full dose may require up to 3 injections one after the other. You may need up to 3 vials to receive a full dose. Gather all the vials you need.
2 Place the vial(s) on a clean, flat surface.
Check the vial(s)
3 Check the expiry date (EXP) on the vial(s).
4 Check the appearance of the medicine.
The medicine must be clear to strongly opalescent and almost colourless to brownish-yellow.
5 Check the vial(s) for any damage – like cracks or scratches.
Warm-up time
6 Place the vial(s) on a clean, flat surface for 30 minutes, away from direct sunlight. This allows the medicine to reach room temperature.
If the vial is not at room temperature, the cold medicine could make it difficult to withdraw, and harder to inject the medicine. It could also cause discomfort.
Collect the other supplies
7 Collect the other supplies, while the vial reaches room temperature.
The list is for a single injection. Change the number of supplies according to the number of injections you need.
Note: the colour of your supplies might differ from the illustrations.
Choose the injection site
8 Piasky must only be injected in the stomach area (abdomen).
Make sure you do not inject into the same spot multiple times in a row. Each injection must be at least 5 cm apart from the previous one.
Clean the injection site
9 Wash your hands with soap and water.
10 Wipe the injection site with an alcohol pad and let it air dry.
Clean the vial top
11 Remove the coloured cap from the vial. Throw away the coloured cap in the sharps container (see step 43).
12 Wipe the rubber stopper with the other alcohol pad.
Attach the transfer needle
13 Remove the syringe and the transfer needle from their packaging.
14 Push and twist the transfer needle until it is fully attached onto the syringe.
Keep the cap on the needle.
Fill the syringe with air
15 With the needle cap still on, slowly pull back on the plunger and draw air into the syringe to the 2 mL line.
Note: The vial does not contain air. The air injected into the vial will allow the medicine to be withdrawn more easily and prevent the plunger from moving.
Uncap the transfer needle
16 Hold the syringe in the middle and carefully pull the needle cap away from the syringe.
17 Keep the cap on the flat surface.
You will need to put it back on the needle after transferring the medicine.
Inject the air into the vial
18 Hold the vial on the flat surface and insert the needle straight down into the centre of the rubber stopper.
19 Keep the needle in the vial and turn the vial upside down.
20 Make sure that the tip of the needle is above the medicine.
21 With the vial on top, push on the plunger to inject the air into the vial.
22 Keep your fingers pressed down on the plunger to stop it from moving.
Transfer all the medicine
23 Slide the tip of the needle down so it is within the medicine.
24 Slowly pull back the plunger to transfer all the medicine into the syringe.
Make sure you keep the tip of the needle within the medicine at all times as the medicine is transferred into the syringe. You may have to slide the needle down or you may transfer some air into the syringe.
Remove the air bubbles
25 If you have any air bubbles or space filled with air in the syringe, gently tap the side of the syringe with your finger until the air bubbles rise to the top of the syringe.
26 Slowly push the plunger up to push the air bubbles back into the vial.
If you push some medicine into the vial, slowly pull back on the plunger (more slowly this time) to transfer all the medicine from the entire vial (see steps 23 and 24).
Recap the transfer needle
27 Remove the syringe from the vial.
28 Using only one hand, slide the needle into the cap placed on the flat surface.
29 When the needle is covered, lift the syringe up and push the cap to fully attach over the needle.
Warning: Do not use the transfer needle to inject the medicine. The transfer needle is too big to inject the medicine.
Remove the transfer needle
30 Hold the syringe, twist the transfer needle to remove it.
31 Throw away the transfer needle into a sharps disposal container (see step 43).
Attach the injection needle
32 Remove the injection needle from its packaging.
33 Push and twist the injection needle until it is fully attached onto the syringe.
34 Move the safety shield back toward the syringe as shown in the figure above.
Uncap the injection needle
35 Hold the syringe in the middle and carefully pull the needle cap away from the syringe.
Adjust the plunger
36 Slowly push the plunger to the 2-mL line.
Insert the needle
37 With one hand, pinch the cleaned skin area.
38 With the other hand, hold the syringe by the middle, at an angle between 45° to 90° to the skin.
39 With a quick motion, insert the needle all the way into the pinched skin.
Inject the medicine
40 Slowly push the plunger all the way down to inject all the medicine.
41 Let go of the pinched skin and remove the needle.
Cover the injection needle
42 After your injection, press the safety shield over the needle with the thumb until you hear or feel a “click.” If you do not hear a “click,” look to see that the needle is fully covered by the safety shield.
Dispose of the syringe and vial
43 Put your used Piasky vial, syringe, needles and remaining material in a sharps disposal container right after use
Check the injection site
44 There may be a small amount of blood or medicine at the injection site.
You can press a cotton ball or gauze until any bleeding stops. If needed, cover the injection site with a small plaster. If bleeding does not stop contact your doctor.
Your injection is now complete.
Second or third injections
If the prescribed dose is 2 or 3 injections one after another, start again at step 8 with another Piasky vial and new supplies. You may need up to 3 vials for a full dose. Make sure the next injection is not at the same spot you already used.
Disposal of syringes and vials
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These will help protect the environment.
When the container is full, make sure you dispose of it as instructed by your doctor, nurse or pharmacist.
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