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.

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

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.

• If you have any following signs of a meningococcal infection, you should immediately inform your doctor:
  • Fever
  • Feeling sick (nausea or vomiting)
  • Headaches
  • Confusion or irritability
  • Stiff neck or back
  • Muscle aches with flu-like symptoms
  • Sensitivity of the eyes to light
  • Skin rashes or spots
• If you have any following signs of a severe allergic reaction, you should immediately inform your doctor:
  • Tight chest or wheezing
  • Feeling short of breath
  • Fever or chills
  • Severe dizziness
  • Light headedness
  • Swelling of the lips, tongue, face
  • Skin itching, hives, or rash

Very common (may affect more than 1 in 10 people):

• Fever
• A reaction caused by switching from another C5 inhibitor (Type III immune complex reaction; symptoms may include red skin, itching or pain)
• Nose and throat (upper respiratory tract) infection. Symptoms may include runny nose, sneezing, sore throat and cough
• Reactions to the infusion
• Headache

Common (may affect up to 1 in 10 people):

• Allergic reactions (hypersensitivity)
• Urinary tract infection
• Lung infection (pneumonia)
• Reaction to the injection
• Sore throat and runny nose (nasopharyngitis)
• Joint pain (arthralgia)
• Abdominal pain
• Diarrhoea
• Extreme tiredness/weakness (asthenia)
• Fatigue
• Rash

Uncommon (may affect up to 1 in 100 people)

• Bacterial infection (bacteraemia)
• Infection of the kidneys (pyelonephritis)
• Severe reaction to an infection (sepsis), which can be accompanied by severe low blood pressure (septic shock)
• Local reaction at injection site
• Respiratory tract infection

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.

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.

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.

• In this case, your doctor or nurse will show you or your caregiver how to inject your dose of Piasky the right way.
• Do not use Piasky vial until your doctor or nurse has trained you or your caregiver on the right way to inject.
• Do not inject into a vein (intravenous injection).

Storage and handling

• Store Piasky vial in its original carton in the refrigerator between 2 °C - 8 °C until ready to use.
  Piasky unopened vial in its original carton may be kept at room temperature up to 30 °C for no longer than 7 days.
• Keep the Piasky vial in the outer carton in order to protect from light.
• After you remove Piasky vial from the carton, keep Piasky away from direct sunlight.
• Keep Piasky vials, syringes, needles out of the reach of children.
• Each Piasky vial, syringe, and needle can be used only 1 time.
• Keep hands away from the end of needle during use and disposal.
• Do not freeze the vial. Do not use the vial if it has been frozen. Safely throw away the vial in a sharps container (see step 43) and contact your doctor or pharmacist.
• Do not use the vial if it has been kept at room temperature, up to 30 °C, for longer than 7 days. Safely throw away the vial in a sharps container (see step 43) and contact your doctor or pharmacist.
• Do not store syringes filled with Piasky. A syringe filled with the medicine must be used right away.
• Do not shake the vial.
• Do not reuse the vial, the syringe or the needles for another injection.
• Do not share your syringe and needles with other people.

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.

• Your doctor or pharmacist will tell you or your caregiver how many injections you need and how often you need to inject the medicine.
• If your prescribed dose of Piasky is 680 mg, do 2 separate injections one after the other.
• If your prescribed dose of Piasky is 1 020 mg, do 3 separate injections one after the other.
• Always use a new Piasky vial for each injection.
• If you are not sure of the dose, ask your doctor or pharmacist.
• Do not split your full dose if you do not have all the Piasky vials you need. Contact your doctor or pharmacist.

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:

• 1 Piasky vial

Not included in the carton:

• 18 gauge with single bevel transfer needle or 21 gauge standard needle
• 25, 26 or 27 gauge injection needle with safety shield. The needle length should be from ⅜” (9 mm) to ½” (13 mm).
• 2-mL or 3-mL syringe
• 2 alcohol pads (1 for your skin and 1 for the vial)
• 1 sterile cotton ball or gauze
• 1 small plaster
• 1 sharps disposal or puncture-resistant container (see step 43)

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.

• Do not use the vial if the carton is damaged, or if the perforation of the opening is broken. Safely throw away the vial in a sharps container (see step 43) and contact your doctor or pharmacist.

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.

• Do not use if the expiry date (EXP) has passed.
• Do not use if the medicine looks cloudy, discoloured, or has particles in it.
• Do not use if the vial is cracked or broken.
  If you find any of above, safely throw away the vial in a sharps container (see step 43) and contact your doctor or pharmacist.

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.

• Do not speed up the warming process in any way, such as microwave, warm water or direct sunlight.
• Do not remove the vial cap while the vial reaches room temperature.

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.

• 1 transfer needle
• 1 injection needle with safety shield
• 1 syringe
• 2 alcohol pads – 1 for your skin and 1 for the vial
• 1 sterile cotton ball or gauze
• 1 small plaster
• 1 sharps disposal container

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.

• Do not inject into the arm or thigh.
• Do not inject into the 5 cm area around the belly button.
• Do not inject into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

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.

• Do not touch, fan, or blow on the area you have cleaned.

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.

• Do not touch the rubber stopper after it is cleaned.

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.

• Do not use the injection needle (with the safety shield) to withdraw the medicine.

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.

• Do not throw the cap away.
• Do not touch the needle or let the needle touch any surface after the cap has been removed.

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.

• Do not inject the air into the medicine, as this would make bubbles in the medicine.

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.

• Do not completely pull the needle out of the vial.
• Do not completely pull the plunger out of 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.

• Do not hold the cap with your fingers while you slide the needle in it.

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).

• Do not touch the tip of the syringe after the transfer needle has been removed.

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.

• Do not twist or bend the cap while you are pulling it.
• Do not touch the needle or let it touch any surfaces after removing the needle cap.
• Do not put the cap back on after it has been removed because this may damage the needle.
• Do not use the syringe if it has been dropped or damaged.

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.

• Do not hold or push the plunger while inserting the needle.

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.

• Do not recap the needle with the original cap.
• Do not use your two hands to cover the needle.
• Do not remove the needle from the syringe.

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

• Do not throw away your loose needles, syringe and vial, in your household waste.
• Do not try to take the syringe apart.

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.

• Do not rub or massage the area where you have injected.

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.