Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

Pharmacy Guide

Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.

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PiaSky 340 mg solution for injection/infusion

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Crovalimab may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Crovalimab
Source: electronic medicines compendium (emc)
Official leaflet: Read the PIL on emc

What it is and what it is used for

for

What PiaSky is 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. What PiaSky is used for PiaSky is used to treat a disease called paroxysmal nocturnal haemoglobinuria (PNH). It is used in adults and adolescents 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:  Symptoms of anaemia (low levels of red blood cells), such as feeling tired or having low energy and dark urine  Belly pain  Difficulty swallowing 1 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

  

Difficulty getting or keeping an erection (erectile dysfunction) The kidneys not working properly Blood clots, with symptoms such as progressive swelling in one leg or breathlessness when not performing strenuous activities

Patients with PNH can require regular blood transfusions. How PiaSky works 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. 2.

What you need to know before you take it

e PiaSky

Do not use PiaSky   

if you are allergic to crovalimab or any of the other ingredients of this medicine (listed in section 6) if you have a meningococcal infection (a serious infection caused by Neisseria meningitidis bacteria that can affect the lining of the brain and spinal cord and spread throughout the blood) if you have not been vaccinated against meningococcal infection, unless you will take preventive treatment with antibiotics until 2 weeks after you have received this vaccination.

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. Warnings and precautions Talk to your doctor, pharmacist or nurse before using PiaSky.You and/or your caregiver will also be provided with a patient/caregiver guide which contains further information on 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).  Tell your doctor straight away if you have any of the following, which may be signs of a meningococcal infection: Fever Feeling sick (nausea) Vomiting Headache Confusion or irritability Stiff neck or back Muscle aches, with flu-like signs or symptoms Sensitivity of the eyes to light Rashes or spots on your skin 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. 2 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

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. Patient card Your doctor will give you a 'Patient Card' which lists the signs of meningococcal infection and sepsis:  carry it with you at all times during treatment with PiaSky, and  for 11 months after your last dose of PiaSky Other serious infections PiaSky may also increase your risk of other serious infections, such as infections caused by Streptococcus pneumoniae and Haemophilus influenzae. 

Tell your pharmacist or doctor if you have any of the following, which may be signs of an infection: Fever Cough Chest pain Tiredness Feeling short of breath Painful rash Sore throat Burning pain when passing urine Feeling weak or generally unwell

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. 

Tell your doctor if you have any sign of this type of reaction, such as

  • joint pain or other problems related to the muscles, bones and tissues
  • numbness and tingling or a feeling of pins and needles, especially of the hands and feet
  • rash or other skin problems
  • fever 3 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

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:  Headache  Lower back pain  Pain at infusion site and elsewhere  Swelling  Bruising or bleeding  Red skin  Itching and rash 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:  Tight chest or wheezing  Feeling short of breath  Fever or chills  Severe dizziness, or light headedness  Swelling of the lips, tongue, face  Skin itching, hives, or rash 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:  Symptoms of anaemia (low levels of red blood cells), such as feeling tired or having low energy and dark urine  Belly pain  Difficulty swallowing  Difficulty getting or keeping an erection (erectile dysfunction)  The kidneys not working properly  Blood clots, with symptoms such as progressive swelling in one leg or breathlessness when not performing strenuous activities 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      

Symptoms of anaemia (low levels of red blood cells), such as feeling tired or having low energy and dark urine Belly pain Difficulty swallowing Difficulty getting or keeping an erection (erectile dysfunction) The kidneys not working properly Blood clots, with symptoms such as progressive swelling in one leg or breathlessness when not performing strenuous activities 4 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

Children and adolescents 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. Other medicines and PiaSky 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"). Pregnancy, breast-feeding and fertility 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. Driving and using machines PiaSky has no or little influence on the ability to drive and use machines. 3.

How to use PiaSky

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

How to take it

PiaSky 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.

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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. When to use PiaSky 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. How much PiaSky to use 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:  Your first loading dose on Day 1 will be 1 000 mg, given by intravenous infusion over 60 minutes  Your next loading doses on Day 2, 8, 15 and 22 will be 340 mg, given as a single subcutaneous injection  You will be given a maintenance dose of 680 mg, given as two subcutaneous injections, on Day 29 and then every 4 weeks thereafter. If you weigh 100 kg or more:  Your first loading dose on Day 1 will be 1 500 mg, given by intravenous infusion over 90 minutes  Your next loading doses on Day 2, 8, 15 and 22 will be 340 mg, given as a single subcutaneous injection  You will be given a maintenance dose of 1 020 mg, given as three subcutaneous injections, on Day 29 and then every 4 weeks thereafter. 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 use more PiaSky than you should If you think that you have used more PiaSky than prescribed, please contact your doctor, pharmacist or nurse for advice. If you forget to use PiaSky For the treatment to be fully effective, it is very important to take PiaSky as prescribed.  If you miss an appointment with your doctor or nurse to get your injections, make another one straight away.  If you or your caregiver forget to inject all or some of your dose of PiaSky at home, take the missed dose or missed part of the dose as soon as possible and then take the next dose at the normal planned time. Do not double a dose to make up for a missed dose. Check with your doctor, pharmacist or nurse if you are not sure. 6 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

If you stop using PiaSky 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. 4.

Possible side effects

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 7 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

    

Diarrhoea Extreme tiredness/weakness (asthenia) Fatigue Rash Respiratory tract infection

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 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. Reporting of side effects 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. 5.

How to store it

PiaSky

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). Do not freeze. Prior to administration, unopened vials of PiaSky may be stored out of the refrigerator at room temperature if needed and then returned to refrigeration. For temperature excursions outside 2 °C – 8 °C, unopened vials in their original carton may be kept at room temperature (up to 30 °C) for a total combined time of no longer than 7 days. You can tick one box on the inside of the vial carton for each day PiaSky is stored outside refrigeration. Discard if stored out of the refrigerator at room temperature for longer than 7 days. 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. 6.

Contents of the pack and other information

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What PiaSky contains

  • The active substance is crovalimab. Each glass vial contains 340 mg of crovalimab in 2 mL of solution. Each mL of solution for injection/infusion contains 170 mg crovalimab.
  • The other ingredients are histidine, aspartic acid, arginine hydrochloride, poloxamer 188 and water for injections. What PiaSky looks like and contents of the pack PiaSky is a clear to strongly opalescent and almost colourless to brownish-yellow solution for injection/infusion (injection/infusion). Each pack of PiaSky contains 1 glass vial of 2 ml. Marketing Authorisation Holder and Manufacturer Roche Products Limited 6 Falcon Way, Shire Park Welwyn Garden City AL7 1TW United Kingdom

This leaflet was last revised in November 2025.

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7.

Instructions for use

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.

Once removed from the refrigerator, unopened vials in their original carton may be kept at room temperature (up to 30 °C) for a total combined time of no longer than 7 days. For temperature excursion outside 2 °C – 8 °C, at room temperature, you can tick one box on the inside of the vial carton for each day PiaSky is stored outside refrigeration. Discard if stored out of the refrigerator at room temperature for 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. 10 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

   

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 3/8" (9 mm) to 1⁄2" (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

Perforation before opening

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)

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Check EXP date Check medicine appearance Check for damage

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

30 min 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. 12 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

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

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Choose the injection site

Injection area

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 Cap

Rubber stopper

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. 14 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

Attach the transfer needle

Transfer needle

Syringe

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

2 mL Plunger

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

Needle tip

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.

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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

Needle tip within 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.

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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). 17 uk-pil-piasky-clean-251127-340mg-sol-inj-inf



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

Attach the injection needle Safety shield

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

2 mL

36 Slowly push the plunger to the 2 mL line.

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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

"click"

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.

19 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

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.

20 uk-pil-piasky-clean-251127-340mg-sol-inj-inf

Frequently asked questions about PiaSky 340 mg solution for injection/infusion

How do I take PiaSky 340 mg solution for injection/infusion?

PiaSky 340 mg solution for injection/infusion comes as injection containing 340mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in PiaSky 340 mg solution for injection/infusion?

The active substance in PiaSky 340 mg solution for injection/infusion is crovalimab.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for PiaSky 340 mg solution for injection/infusion, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get PiaSky 340 mg solution for injection/infusion without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Crovalimab (1 medicine)
See every medicine containing this substance, or browse the full A–Z of active substances.
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

PiaSky as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age or older with a weight of 40 kg and above with paroxysmal nocturnal haemoglobinuria (PNH):

• In patients with haemolysis with clinical symptom(s) indicative of high disease activity.

• In patients who are clinically stable after having been treated with a complement component 5 (C5) inhibitor for at least the past 6 months.

4.2. Posology and method of administration

Treatment should be initiated under the supervision of a physician experienced in the treatment of haematological disorders.

Posology

The recommended dosing regimen consists of one loading dose administered by intravenous infusion (on Day 1), followed by four additional weekly loading doses administered by subcutaneous injection (on Days 2, 8, 15, and 22). The maintenance dose starts on Day 29 and is then administered every 4 weeks by subcutaneous injection. The doses to be administered are based on the patient's body weight, as shown in Table 1.

For patients switching from treatment with another complement inhibitor, the first intravenous loading dose of PiaSky should be administered at the time of the next scheduled complement inhibitor administration (see section 4.4 for additional information related to switching between complement component 5 [C5] inhibitor treatments). The administration of the additional subcutaneous loading doses and maintenance doses of PiaSky will follow as per the schedule shown in Table 1.

Table 1: PiaSky dosing regimen based on body weight

Body weight

≥ 40 kg to < 100 kg

≥ 100 kg

Loading Dose

Day 1

Day 2, 8, 15, 22

1,000 mg (intravenous)

340 mg (subcutaneous)

1,500 mg (intravenous)

340 mg (subcutaneous)

Maintenance dose

Day 29 and Q4Wa thereafter

680 mg (subcutaneous)

1,020 mg (subcutaneous)

a Q4W=every 4 weeks

The dosing schedule is allowed to occasionally vary within 2 days of the scheduled administration day (except at Day 1 and Day 2). If this occurs, the subsequent dose should be administered according to the regular schedule.

Duration of treatment

PiaSky is intended for long-term treatment unless the discontinuation of this medicinal product is clinically indicated (see section 4.4).

Delayed or missed doses

If an entire planned dose or part of a planned dose of PiaSky is missed, the missing dose or remainder of the planned dose should be administered as soon as possible before the day of the next scheduled dose. The next dose should then be administered on the regular scheduled dosing day. Do not take two doses or administer more than the prescribed dose on the same day to make up for a missed dose.

Dose modifications

Modification of the maintenance dose is required if the patient's body weight changes by 10% or more to become consistently greater than or lower than 100 kg during the course of treatment (see Table 1 for recommended dose). Accordingly, the patient's body weight should be monitored periodically and on an ongoing basis, as appropriate.

Special populations

Elderly

No dose adjustment is required in patients ≥ 65 years of age, although experience with crovalimab in elderly patients in clinical studies is limited (see section 5.2).

Renal impairment

No dose adjustment is recommended for patients with mild, moderate or severe renal impairment (see section 5.2).

Hepatic impairment

No dose adjustment is recommended for patients with mild hepatic impairment. Crovalimab has not been studied in patients with moderate to severe hepatic impairment and no recommendation on posology can be provided (see section 5.2).

Paediatric population

No dose adjustment of crovalimab is required in paediatric patients 12 years of age or older with body weight ≥ 40 kg. The safety and efficacy of crovalimab in children less than 12 years of age and children with body weight < 40 kg have not yet been established. No data are available.

Method of administration

PiaSky is administered as an intravenous infusion (first dose) and as a subcutaneous injection (subsequent doses).

Intravenous administration

PiaSky should be prepared for intravenous administration using appropriate aseptic technique. PiaSky must be diluted and administered by a healthcare professional as an intravenous infusion over 60 minutes ± 10 minutes (1 000 mg) or 90 minutes ± 10 minutes (1 500 mg). PiaSky should not be administered as an intravenous push or bolus.

For instructions on dilution of the medicinal product before administration, see section 6.6.

The infusion of crovalimab may be slowed or interrupted if the patient develops an infusion related reaction. The infusion should be discontinued immediately if the patient experiences a serious hypersensitivity reaction (see section 4.4).

Subcutaneous administration

PiaSky must be used undiluted and should be prepared using appropriate aseptic technique. It is recommended to inject PiaSky into the abdomen. Within the abdomen, injection sites should be rotated with every injection. Injections should never be given into moles, scars, or areas where the skin is tender, bruised, red, hard, or not intact.

Administration by the patient and/or caregiver

After proper training in subcutaneous injection technique, the patient may self-administer PiaSky or the caregiver may administer PiaSky without healthcare professional (HCP) supervision if the treating physician determines that it is appropriate.

Comprehensive instructions for the administration of PiaSky are given at the end of the Package Leaflet.

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

• Patients with unresolved Neisseria meningitidis infection.

• Patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section 4.4).

4.4. Special warnings and precautions for use

Traceability

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Serious meningococcal infection

Due to its mechanism of action, the use of crovalimab may increase the patient's susceptibility to meningococcal infections (septicaemia and/or meningitis). Cases of serious or fatal meningococcal infections/sepsis have been reported in patients treated with terminal complement inhibitors, which is a known class effect.

Meningococcal infection may become rapidly life-threatening or fatal if not recognised and treated early. To reduce the risk of infection, all patients must be vaccinated with a tetravalent meningococcal vaccine at least 2 weeks prior to receiving the first dose of crovalimab. If immediate treatment with crovalimab is indicated in an unvaccinated patient, the required vaccine should be administered as soon as possible and patients should receive prophylactic antibiotics from the time they start crovalimab until 2 weeks after vaccination. Vaccines against serogroups A, C, Y, W, and B where available, are recommended to prevent infections with the commonly pathogenic meningococcal serogroups. Patients must maintain up to date vaccinations according to current local guidelines for vaccination use. If the patient is being switched from other terminal complement inhibitor treatment, physicians should verify that meningococcal vaccination is current according to local guidelines for vaccination use. Vaccination may activate the complement system further. As a result, patients with complement-mediated diseases, including PNH, may experience transient worsening of signs and symptoms of their underlying disease, such as haemolysis. Therefore, patients should be closely monitored for disease symptoms after the recommended vaccination.

Vaccination may not be sufficient to prevent meningococcal infection. Consideration should be given to the prophylactic use of antibacterial agents based on local guidance. All patients should be monitored for early signs of meningococcal infection, evaluated immediately if infection is suspected, and treated with appropriate antibiotics if necessary. Patients should be informed of these signs and symptoms and steps they need to take in seeking medical care immediately. Physicians must discuss the benefits and risks of treatment with PiaSky with the patients and provide them with a patient/caregiver guide and a patient card (see below, “Educational materials”). As instructed by annual reminders, healthcare professionals should ensure patient vaccinations are kept up to date.

Other systemic infections

Due to its mechanism of action, crovalimab must be administered with caution to patients with active systemic infections. Patients may have increased susceptibility to infections, especially with Neisseria spp. and other encapsulated bacteria. Vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections should be administered according to local guidelines.

If local guidelines mandate vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections, this should be performed at least 2 weeks prior receiving the first dose of crovalimab. If immediate treatment with crovalimab is indicated in an unvaccinated patient, the required vaccine should be administered as soon as possible and patients should receive prophylactic antibiotics from the time they start crovalimab until 2 weeks after vaccination or according to local standard of care, whichever is longer.

If PiaSky is administered to patients with active systemic infections, patients should be monitored closely for signs and symptoms of worsening infection. Patients were excluded from clinical studies with crovalimab if they had any active systemic bacterial, viral, or fungal infection within 14 days prior to starting treatment.

Patients should be provided with information from the package leaflet to increase their awareness of the signs and symptoms of potential serious infections.

Type III immune complex reactions

Immune complex formation occurs in patients switching between complement inhibitors which bind different epitopes (see section 4.5). In some patients, the formation of these complexes can result in Type III immune complex mediated reactions, also referred to as Type III immune complex reactions. Patients who have never previously been treated with a C5 inhibitor or patients in whom previous C5 inhibitor treatment has been cleared from the body (i.e. at least 5.5 half-lives of the previous treatment have passed since the last dose) are not at risk of Type III immune complex reactions. Clinical studies with crovalimab reported adverse events of Type III immune complex mediated reactions (see section 4.8).

Signs and symptoms of Type III immune complex reactions observed in clinical studies were arthralgia and other musculoskeletal and connective tissue disorders, rash and other skin and subcutaneous disorders, pyrexia, asthenia/fatigue, gastrointestinal distress, headache and axonal neuropathy. Type III immune complex reactions may also manifest as renal abnormalities, however this was not observed during clinical studies with crovalimab.

Based on time-to-onset for Type III immune complex reactions observed in clinical studies, it is recommended that patients are monitored for the first 30 days after switching from eculizumab or ravulizumab to crovalimab (or vice-versa) for occurrence of the symptoms of Type III immune complex reactions. For mild or moderate Type III immune complex reactions, administration of symptomatic treatment (e.g. topical corticosteroids, antihistamines, antipyretics, and/or analgesics) may be considered. For severe reactions, oral or parenteral corticosteroid therapy can be initiated and tapered as clinically indicated.

Infusion and injection‑related reactions

Administration of crovalimab may cause infusion-related reactions or systemic injection‑related reactions, depending on the route of administration. These may include allergic or hypersensitivity reactions (including anaphylaxis) but also a range of other symptoms such as headache or muscle pain.

In the event of a severe infusion-related reaction after intravenous PiaSky administration, treatment should be interrupted and appropriate medical therapy should be administered. In the event of a severe injection‑related reaction after subcutaneous administration or any incidence of serious allergic reaction following intravenous or subcutaneous administration, patients/caregivers should seek immediate medical attention and appropriate medical therapy should be administered. Patients should confirm with their healthcare professional whether treatment with PiaSky can be continued.

Serious haemolysis after treatment discontinuation in PNH patients

In case of PiaSky discontinuation, patients who do not switch to another treatment for PNH must be closely monitored for signs and symptoms of serious intravascular haemolysis, identified by elevated lactate dehydrogenase (LDH) levels, along with sudden decrease in PNH clone size or haemoglobin, or re-appearance of symptoms such as fatigue, haemoglobinuria, abdominal pain, shortness of breath (dyspnoea), major adverse vascular events (including thrombosis), dysphagia, or erectile dysfunction. If signs and symptoms of haemolysis occur after discontinuation, including elevated LDH, consider restarting appropriate treatment.

Immunogenicity leading to loss of exposure and efficacy

Patients may develop anti-drug antibodies (ADAs) that can interfere with crovalimab exposure. Development of ADAs may lead to loss of crovalimab exposure, which may subsequently result in loss of crovalimab efficacy. Loss of efficacy and loss of exposure resulting from ADA development has been observed in patients treated with crovalimab in clinical studies. Patients should be routinely monitored for clinical signs of loss of exposure and efficacy, including serious intravascular haemolysis. In the event of persistent serious intravascular haemolysis despite compliant treatment with crovalimab, patients should be promptly assessed to evaluate the aetiology and the possibility of the development of ADAs leading to loss of exposure and efficacy should be considered. An assessment of the benefits vs risks of continuing crovalimab should be made and a switch to an alternative therapy should be considered. Patients/caregivers should be advised to seek immediate medical attention if the patient develops signs of worsening PNH. See sections 4.8 and 5.1.

Educational materials

All healthcare professionals who are expected to prescribe, use, or oversee the administration of Piasky must ensure they have received and are familiar with the guide for healthcare professionals. Healthcare professionals will receive a reminder annually to ensure patient vaccinations are kept up to date. Prescribers must explain and discuss the benefits and risks of Piasky therapy with the patient and/or their caregivers, and ensure the patient/caregiver guide and patient card are provided.

Healthcare professionals should instruct patients and/or their caregivers to always carry with them the patient card with information about the key signs and symptoms of meningococcal infections and severe allergic reactions, and to seek emergency medical care if they experience symptoms of meningococcal infections and/or severe allergic reactions.

4.5. Interaction with other medicinal products and other forms of interaction

Crovalimab and other C5 inhibitors bind different epitopes on C5 such that immune complexes comprised of the antibodies bridged by C5 may form when both are present in the circulation. These immune complexes, also referred to as drug-target-drug complexes (DTDCs), can comprise one or more units of C5 bound to both crovalimab and to another C5 inhibitor and are expected to be cleared within approximately 8 weeks (in the case of eculizumab). The immune complexes may be cleared after a longer duration in the case of switch from C5 inhibitors with an extended half-life such as ravulizumab. In some patients, the formation of these complexes results in Type III immune complex reactions (see sections 4.4 and 4.8). In patients switching from another C5 inhibitor therapy, a transient increase in clearance is observed due to the formation of the immune complexes, leading to a faster elimination of crovalimab. However, this transient increase in clearance is not clinically relevant and does not require dose adjustment in patients switching from another C5 inhibitor.

No dedicated interaction studies have been conducted.

Crovalimab is not expected to show pharmacokinetic interactions with other medicinal products interfering with the metabolising cytochrome P450 (CYP) enzymes, since the clearance pathways of immunoglobulins G (IgGs) are distinct from those of small molecules.

4.6. Fertility, pregnancy and lactation

Pregnancy

There is no data from the use of crovalimab in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Human IgG is known to cross the placenta after first trimester of pregnancy. Based on its mechanism of action, crovalimab may potentially cause terminal complement inhibition in the foetal circulation.

Therefore, the use of PiaSky may be considered in pregnant women if the clinical condition of the woman requires treatment with crovalimab.

Breast-feeding

It is not known whether crovalimab is excreted into human breast milk. Human IgG1 is known to be excreted in human milk. A risk to the breastfed infant cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue from PiaSky therapy taking into account the benefit of breast-feeding for the infant and the benefit of therapy for the mother.

Fertility

No clinical data are available on the effect of crovalimab on human fertility. Animal data from repeated‑dose toxicity studies showed no effect on male or female reproductive organs (see section 5.3).

4.7. Effects on ability to drive and use machines

PiaSky has no or negligible influence on the ability to drive and use machines.

4.8. Undesirable effects

Summary of the safety profile

The most common adverse reactions observed were Type III immune complex mediated reaction (18.9%) in patients who switched from treatment with another C5 inhibitor to crovalimab), upper respiratory tract infection (18.6%), pyrexia (13.5%), headache (10.9%) and infusion- related reaction (10.2%). The most common serious adverse reactions observed were Type III immune complex mediated reaction (4.0%) in patients who switched from treatment with another C5 inhibitor to crovalimab) and pneumonia (1.5%).

The safety results from the 44 patients in the COMPOSER study where the median treatment duration was 4.69 years (range: 0.4 - 6.3 years) did not reveal any additional safety concerns associated with long term use of crovalimab.

Tabulated list of adverse reactions

The safety of crovalimab in patients with PNH was evaluated in three Phase III studies, COMMODORE 2 (BO42162), COMMODORE 3 (YO42311), and COMMODORE 1 (BO42161), and one Phase I/II study (COMPOSER, BP39144).

Table 2 lists the adverse reactions that have been reported in association with the use of crovalimab in a pooled analysis of 393 patients enrolled in the Phase III studies, unless otherwise stated. The median treatment duration for crovalimab based on the pooled analysis of 393 patients was 64 weeks (range: 0.1 - 136.4 weeks).

Adverse reactions are listed by MedDRA system organ class. The corresponding frequency category for each adverse reaction is based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000). Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.

Table 2: Summary of adverse reactions occurring in patients treated with PiaSky

MedDRA system organ class

Adverse reactions (MedDRA)

Frequency category

Infections and infestations

Upper respiratory tract infection

Very common

Pneumonia

Common

Respiratory Tract Infection

Urinary Tract Infection

Nasopharyngitis

Sepsis

Uncommon

Septic shock

Bacteraemia

Pyelonephritis

Immune system disorders

Type III immune complex mediated reaction*

Very common

Hypersensitivity

Common

Nervous system disorders

Headache

Very common

Gastrointestinal Disorders

Abdominal pain

Common

Diarrhoea

Skin and subcutaneous tissue disorders

Rash

Common

Musculoskeletal and connective tissue disorders

Arthralgia

Common

General disorders and administration site conditions

Pyrexia

Very common

Asthenia

Common

Fatigue

Injection site reaction

Uncommon

Injury, poisoning and procedural complications

Infusion related reaction

Very common

Injection‑related reaction

Common

*Type III immune complex mediated reaction (also referred to as Type III immune complex reaction) is limited to patients who switch from another C5 inhibitor to crovalimab or from crovalimab to another C5 inhibitor. The frequency of Type III immune complex reactions is reported for a subset of N=201 patients who switched from treatment with another C5 inhibitor to crovalimab, with incidence rates being calculated using these N=201 patients as the denominator. See below.

Description of selected adverse reactions

Type III immune complex reactions (see sections 4.4 and 4.5)

Across Phase III studies, 19.4% (39 out of 201) of patients who switched from treatment with eculizumab or ravulizumab to crovalimab experienced a Type III immune complex reaction (reported as Type III immune complex mediated reaction). Of these 39 patients, 2 patients experienced a second Type III immune complex reaction after discontinuing crovalimab and switching to ravulizumab. The most common signs and symptoms that were reported were arthralgia and rash, and other symptoms reported include pyrexia, headache, myalgia, abdominal pain, asthenia/fatigue and axonal neuropathy. The median time to onset of a Type III immune complex reaction in patients who switched from treatment with eculizumab or ravulizumab to crovalimab was 1.6 weeks (range: 0.7 - 4.4 weeks), with 5.1% of patients (2 of 39) experiencing a Type III immune complex reaction with a time to onset that exceeded 4 weeks. Most cases of Type III immune complex reaction were transient with a median duration of 1.7 weeks (range 0.4 – 34.1 weeks). The majority of patients experienced a Grade 1 or 2 event (23 of 39 patients), with Grade 3 events affecting 8% (16 of 39) of crovalimab-treated patients who switched from eculizumab or ravulizumab. Most events resolved with no change in study treatment with crovalimab.

In the COMPOSER study, among 26 patients who switched from eculizumab to crovalimab, 2 patients each reported 1 adverse event of Type III immune complex reaction. These events were mild/moderate and non-serious. One additional patient developed a mild Type III immune complex reaction after discontinuing crovalimab and switching to a different C5 inhibitor.

Immunogenicity

Across two randomised Phase III studies (COMMODORE 1 and COMMODORE 2) and one single‑arm Phase III study (COMMODORE 3), ADA status was evaluable in 392 patients. Out of these 392 patients, 118 (30.1%) were ADA-positive. No differences in the rates of adverse reactions typically associated with immunogenicity (such as infusion-related reactions, injection site reactions, or hypersensitivity) were observed between ADA-positive and ADA-negative patients (see section 5.1).

Immunogenicity leading to loss of exposure and efficacy

Patients may develop ADAs that can interfere with crovalimab exposure. Out of 392 patients evaluated for ADA status, partial or complete loss of exposure associated with ADA onset was observed in 23 patients (5.9%); among them, 17 (4.3%) had a loss of pharmacological activity coinciding with a loss of exposure and with loss of efficacy, manifesting as a sustained loss of haemolysis control in 7 patients (1.8%).

In case of clinical signs of loss of efficacy, prompt evaluation by a healthcare professional should be sought (see section 4.4).

Infusion and Injection‑Related Reactions

Across Phase III studies, 10.2% of patients who were treated with crovalimab experienced an infusion related reaction. The most common signs and symptoms that were reported were headache (7.1%), rash (0.8%), dizziness (0.8%), abdominal pain (0.5%), erythema (0.5%), nausea (0.5%), pyrexia (0.5%), and paraesthesia (0.3%). All events reported were Grade 1‑2.

Across Phase III studies, 8.4% of patients who were treated with crovalimab experienced an injection‑related reaction. The most common signs and symptoms that were reported were headache (2.5%), injection site erythema (1.0%), injection site pain (1.0%), and injection site rash (1.0%). The majority of events were Grade 1‑2.

Infections with encapsulated bacteria

Based on its mechanism of action, the use of crovalimab may potentially increase the risk of infections, particularly infections caused by encapsulated bacteria including Streptococcus pneumoniae, Neisseria meningitidis types A, C, W, Y, and B, and Haemophilus influenzae (see section 4.4).

Across Phase III studies, infections with encapsulated bacteria that were reported were Klebsiella pneumoniae, Klebsiella (not otherwise specified), Haemophilus influenzae and Neisseria subflava, the latter of which caused an adverse event of bacteriaemia in a patient.

Paediatric population

In 12 paediatric PNH patients with body weight ≥ 40 kg (aged 13‑17 years old) included in COMMODORE 1, COMMODORE 2 and COMMODORE 3 studies, the safety profile appeared similar to that observed in adult PNH patients. The adverse reactions associated with crovalimab that were reported in paediatric PNH patients are upper respiratory tract infection (16.7%), urinary tract infection (16.7%), fatigue (16.7%), pyrexia (16.7%), headache (8.3%), infusion-related reaction (8.3%) and injection‑related reaction (8.3%).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see details below)

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

4.9. Overdose

In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.

🇷🇴 Known in Romania as

Medicines sold in Romania with the same active substance: Cunoscut în România ca

  • PIASKY 340 mg prescriptionCROVALIMABUM · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →

🇵🇱 Known in Poland as

Medicines sold in Poland with the same active substance: W Polsce znany jako

  • PiaskyCrovalimabum · injection / infusion

Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →

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Ask anything about PiaSky 340 mg solution for injection/infusion. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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