PiaSky® (crovalimab) Safety Information

PiaSky® Safety Profile and Important Information

Contraindications:

• Patients with a known hypersensitivity (allergic reaction) to PiaSky^® or any of the excipients
• Patients with an unresolved Neisseria meningitidis infection
• Patients not currently vaccinated against Neisseria meningitidis, unless the risks of delaying PiaSky^® treatment outweigh the risks of developing a meningococcal infection. In such cases, prophylactic treatment with appropriate antibiotics should be given from the start of PiaSky^® treatment until 2 weeks after vaccination

Pregnancy and breastfeeding:

• There are insufficient data on PiaSky^® use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• It is not known whether PiaSky^® is excreted in human breast milk, if it has an impact on milk production nor if there is an effect on the breastfed child

Meningococcal Infection Risk:

PiaSky^® may make patients less able to fight infections, especially meningococcal infection. To reduce this risk, a tetravalent meningococcal vaccine is necessary.

Closely monitor patients for early signs of meningococcal infection and evaluate patients immediately if infection is suspected. Treat with appropriate antibiotics if necessary. Inform patients of these signs and symptoms and steps they need to take in seeking medical care immediately.

Transient Immune Complex Reactions risk for C5i switch patients:

Across the COMMODORE 1 and 2 Trials, 19% (n=39/201) of patients who switched to PiaSky^® from another C5 inhibitor reported transient immune complex reactions (TICRs, also known as Type III immune complex reactions). Symptoms of TICRs include arthralgia and rash.

In patients switching from other C5is to PiaSky^®, or vice versa, immune complexes form between PiaSky^®, C5, and the other C5i. These complexes may lead to a one-time TICR in a fraction of switch patients.¹

• Patients who switched saw a median onset time for TICRs of 1.6 weeks with a duration of 1.7 weeks.¹
• The majority of events were grade 1-2 and did not affect trial treatment once resolved.¹
• Treatment-naïve patients or patients who have cleared a prior C5i from their body are not at risk of developing TICRs.¹
• It is not recommended to switch patients who are experiencing TICR symptoms to another C5i, as the underlying reason for those symptoms can cause worsening reactions.²
• It is recommended to monitor patients for the first 30 days after switching from a C5i to PiaSky^® for symptoms of TICRs.²
  • Mild or moderate TICRs: symptomatic treatment e.g. topical corticosteroids, antihistamines, antipyretics, and/or analgesics may be considered.²
  • Severe TICRs: oral or systemic corticosteroid therapy can be initiated and tapered as clinically indicated.²

Other Adverse Reactions:

Injection site reactions may include:

• Pain at injection site and elsewhere
• Swelling
• Bruising or bleeding
• Red skin
• Itching and Rash

Other common side effects may include:

• Headaches
• Lower back pain
• Upper respiratory tract infection
• Fever
• Runny nose

Please refer to the PiaSky^® SmPC document for full safety information.