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Piasky is a brand name for Crovalimab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's EMA label. Tap a section to expand.
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. 4 for additional information related to switching between complement 3 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. 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. 2). 2). 4 Hepatic impairment No dose adjustment is recommended for patients with mild hepatic impairment. 2). Paediatric population No dose adjustment of crovalimab is required in paediatric patients 12 years of age or older with body weight ≥ 40 kg.
2%). 5%). 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. 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. 9 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 10 another C5 inhibitor.
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.
1. Patients with unresolved Neisseria meningitidis infection. 4). 5
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. 6. The infusion of crovalimab may be slowed or interrupted if the patient develops an infusion related reaction. 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.
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. 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. 1% of patients (2 of 39) experiencing a Type III immune complex reaction with a time to onset that exceeded 4 weeks.
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. 1%) were ADA-positive. 1). Immunogenicity leading to loss of exposure and efficacy Patients may develop ADAs that can interfere with crovalimab exposure.
8%). In case of clinical signs of loss of efficacy, prompt evaluation by a healthcare professional should be sought (see section […]
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.
6 Patients should be provided with information from the package leaflet to increase their awareness of the signs and symptoms of potential serious infections. 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.
e. 5 half-lives of the previous treatment have passed since the last dose) are not at risk of Type III immune complex reactions. 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.
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 […]