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Fabhalta is a brand name for Iptacopan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Paroxysmal nocturnal haemoglobinuria FABHALTA is indicated as monotherapy in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have haemolytic anaemia. Complement 3 glomerulopathy FABHALTA is indicated for the treatment of adult patients with complement 3 glomerulopathy (C3G) in…
Verbatim from this product's EMA label. Tap a section to expand.
Posology The recommended dose is 200 mg taken orally twice daily. Healthcare professionals should advise patients about the importance of adherence to the dosing schedule. 4). If a dose or doses are missed, the patient should be advised to take one dose as soon as possible (even if it is shortly before the next scheduled dose) and then to resume the regular dosing schedule.
Patients with PNH who have missed several consecutive doses should be monitored for potential signs and symptoms of haemolysis. PNH is a disease that requires chronic treatment. 4). 3 Patients with PNH switching from anti-C5 (eculizumab, ravulizumab) or other PNH therapies to iptacopan To reduce the potential risk of haemolysis with abrupt treatment discontinuation: • For patients switching from eculizumab, iptacopan should be initiated no later than 1 week after the last dose of eculizumab.
• For patients switching from ravulizumab, iptacopan should be initiated no later than 6 weeks after the last dose of ravulizumab. Switches from complement inhibitors other than eculizumab and ravulizumab have not been studied. Patients with C3G after kidney transplantation (recurrent C3G) Diagnosis of recurrent C3G should be made based on histological C3 deposition in the glomeruli of the transplanted kidney.
C3 deposition may be detected in a routine post-transplantation biopsy; otherwise, a biopsy should be performed when clinical signs indicate recurrent C3G. 1), treatment with iptacopan can be started before the onset of clinical signs such as estimated glomerular filtration rate (eGFR) decrease or urine protein-to-creatinine ratio (UPCR) increase.
1). 2). Renal impairment No dose adjustment is required in patients with mild (eGFR between 60 and <90 ml/min) or moderate (eGFR between 30 and <60 ml/min) renal impairment. 2). Hepatic impairment The use of iptacopan is not recommended in patients with severe hepatic impairment (Child-Pugh class C).
2). Paediatric population The safety and efficacy of iptacopan in children aged below 18 years have not been established. No data are available. Method of administration For oral use. 2).
0%). 2%). 9%). The most commonly reported serious adverse reaction was pneumococcal infection (1%). Tabulated list of adverse reactions Table 1 shows the adverse reactions observed in the clinical studies with iptacopan in patients with PNH and C3G.
Adverse reactions are listed by MedDRA system organ class (SOC) and frequency, using 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) or very rare (<1/10 000).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 7 Table 1 Adverse reactions System Organ Class Adverse reaction Frequency category PNH C3G Infections and infestations Upper respiratory tract infection1 Very common Very common Urinary tract infection2 Common Bronchitis3 Common Pneumococcal infection4 Common Pneumonia bacterial Uncommon Blood and lymphatic system disorders Platelet count decreased Common Nervous system disorders Headache5 Very common Dizziness Common Gastrointestinal disorders Diarrhoea Very common Abdominal pain6 Common Nausea Common Skin and subcutaneous tissue disorders Urticaria Uncommon Musculoskeletal and connective tissue disorders Arthralgia Common 1 Upper respiratory tract infection includes preferred terms influenza, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, and viral upper respiratory tract infection.
2 Urinary tract infection includes preferred terms urinary tract infection and cystitis escherichia. 3 Bronchitis includes preferred terms bronchitis, bronchitis haemophilus and bronchitis bacterial. 4 Pneumococcal infection includes preferred terms pneumonia pneumococcal and pneumococcal sepsis.
5 Headache includes preferred terms headache and head discomfort. 6 Abdominal pain includes preferred terms abdominal pain, abdominal pain upper, abdominal tenderness and abdominal discomfort. 6%) patients with PNH reported serious bacterial pneumonia while receiving treatment with iptacopan; the patient had been vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type B and recovered following treatment with antibiotics while continuing treatment with iptacopan.
Serious infections caused by encapsulated bacteria The use of complement inhibitors, such as iptacopan, may predispose individuals to serious, life- threatening or fatal infections caused by encapsulated bacteria. To reduce the risk of infection, all patients must be vaccinated against encapsulated bacteria, including Neisseria meningitidis and Streptococcus pneumoniae.
It is recommended to vaccinate patients against Haemophilus influenzae type B if vaccine is available. Healthcare professionals should refer to local vaccination guideline recommendations. Vaccines should be administered at least 2 weeks prior to administration of the first dose of iptacopan.
If treatment must be initiated prior to vaccination, patients should be vaccinated as soon as possible and provided with antibacterial prophylaxis until 2 weeks after vaccine administration. If necessary, patients may be revaccinated in accordance with local vaccination guideline recommendations.
Vaccination reduces, but does not eliminate, the risk of serious infection. Serious infection may rapidly become life-threatening or fatal if not recognised and treated early. Patients should be informed of and monitored for early signs and symptoms of serious infection.
Patients should be immediately evaluated and treated if infection is suspected. 8). PNH laboratory monitoring Patients with PNH receiving iptacopan should be monitored regularly for signs and symptoms of haemolysis, including measuring lactate dehydrogenase (LDH) levels.
Monitoring of PNH manifestations after treatment discontinuation If treatment must be discontinued, patients with PNH should be closely monitored for signs and symptoms of haemolysis for at least 2 weeks after the last dose. These signs and symptoms include, but are not limited to, elevated LDH levels along with sudden decrease in haemoglobin or PNH clone size, fatigue, haemoglobinuria, abdominal pain, dyspnoea, dysphagia, erectile dysfunction, or major adverse vascular events (MAVEs), including venous or arterial thrombosis.
1. 4). • Patients with unresolved infection caused by encapsulated bacteria, including Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae type B, at treatment initiation. 4
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In C3G completed clinical studies, 1 patient with C3G reported serious pneumococcal infection with pneumonia and sepsis while receiving treatment with iptacopan; the patient had been vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae type B and recovered following treatment with antibiotics.
Iptacopan treatment was interrupted and restarted after recovery. Platelet count decreased in patients with PNH Decrease in platelet count events was reported in 12/164 (7%) patients with PNH. Of these, 5 patients had events of mild severity, 5 had moderate events and 2 had severe events.
Patients with severe events had concurrent anti-platelet antibodies or idiopathic bone marrow aplasia with pre-existing thrombocytopenia. The events started within the first 2 months of iptacopan treatment in 7/12 patients, and after a longer exposure (111 to 951 days) in 5/12 patients.
At the cut-off date, 7 (58%) patients had recovered or events were resolving and iptacopan treatment was continued throughout in all patients. 7 mmol/l were seen at month 6 for total cholesterol and LDL-cholesterol. The mean values remained within the normal ranges.
7 mmHg at month 6). The mean DBP did not exceed 80 mmHg. 1). In patients treated with iptacopan 200 mg twice a day in the C3G clinical study, no clinically relevant differences were observed in total cholesterol, LDL-cholesterol or blood pressure compared to placebo.
Heart rate decrease in patients with PNH In patients treated with iptacopan 200 mg twice a day in PNH clinical studies, a mean decrease in heart rate of approximately 5 bpm was seen at month 6 (mean of 68 bpm). 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 via the national reporting system listed in Appendix V.
If treatment discontinuation is necessary, alternative therapy should be considered. If haemolysis occurs after discontinuation of iptacopan, restarting treatment should be considered. 5). If an alternative concomitant medicinal product cannot be identified, patients with PNH should be monitored for potential signs and symptoms of haemolysis.
Treatment of patients with C3G Patients with C3G treated with immunosuppressant medicinal products may show modest proteinuria reduction with iptacopan, which is likely linked to a more treatment-resistant nature of C3G in these patients.
There is no experience with the use of iptacopan in patients with C3G in native kidney who have proteinuria below 1 g/g at treatment initiation. 5 Educational materials All physicians who intend to prescribe FABHALTA must ensure they have received and are familiar with the physician educational materials.
Physicians must explain and discuss the benefits and risks of FABHALTA therapy with the patient and provide them with the patient information pack. The patient should be instructed to seek prompt medical care if they experience any sign or symptom of serious infection or serious haemolysis (patients with PNH) following treatment discontinuation.