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Tavneos is a brand name for Avacopan. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) (see section 4.2).
Verbatim from this product's EMA label. Tap a section to expand.
4). Posology The recommended dose is 30 mg Tavneos (3 hard capsules of 10 mg each) taken orally twice daily, morning and evening, with food. Tavneos should be administered in combination with a rituximab or cyclophosphamide regimen as follows: • rituximab for 4 weekly intravenous doses or, • intravenous or oral cyclophosphamide for 13 or 14 weeks, followed by oral azathioprine or mycophenolate mofetil and, • glucocorticoids as clinically indicated.
1. Clinical study data are limited to 52 weeks of exposure followed by 8 weeks of observation. 3 Missed doses If a patient misses a dose, the missed dose is to be taken as soon as possible, unless within three hours of the next scheduled dose.
If within three hours, then the missed dose is not to be taken. Dose management Treatment must be re-assessed clinically and temporarily stopped if: • alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is more than 3 times the upper limit of normal (ULN).
e. requiring hospitalisation or prolonged hospitalisation). Treatment may be resumed: • upon normalisation of values and based on an individual benefit/risk assessment. If treatment is resumed, hepatic transaminases and total bilirubin are to be monitored closely.
5, • ALT or AST > 3 × ULN with the appearance of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or eosinophilia (> 5%), • an association between avacopan and hepatic dysfunction has been established.
2). 2). Avacopan has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) and it is therefore not recommended for use in these patient populations. 2). 73 m², who are on dialysis, in need of dialysis or plasma exchange.
Severe disease manifested as alveolar haemorrhage Avacopan has not been studied in patients with severe disease manifested as alveolar haemorrhage. 4 Paediatric population The safety and efficacy of avacopan in adolescents (12 to 17 years of age) have not yet been established.
1 but no recommendation on a posology can be made. The safety and efficacy of avacopan in children below 12 years of age have not yet been established. No data are available. Method of administration This medicinal product is for oral use.
The hard capsules are to be taken with food and swallowed whole with water and must not be crushed, chewed, or opened. 5).
1%). 8%). Tabulated list of adverse reactions The adverse reactions observed in the ANCA-associated vasculitis pivotal phase 3 study and in the post-marketing setting in patients treated with avacopan are listed in Table 1 by system organ class (SOC) and by frequency.
Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and not known (frequency cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
8 Table 1: Adverse reactions System Organ Class Very Common (≥ 1/10) Common (≥ 1/100 to < 1/10) Uncommon (≥ 1/1,000 to < 1/100) Not Known Infections and infestations Upper respiratory tract infection, Nasopharyngitis Pneumonia, Rhinitis, Urinary tract infection, Sinusitis, Bronchitis, Gastroenteritis, Lower respiratory tract infection, Cellulitis, Herpes zoster, Influenza, Oral candidiasis, Oral herpes, Otitis media Blood and lymphatic system disorders Neutropenia1 Nervous system disorders Headache Gastrointestinal disorders1 Nausea, Diarrhoea, Vomiting Abdominal pain upper Hepatobiliary disorders Liver function test increased1,2 Drug-induced liver injury1, Vanishing bile duct syndrome1 Skin and subcutaneous tissue disorders Angioedema1 Investigations White blood cell count decreased3 Blood creatine phosphokinase increased1 1 See section “Description of selected adverse reactions”.
2 Alanine aminotransferase increased, total blood bilirubin increased, hepatic function abnormal, gamma glutamyl transferase increased, hepatic enzyme increased, transaminases increased. 3 Includes leukopenia. 6% of patients in the prednisone group had an adverse reaction of elevated liver function test (LFT).
6%) in one patient diagnosed with asymptomatic hepatitis, cytolysis and anicteric cholestasis without hepatocellular insufficiency. 7%). 0% of patients in the prednisone group. 7% of patients in the prednisone group. All serious hepatic events resolved with either the withdrawal of avacopan and/or other potentially hepatotoxic medicinal products, including trimethoprim and sulfamethoxazole.
Hepatotoxicity Serious adverse reactions of elevated hepatic transaminases with elevated total bilirubin have been observed in patients receiving avacopan in combination with cyclophosphamide (followed by azathioprine or mycophenolate) or rituximab, and trimethoprim and sulfamethoxazole.
8). Hepatic transaminases and total bilirubin must be obtained prior to initiation of therapy. Avacopan must be avoided in patients with signs of liver disease, such as elevated AST, ALT, alkaline phosphatase (ALP), or total bilirubin > 3 times ULN.
2). 2). 5 × 109/L. Patients receiving avacopan must be instructed to report immediately any evidence of infection, unexpected bruising, bleeding, or any other manifestations of bone marrow failure. 8). 5 Patients must be assessed for any serious infections.
Avacopan has not been studied in patients with hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infections. Before and during treatment, patients must notify their physician if they have been diagnosed with tuberculosis, hepatitis B, hepatitis C, or HIV infection.
Be cautious when treating patients with a history of tuberculosis, hepatitis B, hepatitis C, or HIV infection. Avacopan does not decrease the formation of the membrane attack complex (C5b-9) or terminal complement complex (TCC). No cases of Neisseria meningitidis have been identified in the avacopan clinical programme.
Monitor patients treated for ANCA-associated vasculitis according to standard practice for clinical signs and symptoms of Neisseria infections. Pneumocystis jirovecii pneumonia prophylaxis Pneumocystis jirovecii pneumonia prophylaxis is recommended for adult patients with GPA or MPA during avacopan treatment, as appropriate according to local clinical practice guidelines.
Immunisation The safety of immunisation with live vaccines, following avacopan therapy has not been studied. Administer vaccinations preferably prior to initiation of treatment with avacopan or during quiescent phase of the disease.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). 4%) in each treatment group. A single case of agranulocytosis was reported each in the prednisone group and in the avacopan group. The patient in the avacopan group was noted to have central neutropenia on a bone marrow biopsy which resolved spontaneously without additional treatment.
6%) in the prednisone group had adverse reactions of increased creatine phosphokinase (CPK). 2%) in the avacopan group had an adverse reaction of angioedema. One patient was hospitalised for the event. Avacopan was paused and both events resolved without sequelae.
Avacopan was restarted in one patient and angioedema did not reoccur. 3%). Special populations Paediatric population A total of 3 adolescents were studied in the phase 3 study, one in the prednisone group and two in the avacopan group.
1). Elderly patients The safety profile was similar between patients ≥ 65 years of age and adult patients < 65 years of age in the clinical studies. 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. 10
8). Patients must notify their physician if they develop any symptoms such as swelling of the face, lips, or tongue, throat tightness, or difficulty breathing. Avacopan must be withheld in cases of angioedema. , carbamazepine, enzalutamide, mitotane, phenobarbital, phenytoin, rifampicin, and St.
5). Patients anticipated to require long-term administration of these medicinal products are not to be treated with avacopan. If short-term co-administration cannot be avoided in a patient already using avacopan, the patient must be closely monitored in case of any reoccurrence of disease activity.
Cardiac disorders Patients with GPA or MPA are at risk of cardiac disorders such as myocardial infarction, cardiac failure, and cardiac vasculitis. Serious adverse events (SAEs) of cardiac disorder have been reported in patients treated with avacopan.
A treatment regimen based on the combination with cyclophosphamide followed by azathioprine may carry an increased risk for cardiac disorders as compared to a regimen based on the combination with rituximab. Malignancy Immunomodulatory medicinal products may increase the risk for malignancies.
1). 6 Macrogolglycerol hydroxystearate content This medicinal product contains macrogolglycerol hydroxystearate, which may cause stomach upset and diarrhoea.