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Beqvez (Previously Durveqtix) is a brand name for Fidanacogene Elaparvovec. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BEQVEZ is indicated for the treatment of severe and moderately severe haemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX inhibitors and without detectable antibodies to variant AAV serotype Rh74. Medicinal product no longer authorised 3
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be administered in a qualified treatment centre by a physician experienced in the treatment of haemophilia. 4). 4). Patient selection Eligibility for treatment should be confirmed within 8 weeks prior to infusion by the following test results: • negative for AAVRh74var pre-existing antibodies should be assessed by a CE-marked in vitro diagnostic (IVD) with the corresponding intended purpose.
If the CE-marked IVD is not available, an alternative validated test should be used. 4). 6 Bethesda Units (BU). 3). Posology The recommended dose of BEQVEZ is a single-dose of 5 × 1011 vector genomes per kg (vg/kg) of body weight.
To determine the patient’s dose, the following calculation steps are needed:
Calculation of patient’s dose weight The dose of BEQVEZ is based on the patient’s body mass index (BMI) in kg/m2. Table 1. Patient’s dose weight adjustment according to BMI Patient’s BMI Patient’s dose weight (kg) adjustment ≤ 30 kg/m2 Dose weight = Actual body weight > 30 kg/m2 Determine using the following calculation: Dose weight (kg) = 30 kg/m2 × [Height (m)]2 Note: • The intermediate calculation of height (m2) should NOT be rounded.
• Dose weight should be rounded to 1 decimal place. Calculation of patient’s dose volume in millilitres (mL) Patient’s dose weight in kilograms (kg) × target dose per kilogram (5 × 1011 vg/kg) = dose in vg to be administered Dose in vg to be administered ÷ Actual concentration (vg/mL)* = patient’s dose volume in mL *See the accompanying LIS for information pertaining to the actual concentration of vg per vial.
Medicinal product no longer authorised 4 Special populations Hepatic impairment The safety and efficacy of fidanacogene elaparvovec in patients with severe hepatic impairment have not been studied. 4). Patients who are HCV positive /HBV positive /HIV positive No dose adjustment is needed in patients who are hepatitis C virus (HCV) positive, hepatitis B virus (HBV) positive and/or human immunodeficiency virus (HIV) positive.
4). Renal impairment No dose adjustment is needed in patients with renal impairment. 0 mg/dL). Elderly The safety and efficacy of fidanacogene elaparvovec in patients ≥ 63 years old have not been established. No dose adjustment is needed in elderly patients.
Paediatric population The safety and efficacy of fidanacogene elaparvovec in children and adolescents under 18 years of age have not yet been established. No data are available. Method of administration For intravenous use after dilution.
3%). Tabulated list of adverse reactions The safety of fidanacogene elaparvovec was evaluated in 60 patients who received the recommended dose (5 × 1011 vector genomes/kg) in 2 open-label clinical studies. The adverse reactions identified with fidanacogene elaparvovec are presented in Table
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. Pre-existing immunity against AAVRh74var Anti-AAVRh74var antibody formation can take place after exposure to a virus very similar to the modified virus.
2). , within 8 weeks) following antibody testing confirming the absence of anti-AAVRh74var antibodies. 5 × ULN (at most within 4 weeks) • current liver-related coagulopathy, hypoalbuminemia, persistent jaundice, cirrhosis, active viral hepatitis • history of portal hypertension, splenomegaly, or hepatic encephalopathy • negative fibrosis assessment (at most 3 months before infusion) In case of radiological liver abnormalities and/or sustained liver enzyme elevations, consideration of a consultation with a hepatologist is recommended to assess eligibility for BEQVEZ administration.
Patients with active infections, either acute or uncontrolled chronic There is no clinical experience with administration of fidanacogene elaparvovec in patients with acute infections (such as acute respiratory infections or acute hepatitis) or uncontrolled chronic infections (such as active chronic hepatitis B).
It is possible that such acute or uncontrolled infections may affect the response to fidanacogene elaparvovec and reduce its efficacy and/or cause adverse reactions. 3). If there are signs or symptoms of acute or uncontrolled chronic active infections, fidanacogene elaparvovec treatment must be postponed until the infection has resolved or is controlled.
Limited clinical data are available in patients with controlled HIV infection treated with fidanacogene elaparvovec. Infusion-related reactions Infusion reactions, including hypersensitivity reactions and anaphylaxis, are possible during or shortly after fidanacogene elaparvovec infusion.
Patients should be closely monitored for infusion reactions throughout the infusion period and at least for 3 hours after end of infusion. The recommended infusion rate should be closely adhered to, in order to ensure patient tolerability.
1. 4). 4). Medicinal product no longer authorised 5
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6). Do not infuse as an intravenous push or bolus. In the event of an infusion reaction during administration, the infusion rate should be slowed or stopped to ensure patient tolerability. 4). , lot number) on the vials, inner cartons, outer cartons, and accompanying documentation.
The total number of vials to be administered must also be confirmed with the patient-specific information on the LIS. 6.
2). Based on Medicinal product no longer authorised 6 clinical judgement, management of infusion reactions should be done according to guidelines for management of allergic reactions, including the discontinuation and/or the administration of appropriate treatment.
To minimise the risk of acute hypersensitivity reactions, patients should be closely monitored for clinical signs and symptoms of infusion reactions and acute or delayed hypersensitivity reactions. Patients should be informed of the early symptoms and signs of hypersensitivity reactions and should be advised to contact their physician and/or seek immediate emergency care if they experience an infusion-related reaction.
Discontinuation of factor IX concentrates Following fidanacogene elaparvovec infusion, patients should discontinue prophylaxis once the endogenous FIX:C activity levels are considered sufficient to prevent spontaneous bleeding. 8). Although the exact aetiology of elevations has not yet been established, it is believed that immune-mediated elevations in liver function tests (LFTs) are the result of an AAV capsid triggered response with subsequent hepatocyte lysis and inflammation.
ALT/AST and factor IX activity levels should be monitored following the administration of fidanacogene elaparvovec (see Table 2). Monitoring of creatine phosphokinase (CPK) is recommended to evaluate for alternative causes for ALT elevations (including potentially hepatotoxic medications or agents, alcohol consumption, or strenuous exercise).
Corticosteroid treatment should be instituted in response to aminotransferase elevations to control hepatic reactions and prevent or mitigate a potential reduction in transgene expression (see Table 3 and Table 4). During the first six months after BEQVEZ administration, the purpose of hepatic and factor IX monitoring is to detect increases in transaminases which may be suggestive of or accompanied by decreased factor IX activity and may indicate the need to initiate corticosteroid treatment.
Following the first 6 months post-BEQVEZ administration, hepatic and factor IX monitoring is intended to assess liver health and bleeding risk. Table 2. Recommended hepatic function (ALT and AST) and factor IX activity monitoring* Timeframe Monitoring frequencya Weeks 1 to 12 Once or twice weekly Weeks 13 to 18 Weekly Weeks 19 to 52 (end of year 1) At weeks 24, 32, 42 and 52 Year 2 to end of year 3b Quarterly Year 4 to end of year 6 Twice yearly After year 6 Annually * It is recommended where possible to use the same laboratory for monitoring over time, particularly during the timeframe for corticosteroid treatment decision making, to minimise the impact of inter-laboratory variability.
a Weekly monitoring is recommended, and as clinically indicated, […]