GLYBERA Solution for injection (2017)
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Περιεχόμενα
1. Name of the medicinal product
Glybera 3 × 10<sup>12</sup> genome copies/ml solution for injection.
2. Qualitative and quantitative composition
Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPL<sup>S447X</sup> in a vector. The vector comprises a protein shell derived from adeno-associated virus serotype 1 (AAV1), ...
3. Pharmaceutical form
Solution for injection. Clear, to slightly opalescent, colourless solution.
4.1. Therapeutic indications
Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis ...
4.2. Posology and method of administration
Glybera should only be used when the diagnosis of LPLD has been confirmed by an adequate genetic test (see section 5.1). Glybera therapy must be prescribed by and administered under the supervision of ...
4.3. Contraindications
Hypersensitivity to the active substance or any of the excipients of Glybera listed in section 6.1. Immunodeficiency. Patients with increased bleeding risk (such as thrombocytopenia) and muscle disease ...
4.4. Special warnings and precautions for use
This medicinal product contains genetically-modified organisms. Local biosafety guidelines applicable for such products should be followed (see section 6.6). Glybera should only be administered to patients ...
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed. Anti-platelet or other anti-coagulant medicinal products must not be used ...
4.6. Fertility, pregnancy and lactation
Contraception in males and females Women of childbearing potential must be advised to use reliable barrier contraception methods in accordance with the guidelines for immunosuppressants for a minimum of ...
4.7. Effects on ability to drive and use machines
Glybera has minor influence on the ability to drive and use machines¸ dizziness was commonly observed after Glybera administration (see section 4.8). Patients experiencing dizziness are advised to not ...
4.8. Undesirable effects
Summary of the safety profile The most commonly reported adverse reaction is pain in extremity occurring in approximately one third of patients. One patient was diagnosed with pulmonary embolism 7 weeks ...
4.9. Overdose
Pre-clinical studies with doses ten times the recommended dose (1 1013 gc/kg) did not lead to any general systemic untoward signs or symptoms. Symptomatic and supportive treatment, as deemed necessary ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Lipid modifying agents, other lipid modifying agents <b>ATC code:</b> C10AX10 Mechanism of action Glybera contains the human LPL gene variant LPL<sup>S447X</sup> in an ...
5.2. Pharmacokinetic properties
Glybera is expected to be degraded by endogenous protein and DNA catabolic pathways. Non-clinical biodistribution Following intramuscular administration of Glybera to mice, vector DNA was transiently detected ...
5.3. Preclinical safety data
Upon injection, Glybera was well tolerated in all animal studies performed with no notable clinical signs. In mice local cellular infiltrates and signs of degeneration and regeneration without necrosis, ...
6.1. List of excipients
Disodium phosphate anhydrous Potassium chloride Potassium dihydrogen phosphate Sodium chloride Sucrose Water for injections
6.2. Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3. Shelf life
18 months for frozen vials. Once thawed the medicinal product must be used immediately; if not used immediately, the vials should be stored in a refrigerator at 2°C to 8°C, and protected from light for ...
6.4. Special precautions for storage
Store and transport vial frozen -25°C to -15°C. Keep the vial in the outer carton in order to protect from light.
6.5. Nature and contents of container
1 ml solution in a 2 ml vial (glass) with siliconised chlorobutyl, injection stopper and flip-off seal. Each preformed transparent sealed plastic casing contains either 2 or 3 individual vials with a ...
6.6. Special precautions for disposal and other handling
Instructions for preparation and handling and disposal Refer to local biosafety guidelines applicable for handling and disposal of medicinal products containing genetically-modified organisms. Work surfaces ...
7. Marketing authorization holder
uniQure biopharma B.V., Meibergdreef 61, 1105 BA Amsterdam, The Netherlands
8. Marketing authorization number(s)
EU/1/12/791/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 25 October 2012
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