BESPONSA Powder for concentrate for solution for infusion (2020)
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Περιεχόμενα
Name of the medicinal product
BESPONSA 1 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
Each vial contains 1 mg inotuzumab ozogamicin. After reconstitution (see section 6.6), 1 mL of solution contains 0.25 mg inotuzumab ozogamicin. Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) ...
Pharmaceutical form
Powder for concentrate for solution for infusion. White to off-white, lyophilised cake or powder.
Therapeutic indications
BESPONSA is indicated as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome ...
Posology and method of administration
BESPONSA should be administered under the supervision of a physician experienced in the use of cancer therapy and in an environment where full resuscitation facilities are immediately available. When considering ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients who have experienced prior confirmed severe or ongoing venoocclusive liver disease/sinusoidal obstruction ...
Special warnings and precautions for use
Traceability In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded in the patient file. Hepatotoxicity, ...
Interaction with other medicinal products and other forms of interaction
No formal clinical drug interaction studies have been performed (see section 5.2). Based on in vitro data, coadministration of inotuzumab ozogamicin with inhibitors or inducers of cytochrome P450 (CYP) ...
Fertility, pregnancy and lactation
Women of childbearing potential/Contraception in males and females Women of childbearing potential should avoid becoming pregnant while receiving BESPONSA. Women should use effective contraception during ...
Effects on ability to drive and use machines
BESPONSA has moderate influence on the ability to drive and use machines. Patients may experience fatigue during treatment with BESPONSA (see section 4.8). Therefore, caution is recommended when driving ...
Undesirable effects
Summary of the safety profile The most common (≥20%) adverse reactions were thrombocytopenia (51%), neutropenia (49%), infection (48%), anaemia (36%), leukopenia (35%), fatigue (35%), haemorrhage (33%), ...
Overdose
In clinical studies in patients with relapsed or refractory ALL, the maximum single and multiple doses of inotuzumab ozogamicin were 0.8 mg/m² and 1.8 mg/m², respectively, per cycle, given as 3 divided ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agent, monoclonal antibodies ATC code: L01XC26 Mechanism of action Inotuzumab ozogamicin is an ADC composed of a CD22-directed monoclonal ...
Pharmacokinetic properties
In patients with relapsed or refractory ALL treated with inotuzumab ozogamicin at the recommended starting dose of 1.8 mg/m²/cycle (see section 4.2), steady-state exposure was achieved by Cycle 4. The ...
Preclinical safety data
Repeat-dose toxicity In animals, the primary target organs included the liver, bone marrow and lymphoid organs with associated haematological changes, kidney, and nervous system. Other observed changes ...
List of excipients
Sucrose Polysorbate 80 Sodium chloride Tromethamine
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
Shelf life Unopened vial: 5 years. Reconstituted solution: BESPONSA contains no bacteriostatic preservatives. The reconstituted solution must be used immediately. If the reconstituted solution cannot be ...
Special precautions for storage
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original carton in order to protect from light. For storage conditions after reconstitution and dilution, see section 6.3.
Nature and contents of container
Type I amber glass vial with chlorobutyl rubber stopper and crimp seal with flip off cap containing 1 mg of powder. Each carton contains 1 vial.
Special precautions for disposal and other handling
Instructions for reconstitution, dilution, and administration Use appropriate aseptic technique for the reconstitution and dilution procedures. Inotuzumab ozogamicin (which has a density of 1.02 g/mL at ...
Marketing authorization holder
Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Marketing authorization number(s)
EU/1/17/1200/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 29 June 2017
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