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SPC: BLINCYTO Powder for concentrate solution (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.

Qualitative and quantitative composition

One vial of powder contains 38.5 micrograms blinatumomab. Reconstitution with water for injections results in a final blinatumomab concentration of 12.5 micrograms/mL. Blinatumomab is produced in Chinese ...

Pharmaceutical form

Powder for concentrate and solution for solution for infusion. BLINCYTO powder (powder for concentrate): White to off-white powder. Solution (stabiliser): Colourless-to-slightly yellow, clear solution ...

Therapeutic indications

BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome negative CD19 positive relapsed or refractory B-precursor acute lymphoblastic leukaemia (ALL). BLINCYTO is ...

Posology and method of administration

Treatment should be initiated under the direction of and supervised by physicians experienced in the treatment of haematological malignancies. For the treatment of Philadelphia chromosome negative relapsed ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Breast-feeding (see section 4.6).

Special warnings and precautions for use

Neurologic events Neurologic events including events with a fatal outcome have been observed. Grade 3 (CTCAE version 4.0) or higher (severe or life-threatening) neurologic events following initiation of ...

Interaction with other medicinal products and other forms of interaction

No formal drug interaction studies have been performed. Results from an in vitro test in human hepatocytes suggest that blinatumomab did not affect CYP450 enzyme activities. Initiation of BLINCYTO treatment ...

Fertility, pregnancy and lactation

Pregnancy Reproductive toxicity studies have not been conducted with blinatumomab. In an embryo-foetal developmental toxicity study conducted in mice, the murine surrogate molecule crossed the placenta ...

Effects on ability to drive and use machines

Blinatumomab has major influence on the ability to drive and use machines. Confusion and disorientation, coordination and balance disorders, risk of seizures and disturbances in consciousness can occur ...

Undesirable effects

Summary of the safety profile The adverse reactions described in this section were identified in clinical studies of patients with B-precursor ALL (N=843). The most serious adverse reactions that may occur ...

Overdose

Overdoses have been observed including one patient who received 133-fold the recommended therapeutic dose of BLINCYTO delivered over a short duration. Overdoses resulted in adverse reactions which were ...

Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, other Antineoplastic agents ATC code: L01XC19 Mechanism of action Blinatumomab is a bispecific T-cell engager antibody construct that binds specifically ...

Pharmacokinetic properties

The pharmacokinetics of blinatumomab appear linear over a dose range from 5 to 90 mcg/m²/day (approximately equivalent to 9-162 mcg/day) in adult patients. Following continuous intravenous infusion, the ...

Preclinical safety data

Repeat-dose toxicity studies conducted with blinatumomab and the murine surrogate revealed the expected pharmacologic effects (including release of cytokines, decreases in leukocyte counts, depletion of ...

List of excipients

Powder: Citric acid monohydrate (E330) Trehalose dihydrate Lysine hydrochloride Polysorbate 80 Sodium hydroxide (for pH-adjustment) Solution (stabiliser): Citric acid monohydrate (E330) Lysine hydrochloride ...

Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.

Shelf life

Shelf life Unopened vials: 5 years. Reconstituted solution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C-8°C or 4 hours at or below 27°C. From a microbiological point ...

Special precautions for storage

Store and transport refrigerated (2°C-8°C). Do not freeze. Store the vials in the original package in order to protect from light. For storage conditions after reconstitution and dilution of the medicinal ...

Nature and contents of container

Each BLINCYTO pack contains 1 vial of powder for concentrate for solution for infusion and 1 vial of solution (stabiliser): 38.5 micrograms blinatumomab powder in a vial (type I glass) with a stopper (elastomeric ...

Special precautions for disposal and other handling

Aseptic preparation Aseptic handling must be ensured when preparing the infusion. Preparation of BLINCYTO should be: performed under aseptic conditions by trained personnel in accordance with good practice ...

Marketing authorization holder

Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands

Marketing authorization number(s)

EU/1/15/1047/001

Date of first authorization / renewal of the authorization

Date of first authorisation: 23 November 2015 Date of last renewal: 19 April 2018

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