CABAZITAXEL ACCORD Concentrate for solution for infusion (2020)

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Περιεχόμενα

1. Name of the medicinal product

Cabazitaxel Accord 20 mg/ml concentrate for solution for infusion.

2. Qualitative and quantitative composition

Each ml of concentrate contains 20 mg cabazitaxel. Each vial of 3 ml of concentrate contains 60 mg cabazitaxel. Excipient with known effect: The finished product contains 395 mg/ml of ethanol anhydrous, ...

3. Pharmaceutical form

Concentrate for solution for infusion (sterile concentrate). The concentrate is a clear colourless to pale yellow or brownish yellow solution.

4.1. Therapeutic indications

Cabazitaxel Accord in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing ...

4.2. Posology and method of administration

The use of cabazitaxel should be confined to units specialised in the administration of cytotoxics and it should only be administered under the supervision of a physician experienced in the use of anticancer ...

4.3. Contraindications

Hypersensitivity to cabazitaxel, to other taxanes, or polysorbate 80 or any excipients listed in section 6.1. Neutrophil counts less than 1,500/mm3. Moderate and severe hepatic impairment (total bilirubin ...

4.4. Special warnings and precautions for use

Hypersensitivity reactions All patients should be pre-medicated prior to the initiation of the infusion of cabazitaxel (see section 4.2). Patients should be observed closely for hypersensitivity reactions ...

4.5. Interaction with other medicinal products and other forms of interaction

In vitro studies have shown that cabazitaxel is mainly metabolised through CYP3A (80% to 90%) (see section 5.2). CYP3A inhibitors Repeated administration of ketoconazole (400 mg once daily), a ...

4.6. Pregnancy and lactation

Pregnancy There are no data from the use of cabazitaxel in pregnant women. Studies in animals have shown reproductive toxicity at maternotoxic doses (see section 5.3) and that cabazitaxel crosses the placenta ...

4.7. Effects on ability to drive and use machines

Cabazitaxel has moderate influence on the ability to drive and use machines as it may cause fatigue and dizziness. Patients should be advised not to drive or use machines if they experience these adverse ...

4.8. Undesirable effects

Summary of safety profile The safety of cabazitaxel in combination with prednisone or prednisolone was evaluated in 371 patients with metastatic castration resistant prostate cancer who were treated with ...

4.9. Overdose

There is no known antidote to cabazitaxel. The anticipated complications of overdose would consist of exacerbation of adverse reactions as bone marrow suppression and gastrointestinal disorders. In case ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, taxanes ATC code: L01CD04 Mechanism of action Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in ...

5.2. Pharmacokinetic properties

A population pharmacokinetic analysis was carried out in 170 patients including patients with advanced solid tumours (n=69), metastatic breast cancer (n=34) and metastatic prostate cancer (n=67). These ...

5.3. Preclinical safety data

Adverse reactions not observed in clinical studies, but seen in dogs after single dose, 5-day and weekly administation at exposure levels lower than clinical exposure levels and with possible relevance ...

6.1. List of excipients

Polysorbate 80 Citric acid Ethanol anhydrous

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6. PVC infusion containers or polyurethane infusion sets should not be used for the preparation ...

6.3. Shelf life

Unopened vial: 3 years. After opening: Each vial is for single use and should be used immediately after opening. If not used immediately, inuse storage times and conditions are the responsibility ...

6.4. Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light. For storage conditions after dilution of the medicinal ...

6.5. Nature and contents of container

3 ml of concentrate in a 6 ml clear tubular glass vial (type I) closed with a 20 mm grey siliconized rubber closure (type I) with teflon film on plug surface and sealed by an aluminium cap covered with ...

6.6. Special precautions for disposal and other handling

Cabazitaxel should only be prepared and administered by personnel trained in handling cytotoxic agents. Pregnant staff should not handle the product. As for any other antineoplastic agent, caution should ...

7. Marketing authorization holder

Accord Healthcare S.L.U., World Trade Center, Moll de Barcelona, s/n, Edifici Est 6ª planta, Barcelona, 08039, Spain

8. Marketing authorization number(s)

EU/1/20/1448/001

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