APEALEA Powder for solution for infusion (2022)

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Περιεχόμενα

1. Name of the medicinal product

Apealea 60 mg powder for solution for infusion.

2. Qualitative and quantitative composition

One vial of powder contains 60 mg of paclitaxel. After reconstitution, each mL of solution contains 1 mg of paclitaxel (micellar). Excipients with known effect: Each vial contains 3.77 mg (0.164 ...

3. Pharmaceutical form

Powder for solution for infusion. Greenish-yellow to yellow powder.

4.1. Therapeutic indications

Apealea in combination with carboplatin is indicated for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube ...

4.2. Posology and method of administration

Apealea should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents. It should not be interchanged with other paclitaxel formulations. ...

4.3. Contraindications

Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4). Breast-feeding (see section 4.6). Baseline neutrophil count <1.5 × 109/L. ...

4.4. Special warnings and precautions for use

Haematology Paclitaxel causes myelosuppression (primarily neutropenia). Neutropenia is a dose-dependent and dose-limiting adverse reaction. Therefore, frequent complete blood cell counts should be performed ...

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

No studies have been performed to evaluate drug-drug interactions between Apealea and other medicinal products. The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 ...

4.6. Fertility, pregnancy and lactation

Women of childbearing potential/Contraception Women of childbearing potential must use effective contraception during treatment and for six months afterwards. Pregnancy There are very limited data on the ...

4.7. Effects on ability to drive and use machines

Apealea has moderate influence on the ability to drive or use machines. Apealea may cause adverse reactions such as fatigue (very common) and dizziness (common) that may affect the ability to drive or ...

4.8. Undesirable effects

Summary of the safety profile The most common clinically significant adverse reactions associated with the use of Apealea are neutropenia, gastrointestinal disorders, peripheral neuropathy, arthralgia/myalgia, ...

4.9. Overdose

There is no known antidote for paclitaxel overdose. In the event of an overdose, the patient should be closely monitored. Treatment should be directed at the major anticipated toxicities, which are nausea, ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Antineoplastic agents, taxanes ATC code: L01CD01 Mechanism of action Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin ...

5.2. Pharmacokinetic properties

When Apealea (paclitaxel micellar) is administered intravenously, its pharmacokinetic profile suggests that the formulation immediately releases paclitaxel into the blood. The pharmacokinetics of paclitaxel ...

5.3. Preclinical safety data

Mutagenesis, carcinogenesis, impairment of fertility In vitro studies using different cell systems have shown paclitaxel to be clastogenic inducing chromosomal aberrations, micronuclei and DNA ...

6.1. List of excipients

N-(all-trans-retinoyl)-L-cysteic acid methyl ester sodium salt N-(13-cis-retinoyl)-L-cysteic acid methyl ester sodium salt Sodium hydroxide (for pH adjustment)

6.2. Incompatibilities

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

6.3. Shelf life

Unopened vial: 3 years. After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C in lactated and acetated Ringers solution and for 4 hours ...

6.4. Special precautions for storage

Store in a refrigerator (2°C–8°C). Keep the vial in the outer carton in order to protect from light. For storage conditions after reconstitution of the medicinal product, see section 6.3.

6.5. Nature and contents of container

Clear type I glass vial with a silicon coated butyl rubber stopper, an aluminium overseal and a plastic flip-off cap containing powder equivalent to 60 mg of paclitaxel. Pack size: 1 vial.

6.6. Special precautions for disposal and other handling

Administration precautions Paclitaxel is an antineoplastic medicinal product and as with other potentially toxic compounds, caution should be exercised in handling Apealea. The use of gloves, goggles and ...

7. Marketing authorization holder

Inceptua AB, Gustavslundsv. 143, 16751 Bromma, Sweden

8. Marketing authorization number(s)

EU/1/18/1292/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 20 November 2018

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