PROLEUKIN Powder for solution for injection or infusion (2020)

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Περιεχόμενα

Name of the medicinal product

PROLEUKIN 18 106 IU. Powder for solution for injection or infusion.

Qualitative and quantitative composition

After reconstitution with 1.2 ml water for injections, according to the instructions (see section 6.6), each 1 ml solution contains 18 106 IU (1.1 mg) aldesleukin. Each vial of Proleukin powder ...

Pharmaceutical form

Powder for solution for injection or infusion. The powder is sterile, white and lyophilized.

Therapeutic indications

Treatment of metastatic renal cell carcinoma. Risk factors associated with decreased response rates and median survival are: A performance status of ECOG* 1 or greater More than one organ with metastatic ...

Posology and method of administration

Proleukin should be administered intravenously by continuous infusion or by subcutaneous injection. The following dosage regimen is recommended to treat adult patients with metastatic renal cell carcinoma. ...

Contraindications

Proleukin therapy is contra-indicated in the following patients: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients with a performance status of ECOG ≥2*. ...

Special warnings and precautions for use

Patient screening See also section 4.3. Clinical studies have shown that patients with metastatic renal cell carcinoma can be divided into 4 distinct risk groups, predictive for survival and to some extent ...

Interaction with other medicinal products and other forms of interaction

Fatal Tumour Lysis Syndrome has been reported in combination with treatment with cisplatinum, vinblastine and dacarbazine. Concomitant use of the mentioned active substances is therefore not recommended. ...

Fertility, pregnancy and lactation

Women of child-bearing potential and contraception in males and females Both sexually active men and women should use effective methods of contraception during treatment. Pregnancy There are no adequate ...

Effects on ability to drive and use machines

Proleukin may affect central nervous system function. Hallucination, somnolence, syncope, convulsions may occur during treatment with Proleukin and may affect the patients ability to drive and operate ...

Undesirable effects

Frequency and severity of adverse reactions to Proleukin have generally been shown to be dependent on route of administration, dose and schedule. Most adverse reactions are self-limited and might reverse ...

Overdose

Adverse reactions following the use of Proleukin are dose-related. Therefore patients can be expected to experience these events in an exaggerated fashion when the recommended dose is exceeded. Adverse ...

Pharmacodynamic properties

Pharmacotherapeutic group: immunostimulants, cytokines and immunomodulators, interleukins, aldesleukin ATC code: L03AC01 Proleukin acts as a regulator of the immune response. The biological activities ...

Pharmacokinetic properties

The pharmacokinetic parameters of IL-2, following an intravenous or subcutaneous administration of aldesleukin in metastatic renal cell carcinoma and metastatic malignant melanoma patients is as follows: ...

Preclinical safety data

Animal data on repeated dose toxicity and local tolerance do not add any information to what is already mentioned in other sections of the SPC. Aldesleukin has not been evaluated for effects on fertility, ...

List of excipients

Mannitol (E421) Sodium laurilsulfate Sodium dihydrogen phosphate dihydrate (pH adjuster) Disodium hydrogen phosphate dihydrate (pH adjuster)

Incompatibilities

Reconstitution and dilution procedures other than those recommended may result in incomplete delivery of bioactivity and/or formation of biologically inactive protein. Use of Bacteriostatic Water for Injection ...

Shelf life

Shelf life: 45 months. After reconstitution: 24 hours. Diluted Proleukin should be used within 48 hours after reconstitution, which includes the time taken for infusion.

Special precautions for storage

Store at 2°C to 8°C (in a refrigerator). Do not freeze. Store in the original package in order to protect from light. When reconstituted or reconstituted and diluted according to the directions, chemical ...

Nature and contents of container

Proleukin is supplied in 5 ml single-use clear Type I glass vials with a stopper of synthetic rubber. The product is supplied in carton boxes of 1 or 10 vials. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Reconstitution of Proleukin powder for solution for injection or infusion: Vials (which contain 22 million IU aldesleukin) must be reconstituted with 1.2 ml of Water for Injections. After reconstitution ...

Marketing authorization holder

Clinigen Healthcare Ltd., Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom

Marketing authorization number(s)

PL 31644/0003

Date of first authorization / renewal of the authorization

18th October 2006 / 01 December 2009

Date of revision of the text

10 April 2020

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