Abraxane

  • Name:

    Abraxane

  • Company:
    info
  • Active Ingredients:

    Paclitaxel Albumin

  • Legal Category:

    Product subject to restricted prescription (C)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/19

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Summary of Product Characteristics last updated on medicines.ie: 18/11/2019

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Celgene Ltd

Celgene Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abraxane Active Ingredients Paclitaxel Albumin
Medicine Name Imnovid Active Ingredients Pomalidomide
Medicine Name Otezla 10mg, 20mg, 30mg Active Ingredients Apremilast
Medicine Name Revlimid 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 25 mg hard capsules Active Ingredients Lenalidomide
Medicine Name Thalidomide Active Ingredients Thalidomide
Medicine Name Vidaza Active Ingredients azacitidine
1 - 0 of 6 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 18 November 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), scleroderma has been added.

Updated on 18 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Updated on 18 November 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), scleroderma has been added.

Updated on 20 June 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 May 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 1 April 2019 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 1 April 2019 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

  • Update of Annex I Section 4.6 and 5.3 to add new information on pregnancy, fertility and lactation.

Updated on 7 August 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 7 August 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Updated on 18 July 2018 SmPC

Reasons for updating

  • File format updated to PDF

Legal category: Product subject to restricted prescription (C)

Updated on 5 June 2018 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update to section 4.6 under Pregnancy to introduce additional recommendation to perform a pregnancy test prior treatment with paclitaxel.

Updated on 5 June 2018 PIL

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision

Updated on 9 March 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to restricted prescription (C)

Updated on 9 March 2018 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update of Annex I, Annex IIIA and IIIB to extend the in-use shelf-life of the finished product - after dilution reconstitution:

Stability of the reconstituted product in vials and bags is extended from 8 to 24 hours when stored in either the vial or infusion bag at 2-8°C and protected from light.

Updated on 6 March 2018 PIL

Reasons for updating

  • New PIL for new product

Updated on 6 March 2018 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 14 February 2018 PIL

Reasons for updating

  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 22 November 2016 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

·         Annual PSUR in Europe covering 07 Jan 2015 to 06 Jan 2016 to add “clopidogrel” to Section 4.5 of the SmPC and section 2 of the PIL as an example of drugs known to interact with Cytochrome P450 isoenzymes inhibitors and inducers. In addition, minor editorial changes were made to section 4.5

·         Correction in section 5.2 of the smPC (range = 3.21%-37.70%).-37.70% replaced 27.70%

Updated on 18 November 2016 PIL

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 6 - date of revision

Updated on 8 September 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 August 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Update of section 4.2 to amend dose reduction recommendations for NSCLC patients with hepatic impairment

Updated on 17 March 2015 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

·          sections 4.1, 4.2, 4.4, 4.5, 4.8, 5.1 and 6.6 to add the new indication below and an instruction to flush the infusion line following ABX administration.

 

Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.

Updated on 6 March 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to side-effects
  • Change to further information section

Updated on 17 November 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

The following sections of the SPC have been changed:

·         Section 4.2 (dose adjustment in special populations)

·         Section 4.4 (warning for hepatic impairment)

·         Section 5.2 (added pharmacokinetic data)

·         Section 6.4 (additional information on special precautions for storage)

Updated on 7 November 2014 PIL

Reasons for updating

  • Change due to harmonisation of PIL
  • Correction of spelling/typing errors

Updated on 11 August 2014 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Details of HPRA added

Updated on 23 July 2014 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 28 April 2014 PIL

Reasons for updating

  • Change to dosage and administration

Updated on 27 April 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.2 - additional information regarding method of administration using an infusion set incorporating a 15 µm filter.

Section 6.6 - additional information regarding method of administration using an infusion set incorporating a 15 µm filter.

Updated on 24 February 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 2 -  update to the amount of sodium on the excipients section

Section 4.1 -  update to the therapeutic indications, now including metastatic adencarcinoma of the pancreas

Section 4.2

-         units change in breast cancer posology

-          Section added for pancreatic cancer posology

-          Pancreatic info added for pancreatic cancer indication in special populations, specifically older people and the paediatric  population

Section 4.3

-          Units change in neutrophil counts

Section 4.4

-          Units change in haematology section

-          Pancreatic combination dosing with gemcitabine added for neuropathy section

-          Sepsis section added and and pnemonitis section mover higher up

-          Patients ≥ 75 years section added

-          ‘Other’ section has been added comprising of pancreatic cancer info

-          Excipients section has been updated regarding the amount of sodium

Section 4.5

-          Section added regarding paclitaxel and gemcitabine, as these are used in combination in our pancreatic licence.

Section 4.8

-          The summary info has been updated to partition abraxane monotherapy (table 4) and abraxane with gemcitabine (table 5) for the breast cancer and pancreatic cancer indications respectively.

-          The skin and subcutaneous tissue disorder section has been updated with respect to info on alopecia

Section 5.1

-          Clinical data has been added for pancreatic cancer

Section  7

-          Manufacturing has been removed

Section 10

-          Date of revision of the text has been updated to 16/01/2014

Updated on 5 February 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Changes to therapeutic indications

Updated on 30 August 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

In section 4.2 "elderly population" has been replaced with "older people"
In section 4.8 (undesirable effects), atrioventricular block has been added, and the section "reporting of suspected adverse reactions" have been added.
In section 7 title "and manufacturer" has been added.

Updated on 3 April 2013 PIL

Reasons for updating

  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 7 February 2013 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

in section 4.8, cystoid macular edema and sepsis, neutropenic sepsis have been added.

Updated on 5 February 2013 PIL

Reasons for updating

  • Change of trade or active ingredient name
  • Change to warnings or special precautions for use
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to improve clarity and readability

Updated on 31 January 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

section 2

Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. [as opposed to "paclitaxel albumin"
Excipients "with known effect" added. "the full list" amended to "a full list"
section 4.2

"Abraxane should only be administered under the supervision of a qualified oncologist in units specialised in the administration of cytotoxic agents. It should not be substituted for or with other paclitaxel formulations." removed from the end of paragraph and added to the start

"impaired renal function" replaced with "renal impairment"
modified section on elderly population.
Paediatric population
"and adolescent aged 0-17 years" added
section 4.3
excipients - "listed in section 6.1" added
Lactation - "see section 4.6" added
 Cardiotoxicity section:"drugs" replaced with "medicinal products"
section 4.6 "treatment" added.
section 4.8
title added "summary of the safety profile"
this text was added:

Tabulated summary of adverse reactions

this text was deleted: from "blood and lymphatic system disorders" up to 6 paragraphs down "general disorders...40% of the patients"
this section was added after the table:

Description of selected adverse reactions

 

Blood and lymphatic system disorders

Neutropenia was the most notable important haematological toxicity (reported in 79% of patients), and was rapidly reversible and dose dependent; leukopenia was reported in 71% of patients. Grade 4 neutropenia (< 0.5 x 109/l) occurred in 9% of patients treated with Abraxane. Febrile neutropenia occurred in four patients on Abraxane. Anaemia (Hb < 10 g/dl) was observed in 46% of patients on Abraxane, and was severe (Hb < 8 g/dl) in three cases. Lymphopenia was observed in 45% of the patients.

 

Nervous system disorders

In general, the frequency and severity of neurotoxicity was dose‑dependent in patients receiving Abraxane. Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.

 

Gastrointestinal disorders

Nausea occurred in 29% of the patients and diarrhoea in 25% of the patients.

 

Skin and subcutaneous tissue disorders

Alopecia was observed in 90% of the patients treated with Abraxane.

 

Musculoskeletal and connective tissue disorders

Arthralgia occurred in 32% of patients on Abraxane and was severe in 6% of cases. Myalgia occurred in 24% of patients on Abraxane and was severe in 7% of cases. The symptoms were usually transient, typically occurred three days after Abraxane administration and resolved within a week.

 

General disorders and administration site conditions

Asthenia/Fatigue was reported in 40% of the patients.

start of section 5.1 was modified as follows:

Pharmacotherapeutic group: Antineoplastic agents, plant alkaloids and other natural products, taxanes, ATC Code: L01CD01

 

Mechanism of action

 

Paclitaxel is an antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilises microtubules by preventing depolymerisation. This stability results in the inhibition of the normal dynamic reorganisation of the microtubule network that is essential for vital interphase and mitotic cellular functions. In addition, paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

 

Abraxane contains human serum albumin‑paclitaxel nanoparticles of approximately 130 nm in size, where the paclitaxel is present in a non-crystalline, amorphous state. Upon intravenous administration, the nanoparticles dissociate rapidly into soluble, albumin bound paclitaxel complexes of approximately 10 nm in size. Albumin is known to mediate endothelial caveolar transcytosis of plasma constituents, and in vitro studies demonstrated that the presence of albumin in Abraxane enhances transport of paclitaxel across endothelial cells. It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp‑60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin‑binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).

 

Clinical efficacy and safety

 

Breast cancer ("carcinoma" deleted)

 

"229" patients replaced with number in letters: "Two hundred and twenty nine"
section 6.3
"3 years" formatting change only
section 6.4
"this medicinal does not require... conditions" replaced with "keep the vial in the outer carton in order to protect from light"
section 6.5
"(as paclitaxel albumin)" modified to "formulated as albumin bound nanoparticles"
section 6.6
"drug" to "medicinal product"
"(as paclitaxel albumin)" modified to "formulated as albumin bound nanoparticles"
last paragraph modified to:
"

The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, PVC or non‑PVC type intravenous bag. The use of specialized di(2-ethylhexyl)phthalate (DEHP)‑free solution containers or administration sets is not necessary to prepare or administer Abraxane infusions. In‑line filters should not be used.

"

Updated on 3 August 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

- Update of Section 4.4 to extend the hypersensitivity warning, specifically mentioning rare cases of anaphylactic reactions
- Update of Section 7 to remove the county name "Middlesex" from the address of the MAH Celgene Europe Ltd
- Update of Section 10 to include date of revision of the text

Updated on 31 July 2012 PIL

Reasons for updating

  • Change to MA holder contact details
  • Change to name of manufacturer

Updated on 6 June 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.4 (Special warnings and precautions for use) - paragraph added about pneumonitis
Section 4.8 (Undesirable effects) - section added after Table 1 regarding the incidence and occurance of pneumonitis

Updated on 30 April 2012 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 July 2011 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

Section 4.8 - Addition of Stevens-Johnson syndrome, toxic epidermal necrolysis as very rare side effects. Addition of Extravasation as a rare side effect.
Footnote under Table 1 added to state: "As reported in the postmarketing surveillance of Abraxane"

section 6.5 - Addition of generic drug name.

Section 6.6 - Addition of paragraph regarding extravasation and addition of generic drug name in third paragraph.

Section7.0 - Change of address

Section 10.0 - update to 07/2011

Updated on 22 July 2011 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 April 2011 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to restricted prescription (C)

Free text change information supplied by the pharmaceutical company

None provided