ARANESP PFS with needle guard

  • Name:

    ARANESP PFS with needle guard

  • Company:
    info
  • Active Ingredients:

    Darbepoetin alfa

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 11/12/19

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Summary of Product Characteristics last updated on medicines.ie: 11/12/2019

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Amgen Ltd

Amgen Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name AMGEVITA prefilled pen Active Ingredients adalimumab
Medicine Name AMGEVITA prefilled syringe Active Ingredients adalimumab
Medicine Name Aranesp PFS Active Ingredients Darbepoetin alfa
Medicine Name ARANESP PFS with needle guard Active Ingredients Darbepoetin alfa
Medicine Name Aranesp SureClick Active Ingredients Darbepoetin alfa
Medicine Name Blincyto Active Ingredients Blinatumomab
Medicine Name Imlygic Active Ingredients Talimogene laherparepvec
Medicine Name KANJINTI Active Ingredients Trastuzumab
Medicine Name Kyprolis Active Ingredients Carfilzomib
Medicine Name Mimpara Granules Active Ingredients cinacalcet hydrochloride
Medicine Name Mimpara tablets Active Ingredients cinacalcet hydrochloride
Medicine Name Neulasta On Body Injector Active Ingredients Pegfilgrastim
Medicine Name Neulasta Pre-Filled Syringe Active Ingredients Pegfilgrastim
Medicine Name Neupogen 30 MU (0.3 mg/ml) solution for injection Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 30 MU (0.6 mg/ml) Active Ingredients Filgrastim
Medicine Name Neupogen Singleject 48 MU (0.96 mg/ml) Active Ingredients Filgrastim
Medicine Name Nplate Active Ingredients Romiplostim
Medicine Name Parsabiv Active Ingredients etelcalcetide
Medicine Name Prolia Active Ingredients Denosumab
Medicine Name Repatha SureClick Active Ingredients Evolocumab
Medicine Name Vectibix Active Ingredients Panitumumab
Medicine Name XGEVA Active Ingredients Denosumab
1 - 0 of 22 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 11 December 2019 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4 Side Effects

CRF Patients:

Uncommon: may affect up to 1 in 100 people

  • Blood clots (thrombosis)
  • Convulsions (fits and seizures)
  • Bruising and bleeding at the site of injection
  • Blood clots in a dialysis access

 

Cancer patients

Very common: may affect more than 1 in 10 people

  • Allergic reactions
  • Fluid retention (oedema)

 

Common: may affect up to 1 in 10 people

  • High blood pressure (hypertension)
  • Blood clots (thrombosis)
  • Pain around the area injected
  • Rash and/or redness of the skin
  • Fluid retention (oedema)

 

Uncommon: may affect up to 1 in 100 people

  • Convulsions (fits and seizures)
  • Bruising and bleeding at the site of injection

 

All Patients:

Not known:

  • Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in association with epoetin treatment. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Aranesp if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2.
  • Bruising and bleeding at the site of injection

 

Date of revision of the text

November 2019

Updated on 11 December 2019 SmPC

Reasons for updating

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

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special Warnings and Precautions

The reported risk of thrombotic vascular events (TVEs) should be carefully weighed against the benefits to be derived from treatment with darbepoetin alfa particularly in patients with pre-existing risk factors for TVE, including obesity and prior history of TVEs (e.g., deep venous thrombosis, pulmonary embolism, and cerebral vascular accident).

 

And addition of the below to points to the “Cancer Patients” section:

  • an observed 9% increase in risk for PD or death in the epoetin alfa plus SOC group from a primary analysis and a 15% increased risk that cannot be statistically ruled out in patients with metastatic breast cancer receiving chemotherapy when administered to achieve a haemoglobin concentration range of 10 to 12 g/dL (6.2 to 7.5 mmol/L).
  • non-inferiority of darbepoetin alfa to placebo for overall survival and progression free survival in patients with advanced stage non-small cell lung cancer receiving chemotherapy when administered to a target haemoglobin of 12 g/dL (7.5 mmol/L) (see section 5.1).

Section 4.6 Pregnancy and Lactation

Breast-feeding

Women who become pregnant during Aranesp treatment are encouraged to enrol in Amgen’s Pregnancy Surveillance programme. Contact details are provided in section 6 of the Patient Information Leaflet.

 

It is unknown whether Aranesp is excreted in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Aranesp therapy taking into account the benefit of breast-feeding for the child and the benefit of

therapy for the woman.

 

Section 4.8 Undesirable Effects

To the CRF AE Table:

  • Addition of Dialysis Vascular Access Thrombosis as a Uncommon AE
  • Reclassification of Injection site bruising and Injection site haemorrhage as Uncommon AEs

Text added on the footnote of the table regarding specific AEs

 

To the Oncology AE Table:

  • Reclassification of Oedema as a Common AE
  • Reclassification of Injection site bruising and Injection site haemorrhage as Uncommon AEs

Text added on the footnote of the table regarding specific AEs

 

The frequency of all hypersensitivity reactions was estimated from clinical trial data as very common in CRF patients. Hypersensitivity reactions were also very common in the placebo groups. There have been reports, from post-marketing experience, of serious hypersensitivity reactions including anaphylactic reaction, angioedema, allergic bronchospasm, skin rash and urticaria associated with

darbepoetin alfa.

 

In CRF patients on haemodialysis, events of vascular access thrombosis (such as vascular access complication, arteriovenous fistula thrombosis, graft thrombosis, shunt thrombosis, arteriovenous fistula site complication, etc.) have been reported in post-marketing data. The frequency is estimated from clinical trial data as uncommon.

Section 5.1 Pharmacodynamic Properties

Cancer patients receiving chemotherapy

EPO-ANE-3010, a randomised, open-label, multicentre study was conducted in 2,098 anaemic women with metastatic breast cancer, who received first line or second line chemotherapy. This was a non inferiority study designed to rule out a 15% risk increase in tumour progression or death of epoetin alfa plus standard of care (SOC) as compared with SOC alone. At the time of clinical data cutoff, the

median progression free survival (PFS) per investigator assessment of disease progression was 7.4 months in each arm (HR 1.09, 95% CI: 0.99, 1.20), indicating the study objective was not met. Significantly fewer patients received RBC transfusions in the epoetin alfa plus SOC arm (5.8% versus

11.4%); however, significantly more patients had thrombotic vascular events in the epoetin alfa plus SOC arm (2.8% versus 1.4%). At the final analysis, 1,653 deaths were reported. Median overall survival in the epoetin alfa plus SOC group was 17.8 months compared with 18.0 months in the SOC

alone group (HR 1.07, 95% CI: 0.97, 1.18). The median time to progression (TTP) based on investigator-determined progressive disease (PD) was 7.5 months in the epoetin alfa plus SOC group and 7.5 months in the SOC group (HR 1.099, 95% CI: 0.998, 1.210). The median TTP based on IRCdetermined PD was 8.0 months in the epoetin alfa plus SOC group and 8.3 months in the SOC group (HR 1.033, 95% CI: 0.924, 1.156).

 

In a randomised, double-blind, placebo-controlled phase 3 study 2,549 adult patients with anaemia receiving chemotherapy for the treatment of advanced stage non-small cell lung cancer (NSCLC), were randomised 2:1 to darbepoetin alfa or placebo and treated to a maximum Hb of 12 g/dL. The

results showed non-inferiority for the primary endpoint of overall survival with a median survival for darbepoetin alfa versus placebo of 9.5 and 9.3 months, respectively (stratified HR 0.92; 95% CI: 0.83– 1.01). The secondary endpoint of progression free survival was 4.8 and 4.3 months, respectively

(stratified HR 0.95; 95% CI: 0.87–1.04), ruling out the pre-defined 15% risk increase.

Date of revision of the text

November 2019

Updated on 3 August 2018

Updated on 17 October 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 October 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 October 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

information update to administration in section 4.2
Update with new AEs in Section 4.8
Date of revision changed to September 2017

Updated on 17 October 2017 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 September 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 1 September 2017 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 Addition of severe cutaneous adverse reactions
Section 4.8 Addition of severe cutaneous adverse reactions
Section 10 date of revision updated to August 2017

Updated on 10 April 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 5 October 2015 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 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2 Language around utilisation of lowest possible dose has been strengthened

Section 4.4 Text added around investigation of causes for non-responders

Section 5.1 Addition of result from post-hoc analysis data

Section 10 Date of revision of the text updated to September 2015

Updated on 5 October 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change to dosage and administration

Updated on 30 July 2015 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided

Updated on 30 July 2015 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 24 September 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 14 August 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 5 March 2013 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 30 January 2012 PIL

Reasons for updating

  • Change to improve clarity and readability

Updated on 14 December 2011 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to improve clarity and readability

Updated on 25 May 2011 PIL

Reasons for updating

  • New PIL for new product