Last Updated on eMC 23-08-2017 View medicine  | Biogen Idec Ltd Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Reasons for adding or updating:

  • Change to section 7 - Marketing authorisation holder

Date of revision of text on the SPC:31-07-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

7. MARKETING AUTHORISATION HOLDER

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects

Date of revision of text on the SPC:30-06-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



·         Summary of Product Characteristics (SmPC)

Location

Update

SmPC, section 4.8 Undesirable effects

Hepatobiliary disorders:

Uncommon:        Elevated liver enzymes*

Rare:      Elevated liver enzymes, aAutoimmune hepatitis

SmPC, section 4.8 Undesirable effects

Elevated liver enzymes

In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon). In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of adverse events of elevated liver enzymes was 4.18% (frequency common).

   

Reasons for adding or updating:

  • 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 6.1 - List of excipients
  • 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
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration

Date of revision of text on the SPC:31-05-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

50 mg solution for injection in pre-filled syringe

Each pre-filled syringe contains 50 mg of etanercept in a total volume of 1 ml.

 

50 mg solution for injection in pre-filled pen

Each pre-filled pen contains 50 mg of etanercept in a total volume of 1 ml.

 

 

Reasons for adding or 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:30-01-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

In section 4.1, Juvenile Idiopathic Arthritis, Pediatric plaque psoriasis, enthesitis-related arthritis and Psoriatic Arthritis added. Consequential updates were implemented in other impacted sections of the SPC.

Reasons for adding or 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 4.8 - Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Date of revision of text on the SPC:28-06-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



In section 4.2 and in Section 4.8, under the subtitle "special populations", "elderly (above 65 years)" was changed to state "elderly".

In Section 4.4 Special warnings and precautions for use, the text highlighted in red was added.

Congestive heart failure
Physicians should use caution when using Benepali in patients who have congestive heart failure (CHF). There have been postmarketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking Etanercept.
There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. Some of these patients have been under 50 years of age. Two large clinical trials evaluating the use of Etanercept in the treatment of CHF were terminated early due to lack of efficacy. Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Etanercept treatment.

In section 4.8 Undesirable effects: "Worsening of congestive heart failure" was changed to "Congestive heart failure".

Section 5.1, under the subheader "Adult patients with non-radiographic axial spondyloarthritis" was updated due to new originator etanercept data as indicated below. The strike through text was deleted and purple text added. Section 5.1, under the subheader "Adult patients with non-radiographic axial spondyloarthritis" was updated due to new originator etanercept data as indicated below. The strike through text was deleted and purple text added.

MRIs  of  the  sacroiliac joint and spine were obtained to assess inflammation at  baseline  and  at  week  12.  The double-blind period was followed by an open- label period during which all patients receive etanercept 50 mg weekly for up to an additional 92 weeks.  

MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104.

 

 

 

 

 

 

 

 

In Section 5.2, formatting changes only occurred to introduce a line space was added between text and subheaders

 

 

 

 

 

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation

Date of revision of text on the SPC:28-03-2016

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



4.8    Fertility, pregnancy and lactation


Women of childbearing potential

Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy.

 

Pregnancy

Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept. A higher rate of major birth defects was observed in an observational study comparing pregnancies exposed to etanercept during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists (adjusted odds ratio 2.4, 95% CI: 1.0-5.5). The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified. No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed. Benepali is not recommended during pregnancy.

 

Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with etanercept during pregnancy. The clinical impact of this is unknown, however, infants may be at increased risk of infection. Administration of live vaccines to infants for 16 weeks after the mother’s last dose of Benepali is generally not recommended.

 

Reasons for adding or updating:

  • New SPC for new product

Date of revision of text on the SPC:01-01-0001

Legal Category:POM

Black Triangle (CHM): YES