Last Updated on eMC 18-10-2017 View medicine  | Roche Products Limited 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 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:25-09-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



4.8       Undesirable effects

 

[ … ]

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions (see details below).

 

Ireland

HPRA Pharmacovigilance

Earlsfort Terrace

IRL - Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

 

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

United Kingdom

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

 

 

 

6.4     Special precautions for storage

 

Blisters:

Store in the original package in order to protect from moisture.

 

Bottles:

Store in the original package and keep the bottle tightly closed in order to protect from moisture.

 

6.5       Nature and contents of container

 

Aluminium/aluminium (PA/Alu/PVC/Alu) perforated blisters containing 8 hard capsules.

Pack size: 224 (4 packs of 56) hard capsules.

 

HDPE bottle with a child-resistant closure and an integrated desiccant.

Pack size: 240 hard capsules.

 

Not all pack sizes may be marketed.

 

 

 

8.       MARKETING AUTHORISATION NUMBER(S)

 

EU/1/16/1169/001

EU/1/16/1169/002

 

10.     DATE OF REVISION OF THE TEXT

 

25 September 2017

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:09-06-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Underlined text has been added:

 

4.8       Undesirable effects

 

Summary of the safety profile

 

The safety of Alecensa has been evaluated in 253 patients in pivotal phase II clinical trials (NP28761, NP28673) with ALK-positive non-small cell lung cancer (NSCLC) treated with the recommended dose of 600 mg twice daily. The median duration of exposure to Alecensa was 11 months.

 

The most common adverse drug reactions (ADRs) (≥ 20%) were constipation (36%), oedema (34%, including oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema), myalgia (31%, including myalgia and musculoskeletal pain) and nausea (22%).

 

Tabulated list of adverse drug reactions

Table 3 summarises the ADRs occurring in patients who received Alecensa in pivotal clinical trials and during post-marketing.

 

The ADRs listed in Table 3 are presented by system organ class and frequency categories, defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

 

Table 3 Summary of ADRs occurring in patients treated with Alecensa in pivotal phase II clinical trials (NP28761, NP28673) and during post-marketing

 

System organ class

    ADRs (MedDRA)

Alecensa

N=253

 

All grades

(%)

Frequency category (all grades)

Grades 3-4*

(%)

Blood and lymphatic system disorders

 

 

 

    Anaemia1)

16

Very common

2.0

Eye disorders

 

 

 

    Vision disorders2)

12

Very common

0

Cardiac disorders

 

 

 

    Bradycardia3)

7.9

Common

0

Respiratory, thoracic and mediastinal disorders

 

 

 

    Interstitial lung disease / pneumonitis

0.4

Uncommon

0.4

Gastrointestinal disorders

 

 

 

    Diarrhoea

18

Very common

1.2

    Vomiting

13

Very common

0.4

    Constipation

36

Very common

0

    Nausea

22

Very common

0.4

Hepatobiliary disorders

 

 

 

    Drug-induced liver injury4)

0.8

Uncommon

0.8

    Increased AST

16

Very common

2.8

    Increased ALT

14

Very common

3.2

    Increased bilirubin5)

17

Very common

3.2

    Increased alkaline phosphatase**

7.5

Common

0.4

Skin and subcutaneous tissue disorders

 

 

 

    Rash6)

20

Very common

0.4

    Photosensitivity

12

Very common

0

Musculoskeletal and connective tissues disorders

 

 

 

    Myalgia7)

31

Very common

1.2

    Increased blood creatine phosphokinase

13

Very common

3.6

Renal and urinary disorders

 

 

 

    Blood creatinine increased

6.7

Common

0.4

General disorders and administration site conditions

 

 

 

    Oedema8)

34

Very common

0.8

* No Grade 5 events observed

**Increased alkaline phosphatase was reported in the post-marketing period. Cases were also reported in pivotal Phase II clinical trials NP28761 and NP28673.

1) includes cases of anaemia and haemoglobin decreased

2) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, and diplopia

3) includes cases of bradycardia and sinus bradycardia

4) includes one patient with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy

5) includes cases of blood bilirubin increased, hyperbilirubinaemia and bilirubin conjugated increased

6) includes cases of rash, rash maculopapular, dermatitis acneiform, erythema, rash generalised, rash papular, rash pruritic and rash macular

7) includes cases of myalgia and musculoskeletal pain

8) includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema

 

10.     DATE OF REVISION OF THE TEXT

 

09 June 2017

 

Reasons for adding or updating:

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

Date of revision of text on the SPC:18-04-2017

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



6.3 Shelf-life

Updated from 2 to 3 years

10 Date of Revision of Text

18 April 2017

 

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