Last Updated on eMC 12-07-2018 View medicine  | AstraZeneca UK 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 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:28-06-2018

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 2 & 3 - admin/editorial changes
Section 4.2 – Renal impairment dosing – no dose adjustment needed for GFR<45mL/min. Dose reduced to 2.5mg for patients with GFR<45mL/min.
Section 4.4 –In patients with GFR<45mL/min recommended dose is 2.5mg.
Section 4.8 – MHRA AE reporting updated
Section 5.2 – Study results for renal impairment patients updated
Sections 6.1, 6.5 & 8 – admin/editorial changes

Reasons for adding or updating:

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

Date of revision of text on the SPC:26-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Section 4.8- UK Reporting details amended to be aligned with Appendix V of QRD template

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • Change to section 10 - Date of revision of the text
  • Correction of spelling/typing errors
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC:26-06-2017

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.1 Indication text re-written to reflect new text in section 5.1.

Section 4.2 Minor editorial changes

Section 4.5 Minor editorial update.

Section 4.8 Minor editorial update including correction of spelling.

Section 5.1 information on ‘saxagliptin add on to dapagliflozin plus metformin therapy ‘added  and also information on ‘saxagliptin and dapagliflozin added on to metformin therapy’ added. Some text repositioned within this section.

Section 5.2 Minor editorial update.

Section 9 correction of date of first authorisation

Section 10- revision of date of update

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:28-04-2016

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 5.1 Savor all cause mortality data included.

Section 10 Revision date updated.

Reasons for adding or 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

Date of revision of text on the SPC:01-10-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.4 –updated text on cardiac failure warnings.

Section 4.4 – addition of arthalgia warning.

Section 4.8 – addition of footnote referring to section 4.4 for arthalgia side effect.

Section 10 – date of revision updated.

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:24-04-2015

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 4.8 – Add constipation as unknown frequency a side effect. Update MT ADR reporting address in line with QRD Template.

Section 10 – Update to revision date.

Reasons for adding or updating:

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

Date of revision of text on the SPC:15-10-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 7 MAH change 
- Section 10 revision date

Reasons for adding or updating:

  • Change to section 1 - Name of the medicinal product
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:24-07-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 1: data presented in line with QRD wording

- Section 4.2: Elderly populations and renal impairment wording updated in line with SAVOR study.

- Section 4.2: Method of administration section updated in line with Renewal changes.

- Section 4.4: Elderly populations, renal impairment, cardiac failure wording updated in line with SAVOR study.

- Section 4.5: Text reordered.

- Section 4.7: wording updated in line with QRD text during renewal.

- Section 4.8: Text updated in line with SAVOR study

- Section 4.8: AE reporting wording updated.

- Section 4.9: Overdose wording updated in line with Renewal changes.

- Section 5.1: updated in line with SAVOR study.
- Section 10 Updated date of revision

Reasons for adding or updating:

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

Date of revision of text on the SPC:26-06-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.4 Acute Pancreatitis text added
- Section 10 updated date of revision

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.8 - Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:23-04-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



 

- Section 4.8 Additon of ‘Diarrhoea’ in Table 2 and associated footnote
- Section 4.8 Amended IMB address details for AE reporting

- Seciton 10 Revision date

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

Date of revision of text on the SPC:26-07-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.1 – addition of monotherapy indication

-Section 4.2 – change of wording ‘elderly’ to ‘older people’

- Section 4.8 – change from 10.2% to 10.1% under the sub-heading Hypoglycaemia

                     – addition of Adverse event reporting wording as per Appendix 5

- Section 5.1 – addition of the following text: (see Table 3). The findings of these studies were confirmed with two subsequent 24‑week regional (Asian) monotherapy studies comparing saxagliptin 5 mg with placebo.

-Section 5.2 – change of wording ‘elderly’ to ‘older people’

- Section 10 – updated date of revision

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:23-05-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 4.8 – information provided in ‘Post marketing experience from clinical trials and spontaneous reports’ under Table 2; addition of ‘Abdominal pain’ and frequency ‘Unknown’

- Section 10 – updated date of revision

Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Date of revision of text on the SPC:18-02-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



- Section 2 – administrative changes to comply with EU template


- Section 4.1 – addition of Triple Oral Therapy indication


- Section 4.2 – modified to include advice not to split of cut tablets and also when using Onglyza in combination with insulin or sulphonylurea


- Section 4.3 – cross reference to section 6.1 included


- Section 4.5 – combined oral contraceptive included in list of products that Onglyza does not meaningfully alter the pharmacokinetics of


- Section 4.6 – typographical change


- Section 4.7 – advice included to warn patients of the risk of hypoglycaemia when used in
combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas)


- Section 4.8 – information provided in description of selected adverse reactions when Onglyza used as an add-on to metformin plus a sulphonylurea; additional information regarding hypoglycaemia


- Section 5.1 additional information regarding Onglyza add-on combination therapy with metformin and sulphonylurea; Additional study data included in Table 3


- Section 6.6 – minor update to comply with EU-template


- Section 10 – updated date of revision

 

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC:22-12-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Removal of Black Triangle

No other changes.

Reasons for adding or 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

Date of revision of text on the SPC:22-12-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.4

 

Additional Text

 

Pancreatitis

In post-marketing experience there have been spontaneously reported adverse reactions of acute pancreatitis. Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. Resolution of pancreatitis has been observed after discontinuation of saxagliptin. If pancreatitis is suspected, Onglyza and other potentially suspect medicinal products should be discontinued.

 

 

Section 4.8

 

Table 2           Frequency of additional adverse reactions by system organ class

 

Addition of:

 

Gastrointestinal disorders

Nausea                                    Common

Pancreatitis                             Uncommon

 

Dermatitis                                Uncommon

Pruritus                                    Uncommon

 

 

Section 10

 

Date of revision changed to 22nd December 2011

 

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
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:22-11-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.1

 

New paragraph added

 
·         in combination with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.

 

 

Section 4.2

 

Addition of word insulin to first paragraph.

 

 

Section 4.4

 

General

 

New paragraph added.

 

 Onglyza is not a substitute for insulin in insulin‑requiring patients.

 

Hepatic impairment

 

Text amended to:

 

Use with medicinal products known to cause hypoglycaemia

Sulphonylureas and insulin are known to cause hypoglycaemia. Therefore, a lower dose of sulphonylurea or insulin may be required to reduce the risk of hypoglycaemia when used in combination with Onglyza.  

 

Section 4.8

 

New Paragraph added before “Investigations” paragraph

 

When used as add‑on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for Onglyza 5 mg and 19.9% for placebo.

 

Section 5.1

 

New paragraph added after paragraph 10

 

Saxagliptin add‑on combination therapy with insulin (with or without metformin)

A total of 455 patients with type 2 diabetes participated in a 24‑week randomised, double‑blind, placebo‑controlled study to evaluate the efficacy and safety of saxagliptin in combination with a stable dose of insulin (baseline mean: 54.2 Units) in patients with inadequate glycaemic control (HbA1c ≥ 7.5% and ≤ 11%) on insulin alone (n=141) or on insulin in combination with a stable dose of metformin (n=314). Saxagliptin 5 mg add‑on to insulin with or without metformin provided significant improvements after 24 weeks in HbA1c and PPG compared with placebo add‑on to insulin with or without metformin. Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add‑on to insulin regardless of metformin use (−0.4% for both subgroups). Improvements from baseline HbA1c were sustained in the saxagliptin add‑on to insulin group compared to the placebo add‑on to insulin group with or without metformin at Week 52. The HbA1c change for the saxagliptin group (n=244) compared to placebo (n=124) was ‑0.4% at Week 52.

 

Paragraph 12 Text amended to:

 

Patients with renal impairment

A 12 week, multi-centre, randomised, double-blind, placebo controlled study was conducted to evaluate the treatment effect of saxagliptin 2.5 mg once daily compared with placebo in 170 patients (85 patients on saxagliptin and 85 on placebo) with type 2 diabetes (HbA1c 7.0-11%) and renal impairment (moderate [n=90]; severe [n=41]; or ESRD [n=39]). In this study, 98.2% of the patients received other antihyperglycaemic treatments (75.3% on insulin and 31.2% on oral antihyperglycaemics; some received both). Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo). Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however the number of patients who completed 52 weeks without modification of other antihyperglycaemic treatments was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group). The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups. There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.

 

Table 3

 

Add-on Combination Studies updated.

 

New Paragraph at end of Section 5.1

 

Paediatric population

The European Medicines Agency has deferred the obligation to submit the results of studies with Onglyza in one or more subsets of the paediatric population in the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).

 

 

Section 10

 

Date of revision changed to 22nd November 2011

 

European Medicines Agency website address updated.

Reasons for adding or updating:

  • Change to section 4.3 - Contraindications
  • 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

Date of revision of text on the SPC:24-10-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.3

 

 Additional text.

 

or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl peptidase 4 (DPP4) inhibitor (see sections 4.4 and 4.8).

 

Section 4.4

 Addition of new text

 

During postmarketing experience, including spontaneous reports and clinical trials, the following adverse reactions have been reported with the use of saxagliptin: serious hypersensitivity reactions, including anaphylactic reaction, anaphylactic shock, and angioedema. If a serious hypersensitivity reaction to saxagliptin is suspected, discontinue Onglyza, assess for other potential causes for the event, and institute alternative treatment for diabetes (see sections 4.3 and 4.8).

 

 

Section 4.8

New text and table (2)

 

Deletion of text under ‘Description of selected adverse reactions’.

 

In addition to the adverse reactions described above, adverse events reported regardless of causal relationship to the medicinal product and occurring more commonly in patients treated with Onglyza include hypersensitivity (0.6% vs. 0%) and rash (1.4% vs. 1.0%) as compared with placebo.

 

Section 10

Date of revision updated to 24th October 2011.

Reasons for adding or updating:

  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:02-03-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



SPC Changes Onglyza 2.5mg & 5mg film coated tablets

 

Section 1

 

Addition of 2.5mg dose, now reads as,

 

“Onglyza2.5 mg film‑coated tablets

Onglyza5 mg film‑coated tablets”

 

Section 2

Addition of details for 2.5mg dose, now reads as,

 

” Each tablet contains 2.5 mg saxagliptin (as hydrochloride).

 

Each tablet contains 5 mg saxagliptin (as hydrochloride).

 

Excipients:

Each tablet contains 99 mg lactose monohydrate.

For a full list of excipients, see section 6.1.”

 

Section 3

Additional of 2.5mg dose, now reads as,

 

” Film‑coated tablet (tablet).

 

Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with “2.5” printed on one side and “4214” printed on the other side, in blue ink.

 

Onglyza 5 mg tablets are pink  , biconvex, round, film‑coated tablet, with “5” printed on one side and “4215” printed on the other side, in blue ink.”

 

Section 4.2

Text changes to Special populations, renal impairment, Elderly and Paediatric population, now reads as,

 

Posology

Add‑on combination therapy

The recommended dose of Onglyza is 5 mg once daily as add‑on combination therapy with metformin, a thiazolidinedione or a sulphonylurea. 

 

The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione, or with metformin and a sulphonylurea, has not been established.

 

Special populations

Elderly (≥65 years)

No dose adjustment is recommended based solely on age. Experience in patients aged 75 years and older is very limited and caution should be exercised when treating this population (see also sections 4.4, 5.1 and 5.2.

 

Renal impairment

No dose adjustment is recommended for patients with mild renal impairment.  

The dose of Onglyza should be reduced to 2.5 mg once daily in patients with moderate or severe renal impairment.

 

The experience in patients with severe renal impairment is very limited. Therefore, saxagliptin should be used with caution in this population. Onglyza is not recommended for patients with end-stage renal disease (ESRD) requiring haemodialysis (see section 4.4).

 

Because the dose of Onglyza should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of Onglyza, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.4 and 5.2).

 

Hepatic impairment

No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2). Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).

 

 

Paediatric population

The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established.No data are available.

 

Method of administration

Onglyza can be taken with or without a meal at any time of the day. If a dose is missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day. ”

 

Section 4.4

Change to first paragraph and addtiional second paragraph, ”Renal impairment”, these paragraphs now reads as,

 

General

Onglyza should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

 

Renal impairment

A single dosage adjustment is recommended in patients with moderate or severe renal impairment. Saxagliptin should be used with caution in patients with severe renal impairment, and is not recommended for use in patients with end-stage renal disease (ESRD) requiring haemodialysis. Assessment of renal function is recommended prior to initiation of Onglyza, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.2 and 5.2).”

 

Section 4.7

Second paragraph, second line, word ”operating” now ”using”.

 

Section 4.8

Under paragraph, Tabulated list of adverse reactions, changes made to first paragraph, now reads as,

 

” Tabulated list of adverse reactions

 

Adverse reactions reported in ≥5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥2% of patients treated with saxagliptin 5 mg and ≥1% more frequently compared to placebo are shown in Table 1.

 

The adverse reactions are listed by system organ class and absolute frequency. Frequencies are defined as Very common (³ 1/10), Common (³ 1/100 to <1/10), Uncommon (³ 1/1,000 to 1/100), Rare (³ 1/10,000 to 1/1,000), or Very rare (<1/10,000), not known (cannot be estimated from the available data).”

 

Table 1:  Heading change from General disorders to, ”General disorders and administration site conditions

 

Paragraph heading Laboratory tests now ”Invstigations”

 

Section 5.1

Text changes to first paragraph, now reads as,

 

” Pharmacotherapeutic group: Drugs used in diabetes. Dipeptidyl peptidase 4 (DPP‑4) inhibitors, ATC code: A10BH03”

 

New heading and text, Patients with renal impairment, reads as,

 

” Patients with renal impairment

A 12 week, multi-centre, randomised, double-blind, placebo controlled study was conducted to evaluate the treatment effect of saxagliptin 2.5 mg once daily compared with placebo in 170 patients (85 patients on saxagliptin and 85 on placebo) with type 2 diabetes (HbA1c 7.0-11%) and renal impairment (moderate [N=90]; severe [N=41]; or ESRD [N=39]). In this study, 98.2% of the patients were treated with other antihyperglycaemic medication (75.3% on insulin and 31.2% on oral antihyperglycaemic drugs; some received both). Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo). Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however the number of patients who completed 52 weeks without modification of other antihyperglycaemic medications was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group). The incidence of confirmed hypoglycaemic events was somewhat higher in the saxagliptin group (9.4%) versus placebo group (4.7%) although the number of subjects with any hypoglycaemic event did not differ between the treatment groups. There was no adverse effect on renal function as determined by estimated glomerular filtration rate or CrCL at Week 12 and Week 52.”

 

 

Section 6.1

Additional text to film coating, now reads as,

 

Film coating:
Polyvinyl alcohol
Macrogol/3350
Titanium dioxide (E171)
Talc (E553b)
Iron oxide red (E172) 5 mg Tablets only

Iron oxide yellow (E172) 2.5 mg Tablets only

Printing ink:

Shellac

Indigo carmine aluminium lake (E132)”

 

Section 6.5

Additional information for 2.5mg dose, reads as,

 

” 2.5 mg Tablets

Alu/Alu blister.

Pack sizes of 14, 28, and 98 film‑coated tablets in non‑perforated calendar blisters.

Pack sizes of 30x1 and 90x1 film‑coated tablets in perforated unit dose blisters.

Not all pack sizes may be marketed.”

 

Section 8

New first paragraph for 2.5mg dose, now reads as,

 

” EU/1/09/545/012 - Onglyza 2.5 mg film-coated tablet oral use non-perforated calendar blister (Alu/Alu)-28 tablets”

 

Section 9

Now reads as,

 

“5 mg Tablets- 1st October 2009

2.5 mg Tablets – 2nd March 2011”

 

Section 10

Now reads as,

 

“2nd March 2011”

 

 

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:06-09-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



SPC Changes – Onglyza 5mg Tablets

 

Section 5.1

 

Two new paragraphs (6th and 7th) in sub-section ‘Clinical safety and efficacy’ reads as,

 

”Saxagliptin add-on to metformin compared with SU add-on to metformin

A 52‑week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (428 patients) compared with sulphonylurea (glipizide, 5 mg titrated as needed to 20 mg, mean dose of 15 mg) in combination with metformin (430 patients) in 858 patients with inadequate glycaemic control (HbA1c 6.5%‑10%) on metformin alone. The mean metformin dose was approximately 1900 mg in each treatment group. After 52 weeks, the saxagliptin and glipizide groups had similar mean reductions from baseline in HbA1c in the per-protocol analysis (‑0.7% vs. –0.8%, respectively, mean baseline HbA1c of 7.5% for both groups). The intent-to-treat analysis showed consistent results. The reduction in FPG was slightly less in the saxagliptin-group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study. Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide. Patients treated with saxagliptin exhibited a significant decrease from baseline in body weight compared to a weight gain in patients administered glipizide (-1.1 vs. +1.1 kg).

 

Saxagliptin add-on to metformin compared with sitagliptin add-on to metformin

An 18‑week study was conducted to evaluate the efficacy and safety of saxagliptin 5 mg in combination with metformin (403 patients), compared with sitagliptin 100 mg in combination with metformin (398 patients) in 801 patients with inadequate glycaemic control on metformin alone. After 18 weeks, saxagliptin was non-inferior to sitagliptin in mean reduction from baseline in HbA1c in both the per-protocol and the full analysis sets . The reductions from baseline in HbA1c respectively for saxagliptin and sitagliptin in the primary per-protocol analysis were ‑0.5% (mean and median) and ‑0.6% (mean and median). In the confirmatory full analysis set, mean reductions were ‑0.4% and ‑0.6% respectively for saxagliptin and sitagliptin, with median reductions of ‑0.5% for both groups.”

 

 

Section 10, Date of revision of text

6th September 2010

 

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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC:02-07-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Section 4.1

Additional text ‘aged 18 years and older’

Add‑on combination therapy

Onglyza is indicated in adult patients aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control:

 

Section 4.2

Change of text under heading  ‘Paediatric population’:

The safety and efficacy of Onglyza in children aged birth to < 18 years have not yet been established: no data are available.

 

Section 4.6

Change of text under heading ‘Pregnancy’:

The use of saxagliptin has not been studied in pregnant women. Studies in animals have shown reproductive toxicity at high doses (see section 5.3). The potential risk for humans is unknown. Onglyza should not be used during pregnancy unless clearly necessary.

 

New sub heading  and text for ‘Fertility’

Fertility

The effect of saxagliptin on fertility in humans has not been studied. Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity (see section 5.3).

 

Section 4.7

Additional text:

Onglyza may have a negligible influence on the ability to drive and use machines.

 

Section 5.1

updated to include the addition of the long-term data for the following trials:
- Saxagliptin add on to metformin therapy
- Saxagliptin in combination with metformin as initial therapy
- Saxagliptin add on to glibenclamide therapy
- Saxagliptin add on to thiazolidinedione therapy

 
Section 10

New revision date of text: 2nd July 2010

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