Summary of Product Characteristics
last updated on the eMC:
24/11/2009
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.
Updated on 24/11/2009 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 10-Nov-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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1) The indication has been updated to allow use of Januvia as add-on to insulin (with or without metformin) when diet and exercise plus stable dosage of insulin do not provide adequate glycaemic control.
2) The dosage section has been updated to include information on dosage with insulin.
3) The sub-section on hypoglycaemia in section "4.4 Special warnings and precautions for use" has been updated with regards to insulin.
4) In section 4.8 of the SPC, table 1 has been updated with side effects from a 24 week study with sitagliptin with or without metformin. Details of the trial have also been added to this section.
5) Section 5.1 has been updated with details from a 24-week placebo-controlled study designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1500 mg).
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Updated on 09/09/2009 and displayed until 24/11/2009
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 21-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.1, has been updated to include a restricted first-line indication
i.e. when metformin is inappropriate due to contraindications or intolerance.
The first paragraph in section 4.2 has been amended slightly to reflect the updated indication.
The following paragraph has been added to section 4.8:
"In an additional 24-week study of sitagliptin 100 mg once daily compared to metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin compared to metformin was 5.9 % and 16.7 %, respectively, primarily due to a higher incidence of gastrointestinal adverse reactions in the metformin group. In this study 0.6 % of patients treated with sitagliptin and 2.3 % of patients treated with metformin were discontinued due to adverse experiences considered as drug-related."
Also in section 4.8 under post-marketing experience, "cutaneous vasculitis" and "pancreatitis" have been added.
In section 5.1 further information has been added regarding a 24 week study to investigate the efficacy and safety of sitagliptin compared to metformin.
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Updated on 11/06/2009 and displayed until 09/09/2009
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 02-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 4.1 (Indications) has been expanded to include with the following addition:
For patients with type 2 diabetes mellitus in whom use of a PPARg agonist (i.e. a thiazolidinedione) is appropriate, Januvia is indicated:
· in combination with the PPARg agonist when diet and exercise plus the PPARg agonist alone, do not provide adequate glycaemic control.
· in combination with PPARγ agonist and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
Section 4.2 (Dosage) has been amended as follows:
The dose of JANUVIA is 100 mg once daily. The dosage of metformin and/or PPARg agonist should be maintained, and sitagliptin administered concomitantly.
Section 4.4 (Precautions)
The paragraph on "Hypoglycemia when used in combination with other anti-hyperglycaemic agents" has been updated as follows:
In clinical trials of JANUVIA as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i.e metformin and/or PPARγ agonistor pioglitazone), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo……
Section 4.8 (Side Effects) has been updated with data from a clinical trial where sitagliptin with a PPARg agent (rosiglitazone) and metformin where administered.
Section 4.9 (Overdose) has been updated to include the following information:
In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Section 5.1 (Pharmacodynamics) has been updated to include information on a two day study in healthy subjects to measure GLP-1 concentrations when administered sitagliptin alone, metformin alone and stigliptin and metformin together. Information on a 54 week placebo-controlled trial to evaluate the efficacy and safety of sitagliptin added to combination of rosiglitazone and metformin.
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Updated on 13/03/2008 and displayed until 11/06/2009
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Reasons for adding or updating:
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Update of sections 4.3, 4.4 and 4.8 of the Summary of Product Characteristics to include information on hypersensitivity reactions and exfoliative skin conditions including Stevens-Johnson syndrome.
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Updated on 17/01/2008 and displayed until 13/03/2008
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 12/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 has been revised to add a dual oral combination indication of sitagliptin with a sulphonylurea and to add a triple oral combination indication of sitagliptin with metformin and a sulphonylurea.
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Section 4.2 and 4.4 add information that use of Januvia with a sulphonylurea may require a lower dose of the sulphonylurea to reduce the risk of hypoglycaemia.
Section 4.8 updates the AE profile with those from the new indications and rearranges the side effects into a tabular format.
In addition there are updates of sections 4.8 and 5.1 to reflect the results of a new clinical trial of initial combination therapy of sitagliptin and metformin and there is additional information into 5.1 from the studies with a sulphonylurea. Information in 5.1 on placebo-controlled monotherapy and combination therapy studies is now presented in a tabular format and some editorial changes have been made in this section.
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Updated on 23/10/2007 and displayed until 17/01/2008
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 updated to include the following new information:
During post-marketing experience the following additional side-effects have been reported (frequency not known): hypersensitivity reactions, including anaphylaxis, angioedema, rash and urticaria.
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Updated on 27/04/2007 and displayed until 23/10/2007
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 19/04/2007 and displayed until 27/04/2007
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Reasons for adding or updating:
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