Updated on 12/03/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 23-Feb-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
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Free-text change information supplied by the pharmaceutical company
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A number of editorial changes have been made to the SmPC. The main changes are detailed below:
To section 4.6 the title has changed to "Fertility, pregnancy and lactation" and a new statement on fertility has been added:
"Fertility
Animal data do not suggest an effect of treatment with sitagliptin on male and female fertility. Human data are lacking."
This is standard statement is part of the QRD template for SmPCs.
To section 4.8 "Undesirable effects", the following statement has been added to the beginning of this section:
"Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported. Hypoglycemia has been reported in combination with sulphonylurea (4.7%-13.8%) and insulin (9.6%)."
To the tabulated list "interstitial lung disease" has been added as a new adverse reaction with "frequency unknown" when sitagliptin is used alone, and in dual or triple therapy.
To the tabulated list of adverse reactions the following changes have been made: "upper respiratory tract infections" has been added as "common" with a PPARγ agonist and metfromin; "hypoglycaemia" has been added as "common" with metformin; "flatulence" has been added as "common", "constipation" has been added as "uncommon" and "vomiting" has been added as "common" with metformin; "blood glucose decreased" has been added as common with a PPARγ agonist.
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Updated on 20/01/2012 and displayed until 12/03/2012
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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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 5.1 - Pharmacodynamic Properties
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Change to section 5.2 - Pharmacokinetic Properties
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Introduction of new strength
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| Date of revision of text on the SPC: 22-Dec-2011 |
| Legal Category: POM |
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A change has been made to the dosage regimen for renally impaired patients which necessitates lower tablet strengths of 25mg and 50 mg which will become available.
Specific wording changes are:
To section 4.2 Posology and method of administration the following has been added:
"Renal impairment
When considering the use of sitagliptin in combination with another anti-diabetic product, its conditions for use in patients with renal impairment should be checked.
For patients with mild renal impairment (creatinine clearance [CrCl]
50 ml/min), no dose adjustment for Januvia is required.
For patients with moderate renal impairment (CrCl
30 to <50 mL/min), the dose of Januvia is 50 mg once daily.
Clinical study experience with Januvia in patients with moderate or severe renal impairment is limited. Therefore, use of Januvia is not recommended in this patient population (see section 5.2).
To section 4.4, the sub-section on renal impairment has been updated:
Renal impairment
Januvia is renally excreted. To achieve plasma concentrations of Januvia similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal impairment, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
When considering the use of sitagliptin in combination with another anti-diabetic product, its conditions for use in patients with renal impairment should be checked.
As the experience is limited, patients with moderate to severe renal impairment should not be treated with Januvia (see section 5.2).
Section 5.1 has been updated with information on three studies in patients with moderate to severe renal impairment, patients with ESRD who were on dialysis, and patients with type 2 diabetes and chronic renal impairment.
To section Section 5.2, the sub-section on renal impairment has been updated to include the statement:
"To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with moderate and severe renal impairment, as well as in ESRD patients requiring dialysis."
In addition to the above changes, as the SmPC now contains the 25 mg and 50 mg tablet strengths as well as the 100 mg tablet. Sections 1, 2 ,3 and 8 have been updated to reflect this.
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Updated on 15/09/2011 and displayed until 20/01/2012
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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: 24-Aug-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
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To section 4.8 of the SmPC arthralgia and myalgia were added as adverse drug reactions. In addition, section 4.8 was re-structured. The adverse reactions identified from clinical studies and from post-marketing experience are presented in one table with reduced footnotes in order to present clearer safety information.
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Updated on 10/02/2011 and displayed until 15/09/2011
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Reasons for adding or updating:
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 26-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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Updated on 04/01/2011 and displayed until 10/02/2011
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Reasons for adding or updating:
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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: 26-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
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To section 4.4, the following sub-section has been added on pancreatitis:
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 sitagliptin (with or without supportive treatment), but very rare cases of necrotizing or haemorrhagic pancreatitis and/or death have been reported. If pancreatitis is suspected, Januvia and other potentially suspect medicinal products should be discontinued.
To section 4.8. "Undesirable Effects", and under the sub-section "Post marketing data", the statement on pancreatitis f has been expanded:
acute pancreatitis, including fatal and non-fatal haemorrhagic and necrotizing pancreatitis (see section 4.4);
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Updated on 24/11/2010 and displayed until 04/01/2011
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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: 03-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
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| Section 4.8: "Vomiting" has been added as a side-effect seen with post-marketing experience.
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Updated on 25/08/2010 and displayed until 24/11/2010
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 06-Aug-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
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To section 4.8. "Undesirable Effects", the following has been added in the post-marketing section in line with of adverse events reports :
"….impaired renal function, including renal failure (sometimes requiring dialysis)".
To sections 4.1 Contraindications, 4.2 Posology and method of administration, 4.5 Interactions with other medicinal products and other interactions, 4.6 Fertility, pregnancy and lactation, 4.7 Effects on ability to drive and operate machines, 4.9 overdose, 5.1 pharmacodynamics properties and 5.2 pharmacokinetic properties, editorial changes have been made in line with the latest guidance from the CHMP on drafting SmPCs.
To Section 4.5 Interactions with other medicinal products and other interactions, the following text is added:
"In addition, patients should be alerted to the risk of hypoglycaemia when Januvia is used in combination with sulphonylurea agents or with insulin."
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Updated on 24/11/2009 and displayed until 25/08/2010
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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):
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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):
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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.
S
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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