Xultophy 100 units/ml + 3.6 mg/ml solution for injection
*Company:
Novo Nordisk LimitedStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 03 October 2024
File name
Xultophy-SmPC-IE-ver18-Sep2024-cl.pdf
Reasons for updating
- Correction of spelling/typing errors
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 01 October 2024
File name
Xultophy-SmPC-IE-ver18-Sep2024-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Addition of a paragraph on Aspiration in association with general anaesthesia or deep sedation to Section 4.4.
Updated on 01 October 2024
File name
Xultophy PIL-09-2024-v11-cl.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
Free text change information supplied by the pharmaceutical company
-Addition of the following sentence to Section 2, Warnings and precautions:
If you know that you are due to have surgery where you will be under anesthesia (sleeping), please tell your doctor that you are taking Xultophy.
Updated on 24 January 2024
File name
Xultophy PIL-12-2023-v10-cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Free text change information supplied by the pharmaceutical company
Added to possible side effects: Dizziness under common and delayed gastric emptying under Not Known. Revision Date updated to 12/2023
Updated on 24 January 2024
File name
Xultophy-SmPC-IE-ver17-Dec2023-cl.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
- Change to improve clarity and readability
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Added to section 4.8 undesirable effects: Dizziness added under common and Delayed gastric emptying added under unknown. In addition minor formatting changes made throughout document (spaces, remove underlining, italics)
Updated on 25 August 2023
File name
Xultophy PIL-06-2023-v9-cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to date of revision
Free text change information supplied by the pharmaceutical company
Added to side effects: Change in how things taste.
Reference to glucagon injection changed to remove the word injection.
Updated on 25 August 2023
File name
Xultophy-SmPC-IE-ver16-Jun2023-cl.pdf
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Dysgeusia added to section 4.8 undesirable effects.
text amended in section 4.9 in yellow highlight:
Severe hypoglycaemic episodes, where the patient is not able to treat himself, can be treated with glucagon (0.5 to 1 mg) given intramuscularly, subcutaneously or intranasally by a trained person, or with glucose given intravenously by a healthcare professional. Glucose must be given intravenously if the patient does not respond to glucagon within 10 to 15 minutes. Upon regaining consciousness, administration of oral carbohydrates is recommended for the patient in order to prevent a relapse.
Updated on 23 March 2023
File name
Xultophy PIL-03_2023_v9_cl.pdf
Reasons for updating
- Change to section 6 - date of revision
- Addition of information on reporting a side effect.
Free text change information supplied by the pharmaceutical company
United Kingdom updated to United Kingdom (Northern Ireland)
Date of revision updated to 09/2022
Updated on 03 October 2020
File name
Xultophy PIL-09-2020-v8-clean.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Section 2 – what you need to know - warnings and precautions
New text:
Skin changes at the injection site
The injection site should be rotated to help prevent changes to the fatty tissue under the skin, such as skin thickening, skin shrinking or lumps under the skin. The insulin may not work very well if you inject into a lumpy, shrunken or thickened area (see section 3 ‘How to use Xultophy®’). Tell your doctor if you notice any skin changes at the injection site. Tell your doctor if you are currently injecting into these affected areas before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Section 4 – possible side effects
New text:
Skin changes at the injection site:
If you inject insulin at the same place, the fatty tissue may shrink (lipoatrophy) or thicken (lipohypertrophy) (may affect up to 1 in 100 people). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis; how often this occurs is not known). The insulin may not work very well if you inject into a lumpy, shrunken or thickened area. Change the injection site with each injection to help prevent these skin changes.
Deleted text from ‘Uncommon (may affect up to 1 in 100 people)’:
Skin changes where you give the injection (‘lipodystrophy’) the fatty tissue under the skin may shrink (‘lipoatrophy’) or get thicker (‘lipohypertrophy’). Changing the place where you inject each time may reduce the risk of these skin changes. If you notice these skin changes, tell your doctor or nurse. If you keep injecting in the same place, these changes can become more severe and affect the amount of medicine your body gets from the pen.
Updated on 03 October 2020
File name
Xultophy-SmPC-IE-ver15-Sep2020-clean.pdf
Reasons for 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
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2 - method of administration
Updated text:
Injection sites should are always to be rotated within the same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis (see sections 4.4 and 4.8).
Section 4.4
New text:
Skin and subcutaneous tissue disorders
Patients must be instructed to perform continuous rotation of the injection site to reduce the risk of developing lipodystrophy and cutaneous amyloidosis. There is a potential risk of delayed insulin absorption and worsened glycaemic control following insulin injections at sites with these reactions. A sudden change in the injection site to an unaffected area has been reported to result in hypoglycaemia. Blood glucose monitoring is recommended after the change in the injection site from an affected to an unaffected area, and dose adjustment of antidiabetic medications may be considered.
Section 4.8
Addition to adverse reaction list, skin and subcutaneous tissue disorders:
Not known – cutaneous amyloidosis†
† ADR from postmarketing sources.
Skin and subcutaneous tissue disorders
Lipodystrophy (including lipohypertrophy, lipoatrophy) and cutaneous amyloidosis may occur at the injection site and delay local insulin absorption. Continuous rotation of the injection site within the particular given injection area may help to reduce or prevent the risk of developing these reactions (see section 4.4).
Updated on 15 May 2020
File name
Xultophy package leaflet-May2020-v7-clean.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 4 - how to report a side effect
Free text change information supplied by the pharmaceutical company
Section 1
Subsection updated as follows:
"If you use basal insulin
You should stop your basal insulin treatment prior to starting on Xultophy."
Section 4
HPRA reporting details shortened to 'HPRA Pharmacovigilance, Website: www.hpra.ie"
Updated on 15 May 2020
File name
Xultophy-SmPC-IE-ver14_May2020_clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.2:
Transfer from any basal insulin regimen that includes a basal insulin component
Therapy with other basal insulin regimens should be discontinued prior to initiation of Xultophy. When transferring from basal any other insulin therapy that includes a basal insulin component, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 4.4 and 5.1). The recommended starting dose should not be exceeded, but may be reduced to avoid hypoglycaemia in selected cases. Close glucose monitoring is recommended during the transfer and in the following weeks.
Section 4.8, how to report a side effect
Reporting details for the HPRA reduces as per QRD Appendix V.
Section 5.1
Figure 7 replaced to correct minor change
Updated on 04 October 2019
File name
Xultophy-SmPC-IE-ver 13_Oct2019_clean.pdf
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
- Removal of Black Inverted Triangle
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Black triangle removed
Section 9 updated to include "Date of latest renewal: 08 July 2019"
Updated on 04 October 2019
File name
Package leaflet_v6-clean.pdf
Reasons for updating
- Removal of Black Inverted Triangle
Free text change information supplied by the pharmaceutical company
Black triangle removed
Updated on 22 July 2019
File name
Package leaflet_v5-clean.pdf
Reasons for updating
- Change to section 6 - what the product contains
Updated on 22 July 2019
File name
Xultophy-SmPC-IE-ver 12-July 2019_clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.3 - Shelf life
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.4:
Sentence update: "In case of discontinuation of Xultophy, ensure that instruction for initiation of alternative antidiabetic medication treatment is followed"
Section 4.8:
Text update in Table 1. 'Adverse Drug Reaction' updated to 'Adverse reaction'
Reporting of side effects: reporting of adverse event to the MHRA deleted. Reporting to the HPRA remains.
Section 6.3:
Text updates: "After first opening, the medicinal product can be stored for 21 days at a maximum temperature of 30°C. The medicinal product should be discarded 21 days after first opening"
Updated on 26 June 2019
File name
Package leaflet_v4-clean.pdf
Reasons for updating
- New PIL for new product
Updated on 25 June 2019
File name
Xultophy-SmPC-ver 11-Sept 2018_clean.pdf
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)