XULTOPHY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

INSULIN DEGLUDEC; LIRAGLUTIDE

Available from:

NOVO NORDISK LTD., ISRAEL

ATC code:

A10AE56

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

INSULIN DEGLUDEC 100 U/ML; LIRAGLUTIDE 3.6 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

NOVO NORDISK A/S, DENMARK

Therapeutic area:

INSULIN DEGLUDEC AND LIRAGLUTIDE

Therapeutic indications:

Xultophy® is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to other oral medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control, and the population studied, see sections 4.4, 4.5 and 5.1

Authorization date:

2021-02-28

Patient Information leaflet

Xultophy IL PIL AUG 2023
–
Notification
Page 1 of 17
Xultophy-PIL-ENG-D19-F
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
XULTOPHY
®
SOLUTION FOR INJECTION UNDER THE SKIN
ACTIVE INGREDIENTS: insulin degludec 100 U/mL + liraglutide 3.6 mg/mL
Inactive ingredients and allergens in this medicine: See section 2
under ‘Important
information about some of this medicine’s ingredients’ and section
6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine.
If you have any further questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them, even if it seems to you that their medical condition is similar
to yours.
1.
WHAT IS THIS MEDICINE INTENDED FOR?
Xultophy is intended for the treatment of adults with uncontrolled
type 2 diabetes
mellitus to improve control of blood sugar level in addition to diet
and exercise along
with other oral medicines for diabetes.
THERAPEUTIC GROUP:
Medicines used to treat diabetes. Long-acting insulins and analogues
for injection.
You have diabetes because your body:
•
does not make enough insulin to control the level of sugar in your
blood or
•
is not able to use the insulin properly.
Xultophy contains two active ingredients that help your body control
your blood
sugar:
•
insulin degludec - a long-acting basal insulin which helps lower your
blood sugar levels.
•
liraglutide -
a ‘GLP
-1 analogue' that helps your body make more insulin during meals and
lowers the amount of sugar made by your body.
Xultophy is given with oral medicines for diabetes (such as metformin,
pioglitazone
and sulfonylurea medicines) when these medicines (used alone or with
GLP-1
treatment or with basal insulin) are not enough to control your blood
sugar levels.
IF YOU USE GLP-1:
You should stop your GLP-1 treatment before

Summary of Product characteristics

Xultophy IL SPC AUG 23 – Notification
1.
NAME OF THE MEDICINAL PRODUCT
Xultophy®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution contains 100 units insulin degludec* and 3.6 mg
liraglutide*.
*Produced in
_Saccharomyces cerevisiae _
by recombinant DNA technology.
One pre-filled pen contains 3 mL equivalent to 300 units insulin
degludec and 10.8 mg liraglutide.
One dose step contains 1 unit of insulin degludec and 0.036 mg of
liraglutide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless, isotonic solution.
_ _
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Xultophy is indicated for the treatment of adults with insufficiently
controlled type 2 diabetes mellitus
to improve glycaemic control as an adjunct to diet and exercise in
addition to other oral
medicinal products for the treatment of diabetes. For study results
with respect to combinations,
effects on glycaemic control, and the population
studied, see sections 4.4, 4.5 and 5.1.
4.2
Posology and method of administration
Posology
Xultophy is given once daily by subcutaneous administration. Xultophy
can be administered at any
time of the day, preferably at the same time of the day.
Xultophy is to be dosed in accordance with the individual patient’s
needs. It is recommended to
optimise glycaemic control via dose adjustment based on fasting plasma
glucose.
Adjustment of dose may be necessary if patients undertake increased
physical activity, change their
usual diet or during concomitant illness.
Patients who forget a dose are advised to take it upon discovery and
then resume their usual once-daily
dosing schedule. A minimum of 8 hours between injections should always
be ensured. This also
applies when administration at the same time of the day is not
possible.
Xultophy is administered as dose steps. One dose step contains 1 unit
of insulin degludec and
0.036 mg of liraglutide. The pre-filled pen can provide from 1 up to
50 dose steps in one injection in
Xultophy IL SPC AUG 23 – N