Insulin degludec with liraglutide subcutaneous
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of insulin degludec with liraglutide.
Drugs List
Therapeutic Indications
Uses
Diabetes mellitus Type 2 where oral therapy inadequate
Treatment of adults with uncontrolled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise, in addition to other oral antidiabetic treatment.
Dosage
To be administered once daily at any time of day, but at the same time each day, according to individual requirements.
Adults
Add-on to oral glucose lowering medicinal products
Starting dose: 10 dose steps (10 units of insulin degludec and 0.36 mg of liraglutide) daily.
Maximum dose: 50 dose steps daily.
Transfer from GLP-1 receptor agonist or from basal insulin
Starting dose: 16 dose steps (16 units of insulin degludec and 0.6 mg of liraglutide) daily.
Maximum dose: 50 dose steps daily.
If transferring from a long acting GLP-1 receptor agonist prolonged action should be taken into consideration. Insulin degludec with liraglutide should be initiated when the next dose of long acting GLP-1 receptor agonist would have been taken.
Administration
Subcutaneous injection only.
Administer in the thigh, upper arm or abdominal wall.
Contraindications
Children under 18 years
Breastfeeding
End stage renal disease
Gastroparesis
Inflammatory bowel disease
New York Heart Association class IV failure
Pregnancy
Severe hepatic impairment
Precautions and Warnings
Dehydration
History of thyroid disorder
Mild hepatic impairment
Mild renal impairment
Not suitable for treatment of diabetic ketoacidosis
Advise patient to take precautions to avoid hypoglycaemia whilst driving
Consider sulfonylurea dose reduction if added to sulfonylurea therapy
Change in injection site area may necessitate dose adjustment
Consider cutaneous amyloidosis if injection site subcutaneous lumps occur
Rotate injection sites within a given area to avoid lipodystrophy
Solution must not be drawn from cartridge or pre-filled pen into a syringe
Use designated delivery device only
Monitor closely during and after transfer from insulin or GLP-1 agonist
Monitor dosage closely in presence of renal or hepatic impairment
Advise patient to report cutaneous amyloidosis symptoms
Advise patients to report symptoms of acute pancreatitis immediately
Antibodies to ingredient may develop
Compensatory response to hypoglycaemia may be impaired
Advise patient to seek advice at first indications of pregnancy
Discontinue if pancreatitis is suspected
Do not restart treatment following confirmation of pancreatitis
Consider dosage modification if diet or exercise levels are changed
Consider dose adjustment during illness or diet/physical activity changes
Advise patient on fluid replacement if GI side effects occur
Advise patient they have to inform the DVLA of antidiabetic medication
Advise patient to contact doctor if travel between time zones is planned
Advise patients to have glucose available in the event of hypoglycaemia
Pregnancy and Lactation
Pregnancy
Insulin degludec with liraglutide is contraindicated during pregnancy.
The manufacturer recommends discontinuing insulin degludec with liraglutide if a patient becomes pregnant or wishes to become pregnant.
Animal studies regarding embryotoxicity and teratogenicity have not shown any differences between insulin degludec and human insulin. However, animal studies have shown reproductive toxicity effects when using liraglutide. Human data is limited and as such a potential risk cannot be ruled out.
Detailed guidance on the treatment of diabetes during pregnancy is available from the National Institute for Health and Clinical Excellence (NICE) at https://www.nice.org.uk/guidance/ng3 .
Lactation
Insulin degludec with liraglutide is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking insulin degludec with liraglutide. The presence of insulin degludec with liraglutide in human breast milk is unknown.
Counselling
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.
Advise patient to always use a new needle. The re-use of insulin pen needles increases the risk blocked needles which can cause over or underdosing.
Patients should be shown the container to confirm the version of insulin is the one they are expecting.
Advise patients of the warning signs of hypoglycaemia.
Patients should be aware that emotional upset or concurrent illness, especially infection and fever, will usually increase insulin requirements.
Advise patients to report symptoms of acute pancreatitis (e.g. severe abdominal pain) immediately.
Patients whose blood glucose is greatly improved, e.g. by intensified insulin therapy, may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.
Advise female patients to consult their GP if pregnancy is suspected or planned.
Patients should carry glucose tablets or other suitable form of sugar with them to take in the event of hypoglycaemia and should be advised of the warning signs that they may experience.
Patient should be advised that injection sites should be rotated within the same area to minimise the risk of developing lipodystrophy.
Advise patient to seek medical advice regarding dosage if they are intending to travel between different time zones.
Advise patients that their ability to drive or operate machinery may be impaired.
Advise patient to report to DVLA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found by accessing Gov.uk website.
Advise patient to report cutaneous amyloidosis symptoms.
Side Effects
Abdominal distension
Abdominal pain
Abnormal hunger
Allergic reaction
Anaphylactic reaction
Anxiousness
Cholecystitis
Cholelithiasis
Cold sweat
Concentration difficulties
Confusion
Constipation
Cool pale skin
Cutaneous amyloidosis
Decreased appetite
Dehydration
Diarrhoea
Drowsiness
Dyspepsia
Dyspnoea
Elevated amylase levels
Elevated serum lipase
Eructation
Facial swelling
Fatigue
Flatulence
Gastritis
Gastroesophageal reflux disease
Headache
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Increased heart rate
Injection site reactions
Insulin antibodies
Lipodystrophy (injection site)
Nausea
Necrotising pancreatitis
Nervousness
Palpitations
Pancreatitis
Peripheral oedema
Pruritus
Rash
Tachycardia
Tiredness
Tremor
Urticaria
Visual disturbances
Vomiting
Weakness
Worsening of diabetic retinopathy (temporary)
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: June 2019
Reference Sources
Summary of Product Characteristics: Xultophy 100 units/ml + 3.6 mg/ml solution for injection in a pre-filled pen. Novo Nordisk Ltd. Revised September 2018.
MHRA Drug Safety Update September 2020
Available at: https://www.mhra.gov.uk
Last accessed: 16 December 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 June 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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