Liraglutide parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing liraglutide
Drugs List
Therapeutic Indications
Uses
Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone
Weight management in adults with BMI > 30 - adjunct
Weight management in adults with BMI 27 to < 30 with comorbidity -adjunct
Treatment of adult patients with type 2 diabetes mellitus:
As monotherapy when diet and exercise do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate.
In combination with other glucose lowering medication including insulin where the existing regimen with diet and exercise does not provide adequate glycaemic control.
Weight management in adults as an adjunct to diet and exercise:
In patients with an initial body mass index of 30kg/m square or greater.
In patients with an initial body mass index of 27 to 29kg/m square with at least one weight-related comorbidity such as dysglycaemia (pre-diabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.
Dosage
Adults
Type 2 diabetes
A starting dose of 0.6mg daily is recommended in order to improve gastro-intestinal tolerability.
After at least 1 week, increase to 1.2mg.
After another week at 1.2mg the dose may be increased to a maximum of 1.8mg daily if required.
Weight management
A starting dose of 0.6mg daily is recommended in order to improve gastro-intestinal tolerability.
The dose should be increased to 3mg daily in increments of 0.6mg at weekly intervals.
If the increase in dose is not tolerated for 2 consecutive weeks, consider discontinuing treatment.
Patients with Renal Impairment
Creatinine clearance 30ml/minute or greater
No dose adjustment required.
Creatinine clearance less than 30ml/minute
Avoid if treating weight management.
No dose adjustment recommended, however, avoid in end stage renal disease.
Additional Dosage Information
When used in combination with a sulfonylurea or basal insulin therapy, a lower dose of the sulfonylurea or basal insulin should be considered to reduce the risk of hypoglycaemia.
Missed dose
If missed for more than 12 hours, the dose should be skipped and the patient should resume the regimen with the next schedule dose. An extra dose should not be taken to make up for the missed dose.
Administration
Inject subcutaneously into the abdomen, thigh or upper arm.
Inject around the same time each day independent of meals. Injection site and timing may be changed without the need for dose adjustment.
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
Patients over 75 years
Dehydration
History of pancreatitis
Mild hepatic impairment
Renal impairment - creatinine clearance below 30 ml/minute
Thyroid dysfunction
Not all available brands are licensed for all indications
Exclude pregnancy prior to initiation of treatment
Insulin dose adjustment: Reduce insulin dose gradually and monitor for DKA
Monitor heart rate
Monitor patient for hypoglycaemia if adjunct to insulin or sulfonylurea
Advise patient of potential risk of dehydration
Advise patient to report symptoms of cholelithiasis and cholecystitis
Advise patients to report symptoms of acute pancreatitis immediately
Discontinue permanently if acute pancreatitis occurs
Discontinue if heart rate is increased for sustained period
Discontinue if pancreatitis is suspected
Weight loss: Discontinue if after 12 weeks at 3mg dose, weight loss is < 5%
Advise patient on fluid replacement if GI side effects occur
Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk
Use with caution in patients with thyroid dysfunction as adverse events such as goitre have been reported in clinical trials, particularly in patients with a pre-existing thyroid disease.
Pregnancy and Lactation
Pregnancy
Liraglutide is contraindicated in pregnancy.
Manufacturers advise that liraglutide should be discontinued if the patient wishes to become pregnant or if pregnancy occurs during treatment.
There is limited data available on the use of liraglutide during pregnancy.
Animal studies have showed development toxicity (structural anomalies and decreased body weight) in 2 animal species.
Lactation
Liraglutide is contraindicated in breastfeeding.
Manufacturers advise that liraglutide should not be used during breastfeeding.
It is not known whether liraglutide is excreted in human milk. Animal studies have shown that the transfer of liraglutide and its metabolites into milk is low.
Studies have shown a treatment-related reduction of neonatal growth in rats.
Briggs (2015) suggests that the high molecular weight of liraglutide (3751) indicates that the drug would not pass freely into breast milk. The long half life and low metabolism may, however, increase the likelihood of transfer.
Counselling
Advise patient to report signs of acute pancreatitis: severe abdominal pain with or without back pain.
Advise patients if they develop diarrhoea, vomiting or other fluid losses they should increase their fluid intake.
Advise patient of potential risk of dehydration.
Advise patient to report symptoms of cholelithiasis and cholecystitis.
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.
Side Effects
Abdominal discomfort
Abdominal distension
Abdominal pain
Acute renal failure
Anaphylactic reaction
Angioedema
Anorexia
Asthenia
Bronchitis
Cholecystitis
Cholelithiasis
Constipation
Decreased appetite
Dehydration
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspepsia
Elevated amylase levels
Elevated serum lipase
Eructation
Fatigue
Flatulence
Gastritis
Gastroesophageal reflux disease
Goitre
Headache
Hypoglycaemia
Increased heart rate
Injection site reactions
Insomnia
Intestinal obstruction
Malaise
Nasopharyngitis
Nausea
Necrotising pancreatitis
Pancreatitis
Pruritus
Rash
Renal impairment
Tachycardia
Tooth ache
Urticaria
Vomiting
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: April 2019
Reference Sources
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Summary of Product Characteristics: Saxenda 6 mg/ml solution for injection in pre-filled pen. Novo Nordisk Limited. Revised March 2019.
Summary of Product Characteristics: Victoza 6 mg/ml solution for injection in pre-filled pen. Novo Nordisk Limited. Revised July 2017.
MHRA Drug Safety Update June 2019
Available at: https://www.mhra.gov.uk
Last accessed: 28 August 2019
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 April 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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