Semaglutide injection
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing semaglutide.
Drugs List
Therapeutic Indications
Uses
Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone
The treatment of adults with insufficiently controlled type 2 diabetes as an adjunct to diet and exercise.
As monotherapy
In patients where metformin is consider inappropriate due to contraindication or intolerance.
Adjunctive therapy
In addition to other treatments for diabetes.
Dosage
Adults
Initial dose
0.25mg once a week for 4 weeks.
Maintenance
0.5mg once a week. The dose can be increased to 1mg once a week after at least 4 weeks with a dose of 0.5mg once a week.
Dose greater than 1mg weekly is not recommended.
Additional Dosage Information
When semaglutide is added to existing sulfonylurea or insulin therapy, a reduction in the dose of sulfonylurea or insulin should be considered to reduce the risk of hypoglycaemia.
Missed dose
If a dose is missed within 5 days of scheduled administration, it should be administered as soon as possible.
If a dose is missed by more than 5 days, the missed dose should be skipped and the next should be administered on scheduled day.
In each case, the regular once weekly dosing schedule should be resumed.
Administration
For subcutaneous injection only.
To be administered once a week at any time of the day, can be given with or without meals.
If necessary, the day of the weekly administration can be changed as long as the interval between 2 doses is at least 72 hours. After selecting a new dosing day, the once a week dosing schedule should be continued.
Contraindications
Children under 18 years
Breastfeeding
End stage renal disease
New York Heart Association class IV failure
Pregnancy
Precautions and Warnings
Females of childbearing potential
Patients over 75 years
Diabetic retinopathy
History of pancreatitis
Severe hepatic impairment
Severe renal impairment
For single patient use only
For subcutaneous use only
Use only if the solution is clear and colourless
Insulin dose adjustment: Reduce insulin dose gradually and monitor for DKA
Monitor patient for hypoglycaemia if adjunct to insulin or sulfonylurea
Advise patient to seek medical advice if symptoms of dehydration occur
Advise patients to report symptoms of acute pancreatitis immediately
Discontinue if pancreatitis is suspected
Do not restart treatment following confirmation of pancreatitis
May affect the gastro-intestinal absorption of other drugs
Discontinue treatment at least 2 months before a planned pregnancy
Female: Ensure adequate contraception during treatment
Advise patient on fluid replacement if GI side effects occur
Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk
Caution and close monitoring should be used in diabetic retinopathy patients treated with semaglutide and insulin, as an increased risk of developing diabetic retinopathy complications has been observed in such patients.
Gastrointestinal adverse reactions associated with semaglutide should be considered when treating patients with impaired renal function, due to risk of dehydration and deterioration of renal function.
Pregnancy and Lactation
Pregnancy
Semaglutide is contraindication during pregnancy.
The manufacturer recommends that semaglutide should not be used during pregnancy and semaglutide should be discontinued at least 2 months before a planned pregnancy due to semaglutide's long half-life.
Animal studies have shown reproductive toxicity. Human data is limited and as such a potential risk cannot be ruled out.
Lactation
Semaglutide is contraindicated during breastfeeding.
The manufacturer does not recommend breastfeeding whilst taking semaglutide.
Animal studies have shown semaglutide to be excreted in breast milk, however presence in human breast milk is unknown. Effects on exposed infants are unknown.
Side Effects
Abdominal distension
Abdominal pain
Acute pancreatitis
Anaphylactic reaction
Angioedema
Blindness
Cholelithiasis
Constipation
Decreased appetite
Diabetic ketoacidosis
Diabetic retinopathy complications
Diarrhoea
Dizziness
Dysgeusia
Dyspepsia
Elevated amylase levels
Elevated serum lipase
Eructation
Fatigue
Flatulence
Gastritis
Gastroesophageal reflux disease
Increased heart rate
Injection site reactions
Nausea
Retinal photocoagulation
Vitreous haemorrhage
Vomiting
Weight loss
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 2020
Reference Sources
Summary of Product Characteristics: Ozempic 0.25mg, 0.5mg, 1mg solution for injection in pre-filled pen. Novo Nordisk Limited. Revised March 2021.
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: 10 February 2020
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Semaglutide Last revised: 03 December 2018
Last accessed: 14 January 2019
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