Semaglutide oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of 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: 3mg once daily for one month.
Maintenance dose: 7mg once daily. The dose can be increased to 14mg once daily after at least one month of 7mg once daily dose.
It is not recommended to take two 7mg tablets to achieve a dosage of 14mg once daily.
Additional Dosage Information
Switching between oral and subcutaneous administration
The effect of switching between oral and subcutaneous semaglutide cannot easily be predicted because of the high pharmacokinetic variability of oral semaglutide. Exposure after oral semaglutide 14mg once daily is comparable to subcutaneous semaglutide 0.5mg once weekly. An oral dose equivalent to 1mg of subcutaneous semaglutide has not been established.
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
Advise patient to avoid other oral medications for 30 mins after dose
Record name and batch number of administered product
Consider dose reduction of hypoglycaemic agents
Insulin dose adjustment: Reduce insulin dose gradually and monitor for DKA
Monitor patient for hypoglycaemia if adjunct to insulin or sulfonylurea
Advise patient of potential risk of dehydration
Advise patients to report symptoms of acute pancreatitis immediately
Discontinue if pancreatitis is suspected
Do not restart treatment following confirmation of pancreatitis
Discontinue treatment at least 2 months before a planned pregnancy
Female: Ensure adequate contraception during treatment
Advise patient of importance of full compliance
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.
Compliance with the dosing regimen is recommended for optimal effect of semaglutide. Absorption of semaglutide is highly variable, 2 to 4% of patient will not have any exposure and absolute bioavailability of semaglutide is low.
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.
Pregnancy and Lactation
Pregnancy
Semaglutide is contraindicated during pregnancy.
The manufacturer recommends that semaglutide should not be used during pregnancy or in women of childbearing potential unless they are using a reliable form of contraception. 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.
Counselling
Advise patient that tablet should be swallowed whole on an empty stomach. The absorption of semaglutide is decreased if taken with food or large volumes of water.
Advise patient to avoid other oral medication for 30 minutes after dose.
Advise patient on the importance of full compliance.
Advise patient on the potential risk of dehydration.
Advise patient to report symptoms of acute pancreatitis immediately.
Advise patient on fluid replacement if gastrointestinal side effects occur.
Advise patient to report to DLVA if there is a risk of hypoglycaemia, or if fitness to drive may be impaired due to diabetes complications. Guidance can be found be accessing Gov.uk website.
Side Effects
Abdominal distension
Abdominal pain
Acute pancreatitis
Anaphylactic reaction
Cholelithiasis
Constipation
Decreased appetite
Diabetic retinopathy complications
Diarrhoea
Dyspepsia
Elevated amylase levels
Elevated serum lipase
Eructation
Fatigue
Flatulence
Gastritis
Gastroesophageal reflux disease
Hypoglycaemia
Increased heart rate
Nausea
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: September 2020
Reference Sources
Summary of Product Characteristics: Rybelsus. Novo Nordisk Limited. Revised May 2020.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 September 2020
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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