Dulaglutide parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Solution for injection containing dulaglutide.
Drugs List
Therapeutic Indications
Uses
Monotherapy for type2 diabetes if overweight and metformin inappropriate
Non insulin dependent diabetes mellitus - adjunctive treatment
Treatment of type 2 diabetes mellitus in patients where diet and exercise do not provide adequate glycaemic control.
Monotherapy
In patients where metformin is contraindicated or not tolerated.
Adjunctive therapy
Combined with other glucose-lowering medicinal products including insulin.
Dosage
Adults
Monotherapy
0.75mg once weekly.
Adjunctive therapy
1.5mg once weekly.
For vulnerable patients consider a starting dose of 0.75 mg once weekly.
Additional glycaemic control
1.5mg can be increased to 3mg once weekly after 4 weeks.
3mg can be increased to 4.5mg once weekly after 4 weeks (maximum dose is 4.5mg once weekly).
Additional Dosage Information
When dulaglutide is added to existing therapy of a sulfonylurea or insulin, a reduction in the dose of sulfonylurea or insulin may be considered to reduce the risk of hypoglycaemia.
Missed doses
At least 3 days (72 hours) until the next scheduled dose: Administer missed dose as soon as possible.
Less than 3 days (72 hours) until the next scheduled dose: Omit missed dose.
In both cases the next scheduled dose should be taken as usual.
The day of weekly administration can be changed if necessary, provided the last dose was administered 3 or more days before.
Administration
For subcutaneous injection only. The injection site may be the thigh, abdomen or upper arm.
Dulaglutide injection can be given at any time, without regard to meals.
Contraindications
Children under 18 years
Breastfeeding
Pregnancy
Renal impairment - eGFR below 15ml/minute/1.73m sq
Severe gastrointestinal disorder
Precautions and Warnings
For single use only
For subcutaneous use only
Record name and batch number of administered product
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
Female: Ensure adequate contraception during treatment
Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk
Gastrointestinal adverse reactions, such as nausea, vomiting and diarrhoea, may cause dehydration which could lead to deterioration of renal function. Therefore, patients with impaired renal function should be treated with caution.
Pregnancy and Lactation
Pregnancy
Dulaglutide is contraindicated during pregnancy.
The manufacturer does not recommend the use of dulaglutide during pregnancy.
At the time of writing there is limited published information regarding the use of dulaglutide during pregnancy. Animal studies have shown reproductive toxicity. Skeletal effects and a reduction in foetal growth have been observed rats and rabbits exposed to dulaglutide at higher than recommended doses. The potential risk to humans is unknown.
Lactation
Dulaglutide is contraindicated during breastfeeding.
The manufacturer advises that dulaglutide should not be used during breastfeeding.
It is unknown whether dulaglutide is excreted in human breast milk, therefore risk to newborns/infants cannot be excluded.
Because dulaglutide is a large protein molecule, the amount in milk is expected to be low and absorption is unlikely to happen, as probably destroyed in the infant's gastrointestinal tract (LactMed, 2018).
Counselling
Advise patient to seek medical advise if acute pancreatitis symptoms occur, such as sudden severe abdominal pain.
Advise patient to seek medical advice if symptoms of dehydration occur.
Advise patient of the warning signs of hypoglycaemia, particularly if a sulfonylurea or insulin is to be used concurrently.
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 distension
Abdominal pain
Acute pancreatitis
Alterations in pancreatic enzymes
Anaphylactic reaction
Angioedema
Antibody formation
Cholecystitis
Cholelithiasis
Constipation
Decreased appetite
Dehydration
Diarrhoea
Dyspepsia
Eructation
Fatigue
First degree AV block
Flatulence
Gastroesophageal reflux disease
Hypersensitivity reactions
Hypoglycaemia
Increased heart rate
Injection site reactions
Nausea
Non-mechanical intestinal obstruction
Prolongation of PR interval
Sinus tachycardia
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: February 2021
Reference Sources
Summary of Product Characteristics: Trulicity 0.75mg solution for injection in pre-filled pen. Eli Lilly. Revised November 2020.
Summary of Product Characteristics: Trulicity 1.5mg solution for injection in pre-filled pen. Eli Lilly. Revised November 2020.
Summary of Product Characteristics: Trulicity 3mg solution for injection in pre-filled pen. Eli Lilly. Revised November 2020.
Summary of Product Characteristics: Trulicity 4.5mg solution for injection in pre-filled pen. Eli Lilly. Revised November 2020.
MHRA Drug Safety Update June 2019
Available at: https://www.mhra.gov.uk
Last accessed: 28 August 2019
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
Dulaglutide. Last revised: 03 December 2018
Last accessed: 04 February 2021
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