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Exenatide parenteral prolonged release

Updated 2 Feb 2023 | GLP-1 agonists

Presentation

Prolonged release injection formulations of exenatide.

Drugs List

  • BYDUREON BCise PRE-FILLED PEN 2mg/0.85ml prolonged release suspension for injection
  • exenatide pre-filled pen 2mg/0.85ml prolonged release suspension for injection
  • Therapeutic Indications

    Uses

    Control of type-2 diabetes when combined oral therapies inadequate

    Treatment of type 2 diabetes mellitus in combination with other glucose-lowering medicinal products, together with exercise and diet control.

    Exenatide should be added to the current therapy when this one does not provide adequate glycaemic control.

    Dosage

    Adults

    2mg once a week.

    Exenatide prolonged release injection should be administered on the same day each week. The day of administration can be changed as long as the next dose is at least three days after the previous dose.

    Additional Dosage Information

    When exenatide is used in combination with metformin and/or a thiazolidinedione, the current dose of metformin and/or the thiazolidinedione can be continued.

    When exenatide is used in combination with a sulfonylurea, the dose of sulfonylurea may need to be reduced in order to lower the risk of hypoglycaemia.

    When exenatide is used in combination with basal insulin, dose reduction of insulin if required, should be done in a stepwise manner with careful self-monitoring of blood glucose.

    Missed doses
    Next scheduled dose is due in three days or more: Administer missed dose.

    Next scheduled dose is due in one to two days: Do not administer the missed dose and resume on the next scheduled dosing day.

    Administration

    For subcutaneous injection only.

    Contraindications

    Children under 18 years
    Breastfeeding
    Pregnancy
    Renal impairment - glomerular filtration rate below 30ml/minute
    Severe gastrointestinal disorder

    Precautions and Warnings

    Patients over 75 years
    History of pancreatitis

    Not suitable for treatment of diabetic ketoacidosis
    Not suitable for treatment of Type 1 diabetes mellitus
    Insulin dose adjustment: Reduce insulin dose gradually and monitor for DKA
    Monitor for signs or symptoms of cholelithiasis if rapid weight loss occurs
    Review treatment if weight loss greater than 1.5 kg per week
    Advise patients to report symptoms of acute pancreatitis immediately
    Discontinue permanently if acute pancreatitis occurs
    After discontinuation plasma levels decline over 10 weeks
    Discontinue if pancreatitis is suspected
    Discontinue if renal function deteriorates
    Discontinue this treatment 3 months before a planned pregnancy
    Female: Contraception required during and for 3 months after treatment
    Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

    There have been rare reports of altered renal function, including increased serum creatinine, renal impairment, exacerbation of chronic renal failure, acute renal failure (sometimes requiring haemodialysis) in patients receiving exenatide. In some cases, patients were experiencing events that could affect hydration, such as nausea, vomiting and/or diarrhoea, or were receiving concomitant drugs known to affect renal function and/or hydration such as ACE inhibitors, NSAIDs or diuretics. Effects are reported to be reversible with discontinuation of potentially nephrotoxic medicines (including the exenatide) and supportive therapy.

    Blood glucose monitoring is not required during treatment with exenatide unless it is being used in combination with a sulfonylurea or basal insulin.

    Pregnancy and Lactation

    Pregnancy

    Exenatide is contraindicated during pregnancy.

    Manufacturer recommends discontinuing treatment with exenatide and replacing with insulin therapy in the event of pregnancy.

    At the time of writing there is limited published information regarding the use of exenatide during pregnancy. Animal studies have shown developmental toxicity including structural anomalies and neonatal death. The studies suggest there is a moderate risk when exenatide is used during pregnancy, however, the absence of human data prevents a complete assessment. Ex vivo testing has concluded that exenatide is unlikely to cross the human placenta, however these results may not be representative of the whole gestation period.

    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

    Exenatide is contraindicated during breastfeeding.

    Manufacturer does not recommend the use of exenatide during breastfeeding. However, exenatide appears to present low risk during breastfeeding despite the lack of human data.

    At the time of writing there is limited published information regarding the use of exenatide during breastfeeding. Low amounts of exenatide have been found to be excreted in the milk of rodents. Exenatide has a high molecular weight and a short elimination half-life, suggesting that it is unlikely to be secreted in breast milk in clinically significant amounts. If excreted in breast milk, it is considered unlikely that exenatide will be orally absorbed by the infant as it is likely to be digested in the stomach.

    Counselling

    Advise patient to follow the instructions provided in the product user manual.

    Patients should be shown the container to confirm the version of exenatide is the one they are expecting.

    The injection site may be the thigh, abdomen or upper arm. When used in combination with basal insulin, treatment must be administered as separate injections.

    Exenatide prolonged release injection can be given at any time, without regard to meals.

    Patient should be advised that injection sites should be rotated within the same area to minimise the risk of developing lipodystrophy.

    Advise patient of the characteristic symptom of acute pancreatitis and to seek medical advice if this symptom occurs.

    Patients whose blood glucose is greatly improved may experience a change in their usual warning symptoms of hypoglycaemia and should be advised accordingly.

    Advise female patients to use adequate contraception during and for 3 months after treatment. Patients should consult their GP if pregnancy is suspected or planned. Treatment should be discontinued at least 3 months before a planned pregnancy.

    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 renal failure
    Alopecia
    Anaphylactic reaction
    Angioedema
    Angioneurotic oedema
    Antibody formation
    Asthenia
    Constipation
    Decreased appetite
    Dehydration
    Diarrhoea
    Dizziness
    Dysgeusia
    Dyspepsia
    Eructation
    Fatigue
    Flatulence
    Gastroesophageal reflux disease
    Headache
    Hyperhidrosis
    Hypoglycaemia
    Increased heart rate
    Injection site reactions
    Intestinal obstruction
    Nausea
    Pancreatitis
    Pruritus
    Rash
    Renal impairment
    Serum creatinine increased
    Somnolence
    Thrombocytopenia
    Urticaria
    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: February 2020

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Bydureon 2mg powder and solvent for prolonged-release suspension for injection in pre-filled pen. AstraZeneca UK Ltd. Revised January 2020.

    Summary of Product Characteristics: Bydureon 2mg prolonged-release suspension for injection in pre-filled pen (BCise). AstraZeneca UK Ltd. Revised January 2020.

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