Drugs List

Therapeutic Indications

Uses

Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone

To improve glycaemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise as either: a) Monotherapy- when metformin is unsuitable due to intolerance, or contraindicated due to renal impairment. b) Combination therapy- with other medicinal products for the treatment of diabetes (including insulin), when these products do not provide satisfactory glycaemic control.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Patients over 80 years
History of pancreatitis

Advise patient to take precautions to avoid hypoglycaemia whilst driving
Advise patients to report symptoms of acute pancreatitis immediately
Discontinue if pemphigus-type reactions develop
Discontinue if pancreatitis occurs
Pregnancy confirmed: Change patient to insulin treatment
Advise patient not to take St John's wort concurrently
Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

Pregnancy and Lactation

Pregnancy

Linagliptin is contraindicated in pregnancy.

There is no data from the use of linagliptin during pregnancy. Animal studies have not shown direct or indirect harmful effects.

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

When dieting alone is not successful, insulin is the treatment of choice for both Type 1 and Type 2 diabetes during pregnancy as it provides better control of maternal blood glucose than oral hypoglycaemics, and does not cross the placenta. Hyperglycaemia in the mother, particularly in the early stages of gestation, is associated with a number of foetal and maternal adverse effects, including foetal structural abnormalities. Carefully prescribed insulin therapy will provide better control of the mother's blood glucose thereby preventing the foetal and neonatal complications that occur with the disease (Briggs, 2011).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Linagliptin is contraindicated in breastfeeding.

It is unknown whether linagliptin is excreted in human breast milk. Animal studies have shown excretion of linagliptin and/or metabolite in milk, a risk to the nursing infant cannot be excluded.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Angioedema
Bullous pemphigoid
Constipation
Cough
Elevated amylase levels
Elevated serum lipase
Hypersensitivity reactions
Hypoglycaemia
Nasopharyngitis
Pancreatitis
Rash
Urticaria

Presentation

Tablets containing linagliptin

Drugs List

Therapeutic Indications

Uses

Type 2 diabetes (NIDDM) not controlled by diet,weight loss & exercise alone

To improve glycaemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise as either: a) Monotherapy- when metformin is unsuitable due to intolerance, or contraindicated due to renal impairment. b) Combination therapy- with other medicinal products for the treatment of diabetes (including insulin), when these products do not provide satisfactory glycaemic control.

Dosage

Adults

Elderly

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Patients over 80 years
History of pancreatitis

Advise patient to take precautions to avoid hypoglycaemia whilst driving
Advise patients to report symptoms of acute pancreatitis immediately
Discontinue if pemphigus-type reactions develop
Discontinue if pancreatitis occurs
Pregnancy confirmed: Change patient to insulin treatment
Advise patient not to take St John's wort concurrently
Patient to inform DVLA if fitness to drive impaired or hypoglycaemic risk

Pregnancy and Lactation

Pregnancy

Linagliptin is contraindicated in pregnancy.

There is no data from the use of linagliptin during pregnancy. Animal studies have not shown direct or indirect harmful effects.

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

When dieting alone is not successful, insulin is the treatment of choice for both Type 1 and Type 2 diabetes during pregnancy as it provides better control of maternal blood glucose than oral hypoglycaemics, and does not cross the placenta. Hyperglycaemia in the mother, particularly in the early stages of gestation, is associated with a number of foetal and maternal adverse effects, including foetal structural abnormalities. Carefully prescribed insulin therapy will provide better control of the mother's blood glucose thereby preventing the foetal and neonatal complications that occur with the disease (Briggs, 2011).

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Linagliptin is contraindicated in breastfeeding.

It is unknown whether linagliptin is excreted in human breast milk. Animal studies have shown excretion of linagliptin and/or metabolite in milk, a risk to the nursing infant cannot be excluded.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Advise patient to avoid taking double doses on the same day.

Advise patients to report severe, persistent abdominal pain which may be symptomatic of pancreatitis to the doctor.

Advise patients that they should not self-medicate with St John's Wort.

Advise patients that their ability to drive or operate machinery may be impaired.

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

Angioedema
Bullous pemphigoid
Constipation
Cough
Elevated amylase levels
Elevated serum lipase
Hypersensitivity reactions
Hypoglycaemia
Nasopharyngitis
Pancreatitis
Rash
Urticaria

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: July 2015

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press. Accessed on 01 July 2015.

Summary of Product Characteristics: Trajenta 5mg film-coated tablets. Boehringer Ingelheim. Revised March 2017.

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
Linagliptin. Last revised: 10 March 2015
Last accessed: 01 July 2015