Dose adjustments Reduce dose to 12.5 mg once daily if
Reduce dose to 6.25 mg once daily if eGFR less than
l MONITORING REQUIREMENTS Determine renal function
before treatment and periodically thereafter.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Alogliptin (as Alogliptin benzoate) 6.25 mg Vipidia 6.25mg tablets
| 28 tablet P £26.60 DT = £26.60
Alogliptin (as Alogliptin benzoate) 12.5 mg Vipidia 12.5mg tablets
| 28 tablet P £26.60 DT = £26.60
Alogliptin (as Alogliptin benzoate) 25 mg Vipidia 25mg tablets | 28 tablet P £26.60 DT = £26.60
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, alogliptin above, metformin hydrochloride
Type 2 diabetes mellitus not controlled by metformin
alone or by metformin in combination with either
▶ Adult: 1 tablet twice daily, based on patient’s current
l INTERACTIONS → Appendix 1: alogliptin . metformin
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
Alogliptin (as Alogliptin benzoate) 12.5 mg, Metformin
hydrochloride 1 gram Vipdomet 12.5mg/1000mg tablets | 56 tablet P £26.60 DT = £26.60
l DRUG ACTION Inhibits dipeptidylpeptidase-4 to increase
insulin secretion and lower glucagon secretion.
Type 2 diabetes mellitus as monotherapy (if metformin
inappropriate), or in combination with other
antidiabetic drugs (including insulin) if existing
treatment fails to achieve adequate glycaemic control
▶ Adult: 5 mg once daily, for further information on use
with other antidiabetic drugs—consult product
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea or insulin may need
l INTERACTIONS → Appendix 1: linagliptin
▶ Uncommon Cough . nasopharyngitis
▶ Rare or very rare Angioedema . skin reactions
▶ Frequency not known Pancreatitis
694 Diabetes mellitus and hypoglycaemia BNF 78
SIDE-EFFECTS, FURTHER INFORMATION Discontinue if
symptoms of acute pancreatitis occur such as persistent,
l PREGNANCY Avoid—no information available.
l BREAST FEEDING Avoid—present in milk in animal studies.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised that
linagliptin (Trajenta ®) is accepted for restricted use within
NHS Scotland for the treatment of type 2 diabetes mellitus
as monotherapy when both metformin and a sulfonylurea
are inappropriate (January 2013), and in combination with
metformin when addition of a sulfonylurea is
inappropriate (December 2011).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Trajenta (Boehringer Ingelheim Ltd)
Linagliptin 5 mg Trajenta 5mg tablets | 28 tablet P £33.26 DT =
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, linagliptin p. 694, metformin hydrochloride
Type 2 diabetes mellitus not controlled by metformin
alone or by metformin in combination with either a
▶ Adult: 1 tablet twice daily, based on patient’s current
l INTERACTIONS → Appendix 1: linagliptin . metformin
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (May 2015)
that linagliptin plus metformin combination tablets
(Jentadueto ®) are accepted for restricted use within NHS
Scotland for the treatment of adult patients with type 2
diabetes mellitus in combination with insulin, as an
adjunct to diet and exercise to improve glycaemic control
when a combination of insulin and metformin alone is
inadequate. It is restricted to use in the treatment of
patients for whom a combination of linagliptin and
metformin is an appropriate choice of therapy and the
fixed doses are considered appropriate.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Jentadueto (Boehringer Ingelheim Ltd)
Linagliptin 2.5 mg, Metformin hydrochloride 850 mg Jentadueto
2.5mg/850mg tablets | 56 tablet P £33.26 DT = £33.26
Linagliptin 2.5 mg, Metformin hydrochloride 1000 mg Jentadueto
2.5mg/1000mg tablets | 56 tablet P £33.26 DT = £33.26
l DRUG ACTION Inhibits dipeptidylpeptidase-4 to increase
insulin secretion and lower glucagon secretion.
Type 2 diabetes mellitus as monotherapy (if metformin
inappropriate), or in combination with other
antidiabetic drugs (including insulin) if existing
treatment fails to achieve adequate glycaemic control
▶ Adult: 5 mg once daily, for further information on use
with other antidiabetic drugs—consult product
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea or insulin may need
l CAUTIONS Elderly . history of pancreatitis
l INTERACTIONS → Appendix 1: saxagliptin
▶ Rare or very rare Angioedema
▶ Frequency not known Constipation . nausea
SIDE-EFFECTS, FURTHER INFORMATION Discontinue if
symptoms of acute pancreatitis occur such as persistent,
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated if
patient has a history of serious hypersensitivity to
dipeptidylpeptidase-4 inhibitors.
l PREGNANCY Avoid unless essential—toxicity in animal
l BREAST FEEDING Avoid—present in milk in animal studies.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment; avoid in severe impairment (risk of
l RENAL IMPAIRMENT Use with caution in severe
Dose adjustments Reduce dose to 2.5 mg once daily in
moderate to severe impairment.
l MONITORING REQUIREMENTS Determine renal function
before treatment and periodically thereafter.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised that
saxagliptin (Onglyza ®) is accepted for restricted use within
NHS Scotland for the treatment of type 2 diabetes mellitus
as triple therapy in combination with metformin and a
sulfonylurea, as an alternative to existing dipeptidyl
peptidase-4 inhibitors, when treatment with metformin
and a sulfonylurea is inadequate (November 2013).
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Onglyza (AstraZeneca UK Ltd)
Saxagliptin (as Saxagliptin hydrochloride) 2.5 mg Onglyza 2.5mg
tablets | 28 tablet P £31.60 DT = £31.60
Saxagliptin (as Saxagliptin hydrochloride) 5 mg Onglyza 5mg
tablets | 28 tablet P £31.60 DT = £31.60
Saxagliptin with dapagliflozin 19-Jul-2017
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, saxagliptin p. 695, dapagliflozin p. 704.
Type 2 diabetes mellitus not controlled by metformin
and/or a sulfonylurea with either saxagliptin or
▶ Adult 18–74 years: 5/10 mg once daily
▶ Adult 75 years and over: Initiation not recommended
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea may need to be
DOSE EQUIVALENCE AND CONVERSION
▶ Dose expressed as x/y mg saxagliptin/dapagliflozin.
l INTERACTIONS → Appendix 1: dapagliflozin . saxagliptin
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate impairment; avoid in severe impairment.
Dose adjustments Manufacturer advises avoid if eGFR less
than 60 mL/minute/1.73 m2 (ineffective).
Missed doses Manufacturer advises if a dose is more than
12 hours late, the missed dose should not be taken and the
next dose should be taken at the normal time.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2017)
that saxagliptin with dapagliflozin 5 mg/10 mg (Qtern ®) is
accepted for restricted use within NHS Scotland for the
treatment of patients with type 2 diabetes mellitus in
combination with metformin when the use of a
sulfonylurea is inappropriate, only if:
. metformin and/or a sulfonylurea, in combination with
dapagliflozin or saxagliptin, do not provide adequate
. the patient is already being treated with the free
combination of dapagliflozin and saxagliptin.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Saxagliptin (as Saxagliptin hydrochloride) 5 mg, Dapagliflozin (as
Dapagliflozin propanediol monohydrate) 10 mg Qtern 5mg/10mg
tablets | 28 tablet P £49.56 DT = £49.56
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, saxagliptin p. 695, metformin hydrochloride
Type 2 diabetes mellitus not controlled by metformin
alone or by metformin in combination with either a
▶ Adult: 1 tablet twice daily, based on patient’s current
l INTERACTIONS → Appendix 1: metformin . saxagliptin
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (May 2013)
that Komboglyze ® is accepted for restricted use within NHS
Scotland for the treatment of type 2 diabetes mellitus in
patients unable to achieve adequate glycaemic control
with metformin alone and when the addition of a
sulfonylurea is inappropriate.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Komboglyze (AstraZeneca UK Ltd)
Saxagliptin (as Saxagliptin hydrochloride) 2.5 mg, Metformin
hydrochloride 850 mg Komboglyze 2.5mg/850mg tablets |
56 tablet P £31.60 DT = £31.60
Saxagliptin (as Saxagliptin hydrochloride) 2.5 mg, Metformin
hydrochloride 1 gram Komboglyze 2.5mg/1000mg tablets | 56 tablet P £31.60 DT = £31.60
l DRUG ACTION Inhibits dipeptidylpeptidase-4 to increase
insulin secretion and lower glucagon secretion.
Type 2 diabetes mellitus as monotherapy (if metformin
inappropriate), or in combination with other
antidiabetic drugs (including insulin) if existing
treatment fails to achieve adequate glycaemic control
▶ Adult: 100 mg once daily, for further information on
use with other antidiabetic drugs—consult product
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea or insulin may need
l CONTRA-INDICATIONS Ketoacidosis
l INTERACTIONS → Appendix 1: sitagliptin
▶ Common or very common Headache
▶ Uncommon Constipation . dizziness . skin reactions
▶ Frequency not known Angioedema . back pain . cutaneous
SIDE-EFFECTS, FURTHER INFORMATION Discontinue if
symptoms of acute pancreatitis occur such as persistent,
l PREGNANCY Avoid—toxicity in animal studies.
l BREAST FEEDING Avoid—present in milk in animal studies.
Dose adjustments Manufacturer advises reduce dose to
50 mg once daily if eGFR 30–45 mL/minute/1.73 m2
Manufacturer advises reduce dose to 25 mg once daily if
eGFR less than 30 mL/minute/1.73 m2
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2010)
that sitagliptin (Januvia ®) is accepted for restricted use
within NHS Scotland as monotherapy, to improve
glycaemic control in patients with type 2 diabetes mellitus,
for whom both metformin and sulfonylureas are not
The Scottish Medicines Consortium has advised
(September 2015) that sitagliptin (Januvia ®) is accepted for
use within NHS Scotland as an add-on to insulin (with or
without metformin) to improve glycaemic control in adults
with type 2 diabetes mellitus.
696 Diabetes mellitus and hypoglycaemia BNF 78
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Januvia (Merck Sharp & Dohme Ltd)
Sitagliptin (as Sitagliptin phosphate) 25 mg Januvia 25mg tablets
| 28 tablet P £33.26 DT = £33.26
Sitagliptin (as Sitagliptin phosphate) 50 mg Januvia 50mg tablets
| 28 tablet P £33.26 DT = £33.26
Sitagliptin (as Sitagliptin phosphate) 100 mg Januvia 100mg
tablets | 28 tablet P £33.26 DT = £33.26
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, sitagliptin p. 696, metformin hydrochloride
Type 2 diabetes mellitus not controlled by metformin
alone or by metformin in combination with either a
sulfonylurea or pioglitazone or insulin
l INTERACTIONS → Appendix 1: metformin . sitagliptin
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2008)
that Janumet ® is accepted for restricted use within NHS
Scotland for the treatment of type 2 diabetes mellitus
when the addition of a sulfonylurea to metformin is not
appropriate; it is also accepted for use in NHS Scotland in
combination with a sulfonylurea in patients inadequately
controlled on maximum tolerated doses of metformin and
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Janumet (Merck Sharp & Dohme Ltd)
Sitagliptin (as Sitagliptin phosphate) 50 mg, Metformin
hydrochloride 1 gram Janumet 50mg/1000mg tablets | 56 tablet P £33.26 DT = £33.26
l DRUG ACTION Inhibits dipeptidylpeptidase-4 to increase
insulin secretion and lower glucagon secretion.
Type 2 diabetes mellitus as monotherapy (if metformin
inappropriate), or in combination with other
antidiabetic drugs (including insulin) if existing
treatment fails to achieve adequate glycaemic control
▶ Adult: 50 mg twice daily, reduce dose to 50 mg once
daily in the morning when used in dual combination
with a sulfonylurea. For further information on use
with other antidiabetic drugs—consult product
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea or insulin may need
l CONTRA-INDICATIONS Ketoacidosis
l CAUTIONS Manufacturer advises avoid in severe heart
failure—no information available
l INTERACTIONS → Appendix 1: vildagliptin
▶ Common or very common Dizziness
▶ Uncommon Arthralgia . constipation . headache . hypoglycaemia . peripheral oedema
▶ Rare or very rare Increased risk of infection
▶ Frequency not known Hepatitis . myalgia . pancreatitis . skin reactions
SIDE-EFFECTS, FURTHER INFORMATION Pancreatitis
Discontinue if symptoms of acute pancreatitis occur, such
as persistent severe abdominal pain.
Liver toxicity Rare reports of liver dysfunction;
discontinue if jaundice or other signs of liver dysfunction
l PREGNANCY Avoid—toxicity in animal studies.
l BREAST FEEDING Avoid—present in milk in animal studies.
l HEPATIC IMPAIRMENT Manufacturer advises avoid.
Dose adjustments Reduce dose to 50 mg once daily if eGFR
less than 50 mL/minute/1.73 m2
l MONITORING REQUIREMENTS Monitor liver function
before treatment and every 3 months for first year and
Liver toxicity Patients should be advised to seek prompt
medical attention if symptoms such as nausea, vomiting,
abdominal pain, fatigue, and dark urine develop.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (April 2008)
that vildagliptin (Galvus ®) is accepted for restricted use
within NHS Scotland for the treatment of type 2 diabetes
mellitus in combination with metformin when addition of
a sulfonylurea is inappropriate.
The Scottish Medicines Consortium has advised (October
2009) that vildagliptin (Galvus ®) is accepted for use within
NHS Scotland for the treatment of type 2 diabetes mellitus
in combination with a sulphonylurea for those patients
where the maximal dose of a sulphonylurea as
monotherapy is insufficient, or if metformin is
The Scottish Medicines Consortium has advised (January
2013) that vildagliptin (Galvus ®) is accepted for restricted
use within NHS Scotland as monotherapy for the
treatment of type 2 diabetes mellitus in adults when
treatment with metformin or a sulfonylurea is
The Scottish Medicines Consortium has advised
(December 2013) that vildagliptin (Galvus ®) is accepted for
restricted use within NHS Scotland for the treatment of
type 2 diabetes mellitus in adults as triple therapy in
combination with metformin and a sulfonylurea, as an
alternative to existing dipeptidyl peptidase-4 inhibitors,
when treatment with metformin and a sulfonylurea is
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Galvus (Novartis Pharmaceuticals UK Ltd)
Vildagliptin 50 mg Galvus 50mg tablets | 56 tablet P £33.35 DT
Vildagliptin with metformin 26-Mar-2019
The properties listed below are those particular to the
combination only. For the properties of the components
please consider, vildagliptin p. 697, metformin
Type 2 diabetes mellitus not controlled by metformin
alone or by metformin in combination with either a
▶ Adult: 1 tablet twice daily, based on patient’s current
l INTERACTIONS → Appendix 1: metformin . vildagliptin
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2008)
that vildagliptin with metformin (Eucreas ®) is accepted for
restricted use within NHS Scotland for the treatment of
type 2 diabetes mellitus in patients unable to achieve
adequate glycaemic control with metformin alone or those
already treated with vildagliptin and metformin as
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 21
▶ Eucreas (Novartis Pharmaceuticals UK Ltd)
Vildagliptin 50 mg, Metformin hydrochloride 850 mg Eucreas
50mg/850mg tablets | 60 tablet P £35.68 DT = £35.68
Vildagliptin 50 mg, Metformin hydrochloride 1 gram Eucreas
50mg/1000mg tablets | 60 tablet P £35.68 DT = £35.68
BLOOD GLUCOSE LOWERING DRUGS ›
GLUCAGON-LIKE PEPTIDE-1 RECEPTOR AGONISTS
l DRUG ACTION Dulaglutide is a long-acting glucagon-like
Type 2 diabetes mellitus as monotherapy if metformin
Type 2 diabetes mellitus in combination with insulin or
other antidiabetic drugs (if existing treatment fails to
achieve adequate glycaemic control)
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant insulin or drugs that stimulate
insulin secretion may need to be reduced.
l CONTRA-INDICATIONS Severe gastro-intestinal disease—
l CAUTIONS Congestive heart failure—no information
l INTERACTIONS → Appendix 1: dulaglutide
disorders . hypoglycaemia . nausea . sinus tachycardia . vomiting
▶ Rare or very rare Anaphylactic reaction . angioedema . pancreatitis acute (discontinue)
l PREGNANCY Manufacturer advises avoid—toxicity in
l BREAST FEEDING Manufacturer advises avoid— no
l RENAL IMPAIRMENT Manufacturer advises avoid in severe
impairment and end stage renal disease—no information
l HANDLING AND STORAGE Refrigerated storage is usually
necessary (2 °C – 8 °C). Once in use, may be stored
unrefrigerated for up to 14 days at a temperature not
l PATIENT AND CARER ADVICE Patients or carers should be
given advice on how to administer dulaglutide injection.
Acute pancreatitis Patients should be told how to recognise
signs and symptoms of acute pancreatitis and advised to
seek medical attention if symptoms such as persistent,
severe abdominal pain develop.
Missed doses If a dose is missed, it should be administered
as soon as possible only if there are at least 3 days until the
next scheduled dose; if less than 3 days remain before the
next scheduled dose, the missed dose should not be taken
and the next dose should be taken at the normal time.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (January
2016) that dulaglutide (Trulicity ®) is accepted for restricted
use for treating adults with type 2 diabetes to improve
glycaemic control as add-on therapy in combination with
other glucose-lowering medicines, when these, together
with diet and exercise, do not provide adequate glycaemic
control. It is restricted to use as part of a triple therapy in
patients with inadequate glycaemic control on two oral
anti-diabetic medicines, as an alternative GLP-1 agonist
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Trulicity (Eli Lilly and Company Ltd) A
Dulaglutide 1.5 mg per 1 ml Trulicity 0.75mg/0.5ml solution for
injection pre-filled pen | 4 pre-filled disposable injection P £73.25
Dulaglutide 3 mg per 1 ml Trulicity 1.5mg/0.5ml solution for
injection pre-filled pen | 4 pre-filled disposable injection P £73.25
l DRUG ACTION Binds to, and activates, the GLP-1
(glucagon-like peptide-1) receptor to increase insulin
secretion, suppresses glucagon secretion, and slows gastric
Type 2 diabetes mellitus in combination with metformin
or a sulfonylurea, or both, or with pioglitazone, or with
both metformin and pioglitazone, in patients who have
not achieved adequate glycaemic control with these
▶ BY SUBCUTANEOUS INJECTION USING IMMEDIATE-RELEASE
▶ Adult: Initially 5 micrograms twice daily for at least
1 month, then increased if necessary up to
10 micrograms twice daily, dose to be taken within
1 hour before 2 main meals (at least 6 hours apart)
▶ BY SUBCUTANEOUS INJECTION USING MODIFIED-RELEASE
698 Diabetes mellitus and hypoglycaemia BNF 78
Type 2 diabetes mellitus in combination with basal insulin
alone or with metformin or pioglitazone (or both)
▶ BY SUBCUTANEOUS INJECTION USING IMMEDIATE-RELEASE
▶ Adult: Initially 5 micrograms twice daily for at least
1 month, then increased if necessary up to
10 micrograms twice daily, dose to be taken within
1 hour before 2 main meals (at least 6 hours apart)
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea may need to be
▶ Effect of modified-release exenatide injection
(Bydureon ®) may persist for 10 weeks after
l CONTRA-INDICATIONS Ketoacidosis . severe gastrointestinal disease
l CAUTIONS Elderly . may cause weight loss greater than
l INTERACTIONS → Appendix 1: exenatide
discomfort. gastrointestinal disorders . headache . nausea . skin reactions . vomiting
▶ Uncommon Alopecia . burping . drowsiness . hyperhidrosis .renal impairment.taste altered
▶ Frequency not known Angioedema . pancreatitis acute
SIDE-EFFECTS, FURTHER INFORMATION Severe pancreatitis
(sometimes fatal), including haemorrhagic or necrotising
pancreatitis, has been reported rarely; discontinue
l CONCEPTION AND CONTRACEPTION Women of childbearing age should use effective contraception during
treatment with modified-release exenatide and for
12 weeks after discontinuation.
l PREGNANCY Avoid—toxicity in animal studies.
l BREAST FEEDING Avoid—no information available.
l RENAL IMPAIRMENT For standard-release injection, use
with caution if eGFR 30–50 mL/minute/1.73 m2
standard-release injection, avoid if eGFR less than
. For modified-release injection,
avoid if eGFR less than 50 mL/minute/1.73 m2
l PATIENT AND CARER ADVICE Patients changing from
standard-release to modified-release exenatide
formulation may experience initial transient increase in
blood glucose. Some oral medications should be taken at
least 1 hour before or 4 hours after exenatide injection—
consult product literature for details. Patients or their
carers should be told how to recognise signs and
symptoms of pancreatitis and advised to seek prompt
medical attention if symptoms such as abdominal pain,
Missed doses If a dose of the immediate-release medicine
is missed, continue with the next scheduled dose—do not
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2007)
that standard-release exenatide (Byetta ®) is accepted for
restricted use within NHS Scotland for the treatment of
type 2 diabetes in combination with metformin or
sulfonylurea (or both), as an alternative to treatment with
insulin in patients where treatment with metformin or
sulfonylurea (or both) at maximally tolerated doses has
been inadequate, and treatment with insulin would be the
The Scottish Medicines Consortium has advised (March
2011) that standard-release exenatide (Byetta ®) is
accepted for restricted use within NHS Scotland for the
treatment of type 2 diabetes in combination with
metformin and a thiazolidinedione as a third-line preinsulin treatment option.
The Scottish Medicines Consortium has advised (January
2012) that modified-release exenatide (Bydureon ®) is
accepted for restricted use within NHS Scotland for the
treatment of type 2 diabetes as a third-line treatment
The Scottish Medicines Consortium has advised (June
2012) that standard-release exenatide (Byetta ®) is
accepted for use within NHS Scotland as adjunctive
therapy to basal insulin with or without metformin and/or
pioglitazone in patients with type 2 diabetes who have not
achieved adequate glycaemic control with these agents.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 10
Exenatide 250 microgram per 1 ml Byetta 10micrograms/0.04ml
solution for injection 2.4ml pre-filled pen | 1 pre-filled disposable
injection P £81.89 DT = £81.89
Byetta 5micrograms/0.02ml solution for injection 1.2ml pre-filled pen
| 1 pre-filled disposable injection P £81.89 DT = £81.89
Powder and solvent for prolonged-release suspension for
CAUTIONARY AND ADVISORY LABELS 10
▶ Bydureon (AstraZeneca UK Ltd)
injection P £73.36 DT = £73.36
secretion, suppresses glucagon secretion, and slows gastric
Adjunct in weight management [in conjunction with
dietary measures and increased physical activity in
individuals with a body mass index (BMI) of 30 kg/m2 or
more, or in individuals with a BMI of 27 kg/m2 or more in
the presence of at least one weight-related comorbidity]
▶ Adult: Initially 0.6 mg once daily, then increased in
steps of 0.6 mg, dose to be increased at intervals of at
least 1 week; consider discontinuation if escalation to
the next dose is not tolerated for 2 consecutive weeks.
Discontinue if at least 5% of initial body-weight has
not been lost after 12 weeks at maximum dose;
Type 2 diabetes mellitus [monotherapy (if metformin
inappropriate), or in combination with other
▶ Adult: Initially 0.6 mg once daily for at least 1 week,
then increased to 1.2 mg once daily for at least 1 week,
then increased if necessary to 1.8 mg once daily, for
information on use with other antidiabetic drugs—
consult product literature continued→
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant insulin or sulfonylurea may need
l CONTRA-INDICATIONS Diabetic gastroparesis . inflammatory bowel disease . severe congestive heart
failure—no information available
SAXENDA ® Concomitant use with other products for
weight management. elderly 75 years or over (limited
information). obesity secondary to endocrinological or
VICTOZA ® Diabetic ketoacidosis
l INTERACTIONS → Appendix 1: liraglutide
infection . insomnia . nausea . skin reactions .taste altered .toothache . vomiting
▶ Uncommon Dehydration . malaise . pancreatitis .renal
(discontinue permanently).thyroid disorder
SIDE-EFFECTS, FURTHER INFORMATION Discontinue if
symptoms of acute pancreatitis occur, such as persistent,
l PREGNANCY Manufacturer advises avoid—toxicity in
animal studies (recommendation also supported by tertiary
l BREAST FEEDING Manufacturer advises avoid—no
information available; animal studies suggest that transfer
into milk is low, but excretion into human milk not known
(a tertiary source confirms lack of information in human
lactation, but also states that risk to infants appears to be
negligible.g Blood glucose monitoring of the infant
SAXENDA ® Manufacturer advises use with caution in mild
to moderate impairment; avoid in severe impairment (risk
VICTOZA ® Manufacturer advises avoid in severe
impairment (risk of decreased exposure).
SAXENDA ® Manufacturer advises avoid if creatinine
clearance less than 30 mL/minute.
VICTOZA ® Manufacturer advises avoid in end-stage renal
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8°C)—after first use can also be stored
below 30°C and used within 1 month; keep cap on pen to
l PATIENT AND CARER ADVICE Manufacturer advises
patients and their carers should be told how to recognise
signs and symptoms of acute pancreatitis and advised to
seek immediate medical attention if symptoms develop.
Manufacturer advises patients and their carers should be
informed of the potential risk of dehydration in relation to
gastro-intestinal side-effects and advised to take
precautions to avoid fluid depletion; they should also be
informed of the symptoms of cholelithiasis and
cholecystitis, and of increased heart rate.
SAXENDA ® Missed doses Manufacturer advises if a dose
is more than 12 hours late, the missed dose should not be
taken and the next dose should be taken at the normal
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
▶ Saxenda (Novo Nordisk Ltd) A
Liraglutide 6 mg per 1 ml Saxenda 6mg/ml solution for injection 3ml
pre-filled pen | 5 pre-filled disposable injection P £196.20
Liraglutide 6 mg per 1 ml Victoza 6mg/ml solution for injection 3ml
pre-filled pen | 2 pre-filled disposable injection P £78.48 DT =
£78.48 | 3 pre-filled disposable injection P £117.72
Combinations available: Insulin degludec with liraglutide,
l DRUG ACTION Binds to, and activates, the GLP-1
(glucagon-like peptide-1) receptor to increase insulin
secretion, suppresses glucagon secretion, and slows gastric
Type 2 diabetes mellitus in combination with oral
antidiabetic drugs (e.g. metformin, pioglitazone, or a
sulfonylurea) or basal insulin, or both, when adequate
glycaemic control has not been achieved with these
▶ Adult: Initially 10 micrograms once daily for 14 days,
then increased to 20 micrograms once daily, dose to be
taken within 1 hour before the first meal of the day or
DOSE ADJUSTMENTS DUE TO INTERACTIONS
▶ Dose of concomitant sulfonylurea or insulin may need
l CONTRA-INDICATIONS Ketoacidosis . severe gastrointestinal disease
l CAUTIONS History of pancreatitis
l INTERACTIONS → Appendix 1: lixisenatide
risk of infection . nausea . vomiting
▶ Frequency not known Pancreatitis acute
SIDE-EFFECTS, FURTHER INFORMATION Manufacturer
advises discontinue if symptoms of acute pancreatitis
occur, such as persistent, severe abdominal pain.
l CONCEPTION AND CONTRACEPTION Women of childbearing age should use effective contraception.
l PREGNANCY Avoid—toxicity in animal studies.
l BREAST FEEDING Avoid—no information available.
l RENAL IMPAIRMENT Use with caution if eGFR
l PATIENT AND CARER ADVICE Some oral medications should
be taken at least 1 hour before or 4 hours after lixisenatide
injection—consult product literature for details.
Missed doses If a dose is missed, inject within 1 hour
before the next meal—do not administer after a meal.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (August
2013) that lixisenatide (Lyxumia ®) is accepted for
restricted use within NHS Scotland for the treatment of
type 2 diabetes in combination with oral antidiabetic drugs
or basal insulin (or both), when adequate glycaemic
control has not been achieved with these drugs; use is
restricted to patients in whom a GLP-1 agonist is
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