PRESCRIBING INFORMATION (PI) BYDUREON 2 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-FILLED PEN (exenatide) BYETTA (exenatide) 5 MICROGRAMS AND 10 MICROGRAMS SOLUTION FOR INJECTION IN PRE-FILLED PEN Please note this is a combined PI for BYDUREON and BYETTA; Consult individual Summaries of Product Characteristics before prescribing. USES: For Bydureon and Byetta: Treatment of type 2 diabetes mellitus in combination with metformin, sulphonylurea, thiazolidinedione, or combinations of metformin and sulphonylurea or metformin and thiazolidinedione, in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. For Byetta only: Byetta is also indicated as adjunctive therapy to basal insulin, with or without metformin and/or pioglitazone, in adults who have not achieved adequate glycaemic control with these medicinal products. PRESENTATION: Bydureon: Powder and solvent for prolonged-release suspension for injection containing 2mg exenatide. Byetta: Solution for injection. Each dose contains 5mcg exenatide in 20mcl, or 10mcg exenatide in 40mcl. DOSAGE AND ADMINISTRATION: For Bydureon and Byetta: Administer as subcutaneous injection in the thigh, abdomen, or back of upper arm. Hepatic impairment: No dose adjustment required. Children and adolescents: < 18 years: Safety and efficacy not established. For Bydureon only: The recommended dose is 2mg exenatide once weekly, on the same day each week, at any time of day, with or without meals. Administer immediately after suspension of powder in the solvent. If dose is missed, administer as soon as practical, then resume once weekly dosing schedule. Two injections should not be given in a 24-hour period. Prolonged-release exenatide is for self-administration and for single use only, appropriate training is recommended. Patients switching from immediate-release to prolonged-release exenatide may experience transient elevations in blood glucose concentrations, which generally improve within first two weeks after therapy initiation. When prolonged-release exenatide is added to existing metformin and/or thiazolidinedione therapy, the current dose of these oral therapies can be continued. Increased risk of hypoglycaemia when prolonged-release exenatide is added to sulphonylurea. Consider reduction in dose of sulphonylurea to reduce the risk of hypoglycaemia. Blood glucose self-monitoring may be necessary to adjust the dose of sulphonylurea. If a different glucose-lowering treatment is started after the discontinuation of prolonged-release exenatide, consideration should be given to the prolonged release of the product. Elderly: No dose adjustment required. >75 years: Very limited clinical experience Consideration should be given to the patient s renal function. Renal impairment: No dose adjustment required for patients with mild renal impairment (creatinine clearance (CrCl) 50-80 ml/min). Prolonged-release exenatide is not recommended in patients with moderate (CrCl 30-50ml/min) or severe renal impairment (CrCl<30 ml/min) or end-stage renal disease. For Byetta only: Initiate at 5mcg exenatide per dose, administered twice daily (BID) for at least one month. The dose can then be increased to 10mcg BID. Doses higher than 10mcg BID is not recommended. Administer within the 60 minute period before the morning and PI Combined Bydureon & Byetta CV 17 0050 (based on CV 16 0081) 16/06/2017 SP
evening meal (or two main meals of the day, approximately 6 hours or more apart). Do not administer after a meal. If injection missed, continue treatment with the next scheduled dose. Administer immediate-release exenatide and basal insulin as 2 separate injections. When immediate-release exenatide is added to existing metformin and/or pioglitazone therapy, continue current doses of these agents as no increased risk of hypoglycaemia anticipated. On addition of immediate-release exenatide to sulphonylurea or basal insulin, consider reduction in dose of sulphonylurea or basal insulin to reduce risk of hypoglycaemia. Blood glucose self-monitoring may be necessary to adjust dose of sulphonylurea or basal insulin. Elderly: use with caution, proceed conservatively with dose escalation from 5mcg to 10mcg in >70 years. Very limited clinical experience in ages >75 years. Renal impairment: No dose adjustment required for patients with mild renal impairment (creatinine clearance (CrCl) 50-80 ml/min). Dose escalation from 5mcg to 10mcg should proceed conservatively in moderate renal impairment (CrCl 30-50ml/min). Not recommended in patients with severe renal impairment (CrCl<30 ml/min) or end-stage renal disease. CONTRAINDICATIONS: For Bydureon and Byetta: Hypersensitivity to the active substance or to any of the excipients. WARNINGS AND PRECAUTIONS: For Bydureon and Byetta: General: The concurrent use of prolonged-release exenatide and immediate-release exenatide has not been studied and is not recommended. Not to be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Must not be administered by intravenous or intramuscular injection. Renal impairment: Uncommon, spontaneously reported events of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring haemodialysis. Some occurred in patients experiencing events that may affect hydration and/or receiving medicinal products known to affect renal function/hydration status, including angiotensin converting enzyme inhibitors, angiotensin-ii antagonists, non-steroidal anti-inflammatory medicinal products and diuretics. Reversibility observed with supportive treatment and discontinuation of potentially causative medicinal products, including exenatide. Severe gastrointestinal disease: Not recommended. Acute pancreatitis: Use of GLP-1 receptor agonists has been associated with a risk of developing acute pancreatitis. Spontaneously reported events of acute pancreatitis with exenatide/prolonged-release exenatide. Resolution of pancreatitis has been observed with supportive treatment, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported. Inform patients of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis suspected, discontinue use; if acute pancreatitis is confirmed, Exenatide/prolonged-release exenatide should not be restarted. Caution should be exercised in patients with a history of pancreatitis. Rapid weight loss: Rapid weight loss at a rate of >1.5kg per week has been reported with exenatide, which may have harmful consequences. Monitor for signs and symptoms of cholelithiasis. For Bydureon only: Concomitant medicinal products: Concurrent use of prolonged-release exenatide with insulin, meglitinides, alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied. Discontinuation of treatment: The effect of prolonged-release exenatide may continue as plasma levels of exenatide decline over 10 weeks. Choice of other medicinal products and dose selection should be considered accordingly until exenatide levels decline. For Byetta only: Concomitant medicinal products: Use with caution and follow closely in patients receiving oral medicinal products that require rapid gastrointestinal absorption, that have a narrow therapeutic ratio or that require careful monitoring. Concurrent use of immediate-release exenatide with meglitinides, alpha-glucosidase inhibitors, dipeptidyl PI Combined Bydureon & Byetta CV 17 0050 (based on CV 16 0081) 16/06/2017 SP
peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied and cannot be recommended. Excipients: Contains metacresol, may cause allergic reactions. DRUG INTERACTIONS: For Bydureon and Byetta: Warfarin and cumarol derivatives: Increased INR (International normalised ratio) spontaneously reported during concomitant use, sometimes associated with bleeding (Bydureon only). INR should be closely monitored during initiation of prolonged-release exenatide or immediate-release exenatide and during dose increase of immediate-release exenatide. HMG CoA reductase inhibitors: Concomitant use with exenatide was not associated with consistent changes in lipid profiles. However, lipid profiles should be monitored regularly with Byetta and as appropriate with Bydureon. For Bydureon only: No dose adjustment required for medicinal products sensitive to delayed gastric emptying. For Byetta only: May reduce the extent and rate of absorption of other oral medicinal products and thus these medicinal products may need to be administered at a separate time. Consult SmPC for further details. PREGNANCY AND LACTATION: For Bydureon only: Women of childbearing potential should use contraception during treatment with prolonged-release exenatide. Discontinue at least 3 months before trying to get pregnant. Should not use during pregnancy and breast-feeding. For Byetta only: Discontinue if trying to become pregnant. Should not use during pregnancy and breast-feeding. ABILITY TO DRIVE AND USE MACHINES: For Bydureon and Byetta: exenatide has minor influence on the ability to drive and use machines. Advise patients to take precautions when used in combination with a sulphonylurea or basal insulin (Byetta only) to avoid hypoglycaemia. UNDESIRABLE EFFECTS: Consult SmPC for full list of side effects. For Bydureon and Byetta: Very common ( 1/10): Diarrhoea, nausea. Common ( 1/100 to <1/10): Decreased appetite, dizziness, headache, abdominal distention, constipation, flatulence, abdominal pain, dyspepsia, gastroesophageal reflux disease, pruritus and/or urticaria, asthenia. Uncommon ( 1/1000 to <1/100): Dehydration (generally associated with nausea, vomiting and/or diarrhoea), dysgeusia, somnolence, eructation, altered renal function (including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine), alopecia. Rare ( 1/10,000 to <1/1000): Anaphylactic reaction. Frequency not known: Acute pancreatitis, angioneurotic oedema, macular and papular rash, INR ratio increased with concomitant warfarin use (some reports associated with bleeding). Patients may develop anti-exenatide antibodies following treatment with prolonged-release exenatide or immediate release exenatide. These patients tend to have more injection site reactions (e.g. skin redness, itching). For Bydureon only: Very common ( 1/10): Hypoglycaemia (with sulphonylurea). Common ( 1/100 to <1/10): Vomiting, injection site pruritus, fatigue, injection site erythema. Uncommon ( 1/1000 to < 1/100): Intestinal obstruction, injection site rash, hyperhidrosis. Rare ( 1/10,000 to <1/1000): feeling jittery. Frequency not known (cannot be estimated from available data): Injection site abscesses and cellulitis. Small subcutaneous injection site nodules observed very frequently, consistent with the known properties of PLGA polymer microsphere formulations. For Byetta only: Very common ( 1/10): Hypoglycaemia (with a sulphonylurea or metformin and sulphonylurea), vomiting. Common ( 1/100 to <1/10): Hyperhidrosis, feeling jittery. Uncommon ( 1/1000 to <1/100): injection site reactions, weight decreased. Rare ( 1/10,000 to <1/1000): Intestinal obstruction. PI Combined Bydureon & Byetta CV 17 0050 (based on CV 16 0081) 16/06/2017 SP
Legal category: For Bydureon and Byetta: POM. Marketing authorisation number: Bydureon: EU/1/11/696/003 (pre-filled pen) Byetta: 5mcg - EU/1/06/362/001 and 10mcg - EU/1/06/362/003. Presentation & basic NHS price: Bydureon: 4 x 1 pre-filled pen 73.36. Byetta: 68.24 per pack of 5mcg (1 pen), 68.24 per pack of 10mcg (1 pen). Further information is available from: AstraZeneca AB, SE-151 85 Södertälje, Sweden. [BYDUREON] and [BYETTA] are trademarks of the AstraZeneca group of companies. Date of PI preparation: 06/2017 CV 17 0050 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca on 0800 783 0033. PI Combined Bydureon & Byetta CV 17 0050 (based on CV 16 0081) 16/06/2017 SP
PRESCRIBING INFORMATION FORXIGA 5MG & 10MG FILM-COATED TABLETS (dapagliflozin). Consult Summary of Product Characteristics (SmPC) before prescribing. Indications Adults 18 years and older: For patients with type 2 diabetes mellitus to improve glycaemic control: as monotherapy when diet and exercise alone do not provide adequate glycaemic control and use of metformin is considered inappropriate due to intolerance, or in combination with other glucose-lowering medicinal products including insulin when these, together with diet and exercise, do not provide adequate glycaemic control. Presentation Film-coated tablets. 5mg or 10mg dapagliflozin (as propanediol monohydrate). Dosage and administration Adults: 10mg once daily as monotherapy and add-on combination therapy with other glucose-lowering medicinal products including insulin. Forxiga can be taken at any time of day with or without food. Tablets should be swallowed whole. Consider a lower dose of insulin or insulin secretagogue such as a sulphonylurea when used in combination with dapagliflozin to reduce the risk of hypoglycaemia. Children and adolescents: <18 years: Safety and efficacy not yet established. Elderly: 65 years: No dosage adjustment is recommended based on age. Renal function and risk of volume depletion should be taken into account. 75 years: Not recommended. Mild renal impairment: No dosage adjustment. Moderate & severe renal impairment: Not recommended. Mild or moderate hepatic impairment: No dosage adjustment. Severe hepatic impairment: Starting dose of 5mg is recommended, if well tolerated, dose may be increased to 10mg. Contraindications Hypersensitivity to dapagliflozin, or excipients. Warnings and precautions Not to be used in patients with type 1 diabetes mellitus or for diabetic ketoacidosis(dka). Dapagliflozin is not recommended in patients concomitantly treated with pioglitazone and has not been studied with GLP-1 analogues. Use in patients with renal impairment: Not recommended in moderate to severe renal impairment (CrCl <60ml/min or egfr <60ml/min/1.73m 2 ). Renal function monitoring is recommended: prior to initiation of dapagliflozin and at least yearly thereafter; prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter; for renal function approaching moderate renal impairment, at least 2 to 4 times per year. If renal function falls below CrCl <60ml/min or egfr< 60ml/min/1.73m 2, treatment should be discontinued. Use in patients with hepatic impairment: Exposure is increased in patients with severe hepatic impairment. Use in patients at risk of volume depletion, hypotension and/or electrolyte imbalances: Dapagliflozin is associated with a modest decrease in blood pressure, which may be more pronounced in patients with very high blood glucose concentrations. Not recommended in patients receiving loop diuretics or who are volume depleted. Exercise caution in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients. Careful monitoring of volume status and electrolytes is recommended in conditions leading to volume depletion, such as acute gastrointestinal illness. In volume depleted patients temporary interruption of dapagliflozin is recommended until volume depletion is corrected. Diabetic ketoacidosis: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as
nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level which may be only moderately increased. In patients where DKA is suspected or diagnosed, treatment with dapagliflozin should be discontinued immediately. Treatment should be interrupted in patients hospitalised for major surgical procedures or acute serious medical illnesses and may be restarted once the patient s condition has stabilised. Consider factors in patient history that may predispose to ketoacidosis before initiating dapagliflozin. Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse. SGLT2 inhibitors should be used with caution in these patients. Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Urinary tract infections: Temporary interruption of dapagliflozin should be considered when treating pyelonephritis or urosepsis. Elderly: 65 years: Elderly patients are more likely to have impaired renal function, be treated with medicines such as anti-hypertensives or diuretics, and be at a greater risk of volume depletion. Cardiac failure: Experience in NYHA class I-II is limited, and there is no experience in clinical studies with dapagliflozin in NYHA class III-IV. Elevated haematocrit: Exercise caution in patients with elevated haematocrit. Lower limb amputations: Counsel patients on routine preventative foot care as an increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term, clinical studies with another SGLT2 inhibitor. Urine laboratory assessments: Patients will test positive for glucose in the urine due to mechanism of action. Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take Forxiga. Drug interactions Diuretics: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues: Consider a lower dose of insulin or insulin secretagogue in combination with dapagliflozin to reduce the risk of hypoglycaemia. Interference with 1,5-AG assay: Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Alternative methods should be used. Dapagliflozin has a low potential for other interactions with commonly used agents in patients with type 2 diabetes. Pregnancy and lactation Not recommend during the second and third trimesters of pregnancy. Treatment should be discontinued when pregnancy is detected. Do not use whilst breast-feeding. Driving and using machines Alert patients on the risk of hypoglycaemia when dapagliflozin is used in combination with a sulphonylurea or insulin. Undesirable events Consult SmPC for full list of side effects. Very common ( 1/10): Hypoglycaemia (when used with SU or insulin). Common ( 1/100 to <1/10): Vulvovaginitis, balanitis and related genital infections, urinary tract infection, dizziness, rash, back pain, dysuria, polyuria, haematocrit increased, creatinine renal clearance decreased, dyslipidaemia. Uncommon ( 1/1,000 to < 1/100 Volume depletion. Rare ( 1/10,000 to < 1/1,000): Diabetic ketoacidosis.
Legal Category POM. Marketing authorisation number EU/1/12/795/002 & EU/1/12/795/007 Presentation & basic NHS cost Forxiga 5mg film-coated tablets 28: 36.59; Forxiga 10mg film-coated tablets 28: 36.59. Marketing Authorisation holder AstraZeneca AB, SE-151 85 Södertälje, Sweden. Further information is available from AstraZeneca UK Ltd., 600 Capability Green, Luton, LU1 3LU, UK. [FORXIGA] is a trademark of the AstraZeneca group of companies. Date of preparation: 04/2017. CV 17 0018 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca on 0800 783 0033.
PRESCRIBING INFORMATION QTERN 5mg/10mg film-coated tablets (saxagliptin and dapagliflozin) Consult Summary of Product Characteristics before prescribing. Indication: Qtern is indicated in adults aged 18 years and older with type 2 diabetes mellitus: i) to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control; ii) when already being treated with the free combination of dapagliflozin and saxagliptin. Presentation: 5mg saxagliptin (saxagliptin hydrochloride) and 10mg dapagliflozin (dapagliflozin propanediol monohydrate) film-coated tablets. Dosage and administration: Recommended dose is one tablet once daily, taken orally with or without food. Can be taken at any time of the day and should be swallowed whole. If the dose is missed and it is 12 hours until the next dose, the dose should be taken. If it is <12 hours until the next dose, the missed dose should be skipped and the next dose taken at the usual time. Renal impairment: Can be used in patients with mild renal impairment. Should not be used in patients with moderate to severe renal impairment (creatinine clearance (CrCl) <60 ml/min or estimated glomerular filtration rate (egfr) < 60 ml/min/1.73 m 2 ) or in patients with end-stage renal disease (ESRD). Hepatic impairment: Can be used in patients with mild or moderate hepatic impairment. Patients with moderate hepatic impairment should be evaluated prior to initiation and during treatment. Not recommended for use in patients with severe hepatic impairment. Elderly: 65 years: renal function and risk of volume depletion should be taken into account. 75 years: not recommended due to very limited experience in these patients. Contraindications: Hypersensitivity to the active substances or any of the excipients. History of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angiodema to any dipeptidyl peptidase-4 (DPP-4) inhibitor or to any sodium-glucose co-transporter 2 (SGLT2) inhibitor. Warnings and precautions: Not to be used in patients with type 1 diabetes mellitus or for diabetic ketoacidosis. Acute pancreatitis: DPP-4 inhibitors have been associated with risk of developing acute pancreatitis. Inform patients of the characteristic symptoms of acute pancreatitis: persistent, severe abdominal pain. If pancreatitis suspected discontinue use. If acute pancreatitis confirmed, treatment should not be restarted. Exercise caution in patients with a history of pancreatitis. Renal impairment: Renal function should be monitored: prior to initiation and at least yearly thereafter, prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter, for renal function approaching moderate renal impairment, at least 2 to 4 times per year. Discontinue treatment if renal function falls below CrCl <60 ml/min or egfr < 60 ml/min/1.73 m 2. Patients at risk of volume depletion, hypotension and/or electrolyte imbalances: Qtern increases diuresis associated with a modest decrease in blood pressure, which may be more pronounced in patients with very high blood glucose concentrations. Not recommended in patients at risk of volume depletion (e.g. receiving loop diuretics) or who are volume depleted. Exercise caution in patients for whom a dapagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or elderly patients. Careful monitoring of volume status and electrolytes is recommended in conditions leading to volume depletion. In volume depleted patients temporary interruption of treatment is recommended until volume depletion is corrected.
Diabetic ketoacidosis (DKA): Consider risk of diabetic ketoacidosis in the event of nonspecific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness. Assess patients for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level. If DKA is suspected or diagnosed, discontinue treatment immediately. Treatment should be interrupted in patients hospitalised for major surgical procedures or acute serious medical illnesses and may be restarted once the patient s condition has stabilised. Consider factors in patients history that may predispose to ketoacidosis before initiation of Qtern. SGLT2 inhibitors should be used with caution in patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g. type 2 diabetes patients with low C- peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse. Restarting SGLT2 inhibitor treatment in patients with previous DKA while on SGLT2 inhibitor treatment is not recommended, unless another clear precipitating factor is identified and resolved. Hypersensitivity reactions: Must not be used in patients who have had any serious hypersensitivity reaction to a DPP-4 inhibitor or a SGLT2 inhibitor. If a serious hypersensitivity reaction is suspected, discontinue use and institute an alternative treatment. Urinary tract infections: Patients with signs and symptoms of urinary tract infections (urosepsis and phelonephritis) should be evaluated and promptly treated, if indicated. Elderly: Renal function and risk of volume depletion should be taken into account prior to initiating Qtern. Not recommended in >75 years. Skin disorders: Monitoring for skin disorders, such as blistering, ulceration or rash is recommended. Cardiac failure: Express caution in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment. Advise patients of the characteristics symptoms of heart failure and to immediately report symptoms. Arthralgia: Continuation of therapy should be individually assessed if patients experiences severe joint pain. Treatment with pioglitazone: Not recommended in patients concomitantly treated with pioglitazone. Elevated haematocrit: Caution is warranted. Lower limb amputations: Counsel patients on routine preventative foot care as an increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term, clinical studies with another SGLT2 inhibitor. Use with medicinal products known to cause hypoglycaemia: If used in combination with sulphonylurea, a reduction in the dose of sulphonylurea may be required to minimise the risk of hypoglycaemia. Urine laboratory assessments: Patients taking Qtern will test positive for glucose in their urine. Lactose: Should not be taken by patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose melabsorption. Drug interactions: Diuretics: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension. Dapagliflozin and saxagliptin have a low potential for other interactions with commonly used oral agents in patients with type 2 diabetes. CYP3A4/5: Assess glycaemic control carefully when concomitantly using a potent CYP3A4/5 inducer. Interference with 1,5-AG assay: Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking SGLT2 inhibitors. Alternative methods should be used. Pregnancy and lactation: Do not use during pregnancy or breast-feeding. Driving and using machines: Dizziness has been reported in studies with combined use of saxagliption and dapagliflozin. Patients should be alerted to the risk of hypoglycaemia if used in combination with other antidiabetic medicinal products.
Undesirable events: Consult SmPC for full list of side effects. Very common ( 1/10): Upper respiratory tract infection, hypoglycaemia (when used with SU). Common ( 1/100 to <1/10): Urinary tract infection, vulvovaginitis, balanitis and related genital infection, gastroenteritis, dyslipidaemia, headache, dizziness, abdominal pain, diarrhoea, dyspepsia, gastritis, nausea, vomiting, dysuria, polyuria, rash, arthralgia, back pain, myalgia, fatigue, peripheral oedema, creatinine renal clearance decreased, haematocrit increased. Uncommon ( 1/1000 to <1/100): Hypersensitivity reactions, pancreatitis, volume depletion. Rare ( 1/10,000 to <1/1000): Anaphylactic reactions including anaphylactic shock, diabetic ketoacidosis, angioedema. Legal category: POM. Marketing authorisation number: EU/1/16/1108/002 Presentation & Basic NHS cost: 28 Tablets: 49.56 Marketing Authorisation Holder: AstraZeneca AB, SE-151 85 Södertälje, Sweden Further information is available from: AstraZeneca UK Ltd., 600 Capability Green, Luton. LU1 3LU, UK QTERN is a trade mark of the AstraZeneca group of companies. Date of preparation: 06/2017 CV 17 0055 Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AstraZeneca on 0800 783 0033