(SEMAGLUTIDE TABLETS) - Live.diabetesonthenet
RYBELSUS q(SEMAGLUTIDE TABLETS)A practical guide forUK healthcare professionalsTo improve glycaemic control in adultpatients with insufficiently controlledtype 2 diabetesThis material has been provided in digital format. Not for printing.Adverse events should be reported. Reporting forms and informationcan be found at www.mhra.gov.uk/yellowcard or search for MHRAYellow Card in the Google Play or Apple App Store.Adverse events should also be reported to Novo Nordisk Limited(Telephone Novo Nordisk Customer Care Centre 0800 0232573).Calls may be monitored for training purposes.Click here for the RYBELSUS prescribing informationClick here for the OZEMPIC q (semaglutide) prescribing information
ContentsRYBELSUS 1.3Indication and dosing1.4How should RYBELSUS be taken?1.5RYBELSUS tablets1.6Use of RYBELSUS with other diabetes medications1.7Dosing in special populations1.8Special considerations for RYBELSUS use1.9Interaction of semaglutide with other medicines1.11Selected adverse events1.13Resources available to help you and your patients.14For full information please refer to the RYBELSUS Summary of Product Characteristics.1 Links to thePrescribing Information can be found on the frontand back page.2
RYBELSUS 1RYBELSUS is a glucagon-like peptide-1(GLP‑1) receptor agonist. GLP-1 isa physiological hormone that hasmultiple actions in glucose and appetiteregulation, and in the cardiovascularsystem. Glucose and appetite effects arespecifically mediated via GLP‑1 receptorsin the pancreas and the brain. Throughacting upon these GLP‑1 receptors,RYBELSUS reduces blood glucose in aglucose‑dependent manner by stimulatinginsulin secretion and lowering glucagonsecretion when blood glucose is high. Themechanism of blood glucose lowering alsoinvolves a minor delay in gastric emptyingin the early postprandial phase.RYBELSUS reduces body weight and bodyfat mass through lowering energy intake,involving an overall reduced appetite.In addition, RYBELSUS reduces thepreference for high-fat foods.3
Indication and dosing1RYBELSUS (semaglutide tablets) is indicated for the treatment of adults withinsufficiently controlled type 2 diabetes mellitus to improve glycaemic control as anadjunct to diet and exercise. As monotherapy when metformin is considered inappropriate due to intoleranceor contraindications, including hypersensitivity to the active substance or to anyof the excipients In combination with other medicines for the treatment of diabetesRYBELSUS dosing1 The starting dose of RYBELSUS is 3 mg once daily for 1 month. After 1 month, thedose should be increased to a maintenance dose of 7 mg once daily. After at least1 month with a dose of 7 mg once daily, the dose can be increased to a maintenancedose of 14 mg once daily to further improve glycaemic controlSTARTING DOSE3Start with3 mg once dailyfor 1 monthMAINTENANCE DOSES7Increase doseto 7 mg oncedaily for atleast 1 month14Based on theindividual needs ofyour patient, the dosemay be increased to14 mg once dailyThe maximum recommended single daily dose of RYBELSUS is 14 mg.Taking two 7 mg tablets to achieve the effect of a 14 mg dose has not been studied andis therefore not recommended.Self-monitoring blood glucose is not required in order to adjust the dose of RYBELSUS .4
How should RYBELSUS be taken?1RYBELSUS offers once-daily oral dosing.To optimise exposure, patients must:Take RYBELSUS on an emptystomach upon waking, witha sip of water (no morethan 120 mL)After taking RYBELSUS , waitat least 30 minutes beforeeating, drinking or taking anyother oral medicationTablets should betaken whole andnot split, crushedor chewedFactors decreasing the absorption of RYBELSUS Food intakeprior to dosingIncreased watervolume ( 120 mL)Waiting lessthan 30 minutesWhat should a patient do if they miss a dose?1If a patient misses a dose, they must skip the missed dose and take their normal dose thefollowing day.5
RYBELSUS tablets1 RYBELSUS tablets are available in 3 mg, 7 mg and 14 mg prescription packs with30 tablets in each pack RYBELSUS tablets can be white to light yellow and are oval shaped. They state thedose number in mg (3, 7 or 14) on one side, and ‘novo’ on the other side6
Use of RYBELSUS with otherdiabetes medications1Sulphonylurea and/or insulinWhen semaglutide is used in combination withsulphonylurea and/or insulin, a reduction inthe dose of sulphonylurea or insulin should beconsidered to reduce the risk of hypoglycaemia.Blood glucose self-monitoring is necessary toadjust the dose of sulphonylurea and insulin,particularly when semaglutide is started andinsulin is reduced. A stepwise approach toinsulin reduction is recommended.Metformin and/or SGLT2iWhen semaglutide is used in combinationwith metformin and/or a sodium-glucoseco-transporter-2 inhibitor (SGLT2i) orthiazolidinedione, the current dose ofmetformin and/or SGLT2i or thiazolidinedionecan be continued.7
Dosing in specialpopulations1Renal impairment No dosage adjustment isrequired for mild, moderate,or severe renal impairment Experience with use ofRYBELSUS in patientswith severe renalimpairment is limited Elderly No dose adjustment isrequired based on age Therapeutic experience inpatients 75 years of ageis limited se is not recommended inUend‑stage renal diseaseHepatic impairment No dose adjustment is required forpatients with hepatic impairment Experience with the use ofRYBELSUS in patients with severehepatic impairment is limited Caution should be exercisedwhen treating these patientswith RYBELSUS RYBELSUS is not licensed for use in children and adolescents under 18 years.No data are available.8
Special considerations forRYBELSUS use1Gastrointestinal events The most frequently reported adverse reactions in clinical trials were gastrointestinaldisorders, including nausea, diarrhoea and vomiting Mild to moderate in severity and of short duration The events were most frequently reported during the first months on treatment Patients treated with semaglutide should be advised of the potential risk ofdehydration in relation to gastrointestinal side effects and take precautions to avoidfluid depletionTreatment response Compliance with the dosing regimen is required for optimal effect of semaglutide.Absorption of semaglutide is highly variable and may be minimal (2-4% patients willnot have any exposure)Hypoglycaemia Patients treated with semaglutide in combination with a sulphonylurea or insulin mayhave an increased risk of hypoglycaemia When semaglutide is used in combination with a sulphonylurea or with insulin, areduction in the dose of sulphonylurea or insulin may be considered to reduce the riskof hypoglycaemia Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea andinsulin, particularly when semaglutide is started and insulin is reduced. A stepwiseapproach to insulin reduction is recommendedDiabetic ketoacidosis9 RYBELSUS should not be used in patients with type 1 diabetes mellitus or for thetreatment of diabetic ketoacidosis Diabetic ketoacidosis has been reported in insulin-dependent patients whom hadrapid discontinuation or dose reduction of insulin when treatment with a GLP-1receptor agonist is started. A stepwise approach to insulin reduction is recommended
Acute pancreatitis Acute pancreatitis has previously been observed with the use of GLP-1 receptoragonists. Patients should be informed of the characteristic symptoms of acutepancreatitis If pancreatitis is suspected, semaglutide should be discontinued; if confirmed,semaglutide should not be restarted Caution should be exercised in patients with a history of pancreatitisDiabetic retinopathy In patients with diabetic retinopathy treated with insulin and s.c. semaglutide, anincreased risk of developing diabetic retinopathy complications has been observed,a risk that cannot be excluded for orally administered semaglutide Caution should be exercised when using semaglutide tablets in patients with diabeticretinopathy. These patients should be monitored closely and treated according toclinical guidelinesCongestive heart failure There is no therapeutic experience in patients with congestive heart failure New YorkHeart Association (NYHA) class IV and semaglutide is therefore not recommended inthese patientsSodium content RYBELSUS contains 23 mg of sodium per tablet, equivalent to 1% of the WorldHealth Organization recommended maximum daily intake of 2 g sodium for an adults.c., subcutaneous.10
Interaction of semaglutidewith other medicines1Gastric emptyingSemaglutide delays gastric emptying which may influence the absorption of other oralmedicinal products.What are the effects of RYBELSUS on other medicines?ThyroxineFollowing administration of a single dose of levothyroxine, the total exposure (AUC) ofthyroxine (adjusted for endogenous levels) was increased by 33%. Maximum exposurewas unchanged. Oral semaglutide and levothyroxine have similarities in their dosingconditions. Always advise compliance with the dosing conditions for oral semaglutide,along with monitoring of thyroid parameters, when treating patients with semaglutide atthe same time as levothyroxine.If the use of oral semaglutide and levothyroxine does not seem feasible due to theirdosing conditions, injectable once-weekly semaglutide can be considered for treatingtype 2 diabetes in patients also treated with levothyroxine.WarfarinSemaglutide administration did not change the total and maximum exposure of R- andS-warfarin following a single dose of warfarin. Frequent monitoring of the internationalnormalised ratio is recommended for patients on warfarin or other coumarin derivatives.RosuvastatinTotal exposure (AUC) of rosuvastatin was increased by 41% when co-administered withsemaglutide; however, this increase is not considered clinically relevant.Digoxin, oral contraceptives, metformin, furosemideNo clinically relevant change in exposure of digoxin, oral contraceptives (containingethinylestradiol and levonorgestrel), metformin or furosemide has been observed whenconcurrently administered with semaglutide.11
What are the effects of other medicines on RYBELSUS ?OmeprazoleNo clinically relevant change in exposure of semaglutide has been observed when takenwith omeprazole.12
Selected adverse events1The most common side effects observed in clinical trials were nausea ( 1/10), diarrhoea( 1/10) and vomiting ( 1/100 to 1/10). Generally, these were mild/moderate in severity,of short duration and most frequently reported during the first few months of treatment.Practical tips for patients with gastrointestinal side effects:Encourage patientsto try and:üüüüEat smaller portionsEat slowlyStay hydratedStop eating at first sign of fullnessEncourage patientsto avoid:ûûûûûLarge portionsFried or fatty foodsOverly sweet or spicy foods rinking alcohol and smokingDcigarettesCaffeineFor the full list of adverse events and precautions pleaserefer to the RYBELSUS Summary of Product Characteristics13
Resources available to help youand your patientsTo learn more about RYBELSUS and the resources available to help your patients,you can: Click here for the RYBELSUS patient information leaflet Click here for the RYBELSUS Summary of Product CharacteristicsReference: 1. RYBELSUS Summary of Product Characteristics, Novo Nordisk Ltd.14
Click here for the RYBELSUS prescribing information C lick here for the OZEMPIC q (semaglutide)prescribing informationAdverse event reportingAdverse events should be reported. Reporting forms and informationcan be found at www.mhra.gov.uk/yellowcard or search forMHRA Yellow Card in the Google Play or Apple App Store.Adverse events should also be reported to Novo Nordisk Limited(Telephone Novo Nordisk Customer Care Centre 0800 0232573).Calls may be monitored for training purposes.You can also contact the Novo Nordisk Customer Care Centre on0800 0232573 (8.30am to 5.30pm weekdays and Bank Holidays*)Scan the QR code above to connect to NAOMI, our automated, on-demand, medicalinformation chat service. NAOMI can provide information in response to questions from UKhealthcare professionals and patients. NAOMI is accessible 24/7. Please note, this does notprovide a live link to UK Novo Nordisk Medical Information.*Calls are charged at a local rate and no other costs are incurred by the caller.Calls may be monitored for training purposes.RYBELSUS , OZEMPIC and the Apis bull logo are registered trademarksof Novo Nordisk A/S. 2020 Novo Allé, DK-2880, Bagsværd, DenmarkUK21RYB00319 November 2021
Adverse events should also be reported to Novo Nordisk Limited (Telephone Novo Nordisk Customer Care Centre 0800 0232573). Calls may be monitored for training purposes. Click here for the RYBELSUS prescribing information Click here for the OZEMPIC q (semaglutide) prescribing information This material has been provided in digital format.
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