Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Foundayo contains the active substance orforglipron and is used to treat adults with obesity or overweight. Foundayo influences appetite regulation, which may help you eat less food and reduce your body weight.
Foundayo is used together with a reduced-calorie diet and increased physical activity for weight loss and to help keep the weight under control in adults initially with:
• a BMI of 30 kg/m² or greater (obesity) or,
• a BMI of at least 27 kg/m² but less than 30 kg/m² (overweight) and at least one weight related health problem such as prediabetes, type 2 diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called “obstructive sleep apnoea”, impaired heart function or a history of heart attack, stroke or blood vessel problems.
Foundayo is also used to treat adults with type 2 diabetes mellitus whose blood sugar is not properly controlled. Foundayo reduces the level of sugar in the body only when the levels of sugar are high.
Foundayo is used together with diet and exercise for the treatment of adults with type 2 diabetes:
• on its own, or
• with other medicines for diabetes when they are not enough to control your blood sugar levels. These other medicines may be medicines taken by mouth or by injection such as insulin.
It is important to continue to follow the advice on diet and exercise given to you by your doctor, nurse or pharmacist.
Do not take Foundayo If you are allergic to orforglipron or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions Talk to your doctor, nurse or pharmacist before taking Foundayo if:
• You have or have ever had pancreatitis (inflammation of the pancreas which may cause severe pain in the stomach and back which does not go away; see section 4).
• You are using a sulfonylurea (another diabetes medicine) and/or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur. Your doctor may need to change your dose of these other medicines to reduce this risk.
• You have severe problems with food digestion or food remaining in your stomach for longer than normal (including severe gastroparesis).
• When starting treatment with Foundayo you may feel sick (nausea) or be sick (vomiting) or have diarrhoea. These side effects can cause dehydration (loss of fluids). It is important that you drink enough fluids to prevent dehydration. This is especially important if you have kidney problems. Talk to your doctor, nurse or pharmacist if you have any questions or concerns.
• You are using antihypertensive medicines (for high blood pressure) as low blood pressure can occur. Your doctor may need to change your dose of these medicines to reduce this risk.
• You have gallbladder problems including symptoms such as pain in your upper stomach (abdomen), yellowing of skin or eyes (jaundice), clay-coloured stools or fever.
• You have a problem with your eyes or vision (diabetic retinopathy or macular oedema).
• You know that you are due to have surgery where you will be under anaesthesia (sleeping).
• You have or have had severe heart failure.
Children and adolescents This medicine should not be given to children and adolescents under 18 years of age because it has not been studied in this age group.
Other medicines and Foundayo Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because some medicines may affect the way Foundayo works and Foundayo may affect the way other medicines work. For example, either medicine may become less effective or you may be more likely to experience side effects.
Some medicines may increase the concentration of Foundayo in your blood, such as
• clarithromycin (used to treat bacterial infections)
• itraconazole or ketoconazole(used to treat fungal infections)
• ritonavir or telaprevir (used to treat viral infections)
Some medicines may reduce the amount of Foundayo in your blood, such as
• carbamazepine (used to treat seizures or fits)
• bosentan (used to treat pulmonary hypertension)
• efavirenz (used to treat viral infections)
• rifampicin (used to treat bacterial infections)
• phenytoin (used to treat seizures)
• St. John’s wort ( Hypericum perforatum ) (a herbal product used for depression and anxiety)
Foundayo may increase the amount of this medicine in your blood:
• simvastatin (for lowering cholesterol)
• rosuvastatin (for lowering cholesterol)
• topotecan (a treatment for certain types of cancers)
Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. This medicine should not be used during pregnancy as the effects of this medicine on an unborn child are not known. Therefore, it is recommended to use contraception while using this medicine. If you wish to become pregnant, discuss how to change your treatment with your doctor as you should stop using this medicine at least 3 weeks in advance.
Use of orforglipron may reduce the efficacy of oral hormonal contraceptives. If you are a woman using oral contraceptives, you should consider also using a barrier method of contraception (e.g., a condom) or switching to a non-oral contraceptive method for 30 days after starting Foundayo and for 30 days after each increase in dose.
Breast-feeding It is unknown whether orforglipron passes into breast milk. A risk to newborns and infants cannot be ruled out. Foundayo should not be used during breast feeding.
Driving and using machines It is unlikely that this medicine will affect your ability to drive and use machines.
However, if you use Foundayo in combination with a sulfonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate. Avoid driving or using machines if you get any signs of low blood sugar, e.g. headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating (see section 4). See section 2, ‘Warnings and precautions’ for information on increased risk of low blood sugar. Talk to your doctor for further information.
Foundayo contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to take this medicine.
• The starting dose for Foundayo tablet is 0.8 mg once daily for 30 days. After 30 days your doctor should increase your dose to 2.5 mg once daily.
• After at least 30 days, your doctor can increase your dose to 5.5 mg once daily.
• After at least 30 days, your doctor may increase your dose to the next dose level (9 mg, 14.5 mg, and 17.2 mg) once daily if you need it. In each case your doctor will tell you to stay on a particular dose for at least 30 days before increasing to a higher dose.
• The maximum daily dose of Foundayo tablets is 17.2 mg daily.
• Do not change your dose unless your doctor has told you to.
You can take your once daily dose at any time of the day, with or without food.
Swallow the tablet whole. Do not break, crush or chew the tablet. Do not take more than one tablet per day.
Testing blood glucose levels If you are taking Foundayo with a sulfonylurea and/or insulin, it is important that you test your blood glucose levels as instructed by your doctor, nurse or pharmacist (see section 2).
If you take more Foundayo than you should If you take more Foundayo than you should talk to your doctor immediately. Too much of this medicine can make you feel sick or be sick.
If you forget to take Foundayo If you forget to take a dose, take it as soon as you remember. Do not take more than one dose per day.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Foundayo Do not stop taking Foundayo without talking with your doctor. If you stop taking Foundayo, and you have type 2 diabetes, your blood sugar levels can increase.
If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects Uncommon (may affect up to 1 in 100 people)
• Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away. This is a serious, potentially life-threatening condition. You should see a doctor immediately if you experience such symptoms.
Frequency not known (frequency may not be estimated from the available data).
Some patients taking this type of medication have reported these effects.
• Any sudden changes in your vision or any other unusual visual symptoms. You should tell your doctor if you experience these effects.
• Bowel obstruction which could cause severe tummy pain, a swollen tummy, being sick (vomiting), or not being able to pass wind or open your bowels.
• Severe constipation.
• Serious allergic reactions (anaphylactic reactions). You should get immediate medical help and inform your doctor if you experience symptoms such as breathing problems, swelling of face and throat, wheezing, fast heartbeat, pale and cold skin, feeling dizzy or weak.
• The chance of food or liquid getting into your lungs may increase during surgery or other procedures.
• Kidney problems have been reported sometimes requiring treatment with a kidney machine (dialysis). Signs may include dehydration resulting from vomiting or diarrhoea.
Other side effects Very common (may affect more than 1 in 10 people)
• Feeling sick (nausea)
• Constipation
• Diarrhoea
• Being sick (vomiting)
• Indigestion (dyspepsia)
• Stomach (abdominal) pain
These side effects are usually not severe. Nausea, diarrhoea, and vomiting are most common when first starting orforglipron but decrease over time in most patients.
• Low blood sugar (hypoglycaemia) when orforglipron is used with insulin with or without metformin and/or sodium-glucose co-transporter 2 inhibitors (SGLT2i).
Your doctor may reduce your dose of insulin before you start using this medicine (see section 2).
The warning signs of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar
Common (may affect up to 1 in 10 people)
• Low blood sugar (hypoglycaemia) when orforglipron is used with medicines that contain a sulfonylurea alone or combined with up to two additional diabetes medications for type 2 diabetes. Your doctor may reduce your dose of sulfonylurea before you start using this medicine (see section 2)
• Dizziness
• Headache
• Fast pulse
• Low blood pressure
• Bloating of the stomach
• Burping (eructation)
• Reflux or heartburn (also called gastro-oesophageal reflux disease – GORD) - a disease caused by stomach acid coming up into the tube from your stomach to your mouth
• Gas (flatulence)
• Gallstones
• Hair loss
• Feeling tired (fatigue)
• Increased levels of pancreatic enzymes (such as lipase and amylase) in blood
Uncommon (may affect up to 1 in 100 people)
• Low blood sugar (hypoglycaemia) when orforglipron is used without insulin or sulfonylurea.
• Unusual sense of taste reported
• Unpleasant and abnormal feeling when touched
Reporting of side effects If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.
Store in the original package in order to protect from light. This medicine is light sensitive.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
What Foundayo tablets contain The active substance in Foundayo is orforglipron. Six different strengths of tablets are available.
Foundayo 0.8 mg film-coated tablets: Each tablet contains 0.8 mg of orforglipron
Foundayo 2.5 mg film-coated tablets: Each tablet contains 2.5 mg of orforglipron
Foundayo 5.5 mg film-coated tablets: Each tablet contains 5.5 mg of orforglipron
Foundayo 9 mg film-coated tablets: Each tablet contains 9 mg of orforglipron
Foundayo 14.5 mg film-coated tablets: Each tablet contains 14.5 mg of orforglipron
Foundayo 17.2 mg film-coated tablets: Each tablet contains 17.2 mg of orforglipron
The other ingredients are:
Tablet core: microcrystalline cellulose, crospovidone, copovidone, sodium carbonate anhydrous, magnesium stearate;
Tablet film-coating: poly (vinyl alcohol), titanium dioxide, macrogol, talc, iron oxide red (E172) ( in the 0.8 mg, 5.5 mg, 9 mg and 17.2 mg tablets), iron oxide yellow (E172) (in the 0.8 mg, 2.5 mg, 9 mg and 14.5 mg tablets), and iron oxide black (E172) (in the 5.5 mg and 17.2 mg tablets). See also section 2, “Foundayo contains sodium”.
What Foundayo looks like and contents of the pack Foundayo 0.8 mg film-coated tablets are pink, round (approximately 6 mm in diameter), debossed with ‘G1’ on one side and ‘L’ on the other side.
Foundayo 2.5 mg film-coated tablets are light yellow, round (approximately 6 mm in diameter), debossed with ‘G2’ on one side and ‘L’ on the other side.
Foundayo 5.5 mg film-coated tablets are greyish purple, round (approximately 6 mm in diameter), debossed with ‘G3’ on one side and ‘L’ on the other side.
Foundayo 9 mg film-coated tablets are pink, modified oval shaped (approximately 10 mm x 5 mm), debossed with ‘G4’ on one side and ‘Lilly’ on the other side.
Foundayo 14.5 mg film-coated tablets are light yellow, modified oval shaped (approximately 12 mm x 6 mm), debossed with ‘G5’ on one side and ‘Lilly’ on the other side.
Foundayo 17.2 mg film-coated tablets are greyish purple, modified oval shaped (approximately 12 mm x 6 mm), debossed with ‘G6’ on one side and ‘Lilly’ on the other side.
Foundayo film-coated tablets are available in blister packs of 30 and 90 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder Eli Lilly Nederland B.V.
Orteliuslaan 1000
3528 BD Utrecht
The Netherlands
Manufacturer LILLY, S.A.
Avda
de la Industria
30 Alcobendas
28108 Madrid
Spain
Pfizer Italia S.r.l.
Viale Del Commercio 25/27
Ascoli Piceno
AP
63100
Italy
Other formats
This leaflet is available in other formats. If you would like a copy of this leaflet in Braille, large print, audio or another format, please contact your local Lilly Affiliate.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
United Kingdom Eli Lilly and Company Limited
Tel: + 44-(0) 1256 315000 This leaflet was last revised in August 2026.
Eli Lilly and Company Limited
Address
Lilly House, Basing View, Basingstoke, Hampshire, RG21 4FA
Telephone
+44 (0)1256 315 000
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https://www.lilly.com/uk/
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Foundayo 14.5 mg film-coated tablets comes as tablet containing 14.5 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Foundayo 14.5 mg film-coated tablets is orforglipron.
This leaflet reproduces the patient information leaflet approved for Foundayo 14.5 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Weight management
Foundayo is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of
• ≥30 kg/m2 (obesity), or
• ≥27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight-related comorbidity e.g. prediabetes or type 2 diabetes mellitus, hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.
Type 2 diabetes mellitus
Foundayo is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise:
• as monotherapy, or
• in combination with other medicinal products for the treatment of diabetes.
For study results with respect to combinations, effects on glycaemic control, and the populations studied, see section 4.4, 4.5 and 5.1.
Posology
The starting dose for orforglipron film-coated tablet is 0.8 mg once daily. After at least 30 days, the dose should be increased to 2.5 mg once daily. After at least 30 days on the current dose, the dose can be increased to the next dose 5.5 mg, once daily. The dose may be increased to the next dose level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dose, based on treatment response and tolerability.
The maximum daily dose is 17.2 mg once daily. More than one film-coated tablet a day should not be taken to achieve the effect of a higher dose.
Dose adjustments
Strong CYP3A4 inhibitors
The maximum orforglipron dose should be the 9.0 mg film-coated tablet once daily when co-administered with a strong CYP3A4 inhibitor (see section 4.5).
Strong CYP3A4 inducers
Avoid concomitant use of strong CYP3A4 inducers when taking orforglipron (see section 4.5).
OATP1B inhibitors
The maximum orforglipron dose should be the 9.0 mg film-coated tablet once daily when used concomitantly with a clinical OATP1B inhibitor (see section 4.5).
Concomitant use of insulin secretagogues or insulin
When orforglipron is added to existing therapy of a sulphonylurea and/or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia.
Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and/or insulin. A stepwise approach to insulin reduction is recommended (see sections 4.4 and 4.8).
Missed dose
If a dose is missed, dosing should be resumed as soon as possible. More than one film-coated tablet should not be taken per day.
Special populations
Elderly, gender, race, ethnicity, body weight, renal impairment or hepatic impairmentNo dose adjustment is required based on age, gender, race/ethnicity, body weight, renal function including end-stage renal disease (see section 5.2), or mild or moderate hepatic impairment (see section 5.2). Only very limited data are available from patients aged 85 years and older.
Severe hepatic impairment
Orforglipron is not recommended for use in patients with severe hepatic impairment (see section 5.2).
Paediatric population
The safety and efficacy of orforglipron in children aged less than 18 years have not yet been established. No data are available.
Method of administration
For oral use.
This medicinal product should be taken once-daily at any time of day, without food or water restriction.
Film-coated tablets should be swallowed whole and should not be broken, crushed, or chewed.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Effects of other medicinal products on the pharmacokinetics of orforglipron
Orforglipron is a substrate of CYP3A4 and CYP2J2 as well as P-gp, OATP1B1 and OATP1B3.
Interaction studies were conducted with a hard capsule pharmaceutical form (see section 5.1 for dose equivalence of film-coated tablets and hard capsules).
For a summary of the impact on orforglipron dosing, please see section 4.2
Strong CYP3A4/OATP1B inhibitors
Strong CYP3A4 inhibitors that also inhibit OATP1B (e.g., ritonavir, telaprevir) should be avoided when taking orforglipron.
Strong CYP3A4 inhibitors
Coadministration of the strong CYP3A4 inhibitor clarithromycin (500 mg twice daily) with orforglipron increased orforglipron AUC(0-∞) and Cmax by 3.5-fold and 1.9-fold, respectively. The maximum orforglipron dose should be the 9 mg film-coated tablet dose when coadministered with a strong CYP3A4 inhibitor (e.g. ketoconazole, clarithromycin, itraconazole) (see section 4.2).
Moderate and Strong CYP3A4 inducers
Coadministration of the strong CYP3A4 inducer carbamazepine (300 mg twice daily) with orforglipron decreased orforglipron AUC(0-∞) and Cmax by 82% and 55%, respectively.
Coadministration of a moderate CYP3A4 inducer (e.g. bosentan, efavirenz) or strong CYP3A4 inducer (e.g. rifampicin, phenytoin, St John's wort [hypericum perforatum]) may reduce the effectiveness of orforglipron. Avoid concomitant use of strong CYP3A4 inducers when taking orforglipron. Monitor orforglipron effectiveness and adjust dose as needed when used concomitantly with moderate CYP3A4 inducers.
OATP1B inhibitors
Coadministration of cyclosporine, a clinical OATP1B inhibitor and weak CYP3A4 inhibitor, (200 mg twice daily) with orforglipron increased orforglipron AUC(0-∞) and Cmax by 2.6-fold and 1.3-fold, respectively.
The maximum dosage of orforglipron film-coated tablets is 9 mg once daily when used concomitantly with a clinical OATP1B inhibitor, unless they are also strong inhibitors of CYP3A4 (e.g. ritonavir, telaprevir) (see Strong CYP3A4/OATP1B inhibitors).
Effects of orforglipron on the pharmacokinetics of other medicinal products
BCRP Substrates
Coadministration of rosuvastatin, a clinical BCRP substrate, with daily dosing of 36 mg orforglipron hard capsules (equivalent to 17.2 mg film-coated tablet) increased rosuvastatin AUC(0-∞) and Cmax by 1.7-fold and 1.3-fold, respectively. No dose adjustment of BCRP substrates is necessary with orforglipron administration, except for rosuvastatin where caution is advised when the rosuvastatin dose exceeds 20 mg, and oral topotecan, where patients should be carefully monitored for adverse reactions when oral topotecan is administered with orforglipron.
Simvastatin
Coadministration of simvastatin with daily dosing of 24 mg or 36 mg orforglipron hard capsules (equivalent to 14.5 mg or 17.2 mg film-coated tablet) had no clinically meaningful effect on simvastatin (lactone) pharmacokinetics. Exposure of the active metabolite simvastatin acid was increased up to 2.5-fold when simvastatin was coadministered with orforglipron or administered 2 hours after orforglipron. The dose of simvastatin should be halved when administered with orforglipron.
Potential medicinal product interactions due to gastric emptying delay
Orforglipron delays gastric emptying and has the potential to affect the rate of absorption of other orally administered medicinal products. When paracetamol and orforglipron were co-administered, paracetamol Cmax decreased by 28%. The gastric emptying delay effect is largest after the first 1 mg dose hard capsules (equivalent to 0.8 mg film-coated tablet) and diminishes over time.
No clinically relevant effect of orforglipron-mediated gastric emptying on the pharmacokinetics of commonly administered concomitant medicinal products is expected, based on PBPK modeling, following either a single 1 mg hard capsule (equivalent to 0.8 mg film-coated tablet) dose or with daily dosing up to 36 mg hard capsules (equivalent to 17.2 mg film-coated tablet).
Antidiabetic medicinal products
When orforglipron is added to existing metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or SGLT2i can be continued.
Oral contraceptives
Use of orforglipron may reduce the efficacy of oral hormonal contraceptives. Patients using oral hormonal contraceptives should be advised to switch to a non-oral contraceptive method or add a barrier method of contraception for 30 days after initiation with orforglipron and for 30 days after each dose escalation.
Women of childbearing potential
Women of childbearing potential should use effective contraception during treatment with orforglipron.
Pregnancy
There are no adequate and well-controlled studies of orforglipron in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3).
Orforglipron should not be used during pregnancy. If a patient wishes to become pregnant, or pregnancy occurs, orforglipron should be discontinued. Orforglipron should be discontinued for at least 3 weeks before a planned pregnancy due to the half-life of orforglipron.
Breast‑feeding
It is unknown whether orforglipron is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of orforglipron in milk (see section 5.3).A risk to the newborn/infant cannot be excluded.
Orforglipron should not be used during breast-feeding.
Fertility
The effect of orforglipron on fertility in humans is unknown.
Animal studies with orforglipron did not indicate direct harmful effects with respect to fertility.
For other GLP-1 receptor agonists, an increase in oestrous length and a small reduction in number of ovulations were observed at doses associated with maternal body weight loss (see section 5.3).
No studies have been conducted to determine the effects of orforglipron on the ability to drive and use machines. When orforglipron is coadministered with a sulfonylurea or insulin, patients must be advised to take precautions to avoid hypoglycaemia while driving and using machines. (see sections 4.4 and 4.8).
In the event of overdose, begin appropriate supportive treatment according to the patient's clinical signs and symptoms. Patients may experience gastrointestinal adverse reactions including nausea and vomiting. There is no specific antidote for overdose of orforglipron.
Ask anything about Foundayo 14.5 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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