Foundayo (Orforglipron)

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure how to use this medicine.

The recommended dose for adults:

One tablet to be taken daily, with or without food. Do not take more than one tablet in 24 hours or use it differently from how it has been prescribed.

• Swallow tablets whole. Do not split, crush, or chew the tablet.
• If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day.
• Do not exceed 1 tablet per day.
• If you have missed 7 or more consecutive days of Foundayo, please contact your clinician for advice on how to proceed safely.

Foundayo dose escaltion

• The recommended starting dose of Foundayo is 0.8mg once daily for 30 days. After 30 days, your dose can be increased to 2.5mg once daily.
• After taking 2.5mg for at least 30 days, your dose may be increased to 5.5mg once daily.
• After at least 30 days at each dose level, your dose may be increased to the next available strength (9mg, 14.5mg, or 17.2mg once daily) if appropriate.
• Please speak with your clinician or healthcare provider before increasing your dose. They can advise which dose is most appropriate for you based on your treatment and progress.
• Do not exceed the maximum daily dose of 17.2mg.

Dose adjustments

If you are currently taking any other prescribed medication or over the counter medication, please inform your prescriber. Dose adjustments may need to be made to your existing medication or your Foundayo Tablet.

If you are taking simvastatin and are newly starting Foundayo, your simvastatin dose will need to be reduced and adjusted. Your GP will need to make this amendment to your regular prescribed medication. Please do not change your simvastatin dose yourself. This is because Foundayo can increase the amount of simvastatin that is broken down into its active form in your body. This active form, called simvastatin acid, can be present in the body at levels of up to 2.5 times higher when taken with Foundayo. This could increase the effects and potential side effects of simvastatin.

For this reason, your simvastatin dose will need to be reduced and adjusted when you start Foundayo. Please contact your GP to ensure that your prescription is amended to the appropriate dose before starting treatment.

Testing blood glucose levels

If you are taking Foundayo with a sulfonylurea, it is important that you test your blood glucose levels as instructed by your doctor or nurse.

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.

Maintenance Policy

Once you have reached your target weight, the focus shifts from weight loss to weight maintenance. A maintenance plan can help you maintain your results safely while supporting healthy eating habits and long-term lifestyle changes.

Follow the link below to learn more about our maintenance policy for Wegovy, Mounjaro and Foundayo and find out what to expect during this stage of your treatment:
https://www.medicinemarketplace.com/health-hub/maintenance-guidance-for-wegovy-and-mounjaro/

Switching Between GLP-1 Medications

If you are considering switching between GLP-1 medications, it is important that this is done safely. Your treatment plan and current dose will be reviewed to ensure a smooth transition while minimising the risk of side effects.

Follow the link below to learn more about switching between GLP-1 medications and what to expect during the process:

https://www.medicinemarketplace.com/health-hub/switching-between-glp-1-medications/

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some of the side effects are temporary with continued treatment or disappeared when treatment is stopped.

Side Effects

Very Common

• Nausea
• Constipation
• Diarrhoea
• Vomiting
• Indigestion
• 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 (SGLT2)

Signs of low blood sugar: headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating. Your doctor should tell you how to treat low blood sugar

Common

• 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
• Dizziness
• Headache
• Fast pulse
• Low blood pressure
• Bloating of the stomach
• Burping
• 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

• Unusual sense of taste reported
• Low blood sugar (hypoglycaemia) when orforglipron is used without insulin or sulfonylurea
• Unpleasant and abnormal feeling when touched

Serious Side Effects

If you experience any of the following serious side effects stop taking the medication and seek medical help immediately:

Uncommon

• 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 seek medical attention if experience such symptoms

Frequency Not Known

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

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at 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.

Warning & Precautions

• 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)
• 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

Age Restrictions

Foundayo is supplied to eligible patients aged 18 to 75 years, where treatment is considered clinically appropriate.

Other Medicines and Conditions

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)

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.

Pregnancy and Breastfeeding

This medicine is not suitable for use in pregnancy and breastfeeding.

This medicine should not be used during pregnancy, as it is not known if it may affect your unborn child. Foundayo should not be used during pregnancy or in women of child bearing potential not using contraception. If you wish to become pregnant, you must stop using Foundayo at least 3 weeks before a planned pregnancy.

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.

If you become pregnant when using Foundayo, you should contact your GP and treatment provider.

Patient Information Leaflet

https://www.medicines.org.uk/emc/files/pil.102529.pdf 

Ingredients

• Active Ingredients: Orforglipron
• Other Ingredients: Tablet core: cellulose, microcrystalline, crospovidone, copovidone, sodium carbonate anhrydorus, magnesium stearate. Tablet coating: Poly(vinyl alcohol) titanium oxide, magcrogol, talc, iron oxide red (0.8mg, 5.5mg, 9mg, 17.2mg), iron oxide yellow (0.8mg, 2.5mg, 9mg, 14.5mg), iron oxide balck (5.5mg, 17.2mg)

Product Information

• Brand Name: Foundayo
• Route of Administration: Oral
• Legal Classification: Prescription Only Medication (POM)
• Strength: 0.8mg, 2.5mg, 5.5mg, 9mg, 14.5mg, 17.2mg
• Dosage Form: Tablet

Storage

• 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 foil after EXP. The expiry date refers to the last day of that month.
• Store in the original package in order to protect from light and moisture. This medication 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 to protect the environment.

Advice & Helpful Links

It is vital that Foundayo is used as part of an integrated approach to weight management, with the appropriate support, counselling and behavioural strategies available to you. Wegovy should be used alongside a balanced diet and healthy lifestyle to support weight loss and overall wellbeing.

Protein intake: Including enough protein (100g of protein) in your diet may help maintain muscle mass and increase feelings of fullness. Protein-rich foods include lean meats, fish, eggs, dairy, legumes, and plant-based alternatives.

Total Daily Energy Expenditure (TDEE): Weight loss occurs when calorie intake is lower than energy expenditure. Understanding your estimated daily calorie needs (TDEE) may help with planning meals and managing portion sizes. Reducing calorie intake should be done in a safe and sustainable way.

Please adhere to the dietary recommendations that are given. This includes a nutritionally balanced, mildly hypocaloric diet of 500-600 calorie deficit, in addition to a diet that is rich in fruits, vegetables and protein.

Water intake: Staying well hydrated is important, 2-3L a day, particularly while using appetite-reducing medicines. Drinking water regularly throughout the day may help support digestion and reduce the risk of dehydration, especially if you experience reduced appetite or gastrointestinal side effects.

Exercise: Gradually add more activity to your routine. Even small increases in resistance training or cardio can make a difference.

Regular physical activity, adequate sleep, and consistent eating patterns can support weight management. Making gradual, sustainable changes can help aid with long term maintenance.

https://www.nhs.uk/live-well/exercise/

https://www.nhs.uk/better-health/lose-weight/