Tirzepatide for managing overweight and obesity

  • Technology appraisal guidance
  • TA1026
  • Published: 
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A practical guide to using medicines to manage overweight and obesity

Prescribing, reviewing and stopping tirzepatide

NICE recommends tirzepatide as an option for weight management and it can be prescribed in primary care or a specialist overweight and obesity management service, if people meet the criteria in table 1. See NICE's technology appraisal guidance on tirzepatide for managing overweight and obesity for more information.

The following sections outline the tasks that should be completed at each stage of prescribing tirzepatide.

Initial assessment

See the initial assessment checklist for a list of actions or assessments that may be needed for initial assessment.

At the initial assessment, check that the person is eligible for the medicine, and that they are willing to engage with a reduced-calorie diet and increased physical activity.

Take a full medical history including concomitant medicines and weight-related comorbidities. For further information on how to manage comorbidities, see NICE guidance on weight-related comorbidities.

If not already done, take and record the person's baseline measurements and assessments. Results of previous assessments could be used if they are available and within an appropriate timeframe.

  • Measure and record height and weight (for advice on how to estimate height in people who cannot stand, see the BAPEN 'MUST' Calculator), and calculate BMI (NHS BMI calculator).

  • Undertake any other assessments indicated based on the person's presenting complaint, current comorbidities and to identify unknown comorbidities. This may include blood pressure, lipid profile, QRISK3 score, haemoglobin A1c, blood glucose and any other investigations as directed by the person's history and examination (for example, renal and liver function tests, full blood count and thyroid function tests).

  • Assess and refer as needed to other services, for example, social care, physiotherapy, eating disorder services or other physical or mental health and wellbeing support. See when to refer.

  • If appropriate, ask whether the person plans on becoming pregnant. Tirzepatide is not recommended during pregnancy and plans should be put in place if pregnancy is an option in the future. Liraglutide and semaglutide are also not recommended during pregnancy. See the section on pregnancy and contraception.

Assess for contraindications, special warnings or precautions as specified in the tirzepatide summary of product characteristics (SPC).

Concomitant medicines

Review the person's medicines for any that may cause weight gain, for example, some steroids, hormones, antipsychotics, antidiabetics, antidepressants and some pain management medicines. Review if any of these can be stopped, reduced or changed to an alternative. Liaise with specialists when needed. It may not be possible to adjust or stop concomitant medicines that cause weight gain. Taking weight-gaining medicines are not contraindications to taking tirzepatide. See the tirzepatide SPC for medicines with which tirzepatide should not be used or used with caution.

Tirzepatide causes delayed gastric emptying. This means that some oral medicines (such as those with a narrow therapeutic index) may need monitoring more closely, especially at initiation and dose escalation (see the Specialist Pharmacy Service Monitoring Tool for more information).

Contraception

See the pregnancy and contraception section for the additional contraceptive measures needed when starting and titrating tirzepatide.

Medicines for type 2 diabetes

People with type 2 diabetes who are starting tirzepatide may need adjustment of their antidiabetic medicine and may have to monitor their diabetes control more closely throughout treatment. If their diabetes control changes, the dose of their antidiabetic medicine may need adjusting. See the tirzepatide SPC and the section on people with type 2 diabetes for further details.

Counselling

See the counselling checklist for a summary of points that may need to be discussed with the person.

Weight loss goals

Discuss realistic and safe weight loss goals, taking into account the person's comorbidities and risks. Weight loss of 0.5 kg to 1 kg a week is generally considered to be safe and sustainable, but tailor this to the person. For example, people with type 2 diabetes may lose weight at a slower rate than people without the condition. In older people, a slightly higher BMI can have a protective effect (for example, reducing the risk of all-cause mortality). When discussing weight loss goals with the person, consider comorbidities the person has that may improve, and any personal goals the person has discussed with you (such as having more energy to do the things they enjoy or to find it easier undertaking personal care).

The person should follow a reduced-calorie diet and increase their physical activity when using tirzepatide. Refer to local pathways for available support to achieve this. Explain that weight loss is likely to be greater when tirzepatide is used alongside a reduced-calorie diet and increased physical activity. See the section on diet, physical activity and behavioural approaches.

Pregnancy and contraception

Tirzepatide is not recommended in pregnancy. Additional contraceptive measures are needed when starting and titrating tirzepatide. See the pregnancy and contraception section for further information.

Adverse effects

Advise people on potential adverse effects. There is a risk of gastrointestinal adverse effects with tirzepatide, which are common but usually non-serious. Some adverse effects can lead to serious complications such as severe dehydration, resulting in hospitalisation. Advise people to stay well hydrated to avoid dehydration, especially after any vomiting or diarrhoea. The incidence of nausea, vomiting and diarrhoea are usually higher during the dose escalation period and decreases over time. Other serious but less common adverse effects include gallstone disease and serious allergic reactions.

Acute pancreatitis has been reported in people having tirzepatide treatment. Inform the person about the symptoms of acute pancreatitis and advise them to seek immediate medical help if they develop sudden, severe abdominal pain. The NHS webpage on acute pancreatitis has further information and other symptoms of acute pancreatitis.

Because of the potential risk of pulmonary aspiration during general anaesthesia or deep sedation, tell people using tirzepatide to inform their healthcare team, including the anaesthetist, about this before any surgical procedure.

See the MHRA drug safety updates on the potential risks of pulmonary aspiration during general anaesthesia or deep sedation and a reminder of the potential side effects for further information.

Administering tirzepatide

Advise the person on how to administer tirzepatide and what dose to use. Refer them to the tirzepatide user manual. The company has also produced a document for healthcare professionals to help troubleshoot common KwikPen issues.

Monitoring

Explain to people what follow up and monitoring they can expect. Make sure they understand that the initial follow up will be more intensive to allow for titration and closer monitoring. The follow up may also include visits with dietitians, physical activity specialists (such as physiotherapists) and psychologists, depending on their need and the availability of local services.

If there is concern about inadequate micronutrient intake, consider advising the person to take a supplement that contains the reference nutrient intake for all vitamins and minerals. This may be particularly relevant to older people, who may be at risk of malnutrition.

Reviewing and stopping tirzepatide

Discuss with the person at the initial assessment their weight loss goals and the weight loss required to show that tirzepatide is working for them. Calculate what 5% weight loss from their initial weight is in kilograms and explain to them that the medicine may be stopped if this weight loss is not obtained within a given timeframe. Explain to them that continuing to take a medicine which is not working puts them at risk of adverse effects without the full benefit. See the section on stopping tirzepatide.

Discuss the possible duration of treatment if weight loss is achieved. This could be long term, but they can choose to stop at any time (unless they experience significant adverse effects, when they may need to stop immediately). If they choose to stop, explain to them that without a continued reduced-calorie diet and increased physical activity, stopping the medicine is likely to lead to weight regain.

Issuing the prescription

The starting dose is 2.5 mg once weekly. Tirzepatide is available in a multidose prefilled pen. The multidose pen contains 4 doses (10 mg), so 1 pen is sufficient for a month's supply when starting treatment. Pens are available in packs of 1 pen (equivalent to 1 month) or 3 pens (equivalent to 3 months).

Prescribe a sharps bin and compatible needles. For further details see the company's advice on the Lilly webpage on what needles are recommended for the Mounjaro (tirzepatide) KwikPen. Provide guidance on how they should handle and store their sharps waste. Advise them how to dispose of their sharps waste, following local guidance.

Follow up and monitoring

The follow up and monitoring checklist has a list of actions or assessments that may be needed during dose titration and once on a stable dose.

During dose titration, follow up the person every 4 weeks.

At each appointment, discuss with the person and record in their medical notes, if relevant:

  • If they are having any difficulties with the injections.

  • If they are experiencing any adverse effects – see the managing adverse effects section. As a new medicine, report all suspected reactions to the MHRA Yellow Card reporting site.

  • Any concerns about inadequate micronutrient intake – if so, consider advising the person to take a supplement that contains the reference nutrient intake for all vitamins and minerals, if not already taking.

  • If appropriate, any plans for pregnancy in the near future. See the pregnancy and contraception section for further information. Tirzepatide is not recommended in pregnancy and should be stopped if pregnancy occurs.

  • If they need additional support with the reduced-calorie diet and increased physical activity.

  • What changes or impact they have noticed since their last visit.

Measure and record:

  • height

  • weight

  • BMI

  • waist circumference in people with BMI below 35 kg/m2, so that waist-to-height ratio can be calculated (ask them if they have already measured their waist circumference and if so, record the measurement they give you. Encourage them to measure their own waist-to-height ratio going forward, following the advice in box 1 in the NICE guideline on overweight and obesity management)

  • any other assessments indicated to monitor comorbidities (for example, blood pressure).

Assess and refer as needed to other services, for example, social care, physiotherapy, eating disorder services or other physical or mental health and wellbeing support. See the section on when to refer.

Review any weight loss in the context of the safe and sustainable weight loss goals set at the initial assessment. To encourage the person, discuss any positive impacts seen. As well as weight, BMI or waist-to-height ratio, this may include positive impacts seen on comorbidities and any improvements the person themselves has noticed, including progress toward achieving their personal health goals. If the person has lost more weight than expected, consider assessing for alternative causes that may need further investigation.

If the person is tolerating the current dose, titrate the dose if not already at the maximum effective dose. The dose should be increased by 2.5 mg every 4 weeks. The recommended maintenance doses are 5 mg, 10 mg or 15 mg once weekly. The maximum dose is 15 mg once weekly.

After 6 months on the highest tolerated dose, calculate the person's percentage weight reduction achieved. If less than 5% of the person's initial weight has been lost after 6 months on the highest tolerated dose, discuss with the person the reasons why weight loss may have been less than desired. Decide whether to continue treatment, taking into account the benefits and risks of treatment for the person. Explain to the person that, at this rate of weight loss, the risk of adverse effects continues while any benefits are minimal. Be aware that people with type 2 diabetes may take longer to lose weight than people without the condition. If deciding to stop tirzepatide, see the section on stopping tirzepatide for possible next steps.

Counsel on:

  • what dose changes have been made, if any

  • additional contraceptive measures if the dose is being titrated, if appropriate (see the pregnancy and contraception section)

  • a reduced-calorie diet and increasing physical activity.

For information on follow up and monitoring once the person is on a stable maintenance dose, follow local pathways, service specifications and NHS England policies on follow up and how this might be set up in your service. There are no specific monitoring requirements for tirzepatide.

Waist-to-height ratio

This is a measure of central adiposity and can be used to help assess and predict health risks such as type 2 diabetes, hypertension or cardiovascular disease. People should be advised to try and keep their waist to less than half their height (so a waist-to-height ratio of under 0.5).

Encourage people to measure their own waist-to-height ratio. See box 1 in the NICE guideline on overweight and obesity management or refer them to resources such as the video guide on the NHS obesity page.

In people with a BMI over 35 kg/m2, waist-to-height ratio is not a helpful measure or a good predictor of health risks, because these people are always likely to have a high measurement.

Managing adverse effects

As a new medicine, all suspected reactions should be reported to the MHRA Yellow Card reporting site.

Acute pancreatitis has been reported in people having tirzepatide treatment. If pancreatitis is suspected, tirzepatide should be stopped immediately. The most common symptoms of acute pancreatitis include severe pain in the centre of the abdomen, feeling or being sick or a fever of 38 C or more (the NHS webpage on acute pancreatitis has more information). If the diagnosis of pancreatitis is confirmed, tirzepatide should not be restarted.

If a person experiences adverse effects during dose titration, do not increase the dose until the adverse effect has resolved or becomes tolerable to the person. If the adverse effect does not resolve, consider titrating down the weekly dose by 2.5 mg.

Minor adverse effects can be managed pharmacologically, if appropriate. For example, domperidone for nausea and vomiting, or stool softeners for constipation. Use pharmacological measures for the shortest time possible.

If the adverse effect does not resolve despite dose reduction or pharmacological management, consider stopping tirzepatide. See the stopping tirzepatide section.

Managing comorbidities and concomitant medication

Weight-related comorbidities will need regular review and monitoring, because control may change as weight loss is achieved. For example, people with type 2 diabetes or hypertension may need their concomitant medicines adjusting or stopping if no longer indicated.

Tirzepatide causes delayed gastric emptying, so some oral medicines (such as those with a narrow therapeutic index) may need monitoring during dose escalation (see the Specialist Pharmacy Service Monitoring Tool for more information).

Pregnancy and contraception

Tirzepatide is not recommended during pregnancy because of limited safety data. At the initial assessment and at each follow up, ask whether the person plans to become pregnant. Tirzepatide should be stopped at least 1 month before a planned pregnancy because of its long half-life. The NHS Bumps website has a leaflet about not using GLP-1 receptor agonists in pregnancy.

If a person reports that they are pregnant when taking tirzepatide, tell them to stop taking tirzepatide immediately. The healthcare professional should report any exposure to the UK Teratology Information Service.

If a person is using oral contraception, because of the potential for reduced efficacy, they need to switch to a non-oral contraceptive method, or add a barrier method of contraception, for 4 weeks after starting tirzepatide and after each dose escalation. See the Faculty of Sexual and Reproductive Health (FSRH) statement on GLP-1 agonists and oral contraception for further information, and information for people who experience severe diarrhoea or vomiting.

Stopping tirzepatide

  • If there is a lack of response or inability to tolerate tirzepatide:

  • If weight was lost but the person chooses to stop tirzepatide, continue to offer support to help them maintain any weight loss achieved. Encourage them to continue a reduced-calorie diet and increased physical activity.

Restarting tirzepatide

If a person has previously used tirzepatide and asks to start again, the following should be considered:

  • Their reasons for stopping previously:

    • if this was because of confirmed pancreatitis, tirzepatide should not be restarted

    • if they stopped because of other adverse effects, then consider slower titration, with or without short-term pharmacological management of the adverse effects

    • if they successfully lost weight on tirzepatide, but regained weight on stopping, consider a higher level of diet and physical activity support, with or without restarting tirzepatide.

  • How much weight they lost on tirzepatide, in the context of how long they took it for and what the dose was titrated to. Remember that if a person lost less than 5% of their initial weight after 6 months on the highest tolerated dose, the risks of treatment are likely to outweigh any benefits. Take into account how well the person engaged with the lifestyle measures previously and their willingness to engage on this occasion.

People with type 2 diabetes and overweight or obesity

People with type 2 diabetes can be prescribed tirzepatide for obesity or overweight in primary care or for type 2 diabetes if they meet the criteria set out in the recommendations in either:

Tirzepatide for treating type 2 diabetes is subject to different eligibility criteria.

When prescribing tirzepatide, be aware that:

  • Tirzepatide will impact a person's glucose levels. If they are already under the care of a specialist in diabetes, the specialist should be consulted before starting tirzepatide.

  • If they are already taking a GLP-1 receptor agonist for their diabetes, they cannot have tirzepatide at the same time. This includes dulaglutide, exenatide, liraglutide, semaglutide and combination products which contain GLP-1 receptor agonists.

  • Due to acting on the same pathway, DPP-4 inhibitors (for example, alogliptin, linagliptin, sitagliptin, saxagliptin and vildagliptin) and GLP-1 receptor agonists (including tirzepatide) should not be used at the same time.

  • Starting doses and titration doses of tirzepatide are the same for the obesity and the type 2 diabetes indications, and for people with and without type 2 diabetes. Concomitant antidiabetic medicines may need to be adjusted (the tirzepatide SPC has full details):

    • If being added to existing metformin, the current dose of metformin can be continued.

    • If being added to existing sodium-glucose co-transporter 2 (SGLT2) inhibitor therapy, the current dose of SGLT2 inhibitor can be continued.

    • If being added to existing sulphonylurea, a reduction in the dose of sulphonylurea may need to be considered to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea.

    • If being added to existing insulin, a reduction in the dose of insulin may be considered to reduce the risk of hypoglycaemia. Blood glucose self-monitoring is necessary to adjust the dose of insulin. A stepwise approach to insulin reduction is recommended.

  • In addition to the monitoring recommended for all people, haemoglobin A1c will need to be closely monitored in people with type 2 diabetes, at least every 3 to 6 months during dose adjustments. If their diabetes control changes, the dose of their antidiabetic medicine may need adjusting.

  • Be aware that weight loss in people with type 2 diabetes may be slower than those without the condition.

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