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Tirzepatide

AEMPS

Blood glucose lowering drugs, GLP-1 and GIP receptor agonists

ATC code: A10BJ09

Brand names: Mounjaro, Zepbound

Updated · Methodology

Indications

A

Obesity

First line

Tirzepatide as Zepbound is -approved (November 2023) and -approved (August 2024) for adult obesity with BMI ≥30 or BMI ≥27 with comorbidities. The SURMOUNT programme: SURMOUNT-1 (Jastreboff 2022, n=2539, 72 weeks) showed 15–21% weight loss vs 3% on placebo across 5/10/15 mg doses; SURMOUNT-2 in type 2 diabetes patients (Garvey 2023) and SURMOUNT-3 after intensive lifestyle intervention (Wadden 2023). Efficacy exceeds semaglutide (Wegovy 2.4 mg) in indirect comparisons. AACE 2023 and Obesity Society 2024 guidelines list tirzepatide as first-line. Use requires gradual dose titration due to GI side effects.

Sources

  1. AEMPS: Ficha técnica de Tirzepatida (2024)
  2. New England Journal of Medicine: Tirzepatide Once Weekly for the Treatment of Obesity (2022)
  3. The Lancet: Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial (2023)

ICD-10: E66 · ICD-11: 5B81

A

Type 2 diabetes mellitus

First line

Tirzepatide is first-line therapy for type 2 diabetes, particularly with co-existing obesity. The SURPASS programme (n>13,000) demonstrated superiority over all comparators: SURPASS-2 vs semaglutide 1 mg (Frias 2021, reduction 2.0–2.3% vs 1.9%), SURPASS-3 vs insulin degludec (Ludvik 2021), SURPASS-4 vs insulin glargine (Del Prato 2021), SURPASS-5 (Dahl 2022), and the SURPASS-CVOT cardiovascular outcomes trial. Average HbA1c reduction 2.0–2.6%, weight loss 5–15 kg at 10–15 mg/week. 2024 and 2022 guidelines list tirzepatide as preferred in obesity and cardiovascular risk. Not registered in Russia as of 2026-05-20; available via personal import programmes.

Sources

  1. AEMPS: Ficha técnica de Tirzepatida (2024)
  2. ADA/EASD: Management of Hyperglycaemia in Type 2 Diabetes (2022)

ICD-10: E11 · ICD-11: 5A11

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Weight loss

Not recommended

Tirzepatide as Mounjaro and Zepbound is used by non-diabetics with normal BMI for premium weight loss and anti-aging metabolic trends. The label and AEMPS Ficha Técnica confine Mounjaro to T2D and Zepbound to BMI of 30 or 27 with comorbidities. Normal-BMI RCT data are absent. SURMOUNT-4 2024 showed rapid post-discontinuation regain. Use carries nausea, gastroparesis, pancreatitis, gallstone disease and medullary thyroid cancer risk.

Sources

  1. AEMPS: Ficha técnica de Tirzepatida (2024)
  2. Cochrane: Green tea for weight loss and weight maintenance in overweight or obese adults (2012)
How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Tirzepatide is a dual agonist of GLP-1 and GIP (glucose-dependent insulinotropic polypeptide) receptors. It is the first commercial drug with dual incretin activity. GLP-1 activation stimulates glucose-dependent insulin secretion, slows gastric emptying, reduces appetite and glucagon production. Additional GIP activation enhances the insulinotropic effect and positively affects lipid metabolism. Administered subcutaneously once weekly, half-life is approximately 5 days. Doses 2.5, 5, 7.5, 10, 12.5, and 15 mg.

Safety

Contraindications

  • Personal or family history of medullary thyroid cancer
  • Multiple endocrine neoplasia syndrome type 2 (MEN-2)
  • Active or prior pancreatitis
  • Pregnancy and breastfeeding
  • Severe gastroparesis
  • Hypersensitivity

Serious adverse effects

  • Acute pancreatitis
  • Cholelithiasis and acute cholecystitis
  • Hypoglycemia when combined with sulfonylureas/insulin
  • Acute kidney injury during severe dehydration (vomiting and diarrhoea)
  • Medullary thyroid cancer (FDA warning based on rodent data)
  • Diabetic retinopathy – worsening during rapid HbA1c reduction in patients with pre-existing retinopathy

Common adverse effects

  • Nausea (20–30%)
  • Diarrhoea (15–20%)
  • Vomiting (8–15%)
  • Constipation
  • Decreased appetite
  • Injection site reactions

Pregnancy: can you take Tirzepatide?

EMA summary of product characteristics (section 4.6): there are no or limited data on tirzepatide in pregnant women, and animal studies have shown reproductive toxicity. Women of childbearing potential are advised to use contraception during treatment; tirzepatide is not recommended in pregnancy or in women of childbearing potential not using contraception. If a patient wishes to become pregnant or becomes pregnant, tirzepatide is stopped. Because of its long half-life, treatment is stopped at least 1 month before a planned pregnancy.

Breastfeeding: can you take Tirzepatide?

Contraindicated during breastfeeding: data on excretion in breast milk are unavailable.

Calculate RIDFull profile on NIH LactMed ↗

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Russian practice note

As of 2026-05-20 tirzepatide is not registered in Russia. The drug is imported via personal import programmes from the EU, Turkey, and Belarus (Mounjaro) or the US (Zepbound). Cost of four pre-filled pens (one month): in Russia via grey market – 35,000–60,000 ₽, in the EU – 950–1300 €, in the US – approximately 1000–1500 USD without insurance. Refrigerated storage (2–8°C); transport at up to 30°C is permissible for up to 21 days. Starting dose 2.5 mg/week with titration every 4 weeks to 5, 7.5, 10, 12.5, 15 mg. In patients on sulfonylureas or insulin, doses of these agents should be reduced to prevent hypoglycemia.

Drug interactions

Tirzepatide slows gastric emptying and may theoretically alter absorption of orally administered drugs. Clinically significant interactions with metformin, atorvastatin, digoxin, or warfarin are not described. In women on oral contraceptives, an additional barrier contraceptive method is recommended for 4 weeks during initiation and after each dose escalation.
Label mentions11 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Majoranticonceptivos hormonalesclass named in the label
    «Anticonceptivos orales: La administración de un anticonceptivo oral combinado (0,035 mg de etinilestradiol más 0,25 mg de norgestimato, un profármaco de la norelgestromina) junto con una dosis única…»

    AEMPS, section 4.5 · Open on CIMA

  • MajorEthinylestradiol
    «Anticonceptivos orales: La administración de un anticonceptivo oral combinado (0,035 mg de etinilestradiol más 0,25 mg de norgestimato, un profármaco de la norelgestromina) junto con una dosis única…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateDigoxin
    «En base a los resultados de un estudio con paracetamol que se utilizó como medicamento modelo para evaluar el efecto de tirzepatida en el vaciado gástrico, no se espera que se requieran ajustes de…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderateinsulinclass named in the label
    «Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea): ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin…»

    FDA, section 7 · Open on DailyMed

  • ModerateInsulin
    «Hipoglucemia: Los pacientes que reciben tirzepatida en combinación con un secretagogo de insulina (por ejemplo, una sulfonilurea) o insulina pueden tener un mayor riesgo de hipoglucemia. El riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • Moderateinsulinaclass named in the label
    «Hipoglucemia: Los pacientes que reciben tirzepatida en combinación con un secretagogo de insulina (por ejemplo, una sulfonilurea) o insulina pueden tener un mayor riesgo de hipoglucemia. El riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • Moderatesulfonilureasclass named in the label
    «Hipoglucemia: Los pacientes que reciben tirzepatida en combinación con un secretagogo de insulina (por ejemplo, una sulfonilurea) o insulina pueden tener un mayor riesgo de hipoglucemia. El riesgo de…»

    AEMPS, section 4.4 · Open on CIMA

  • Moderatesulfonylureasclass named in the label
    «Concomitant Use with Insulin or an Insulin Secretagogue (e.g., Sulfonylurea): ZEPBOUND lowers blood glucose. When initiating ZEPBOUND, consider reducing the dose of concomitantly administered insulin…»

    FDA, section 7 · Open on DailyMed

  • ModerateWarfarin
    «En base a los resultados de un estudio con paracetamol que se utilizó como medicamento modelo para evaluar el efecto de tirzepatida en el vaciado gástrico, no se espera que se requieran ajustes de…»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateWarfarin
    «Oral Medications: Monitor patients on oral medications dependent on threshold concentrations for efficacy and those with a narrow therapeutic index (e.g., warfarin) when concomitantly administered…»

    FDA, section 7 · Open on DailyMed

  • hormonal contraceptivesclass named in the label
    «Oral Medications: Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation with ZEPBOUND…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Tirzepatide used for?

Tirzepatide is evaluated for the following indications with varying evidence strength: Type 2 diabetes mellitus (evidence tier A), Obesity (evidence tier A), Weight loss (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Tirzepatide?

Common side effects of Tirzepatide (≥ 1 in 100): Nausea (20–30%), Diarrhoea (15–20%), Vomiting (8–15%), Constipation, Decreased appetite, Injection site reactions. See the Safety section for uncommon and serious reactions.

Is Tirzepatide safe during pregnancy?

EMA summary of product characteristics (section 4.6): there are no or limited data on tirzepatide in pregnant women, and animal studies have shown reproductive toxicity. Women of childbearing potential are advised to use contraception during treatment; tirzepatide is not recommended in pregnancy or in women of childbearing potential not using contraception. If a patient wishes to become pregnant or becomes pregnant, tirzepatide is stopped. Because of its long half-life, treatment is stopped at least 1 month before a planned pregnancy.

Is Tirzepatide compatible with breastfeeding?

Contraindicated during breastfeeding: data on excretion in breast milk are unavailable.

Who should not take Tirzepatide?

Tirzepatide is contraindicated in: Personal or family history of medullary thyroid cancer; Multiple endocrine neoplasia syndrome type 2 (MEN-2); Active or prior pancreatitis; Pregnancy and breastfeeding; Severe gastroparesis. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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