Wirkstoffe & Arzneimittelsicherheit

Gegenanzeigen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.3 · PDF-Seite 6

HOS-148157 · Präparat HOS-099850

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-148158 · Präparat HOS-099850

Tirzepatide delays gastric emptying and thereby has the potential to impact the rate of absorption of concomitantly administered oral medicinal products. This effect, resulting in decreased Cmax and a delayed tmax, is most pronounced at the time of tirzepatide treatment initiation.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-148159 · Präparat HOS-099850

Based on the results from a study with paracetamol, which was used as a model medicinal product to evaluate the effect of tirzepatide on gastric emptying, no dose adjustments are expected to be required for most concomitantly administered oral medicinal products. However, it is recommended to monitor patients on oral medicinal products with a narrow therapeutic index (e.g., warfarin, digoxin), especially at initiation of tirzepatide treatment and following dose increase. The risk of delayed effect should also be considered for oral medicinal products for which a rapid onset of effect is of importance.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): digoxin (HOS-086172) warfarin (HOS-085950)

Wechselwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-148160 · Präparat HOS-099850

Paracetamol

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-148161 · Präparat HOS-099850

Following a 5 mg single dose of tirzepatide, the maximum plasma concentration (Cmax) of paracetamol was reduced by 50 %, and the median (tmax) was delayed by 1 hour. The effect of tirzepatide on the oral absorption of paracetamol is dose and time dependent. At low doses (0.5 and 1.5 mg), there was only a minor change in paracetamol exposure. After four consecutive weekly doses of tirzepatide (5/5/8/10 mg), no effect on the paracetamol Cmax and tmax was observed. The overall exposure (AUC) was not influenced. No dose adjustment of paracetamol is necessary when administered with tirzepatide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-148162 · Präparat HOS-099850

Oral contraceptives

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Wechselwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.5 · PDF-Seite 7

HOS-148163 · Präparat HOS-099850

Administration of a combination oral contraceptive (0.035 mg ethinyl estradiol plus 0.25 mg norgestimate, a prodrug of norelgestromin) in the presence of a single dose of tirzepatide (5 mg) resulted in a reduction of oral contraceptive Cmax and area under the curve (AUC). Ethinyl estradiol Cmax was reduced by 59 % and AUC by 20 % with a delay in tmax of 4 hours. Norelgestromin Cmax was reduced by 55 % and AUC by 23 % with a delay in tmax of 4.5 hours. Norgestimate Cmax was reduced by 66 %, and AUC by 20 % with a delay in tmax of 2.5 hours. This reduction in exposure after a single dose of tirzepatide is not considered clinically relevant. No dose adjustment of oral contraceptives is required.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): norgestimate (HOS-110544) norelgestromin (HOS-110295) ethinyl estradiol (HOS-088135)

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-148167 · Präparat HOS-099850

Summary of safety profile

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-148168 · Präparat HOS-099850

In 14 completed phase 3 studies, 15 169 adult patients were exposed to tirzepatide alone or in combination with other glucose lowering medicinal products. The most frequently reported adverse reactions were gastrointestinal disorders and these were mostly mild or moderate in severity. The incidence of nausea, diarrhoea and vomiting was higher during the dose escalation period and decreased over time (see sections 4.2, and 4.4).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-148169 · Präparat HOS-099850

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-148170 · Präparat HOS-099850

The following related adverse reactions from clinical studies are listed below by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon: ≥ 1/1 000 to < 1/100; rare: ≥ 1/10 000 to < 1/1 000; very rare: < 1/10 000). Within each incidence grouping, adverse reactions are presented in order of decreasing frequency.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-148171 · Präparat HOS-099850

Table 1. Adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8

HOS-148172 · Präparat HOS-099850

System organ Very common Common Uncommon Rare class Immune Hypersensitivity Anaphylactic system reactions reaction#, disorders Angioedema# Metabolism Hypoglycaemia1* Hypoglycaemia1* when Hypoglycaemia1* and nutrition when used with used with metformin when used with disorders sulphonylurea or and SGLT2i- metformin6, insulin, Weight decreased1 Decreased appetite1,7

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 8–9

HOS-148173 · Präparat HOS-099850

8  Nervous system Dizziness2 Dysgeusia, disorders Dysaesthesia## Vascular Hypotension2 disorders Gastrointestina Nausea, Diarrhoea, Dyspepsia, Cholelithiasis, l disorders Vomiting3, Abdominal distention, Cholecystitis, Abdominal pain3, Eructation, Flatulence, Acute pancreatitis, Constipation4 Gastroesophageal Delayed gastric reflux disease emptying Skin and Hair loss2 subcutaneous tissue disorders General Fatigue †8 Injection site reactions Injection site pain disorders and administration site conditions Investigations Heart rate increased, Lipase increased, Amylase increased, Blood calcitonin increased5 # From post-marketing reports. ## From post-marketing reports and SURPASS-CVOT. *Hypoglycaemia defined below. † Fatigue includes the terms fatigue, asthenia, malaise, and lethargy. 1 Adverse reaction that only applies to patients with type 2 diabetes mellitus (T2DM). 2 Adverse reaction that mainly applies to patients with overweight or obesity, with or without T2DM. 3 Frequency was very common in SURPASS-CVOT, weight management, OSA, HFpEF and paediatric T2DM trials, and common in adult T2DM trials. 4 Frequency was very common in SURPASS-CVOT, weight management, OSA and HFpEF trials, and common in adult and paediatric T2DM trials. 5 Frequency was common in SURPASS-CVOT, weight management and HFpEF trials, uncommon in adult T2DM and OSA trials, and very rare in the paediatric T2DM trial. 6 Frequency was common in the paediatric T2DM trial. 7 Frequency was very common in SURPASS-CVOT, and common in adult and paediatric T2DM trials. 8 Frequency was very common in SURPASS-CVOT, and common in weight management, OSA, HFpEF, and adult and paediatric T2DM trials.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-148174 · Präparat HOS-099850

Description of selected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-148175 · Präparat HOS-099850

Hypersensitivity reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-148176 · Präparat HOS-099850

Hypersensitivity reactions have been reported with tirzepatide in pooled adult T2DM placebo-controlled trials, pooled placebo-controlled weight management trials, pooled placebo- controlled OSA trials, and the placebo-controlled HFpEF trial, sometimes severe (e.g., urticaria, eczema, rash, dermatitis). Hypersensitivity reactions were reported in 3.2 %, 5.0 %, 3.0 %, and 4.7 % of tirzepatide-treated patients, respectively, compared to 1.7 %, 3.8 %, 2.1 %, and 3.5 % of placebo- treated patients, respectively.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9

HOS-148177 · Präparat HOS-099850

Cases of anaphylactic reaction and angioedema have been rarely reported with marketed use of tirzepatide.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 9–10

HOS-148178 · Präparat HOS-099850

9 Hypoglycaemia in patients with type 2 diabetes mellitus

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Mounjaro

Mounjaro 2.5 mg solution for injection in pre-filled pen Mounjaro 5 mg solution for injection in pre-filled pen Mounjaro 7.5 mg solution for injection in pre-filled pen Mounjaro 10 mg solution for injection in pre-filled pen Mounjaro 12.5 mg solution for injection in pre-filled pen Mounjaro 15 mg solution for injection in pre-filled pen Mounjaro 2.5 mg solution for injection in vial Mounjaro 5 mg solution for injection in vial Mounjaro 7.5 mg solution for injection in vial Mounjaro 10 mg solution for injection in vial Mounjaro 12.5 mg solution for injection in vial Mounjaro 15 mg solution for injection in vial Mounjaro 2.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 7.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 10 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 12.5 mg/dose KwikPen solution for injection in pre-filled pen Mounjaro 15 mg/dose KwikPen solution for injection in pre-filled pen · Abschnitt 4.8 · PDF-Seite 10

HOS-148179 · Präparat HOS-099850

Type 2 diabetes studies in adults Clinically significant hypoglycaemia (blood glucose < 3.0 mmol/L (< 54 mg/dL)) or severe hypoglycaemia (requiring the assistance of another person) occurred in 10 to 14 % (0.14 to 0.16 events/patient year) of patients when tirzepatide was added to sulphonylurea and in 14 to 19 % (0.43 to 0.64 events/patient year) of patients when tirzepatide was added to basal insulin.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.