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Formation of N-nitrosamine drug substance related impurities in medicines: a regulatory perspective on risk factors and mitigation strategies

Seek immediate medical attention (call 999 or go to A&E) if you experience: Signs of pancreatitis such as severe, persistent abdominal pain radiating to the back, often accompanied by nausea and vomiting Signs of allergic reaction including rash, itching, swelling, difficulty breathing, or feeling faint You should contact your healthcare provider if you experience: Persistent or severe gastrointestinal symptoms including nausea, vomiting, diarrhoea, or abdominal pain that interferes with daily activities or prevents adequate nutrition and hydration Symptoms of gallbladder disease including right upper abdominal pain, particularly after eating fatty meals Hypoglycaemia symptoms (if taking tirzepatide alongside insulin or sulfonylureas) such as trembling, sweating, confusion, or palpitations Changes in vision or eye problems, especially if you have diabetic retinopathy Unexplained rapid heart rate or palpitations Regarding treatment effectiveness, schedule a review appointment if: Your weight loss or blood glucose control has not improved as expected after several months of treatment at the maximum tolerated dose You experience significant weight regain (more than 35% of lost weight) despite maintaining lifestyle modifications You are considering stopping treatment or have concerns about long-term use You are planning pregnancy or become pregnant (tirzepatide should be discontinued) You need to discuss contraception (reduced oral contraceptive effectiveness requires barrier method use for 4 weeks after starting and after each dose increase) You have upcoming surgery or procedures requiring sedation (due to delayed gastric emptying effects) Never discontinue tirzepatide abruptly without medical guidance, particularly if using it for diabetes management, as this may lead to deterioration in glycaemic control

Relative and absolute MACE risk estimates for semaglutide vs placebo To remove the potential impact of the CV effects of active comparators on the analysis, a sensitivity analysis was conducted for semaglutide vs placebo comparator data, thereby excluding active comparator data (Additional file 9: Appendix Figure S3)

doi: 10.1111/dom.12227

Semaglutide helps in weight loss by reducing appetite, increasing feelings of fullness, delaying gastric emptying, and modulating food intake, leading to a lower caloric intake