Obesity Final 2025

OBESITY PHARM 840 SPRING 2025 FEBRUARY 13TH, 2023 CHRISTINA VOSKANIAN, PHARMD BACKGROUND: OBESITY ¡ Obesity is characterized as having abnormal or excessive fat accumulation that may pose a risk to health.1 ¡ Accumulation may occur around abdomen ¡ Body Max Index (BMI) ≥ 30 kg/m2 ¡ Overweight: ≥ 25 kg/m2 ¡ Form of malnutrition ¡ Higher rates of Obesity rather than Underweight in all regions except Asia and sub-Saharan Africa 4 BACKGROUND: OBESITY ¡ !"# = ¡ !"# = !"#$%& #( )* (%"#$%& #( ,)! !"#$%& #( ./0 %"#$%& #( 123450 ! × 703 5 CENTERS FOR DISEASE CONTROL: ADULT BODY MASS INDEX • Frequently subdivided into • BMI: subcategories: • <18.5 ➜ underweight range • Class 1: BMI of 30 to < 35 • 18.5 to <24.9 ➜ healthy weight range • Class 2: BMI of 35 to < 40 • 25.0 to <29.9 ➜ overweight range • Class 3: BMI of 40 or higher • 30.0 or higher ➜ obesity range • Sometimes categorized as “severe” obesity BODY MASS INDEX (BMI) ¡ Per CDC: ¡ BMI does not measure body fat directly ¡ BMI is moderately correlated with more direct measures of body fat taken from: ¡ Skinfold thickness measurements ¡ Bioelectrical impedance ¡ Underwater weighing ¡ Dual energy x-ray absorptiometry (DXA) 12 BODY MASS INDEX (BMI) ¡ Some considerations: ¡ Older adults tend to have more body fat than younger adults (less muscle) ¡ Women may have higher numbers of total body fat than men with equivalent BMI ¡ Muscle may correlate to higher BMI ¡ Should be used as a screening tool 13 CHECKPOINT What body mass index (BMI) range is classified for Obese Class 2? A. 18.5 - 24.9 kg/m2 B. 25 - 29.9 kg/m2 C. 30 - 34.9 kg/m2 D. 35 - 39.9 kg/m2 14 CHECKPOINT What body mass index (BMI) range is classified for Overweight? A. 18.5 - 24.9 kg/m2 B. 25 - 29.9 kg/m2 C. 30 - 34.9 kg/m2 D. 35 - 39.9 kg/m2 15 CHECKPOINT Which of the following is a common characteristic that is associated with obesity? A. Increased fat tissue accumulation B. Low body mass index (BMI) C. Excessive physical activity D. Decreased risk of cancer 16 CHECKPOINT Which of the following statements is true regarding patients with obesity. Body fat: A. Accumulates in the abdominal region B. Is evenly distributed throughout the body C. Accumulates in the arms and legs D. Accumulates in the thighs 17 CDC: CHILDREN'S OBESITY • Race/Ethnicity: ¡ For children and adolescents aged 2-19 years in 2017-2020: • In 14.7 million children and adolescents: 19.7% had obesity • 2– 5-year-old: 12.7% • 6 – 11-year-old: 20.7% • 12- to 19-year-old: 22.2% • Hispanic Children: 26.2% • Non-Hispanic Black children: 24.8% • Non-Hispanic White children: 16.6% • Non-Hispanic Asian children: 9.0% • CDC reported in 2011 – 2014, rate of obesity decreased as the head of household’s level of education increased in children aged 2 - 19 19 FACTORS THAT MAY LEAD TO OBESITY ¡ Insufficient sleep ¡ Lack of nutrition ¡ Lack of activity ¡ Genetics ¡ Illness and Medications ¡ Antidepressant ¡ Antipsychotics ¡ Corticosteroids ¡ Insulins ¡ Social Determinants of Health (SDOH) ¡ Conditions of where you live, learn, eat, work, and play ¡ Disparities in SDOH may affect disease outcomes and risks ¡ Affordability of healthy food options ¡ Peer and social support ¡ Food marketing marketing ¡ Community design 20 CHECKPOINT alot Which of the following factor can contribute to obesity? A. Stress eating B. Community support C. Scheduled mealtimes D. Mindful eating 21 CHECKPOINT Which of the following is a socioeconomic characteristic often associated with obesity? A. Higher income B. Higher education levels C. Access to healthy food options D. Limited access to recreational facilities 22 CHECKPOINT What is not typically associated with an increased risk of developing obesity? A. Genetics B. Poor diet C. Regular exercise D. Sedentary lifestyle 535 HEALTHY FOOD DISPARITY ¡ Access to healthy food is critical ¡ One study found decreased risk of heart disease and diabetes when there are community level access to healthy food ¡ ‘Food Deserts’: geographic areas where residents have a lack of access to affordable, nutritious food options (fresh fruit/vegetables) ¡ Grocery Stores Limited/larger concentration of fast-food options: ¡ Higher rates of convenience stores or fast-food outlets ¡ Food tends to be more processed rather than having fresh options FINANCIAL COST OF OBESITY ¡ Indirect costs9 ¡ Direct costs9 ¡ Outpatient/inpatient services rendered ¡ Pharmacological therapy ¡ Resources lost due to health condition ¡ Lost wages ¡ Insurance costs ¡ Lost work ¡ Surgical ¡ Long term disability ¡ Laboratory testing ¡ Premature death ¡ Presenteeism ¡ Lost productivity due to inability to 34 work at full capacity OBESITY PRESENTATION 37 WAIST CIRCUMFERENCE • Obesity classification by waste circumference • Men whose waist circumference is more than 40 inches • Non-pregnant woman whose waist circumference is more than 35 inches 38 PATHOPHYSIOLOGY 39 Jin X, Qiu T, Li L, et al. Pathophysiology of obesity and its associated diseases. Acta Pharmaceutica Sinica B. 2023;13(6). doi:https://doi.org/10.1016/j.apsb.2023.01.012 PATHOPHYSIOLOGY ¡ Regulation of body weight involved hormones (leptin, insulin, ghrelin, and gut hormones) and neural signals ¡ Moderate appetite and metabolism ¡ Leptin ¡ Secreted by adipose tissue ¡ Acts on the hypothalamus in the brain to suppress appetite and increase energy expenditure ¡ Insulin ¡ Produced by pancreas ¡ Facilitates update of glucose into cells and regulates lipid metabolism ¡ Ghrelin ¡ Mainly released by the stomach ¡ Stimulates hunger 40 CHECKPOINT What is a consequence of elevated adipokine secretion? A. Decreased adipose tissue B. Reduced inflammation C. Increased insulin sensitivity D. Increased inflammation 41 RISK FACTORS Suboptimal nutrition Lack of exercise Family history / genetics Race and ethnicity High stress / environment Poor sleep habits Age Metabolic Syndrome 42 METABOLIC SYNDROME ¡ Metabolic syndrome11 ¡ Risk factors ¡ Obesity (abdominal) ¡ Low physical activity ¡ Genetics ¡ Insulin resistance ¡ High glucose levels ¡ High cholesterol/triglycerides ¡ High blood pressure 43 Fyi METABOLIC SYNDROME Risk Factor Definition Abdominal Obesity • Men • Women Waist Circumference • >40 inches (102 cm) • >35 inches (88cm) Triglycerides ≥150 mg/dL HDL Cholesterol: • Men • Women • • Blood Pressure ≥130/ ≥85 mmHg Fasting Glucose ≥110 mg/dL <40 mg/dL <50 mg/dL 44 Diabetes (T2DM) Hypertension Associated Conditions Dyslipidemia Coronary artery disease Cancer Premature death 45 CONSEQUENCES OF OBESITY Cardiovascular Diseases • Coronary artery disease • Heart failure • Stroke • High blood pressure • Elevated cholesterol levels • Atherosclerosis Type 2 Diabetes Respiratory • Sleep Apnea Joint Problems Liver Disease •Non-alcoholic Fatty Liver Disease is a risk factor due to visceral fat greeted Cancer •Increased risk of certain types of cancer Reproductive Health Reduced Quality of Life Mental Health 46 STIGMA ¡ Childhood obesity can lead to bullying, social isolation, and academic struggle ¡ Reinforced in: ¡ Home life ¡ Healthcare ¡ Media ¡ Can lead to increased anxiety, expression, self-esteem issues, and unhealthy behaviors ¡ Goal in children with obesity should be to reduce stress and increate mental and physical health 47 Source: Pont SJ, Puhl R, Cook SR, Slusser W; SECTION ON OBESITY; OBESITY SOCIETY. Stigma Experienced by Children and Adolescents With Obesity. Pediatrics. 2017 Dec;140(6):e20173034. doi: 10.1542/peds.2017-3034. Epub 2017 Nov 20. PMID: 29158228. CHECKPOINT Which of the following does obesity increase the risk of developing? A. Cancer B. Type 2 Diabetes C. Hypertension D. All the above 48 LIFESTYLE MODIFICATIONS Nutritional Changes Increase Physical Activity Healthier eating with nutritious food options Portion Control Consistent Exercise 150 minutes of moderate intensity exercise per week 50 FOOD INSECURITIES 51 DIETS Keto Paleo Diet Intermittent fasting DASH Diet Carnivore Mediterranean Diet Low Carb Weight Watchers 54 CHECKPOINT Which of the following is a recommended for preventing obesity? A. Following a consistent diet B. Regular physical activity C. Consuming fruits and vegetables D. All the above 55 BARIATRIC SURGERY Indications Contraindications ¡ BMI ≥40 kg/m2 or greater ¡ No absolute contraindications ¡ BMI ≥ 35 kg/m2 AND 1 or more severe ¡ Relative Contraindications: obesity-related comorbidities ¡ Type 2 DM, Hypertension, Hyperlipidemia, Obstructive Sleep Apnea, GERD, Asthma, Non-alcoholic fatty liver disease, etc. ¡ BMI 30 to 34.9 kg/m2 ¡ Not enough evidence to demonstrate long term benefits ¡ Heart Failure ¡ Unstable Coronary Artery Disease ¡ End stage lung disease ¡ Portal Hypertension ¡ Drug/alcohol dependency ¡ Active cancer treatment 56 BARIATRIC SURGERY SUPPLEMENTATION 60 CHECKPOINT Which bariatric surgery involves reducing the size of the stomach and rerouting the small intestine to limit food intake and nutrient absorption? A. Route-en Y Gastric bypass B. Gastric banding C. Sleeve gastrectomy 61 CHECKPOINT Which statement about bariatric surgery is true? A. Recommended for individuals with BMI 24.8 kg/m2 B. Lifestyle changes are not required post procedure C. Procedure involves placing an adjustable band around the intestine D. Reduces comorbidities of obesity 62 PHENTERMINE (ADIPEX-P, LOMAIRA) ¡ Pharmacologic Category: Anorexiant, Sympathomimetic ¡ MOA: reducing appetite secondary to CNS effects, including stimulation of the hypothalamus to release norepinephrine. ¡ Indication: short term weight management adjunct to diet (12 weeks) in adolescents ≥17 years of age ¡ BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Diabetes ¡ Hypertension ¡ Dyslipidemia 64 PHENTERMINE (ADIPEX-P, LOMAIRA) ¡ Dose: ¡ 15 to 37.5 mg by mouth once daily ¡ Lomiara: 8 mg by mouth three times daily ¡ Pregnancy/Breastfeeding: Contraindicated ¡ Contraindications: uncontrolled hypertension, pregnancy, lactation, arrythmias, hyperthyroidism, history of substance use disorder, pulmonary hypertension ¡ Controlled Substance: ¡ C-IV 65 PHENTERMINE (ADIPEX-P, LOMAIRA) ¡ Side Effects: Increased blood pressure, tachycardia, agitation, delirium, mania ¡ Monitoring: weight and waist circumference every month for the first 3 months, then at 3- month intervals ¡ Administration: ¡ Capsules, tablets: Administer before breakfast or 1 to 2 hours after breakfast. Tablets may be divided in half and dose may be given in 2 divided doses. ¡ Lomaira (tablet): Administer 30 minutes before meals. Tablets are scored and may be divided in half. ¡ Counseling points: Anxiety, Constipation, Diarrhea, Dry mouth, Trouble sleeping, Bad taste, Decreased sex drive, Sexual dysfunction, Agitation 66 PHENTERMINE + TOPIRIMATE ER (QSYMA) 545 ¡ Pharmacologic Category: Anorexiant, Sympathomimetic, Antiseizure Agent ¡ MOA: topiramate increases satiety and decreases appetite, phentermine reduces appetite through sympathomimetic effects ¡ Pregnancy/Breastfeeding: ¡ Phentermine: contraindicated ¡ Topiramate: ¡ Increased risk of cleft lip with/without cleft palette ¡ Excreted in breast milk 67 PHENTERMINE + TOPIRIMATE ER (QSYMA) ¡ Indication: chronic weight management adjunct to increased physical activity and reduced calorie diet ¡ BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Diabetes ¡ Hypertension ¡ Dyslipidemia ¡ Pediatric patients (≥12 years of age ) ¡ Initial BMI in the ≥95th percentile standardized for age and sex. ¡ Controlled Substance: ¡ C-IV 68 PHENTERMINE + TOPIRIMATE ER (QSYMA) ¡ Dosing Schedule: ¡ Weeks 1 – 2: ¡ 3.75 mg/23 mg capsule by mouth once daily in the morning ¡ Weeks 3 – 12: ¡ 7.5/46 mg capsule by mouth once daily in the morning ¡ Reevaluate at week 12: ¡ If weight: meansitswaking a It ¡ Reduced by ≥3% from baseline, continue current dose of 7.5 mg phentermine/46 mg topiramate by mouth once once daily 70 PHENTERMINE + TOPIRIMATE ER (QSYMA) ¡ Reevaluate at week 12: ¡ If weight: ¡ Reduced by <3% from baseline after 12 weeks of therapy, increase dose ¡ Weeks 13 – 14: ¡ Increase to 11.25/69 mg capsule by mouth once daily in the morning ¡ Weeks 15+: 15/92 mg capsule by mouth once daily in the morning ¡ Reassess weight after 12 weeks ¡ If weight reduced by ≥5% from baseline, continue current dose. If weight only reduced by <5%, discontinue therapy, as patient is unlikely to see further efficacy 71 PHENTERMINE + TOPIRIMATE ER (QSYMA) ¡ Administration: take in the morning without regard to meals; avoid late evening administration (potential for insomnia) ¡ Side Effects: CNS Depression, Tachycardia, dry mouth ¡ Note: Do not suddenly stop medication, must be tapered slowly due to risk of seizure risk ¡ Monitoring: HR and BP ¡ Counseling points: Headache, dry mouth, numbness and tingling, nausea, diarrhea, change in taste, constipation, stuffy nose, sore throat, back pain, loss of strength and energy 72 PHENTERMINE + TOPIRIMATE (QSYMA) ¡ Risk Evaluation and Mitigation Strategy (REMS) ¡ Required by the FDA to manage known risks associated with drugs to ensure that the benefits of the drug outweighs the risks ¡ Required for Qsymia due to: ¡ Increased risk of congenital malformation, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy • Importance of pregnancy prevention for patients of reproductive potential • Must discontinue Qsymia immediately if pregnancy occurs 73 CHECKPOINT The primary function of phentermine use in patients with obesity is to? A. Inhibit of fat absorption B. Suppress of appetite C. Increase insulin sensitivity D. Reduce inflammation 74 CHECKPOINT Phentermine is a schedule 3 drug. True or False. A. True B. False 75 NALTREXONE HCL/BUPROPION HCL ER (CONTRAVE) ¡ Pharmacologic Category: Anorexiant;Antidepressant, Dopamine/Norepinephrine-Reuptake Inhibitor; Opioid Antagonist ¡ MOA: Naltrexone decreases food cravings, Bupropion decreases appetite ¡ Pregnancy/Breastfeeding: ¡ Naltrexone/Bupropion should be discontinued once pregnancy is detected. Lack of clinical benefit in pregnancy 76 NALTREXONE HCL/BUPROPION HCL ER (CONTRAVE) ¡ Indication: ¡ For chronic weight management adjunct to diet and exercise ¡ BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Contraindication: ¡ Seizure disorder ¡ Uncontrolled Hypertension ¡ Eating disorder ¡ Chronic opioid use ¡ Use of other bupropion containing products ¡ Use of Monoamine Oxidase Inhibitors within 14 days ¡ Avoid use in patients with high risk of alcohol withdrawal (bupropion may lower seizure threshold) 77 NALTREXONE HCL/BUPROPION HCL ER (CONTRAVE) [US Boxed Warning]: Naltrexone/bupropion is not approved for use in the treatment of major depressive or psychiatric disorders; it contains bupropion the same active ingredient in some other antidepressant medications. Antidepressants increase the risk of suicidal thinking and behavior in children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder (MDD) and other psychiatric disorders ¡ Side Effects: ¡ Nausea ¡ Vomiting ¡ Constipation ¡ Dry mouth ¡ Diarrhea ¡ Trouble sleeping 78 NALTREXONE HCL/BUPROPION HCL ER (CONTRAVE) ¡ Dose: ¡ Week 1: 8/90 mg tablet by mouth once daily ¡ Week 2: 8/90 mg tablet by mouth twice daily ¡ Week 3: 8/90 mg tablet; 2 tablets by mouth in the morning and 1 tablet by mouth in the evening ¡ Week 4: 8/90 mg tablet; 2 tablets by mouth twice daily ¡ Consider discontinuation if weight loss is <4% to 5% of baseline after 3 months ¡ Dietary Considerations: ¡ Do not administer with high-fat meals; may result in a significant increase in bupropion and naltrexone systemic exposure 79 ORLISTAT (ALLI [OTC]; XENICAL) ¡ Pharmacologic Category: lipase inhibitor ¡ MOA: decreases absorption of dietary fats ¡ Indication: for weight loss adjunct to diet and exercise ¡ BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Diabetes ¡ Hypertension ¡ Dyslipidemia 80 ORLISTAT (ALLI [OTC]; XENICAL) ¡ Administration: ¡ Take during or up to 1 hour after each fat containing meal ¡ Take 2 hours from multivitamin containing fat-soluble vitamins ¡ Skip dose if a meal is missed or contains no fat ¡ Contraindication: Hypersensitivity to orlistat or to any component of the formulation; pregnancy; chronic malabsorption syndrome; cholestasis ¡ Pregnancy: Contraindicated ¡ Lactation: No human data – potential toxicity 81 ORLISTAT (ALLI [OTC]; XENICAL) ¡ Dose: ¡ Xenical ¡ Oral: 120 mg by mouth 3 times daily with each main meal containing fat (during or up to 1 hour after the meal) ¡ Omit dose if meal is occasionally missed or contains no fat ¡ Alli (OTC) ¡ Oral: 60 mg by mouth 3 times daily with each main meal containing fat ¡ Maximum OTC dose: 180 mg/day 82 ORLISTAT (ALLI [OTC]; XENICAL) ¡ Dose: ¡ Children ≥12 years ¡ Xenical ¡ Oral: 120 mg by mouth 3 times daily with each main meal containing fat (during or up to 1 hour after eating) ¡ Omit dose if meal is occasionally missed or contains no fat 83 ORLISTAT (ALLI [OTC]; XENICAL) ¡ Side effects: ¡ Stomach pain or diarrhea ¡ Not able to control stools ¡ Gas with discharge, oily spotting, and feeling the need to go to the bathroom ¡ Fatty or oily stools ¡ Upset stomach ¡ Headache ¡ Feeling tired or weak ¡ Period (menstrual) changes ¡ Signs of a common cold 84 CHECKPOINT Which of the following medications is a combination of bupropion and naltrexone? A. Contrave B. Belviq C. Alli D. Qsymia 85 CHECKPOINT What is a common side effect associated with Contrave use? A. Increased appetite B. Insomnia C. Cough D. Fatigue 86 CHECKPOINT Which of the following acts as a lipase inhibitor? A. Xenical B. Saxenda C. Liraglutide D. Phentermine 87 LIRAGLUTIDE (SAXENDA) ¡ Pharmacologic Category: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist ¡ MOA: activating GLP-1 receptors in the pancreas resulting in enhanced insulin release and reduced glucagon release-responses ¡ Monitoring: blood sugar, hypoglycemia, pancreatitis ¡ Contraindication: pregnancy, history of thyroid carcinoma ¡ Pregnancy: No Human Data – Animal Data Suggests Risk ¡ Lactation: No Human Data—Probably Compatible 89 LIRAGLUTIDE (SAXENDA) ALERT: US Boxed Warning Thyroid C-cell tumor risk: • Liraglutide causes dose-dependent and treatment duration–dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether liraglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, because the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined. • Liraglutide is contraindicated in patients with a personal or family history of MTC and in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of liraglutide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with liraglutide. 90 LIRAGLUTIDE (SAXENDA) ¡ Indication: weight loss adjunct to diet and exercise ¡ Adult: BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Diabetes ¡ Hypertension ¡ Dyslipidemia ¡ Pediatric: ¡ ≥12 years of age ¡ Body weight >60 kg and ¡ Initial BMI corresponding to ≥30 kg/m2 for adults (obesity) by international cut-offs 91 LIRAGLUTIDE (SAXENDA) ¡ Administration ¡ SubQ injection in upper arm, thigh, or abdomen without regard to meals ¡ Rotate injection sites ¡ Missed dose ¡ If ≤3 days of therapy are missed, resume once-daily dosing with the next prescribed dose; do not administer extra or doubled doses ¡ If >3 days of therapy are missed, therapy should be restarted at the initial dose to avoid GI symptoms 92 LIRAGLUTIDE (SAXENDA) ¡ Dose: ¡ Week 1: 0.6 mg once daily ¡ Week 2: 1.2 mg once daily ¡ Week 3: 1.8 mg once daily ¡ Week 4: 2.4 mg once daily ¡ Week 5: 3.0 mg once daily ¡ Dose increase is dependent on toleration. Continue dose for additional week before increasing 93 LIRAGLUTIDE (SAXENDA) ¡ Evaluate change in body weight after: ¡ 12 weeks at maximum tolerated dose ¡ 16 weeks after initiation of therapy ¡ Discontinue if at least 4% to 5% of baseline body weight loss has not been achieved ¡ Side Effects: ¡ Constipation, diarrhea, stomach pain, upset stomach, vomiting, injection site reaction, headache 94 CHECKPOINT Which of the following acts as a is a GLP-1 receptor agonist? A. Metformin B. Liraglutide C. Naltrexone D. Orlistat 95 lost weight Diabetes SEMAGLUTIDE (WEGOVY, OZEMPIC) ¡ Pharmacologic Category: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist ¡ MOA: activating GLP-1 receptors in the pancreas resulting in enhanced insulin release and reduced glucagon release-responses ¡ Monitoring: blood sugar, hypoglycemia, pancreatitis ¡ Contraindication: pregnancy, history of thyroid carcinoma ¡ Pregnancy: No Human Data – Animal Data Suggests Risk ¡ Lactation: No Human Data—Probably Compatible 97 SEMAGLUTIDE (WEGOVY, OZEMPIC) ALERT: US Boxed Warning Risk of thyroid C-cell tumors: • In rodents, semaglutide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. • Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of semaglutide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with semaglutide. 98 SEMAGLUTIDE (WEGOVY, OZEMPIC) ¡ Ozempic not FDA approved for weight loss but is often prescribed ¡ Indication: ¡ For use of weight loss adjunct to diet and exercise ¡ BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Diabetes ¡ Hypertension ¡ Dyslipidemia ¡ Preferred treatment for weight loss: ¡ BMI ≥27 kg/m2 and T2DM 99 SEMAGLUTIDE (WEGOVY, OZEMPIC) 100 SEMAGLUTIDE (WEGOVY, OZEMPIC) ¡ Dose ¡ Children ≥12 years and Adolescents <18 years: ¡ Wegovy: 2.4 mg SubQ once weekly ¡ Per manufacturer (if maintenance dose of 2.4 mg is not tolerated): ¡ Decrease to 1.7 mg once weekly ¡ If the weekly dose of 1.7 mg is not tolerated, discontinue Wegovy ¡ Administration ¡ Subcutaneous injection in upper arm, thigh, or abdomen without regard to meals ¡ Rotate injection sites 101 SEMAGLUTIDE (WEGOVY, OZEMPIC) ¡ Missed dose ¡ If one dose is missed and next scheduled dose is: ¡ >2 days away, administer the missed dose as soon as possible ¡ <2 days away, do not administer the missed dose and resume dosing on the regularly scheduled day of the week ¡ If 2+ doses are missed: ¡ Resume at the next regularly scheduled day of the week ¡ Consider restarting and follow the dose escalation schedule 102 SEMAGLUTIDE (WEGOVY, OZEMPIC) ¡ Adverse Reactions (significant) ¡ Acute kidney injury ¡ Diabetic retinopathy ¡ Gallbladder disease ¡ Medullary thyroid carcinoma ¡ Pancreatitis ¡ Side Effects ¡ Abdominal pain, nausea, diarrhea, vomiting, constipation, decreased appetite, dyspepsia, dysgeusia (metallic taste) 103 WHAT ABOUT OZEMPIC? SEMAGLUTIDE (WEGOVY, OZEMPIC) 105 CHECKPOINT What is the most common side effect associated with Wegovey? A. Increased appetite B. Hypoglycemiano Blood sugaristooLow C. Weight gain D. Headaches 106 weglitloss TIRZEPATIDE (ZEPOUND, MOUNJARO) ¡ Pharmacologic Category: Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist ¡ MOA: activating GLP-1 receptors in the pancreas resulting in enhanced insulin release and reduced glucagon release-responses ¡ Monitoring: blood sugar, hypoglycemia, pancreatitis ¡ Contraindication: pregnancy, history of thyroid carcinoma ¡ Pregnancy: No Human Data – Animal Data Suggests Risk ¡ Lactation: No Human Data—Probably Compatible 108 TIRZEPATIDE (ZEPOUND, MOUNJARO) ¡ Indication: ¡ For use of weight loss adjunct to diet and exercise ¡ BMI ≥30 kg/m2 or BMI ≥ 27 kg/m2 and ≥1 weight associated comorbidity ¡ Diabetes ¡ Hypertension ¡ Dyslipidemia ¡ Obstructive sleep apnea ¡ Cardiovascular disease 109 TIRZEPATIDE (ZEPOUND, MOUNJARO) 110 TIRZEPATIDE (ZEPOUND, MOUNJARO) ¡ Week 1 – 4: 2.5 mg once weekly ¡ Dose not effective for weight loss, taper is to reduce GI symptoms ¡ Week 4+: increase to 5 mg once weekly ¡ May further increase dose in 2.5 mg/week increments every 4 weeks ¡ Maximum weekly dose: 15 mg/week ¡ Note: If changing the day of administration is necessary, allow at least 72 hours between 2 doses ¡ Missed dose: ¡ < 4 days, administer as soon as possible then, resume usual schedule thereafter ¡ >4 days, skip the missed dose and resume administration at the next scheduled weekly dose 111 TIRZEPATIDE (ZEPOUND, MOUNJARO) ¡ Adverse Reactions (significant) ¡ Acute kidney injury ¡ Diabetic retinopathy ¡ Gallbladder disease ¡ Medullary thyroid carcinoma ¡ Pancreatitis ¡ Side Effects ¡ Abdominal pain, nausea, diarrhea, vomiting, constipation, decreased appetite, dyspepsia, dysgeusia (metallic taste) 112 TIRZEPATIDE (ZEPOUND, MOUNJARO) ALERT: US Boxed Warning Risk of thyroid C-cell tumors • In both male and female rats, tirzepatide causes dose-dependent and treatment-durationdependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined. • Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk for MTC with the use of tirzepatide and inform them of symptoms of thyroid tumors (eg, a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with tirzepatide. 113 WHAT ABOUT MOUNJARO? 114