Tirzepatide (Zepbound) - A New FDA-approved Treatment for Weight Loss. Complete Drug Review.

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The PharmEZ Tutor
This video is a complete drug review of tirzepatide (Zepbound), the latest FDA-approved injectable w...
Video Transcript:
tepati Zep bound a new treatment for weight loss complete drug review hi again everyone and welcome to a special edition of the farm easy tutor today I'll be spotlighting the use of tepati for weight loss this will be a concise review that hopefully will provide you with everything you'll need to know about the drug tepati is a prescription medicine that helps adult with obesity or those who are overweight with weight related medical problems lose weight and keep it off the brand name is Zep bound and it is manufactured by Eli lilan company tepati is a drug that mimics two incretin hormones in the body named gp1 and Gip by activating these receptors hunger and appetite are suppressed it is the first of what is called a dual Agonist weight loss drug there's epti is administered as a once a week injection subcutaneously Under the Skin tepati was first approved by the FDA to help control blood sugar in the treatment of type 2 diabetes in 2022 under the brand named monjaro Zep bound has the same active ingredient as monjaro you can see in the table that monjaro and Zep bound are the same drug to zepeti however the indications for each drug are different as monjaro is used for type 2 diabetes and Zep bound is used for weight loss note that the dose is the same for both drugs obesity is the most prevalent chronic disease worldwide in the United States over 70% of adults are obese or are overweight one out of three adults over 100 million people have obesity treating obesity can improve blood pressure blood sugar and cholesterol levels you have probably heard of the popular drug OIC being used for weight loss however OIC is not indicated for weight loss but indicated only for the treatment of type 2 diabetes therefore OIC is currently being used off label for weight loss wovi is FDA indicated for weight loss but it may be less popular due to its higher cost OIC and wovi share the same active ingredient semaglutide now the drug tepati or Zep bound is a new player being introduced to the growing weight loss Market let's talk about the current injectable drugs being used for weight loss LC glutide was the first glp1 weight loss drug approved in 2014 however it requires a daily injection and the average weight loss of 5 to 8% was less than favorable OIC and wovi share the same active ingredient semaglutide OIC is currently being used off label for weight loss and wovi is FDA approved for weight loss wovi showed a better average weight reduction of 12% zap bound is the newest weight loss drug where Zep bound differs from the other approved agents is that it also imitates a second hormone called Gip one weight loss drug that is yet to be approved is called ratr tide which also works on glucagon tepati is indicated for chronic weight management in adult patients with an initial body mass index BMI of greater than or equal to 30 obesity or an initial body mass index of greater than or equal to 27 overweight in the presence of at least one weight related comorbid condition BMI is calculated by dividing weight in kilograms by height in met squared tables such as these are readily available to easily calculate a patient's BMI if the value falls in the darkened area the patient is overweight if the BMI value falls in the lightly shaded area they are obese tepati should be used in combination with Lifestyle Changes including a healthy diet reduced calorie intake and increased physical activity and exercise tepati should not be used in combination with any other tepati containing products or any other gp1 receptor Agonist avoid using tepati with other products intended for weight loss management including prescription drugs over the con drugs and herbal preparations since the safety and efficacy of Coe Administration has not been established tepati has not been studied in patients with a history of pancreatitis or with severe gastrointestinal disease including severe gastroparesis tepati is an injectable glp1 and Gip receptor Agonist glp1 stands for glucagon like peptide one and Gip stands for glucose dependent insulinotropic poly peptide let's first talk a little bit about the incron hormones gp1 and Gip after eating a meal in response to the presence of food in the gut the small intestine releases incretin peptide hormones the two main incron are gp1 and Gip gp1 gp1 receptors are present in several areas of the brain involved in appetite regulation the brain stem and hypothalamus gp1 acts centrally in the brain to suppress appetite centers causing a loss in appetite and reducing food intake gp1 also slows gastric emptying how quickly food leaves the stomach promoting a feeling of fullness satiety thereby reducing appetite and causing weight loss by eating less in the figure you can see how the stomach is communicating with the brain telling it that it is full the brain gives a thumbs up telling the body to stop eating finally glp1 stimulates insulin secretion and inhibits glucagon secretion thus lowering blood sugar what about Gip Gip is the main incron hormone in healthy people responsible for most of the incretin effects Gip further contributes to the regulation of food intake by reducing appetite increasing sensitivity to insulin and improving on how the body breaks down sugar and fat Gip amplifies glp 1's effects here is a diagram showing where glp1 and Gip Works gp1 primarily works on the CNS to increase satiety on the stomach to decrease gastric emptying and on the pancreas to increase insulin Gip supports the the effects of glp1 working in the CNS pancreas and adapost tissue now we can talk about the mechanism of action of tpde as we said before tepati is a gp1 and GP receptor Agonist tepati mimics the two enrtin hormones gp1 and Gip in the body by selectively binding to and activating their receptors it is thus considered a dual Agonist weight loss drug tepati works by targeting and activating glp1 receptors in the brain that regulate appetite and control hunger here are the physiologic effects of tepati it lowers body weight through decreased calorie intake the effects are likely mediated by affecting appetite it delays gastric emptying creating a sensational fullness the delay is largest after the first dose and this effect diminishes over over time it lowers body weight with greater fat Mass loss than lean mass loss it stimulates insulin secretion in a glucose dependent Manner and reduces glucagon secretion these effects can lead to a reduction of blood glucose and finally it increases insulin sensitivity the starting dose of tepati is 2. 5 Mig subq once weekly the 2. 5 MGR dose is for treatment initiation and not for chronic weight management after 4 weeks increase the dose to 5 Mig subq once weekly increase the dosage in 2.
5 migr increments after at least 4 weeks on the current dose the recommended maintenance doses are 5 milligram 10 mg or 15 mg subq once weekly consider treatment response in tolerability When selecting the maintenance dosage if patients do not tolerate a maintenance dosage use a lower maintenance dose the maximum dosage is 15 mgram subcutaneously once weekly here are some important Administration instructions tepati is available as a single-use injection pen the dose is already preset and the pan is discarded after the shot inspect the syringe visually before use it should be clear and colorless to slightly yellow do not use the particulate matter or discoloration is seen administer once a week on the same day each week at any time of the day with or without meals and inject subcutaneously in the abdomen thigh or upper arm rotate the injection sites with each dose missed doses if one dose is missed and it is within 4 days after the miss dose administer tepati as soon as possible if more than 4 days have passed skip the Mis dose and administer the next dose on the regularly scheduled day if the day of weekly Administration would like to be changed it's okay to do so as long as the time between the two doses is at least 3 days tepati is available in pre-filled single dose pens of the following strengths to 2. 5 5 7. 5 10 12.
5 and 15 mg per5 ml they come in cartons of four single dose pens storage store the tepati pen in the refrigerator between 2° C to 8° C if needed each single dose pen can be stored unrefrigerated at room temperature not to exceed 30° C for up to 21 days if stored at room temperature do not return it to the refrigerator store the pens in the original carton to protect it from light do not freeze and do not use it frozen the pen has glass Parts handle it carefully if you drop the pen on a hard surface do not use it what about dosage adjustments for renal or hepatic impairment no dosage adjustment for tepati is recommended for patients with renal impairment including endstage renal disease and no dosage adjustment of tepati is recommended for patients with any degree of hepatic impairment mild moderate or severe how to use the Zep bound pen prior to initiation of Zep bound patients and caregivers should be trained on the proper injection technique Zep bound is a pre-filled pen for onetime use only the dose is already set on the pen inject Under the Skin subcutaneously only the guide to Parts shows a purple injection button on the top a lock in the middle and the gray base cap and needle at the bottom step one choose your injection site you or another person can inject a medicine in your abdomen or front of thighs keep 2 inches away from your belly button another person should give you the injection in the back of your upper arm change or rotate your injection site each week you may inject in the same body area each week but make sure it is not in the same spot each time do not inject into an area where the skin is tender bruised red or hard step two make sure the pen is locked do not unlock the pen until you are ready to inject pull the gray base cap straight off and throw it away in your household trash do not put the gray base cap back on as this could damage the needle do not touch the needle step three clean the injection site with an alcohol swab or soap and water do not touch the injection site after cleaning step four inject Zep bound place the clear base on the skin then unlock unlock by turning the lock ring press and hold the purple injection button for up to 10 seconds listen for first click which means the injection started and the second click the injection is completed you will know know your injection is complete when the gray plunger is visible step five disposing of your used pen after your injection place the used zip bound pen in an FDA cleared Sharps disposal container right away after use do not throw away the pen in your household trash when your Sharps disposal container is almost full you will need to follow your community guidelines for the right way to dispose of your disposal container for more information refer to the following f DA's website to find specific disposal locations in your area go to Safe needled disposal. org absorption following subq Administration the mean time to Peak plasma concentration of tepati is 24 hours the mean absolute bioavailability after subq Administration is 80% similar exposure was achieved with subq Administration in the abdomen thigh or upper arm distribution the mean bom distribution of tepati is 9. 7 L tepati is highly bound to plasma albumen 99% metabolism tepati is metabolized by proteolytic cleavage of the peptide backbone beta oxidation of the C20 fatty Dia acid moity and amide hydrolysis elimination the primary excretion route of tepati metabolites are via the urine and feces intact tepati is not observed in the urine or feces elimination halflife is approximately 5 days tepati owns an amino acid sequence including a C20 fatty di acid moyy that enables Albin binding and prolongs the halflife steady state plasma tepati concentrations were achieved following four weeks of once a week Administration drug interactions insulin and drugs that cause insulin secretion hypoglycemia tepati lowers blood sugar and can cause hypoglycemia in patients with type 2 diabetes tepati caused hypoglycemia in 4.
2% of patients compared to 1. 3% given Placebo conc competent use with insulin or drugs that cause insulin secretion like sanal uras may increase the risk of hypoglycemia reduction of the dose of insulin or sulan Ura may be necessary inform all patients of the risk of hypoglycemia and educate them on monitoring for signs and symptoms of hypoglycemia another drug interaction can involve oral medications tepati delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medic medications monitor the effects of oral medications con competently administer with tepati especially those with a neurotherapeutic index such as warin another drug interaction can occur with oral hormonal contraceptives the use of tepati May reduce the efficacy of oral hormonal contraceptives due to delayed gastric emptying this delay is largest after the first dose and diminishes over time patients taking oral hormonal contraceptives should switch to a nonoral contraceptive method or add a barrier method of contraception for 4 weeks after initiation with tepati and for four weeks after each dose escalation hormonal contraceptives that are not administered orally should not be affected to stay updated with each installment of the farm easy tutor make sure to subscribe to the to this channel it's easy just click on the black subscribe button below to change it to the word subscribed then to get notified whenever a new video comes out click the down arrow and then select all also if you like videos such as this please take a moment to click on the thumbs up icon below to change the color to Black thanks for your help with this contraindications tepati is contraindicated in patients with a personal or family history of meary thyroid carcinoma MTC or in patients with multiple endocrine neoplasia syndrome type 2 me2 this risk of thyroid seed tumors is an FDA box warning in rats tepati cause an increased incidence of thyroid C cell tumors at clinically relevant plasma exposures it's it's unknown whether tepati causes thyroid C cell tumors including medular thyroid carcinoma in humans consult patients regarding the potential for MTC with the use of tur epatite and inform them of symptoms of the thyroid tumors a lump or swelling in the neck triple swallowing shortness of breath or persistent horseness there are several warnings and precautions to be aware of with the use of tepati among them is severe gastrointestinal disease in clinical trials tepati was associated with severe gastrointestinal adverse reactions with an incidence of 1. 7 to 3.
1% compared to 1% for Placebo tepati is not recommended for use in patients with severe gastrointestinal disease including severe gastroparesis in postmarketing experience of zip bound ilas or intestinal blockage has been reported as an adverse reaction ction in the product labeling gastroparesis and ilas related to weight loss drugs have been recently in the news in July of 2023 three women reported via the FDA Adverse Events tracking system that they developed severe GI symptoms after receiving treatment with semaglutide injections two were diagnosed with severe gastroparesis stomach paralysis in August of 2023 a woman sued Novo Nordisk and Eli Lily the manufacturers of semaglutide and tepati alleging that the companies failed to warn patients of severe GI symptoms including gastroparesis the woman reported stomach pain severe vomiting GI burning hospitalization due to stomach issues and excessive vomiting in September of 2023 following more than a dozen reports of intestinal blockages among people using OIC the FDA added a new warning to the drugs labeling ilas intestinal blockage has been added to the postmarketing experience for OIC warnings for intestinal blockages for other popular diabetes drugs including wovi and monjaro already existed other warnings and precautions include acute kidney injury which can result from dehydration due to tepati GI side effects acute gallbladder disease including K lithiasis and kitis and acute pancreatitis there's a risk for diabetic retinopathy with the use of tepati as well as the possibility of suicidal behavior and ideation serious hypers sensitivity reactions such as anaphylaxis and angioedema have also been reported pregnancy the use of tepati during pregnancy is not recommended due to the risk of fetal harm caused by exposure to the drug and weight loss lactation there are no data on the presence of tepati or its metabolites in animal or human milk the effects on the breastfed infant or the effects on milk production adverse drug reactions the most common adverse reactions reported with tepati were GI related nausea diarrhea vomiting constipation abdominal pain and dyspepsia other adrs included injection sight reactions hair loss and fatigue hair L is reported more frequently in female than in male patients in the tepati group 7. 1% female versus 05% male and in the placebo group 1.
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