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There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Ozempic and Ozempic) during pregnancy. Pregnant women exposed to semaglutide and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
You are encouraged to report negative side effects of prescription products: Contact Novo Nordisk Inc. at 1-833-934-6891 Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch
This information is not comprehensive. Please see the Full Prescribing Information for complete safety information.
You can take Zepbound with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your HealthyID-affiliated provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking Zepbound as prescribed without discussing with your provider first. What should I tell my HealthyID-affiliated provider before using Zepbound? Zepbound has certain drug interactions. It’s important to tell your HealthyID-affiliated provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the Full Prescribing Information for complete safety information.
Mounjaro (tirzepatide), an injectable prescription medicine, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
In clinical trials, acute gallbladder disease was reported by 0.6% of Mounjaro-treated patients and 0% of placebo-treated patients. If cholelithiasis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.
The most common adverse reactions reported in ≥5% of Mounjaro-treated patients in placebo-controlled trials were nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Safety and effectiveness of Mounjaro have not been established and use is not recommended in patients less than 18 years of age.
Please click to access Prescribing Information, including Boxed Warning about possible thyroid tumors, including thyroid cancer, and Medication Guide.
You can take semaglutide with or without food. The medication is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. For detailed instructions on how to administer your dose, refer to your treatment plan or reach out to your HealthyID-affiliated provider. They will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking semaglutide as prescribed without discussing with your provider first.
In particular, tell your provider if you have or have a past history of:
If you are pregnant: Semaglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to semaglutide during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
If you are breastfeeding: Semaglutide was found in the milk of lactating rats. Tell your HealthyID-affiliated provider if you are breastfeeding before you start semaglutide.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
These serious side effects can occur with semaglutide. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
Patients with Hepatic Impairment: According to the manufacturer’s product information, no dosage adjustment of tirzepatide is suggested for patients with hepatic impairment.
Patients with Renal Impairment: No dosage adjustment of tirzepatide is suggested for patients with hepatic impairment. However, tirzepatide is associated with gastrointestinal ADRs, including nausea, vomiting, and diarrhea leading to dehydration, which can cause acute kidney injury. Use with caution in patients prone to dehydration.
Pregnancy Considerations: Available information on tirzepatide use in pregnant women is inadequate to evaluate for a drug-related risk of congenital disabilities and adverse maternal or fetal outcomes. A risk to the mother and fetus is associated with poorly controlled diabetes in pregnancy. In addition, increased incidences of external, visceral, and skeletal malformations have been observed in animal reproduction studies. Therefore, there may be risks to the fetus from exposure to tirzepatide during pregnancy.
Consequently, tirzepatide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Patients of childbearing age should be prescribed tirzepatide after discussing the possible teratogenic effects. Physicians should also discuss the initiation of contraception before prescribing tirzepatide. In addition, the efficacy of oral hormonal contraception declines while on tirzepatide therapy.
There should be shared decision-making on possibly changing the method of contraception to a non-oral route or utilizing barrier contraception for at least four weeks after initiation of tirzepatide therapy.
Breastfeeding Considerations: There is no information on tirzepatide in animal or human milk or its effects on the breastfed infant. Therefore, clinicians should consider the developmental and health benefits of breastfeeding, the mother’s clinical need for tirzepatide, and potential adverse impacts on the breastfed infant from tirzepatide.
Tirzepatide is a large molecule with high molecular weight. Accordingly, the milk concentration is likely to be less, and absorption is unlikely because it is presumably partially destroyed in the infant’s gastrointestinal tract. Therefore, until more clinical data become available, tirzepatide should be used cautiously during breastfeeding, especially in newborn or preterm infants.
Based on available data, most users do not experience significant adverse drug reactions. The primary adverse effects reported are gastrointestinal, but other side effects have also been infrequently reported. Decreased appetite is frequently reported, though this is a potential contributory etiology of intentional weight loss. Below are the adverse drug reactions reported by System Organ Class (SOC).
Gastrointestinal: Decreased appetite is often reported. Nausea and diarrhea may occur in up to 10% of patients, in addition to some infrequent reports of vomiting and acid reflux. Constipation has also been reported in some users.
Delayed gastric emptying hinders the absorption of other oral medications. This is particularly significant in those with preexisting delayed gastric emptying as it can exacerbate their symptoms. It is important to note that the efficacy of oral hormonal contraceptives is decreased, so patients should be advised to use non-oral contraceptive methods.
Cardiovascular: Sinus tachycardia has been reported but may be blunted by concurrent medication use.
Renal: Infrequent cases of acute kidney injury have been reported, likely secondary to dehydration from gastrointestinal losses. These may occur in healthy and preexisting chronic renal disease patients. Monitoring for signs of dehydration is likely to prevent renal injury.
Dermatologic: Hypersensitivity reactions have been infrequently reported at the injection site. The prevalence is not higher than those reported by patients using GLP-1 agonists. Such events should be discussed with a physician and may warrant medication discontinuation.
Pancreatitis: GLP-1 medications are a known risk factor for acute pancreatitis. The risk level for tirzepatide is similar to GLP-1 agonist medications. Patients should be advised to seek care at the local emergency department if they develop severe abdominal pain while on tirzepatide therapy. Asymptomatic elevation of lipase and amylase may also be seen in some patients.
Hepatobiliary: There have been reports of cholelithiasis and cholecystitis occurring in patients on tirzepatide therapy.
Ocular: Patients with preexisting diabetic retinopathy should be advised that those symptoms may temporarily worsen if their glycemic control quickly improves. Any vision changes while using tirzepatide(GLP-1 receptor agonist) should be immediately discussed with a physician.
Endocrine: There is a small risk of hypoglycemia and dose-dependent. This risk is more significant for those on insulin therapy and/or those utilizing sulfonylureas. Patients should be advised on the potential symptoms of hypoglycemia.
Patients should have their hemoglobin A1c and body weight monitored during scheduled follow-up visits. Follow-up intervals will vary depending on the local standard of care for diabetes management and/or obesity treatment. Hemoglobin A1C monitoring can be done as soon as every three months, depending on the patient and their A1C goal.
It is important to note that hemolytic anemia, G6PD deficiency, and pregnancy) can lead to discrepancies between the A1C result and the patient’s true glycemic status. Given the significantly improved insulin sensitivity while on tirzepatide, patients who also use insulin should be instructed to monitor their blood sugars more closely.
It is important to note that hemolytic anemia, G6PD deficiency, and pregnancy) can lead to discrepancies between the A1C result and the patient’s true glycemic status.
Monitoring for side effects, such as gastrointestinal-related symptoms, may also be necessary, especially as the prescribed doses increase. In addition, the asymptomatic elevation of lipase and amylase levels can be seen in patients using tirzepatide. Still, no clinical data suggests any utility in monitoring these markers without symptoms.
Routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection of medullary carcinoma of the thyroid in patients treated with tirzepatide. In addition, such monitoring may increase the risk of unnecessary procedures. However, monitor for the thyroid nodules on physical examination, and if serum calcitonin >50 ng/L, then further diagnostic assessment of the patient for medullary carcinoma of the thyroid is required. Patients with a personal or family history of medullary thyroid carcinoma or MEN 2 should not be prescribed tirzepatide.
Integration of quality of life(QOL) assessment into routine care provides the optimum clinical care for patients with DM-2. Monitoring of Diabetes-Dependent Quality of Life (ADDQoL), Diabetes Quality of Life (DQoL), and Short Form-12 (SF-12) help monitor the QOL in patients with type 2 diabetes mellitus.
Tirzepatide is a novel medication approved for treating type 2 diabetes mellitus with the additional benefit of weight loss. Clinicians are likely to be prescribing it in the setting of uncontrolled diabetes after first-line treatment. Current clinical data has shown tirzepatide to be highly efficacious in improving hemoglobin A1C levels and reducing body weight in a dose-dependent manner.
According to The American Diabetes Association (ADA) 2021 guidelines, an HbA1c goal for many nonpregnant adults of <7% is appropriate. According to guidelines, if the HbA1c target is not achieved after three months of metformin monotherapy, metformin can be combined with a GLP-1 receptor agonist(preferred in patients with a compelling need for weight loss) or other agents based on comorbidities and shared decision-making.
After initiating therapy with tirzepatide, clinicians are likely to follow up with patients in set intervals as early as four weeks or as late as 12 weeks, depending on the dosage and the local standard of care for diabetes management. Pharmacists are likely to play a key role for patients on tirzepatide. Their roles would include dispensing the medication, further counseling patients on adverse effects, and in some cases, they may be monitoring the patients’ hemoglobin A1Cs.
Certain care teams incorporate clinical pharmacists into their diabetes management. Given that tirzepatide can potentially lead to a few adverse effects, it is likely that nurses will have first-line contact with patients regarding these side effects. Knowledge and understanding of the medication’s adverse effects can be beneficial in counseling patients on when to seek further help. Clinicians should also educate patients about warning symptoms of hypoglycemia, such as irritability, tremors, and confusion.
Tirzepatide is also likely to be prescribed in weight loss clinics, similar to GLP-1 medications. Obesity management clinics often incorporate multidisciplinary care that includes dietitians or social workers to help maximize patient outcomes. Given the popularity of semaglutide in weight loss clinics, it is likely that tirzepatide will gain similar popularity among physicians and patients, given the high levels of reported efficacy. However, as the clinical data has shown that weight reduction appears to be dose-dependent, Weight loss management may likely be limited by the ability of the patient to tolerate higher doses of tirzepatide.
A recent systematic review and meta-analysis reported that interprofessional collaboration between specialists, clinicians, nurses, and other healthcare providers could significantly improve Patient-Reported Outcomes (PROs) in patients with type-2 diabetes mellitus. Meticulous record keeping in the patient’s medical record is also crucial so that all interprofessional team members have the same updated and accurate patient data from which to operate and make decisions regarding patient care.
You are encouraged to report negative side effects of prescription products: Contact FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch
