Medication Information:
- Medication: Tirzepatide (brand name: Zepbound)
- Administration Route: Subcutaneous injection
I. Purpose of Medication:
Tirzepatide is prescribed for the treatment of type 2 diabetes mellitus and obesity which has recently been approved for the treatment of moderate to severe obstructive sleep apnea. It is a GLP-1 receptor agonist and GIP receptor agonist designed to help lower blood sugar levels and aid in weight management.
II. Contraindications:
Tirzepatide is not recommended for use in the following conditions:
- Hypersensitivity to Tirzepatide or any of the components of the medication.
- Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2).
- Severe gastrointestinal disease (e.g., gastroparesis).
- Pregnancy or breastfeeding (safety has not been established).
III. Risks:
Patients should be aware of the following potential risks and side effects associated with Tirzepatide:
- Gastrointestinal symptoms such as nausea, vomiting, diarrhea, or constipation.
- Hypoglycemia (low blood sugar), particularly when used in combination with other diabetic medications such as insulin or sulfonylureas.
- Kidney problems, including acute kidney injury.
- Pancreatitis (inflammation of the pancreas), with symptoms like severe abdominal pain.
- Thyroid tumors, as seen in animal studies, though it is unclear if this risk extends to humans.
- Allergic reactions, including anaphylaxis.
- Hypersensitivity reactions such as rash, itching, or difficulty breathing.
- Suicidal ideation or depressive symptoms
- Pulmonary aspiration during general anesthesia or deep sedation.
IV. Benefits:
The primary benefits of Tirzepatide include:
- Improved blood sugar control in patients with type 2 diabetes.
- Significant weight loss, which has been shown to help in managing obesity and related conditions.
- Reduced cardiovascular risk factors, including improved blood pressure and cholesterol profiles.
- Improved quality of life related to weight loss and blood sugar management.
V. Impact on Obstructive Sleep Apnea (OSA):
Results from the SURMOUNT-4 study of patients with moderate to severe obstructive sleep apnea with BMI > 30 demonstrated the following:
-- Patients using Tirzepatide for 1 year at the maximal tolerated dose had a typical weight loss on average of approximately 20% of total body weight.
-- Patients in the study needed to maintain a 500 calorie per day deficit and exercise at least 150 minutes per week.
-- Approximately 81% of patients had some type of adverse event or side effect.
-- After 1 year, 61% of patients had a reduction in AHI (apnea hypopnea index) of 50% as compared to baseline.
-- If the medication is discontinued, approximately 83% of patients will have their weight return to baseline weight based on this study as compared to 10% who stay on the medication. As such, to treat obstructive sleep apnea, this medication would need to be taken on a lifelong basis.
VI. Financial Agreement for Prior Authorization:
To begin treatment with Tirzepatide, prior authorization may be required by your insurance company. This process can take some time and may involve additional paperwork. There is a $40 fee associated with this prior authorization request, which will be the responsibility of the patient. The fee covers the administrative costs associated with submitting and processing the authorization request.
VII. Ongoing monitoring and management:
Before starting GLP-1 medication therapy, the patient agrees to undergo baseline monitoring to assess overall health and establish reference points for future evaluation. The following labs will be required:
- Fasting Blood Glucose (FBG)
- Hemoglobin A1c (HbA1c)
- Comprehensive Metabolic Panel (CMP)
- Lipid Panel (Cholesterol levels)
- Thyroid Function Test (TSH)
- Complete Blood Count (CBC)
- Liver Function Tests (LFTs)
To ensure ongoing safety and effectiveness of the treatment, the following follow-up tests and visits are required:
1. Follow-Up Labs:
- Hemoglobin A1c (HbA1c): Every 3 months
- Fasting Blood Glucose (FBG): Every 3 months
- Comprehensive Metabolic Panel (CMP): Every 6 months or as directed
- Lipid Panel: Every 6 months.
- Thyroid Function Test (TSH): Annually, or more frequently if symptoms arise.
2. Frequency of Follow-Up Visits:
- Initial Visit: Within the first month of starting GLP-1 therapy.
- Subsequent Visits: Every 3 months for the first 12 months, then may be reduced to every 6 months if the patient's condition is stable and progress is made toward treatment goals.
3. Patient Responsibilities:
- By accepting treatment with GLP-1 medications, the patient agrees to the following responsibilities:
- Attend all scheduled follow-up visits.
- Complete all required lab tests and provide results promptly.
- Notify the healthcare provider of any new symptoms, adverse reactions, or changes in health status.
- Follow the prescribed dosage and administration instructions for GLP-1 medications.
- Discuss any concerns regarding treatment, including side effects or lifestyle modifications.
VIII. Acknowledgments and Consent:
I, the undersigned patient, acknowledge the following:
I have been informed of the contraindications, risks, and benefits of Tirzepatide and understand the potential side effects and complications that may arise during treatment.
I understand the potential effects of Tirzepatide on my condition, including improvements in blood sugar control, weight loss, and possible improvement in obstructive sleep apnea as described in the SURMOUNT-4 study.
I am aware of the $40 fee for prior authorization, and I agree to pay this fee. I understand that this fee is non-refundable and covers the administrative costs of processing the authorization request, regardless of whether the medication is authorized.
I agree to follow all instructions for the safe use of Tirzepatide, including regular monitoring and follow-up appointments with my healthcare provider.
I consent to the use of Tirzepatide as part of my treatment plan and agree to notify my healthcare provider of any adverse reactions or concerns during my treatment.