Safety
Important Safety Information for Compounded Tirzepatide Injection
Warning: Risk of Thyroid C-Cell Tumors
Compounded medications are permitted under federal law but are not approved by the FDA and are not evaluated by the FDA for safety, effectiveness, or manufacturing standards. Your Meds1 provider may recommend a specific Compounded Tirzepatide dosage based on your individual health assessment.
Indications and Usage
Compounded Tirzepatide is a prescription injectable medication that may help adults who are obese or overweight, especially those with weight-related conditions, achieve and maintain weight loss. It should be used together with a calorie-restricted diet and increased physical activity.
Compounded Tirzepatide is a synthetic dual agonist targeting GLP-1 and GIP receptors. It is intended for long-term weight management alongside diet and exercise in individuals with an initial body mass index (BMI) of:
- 30 kg/m² or higher (obesity), or
- 27 kg/m² or higher (overweight) with at least one related condition such as hypertension, type 2 diabetes, or dyslipidemia.
Compounded Tirzepatide should not be used in combination with other tirzepatide-containing products or GLP-1 receptor agonists. Its safety when used with other prescription, over-the-counter, or herbal weight loss products has not been established. It is also unknown whether it is safe for individuals with a history of pancreatitis or for those under 18 years of age.
Important Safety Information for Zepbound® (tirzepatide) Injection
- In animal studies, Zepbound caused thyroid tumors, including cancer. It is not known whether this risk applies to humans. Notify your provider immediately if you experience symptoms such as a lump in the neck, hoarseness, difficulty swallowing, or shortness of breath.
- Avoid using Zepbound if you or any family member has a history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
FDA-Approved Use of Zepbound
Zepbound is prescribed, alongside reduced calorie intake and increased activity, for chronic weight management in adults with an initial BMI of:
- 30 kg/m² or greater (obesity), or
- 27 kg/m² or greater (overweight) with at least one weight-related condition such as hypertension, dyslipidemia, type 2 diabetes, sleep apnea, or cardiovascular disease.
Limitations of Use
- Zepbound should not be used with other tirzepatide products or GLP-1 receptor agonists.
- Its safety and effectiveness alongside other weight loss products have not been confirmed.
- It has not been studied in individuals with a history of pancreatitis.
Who Should Not Use Zepbound?
Do not use Zepbound if:
- You or a family member has had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You are allergic to tirzepatide or any ingredients in Zepbound.
Administration of Zepbound
Zepbound may be taken with or without food. It is administered as a subcutaneous injection in the abdomen, thigh, or upper arm once weekly, ideally on the same day each week. Your Meds1-affiliated provider will provide instructions on dosing, which may include gradual increases every four weeks.
Do not change your dosage or stop using Zepbound without consulting your provider first.
What to Discuss with Your Longevity Meds -Affiliated Provider Before Using Zepbound
Zepbound may interact with other medications. Inform your provider about all medicines you are taking, including prescriptions, over-the-counter drugs, vitamins, and supplements.
Be sure to mention:
- Diabetes medications such as insulin or sulfonylureas like Amaryl or Glucotrol XL.
- Oral medications, as Zepbound may affect their absorption.
- Other GLP-1 medications including Mounjaro, Wegovy, Ozempic, Saxenda, Victoza, Byetta, or Bydureon.
- Oral birth control, which may become less effective—consider alternative methods for 4 weeks after starting or adjusting doses.
- Any additional weight loss products or supplements.
Provide your full medical history, particularly if you have experienced:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Digestive system disorders
- Kidney disease
- Pancreatitis
- Depression
- Diabetic retinopathy
- Suicidal thoughts or behaviors
Discuss pregnancy, future pregnancy plans, or breastfeeding:
- Pregnancy: Avoid use due to potential risks to the fetus.
- Reproductive-age individuals: May reduce effectiveness of oral contraceptives.
- Breastfeeding: It is unknown if the drug passes into breast milk—consult your provider.
A pregnancy exposure registry tracks outcomes for those exposed to Zepbound during pregnancy. Contact Eli Lilly and Company at 1-800-LillyRx (+1-401-389-7829).
Providing inaccurate or incomplete medical information may lead to serious health risks, including death.
Serious Side Effects to Monitor
In case of a medical emergency, call 911 immediately.
Serious but uncommon side effects may occur, especially during early treatment or dose adjustments:
- Thyroid C-Cell Tumors — Watch for neck lumps, hoarseness, or swallowing issues.
- Severe Gastrointestinal Issues — Including nausea, vomiting, diarrhea, constipation, or intense abdominal pain.
- Acute Kidney Injury — Often due to dehydration; maintain proper hydration.
- Gallbladder Problems — Symptoms include upper abdominal pain, jaundice, fever, or pale stools.
- Pancreatitis — Severe stomach pain that may spread to the back, with or without vomiting.
- Allergic Reactions — Swelling, rash, breathing difficulty, or dizziness.
- Low Blood Sugar — Especially with diabetes medications; symptoms include dizziness, sweating, and rapid heartbeat.
- Vision Changes — Particularly in those with diabetic retinopathy.
- Suicidal Thoughts or Behavior — Monitor mental health changes closely.
- Do Not Share Injection Pens — Risk of infection transmission.
Common Side Effects of Zepbound
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Indigestion
- Injection site irritation
- Fatigue
- Allergic reactions
- Belching
- Hair loss
- Acid reflux
Report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
Before Using Compounded Tirzepatide
- Ensure your provider explains proper administration techniques.
- Discuss diabetes treatments and risk of low blood sugar.
- If using oral contraceptives, consider alternative methods during dose changes.
Review with your provider:
- Other medical conditions such as pancreatic or kidney issues.
- Current diabetes medications.
- History of eye complications related to diabetes.
- All medications and supplements you are taking.
- Pregnancy or breastfeeding plans.
How to Take Compounded Tirzepatide
- Follow all provided Instructions for Use carefully.
- Inject under the skin in the abdomen, thigh, or upper arm once weekly.
- Rotate injection sites regularly.
- In case of overdose, contact your provider or Poison Control at +1 401 389 7829.
7123 East Orange Blossom Lane Paradise Valley, AZ, 85253 [email protected]
Disclaimer: FDA-approved brand-name drugs such as Wegovy® and Ozempic® are available exclusively from Novo Nordisk®. Mounjaro® and Zepbound® are available exclusively from Eli Lilly and Company®. Meds1 claims no affiliation with or endorsement from the above products or entities.