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Safety

Important Safety Information for Compounded Tirzepatide Injection

Warning: Risk of Thyroid C-Cell Tumors

Compounded drugs are allowed to be prescribed under federal law, but they are not FDA-approved and do not go through FDA reviews for safety, effectiveness, or manufacturing quality. Your Longevity Meds provider may suggest specific doses of Compounded Tirzepatide based on your individual medical evaluation.

Indications and Usage

Compounded Tirzepatide is an injectable prescription medication that may assist adults with obesity or excess weight (overweight) who also have weight-related medical conditions in losing weight and maintaining that loss. It should be combined with a reduced-calorie diet and increased physical activity.

Compounded Tirzepatide is a synthetic dual agonist of the glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. It is used for chronic weight management, alongside a reduced-calorie diet and increased physical activity, in individuals with an initial body mass index (BMI) of:

  • 30 kg/m² or greater (obesity), or
  • 27 kg/m² or greater (overweight) along with at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).

Compounded Tirzepatide should not be used with other products containing tirzepatide or any other GLP-1 receptor agonist medications. Its safety and effectiveness with other prescription, over-the-counter, or herbal weight loss products are unknown. It is unknown if Compounded Tirzepatide can be used in people with a history of pancreatitis. Its safety and effectiveness in children under 18 years of age are unknown.

Important Safety Information for Zepbound® (tirzepatide) Injection

  • In studies with rats, Zepbound caused thyroid tumors, including thyroid cancer. It is not known if Zepbound will cause thyroid tumors or medullary thyroid carcinoma (MTC) in humans. Inform your provider if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath—these could be signs of thyroid cancer.
  • Do not use Zepbound if you or any family member has ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA-Approved Use of Zepbound

Zepbound is indicated, along with a reduced-calorie diet and increased physical 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 comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

Limitations of Use

  • Zepbound should not be combined with other tirzepatide-containing products or other GLP-1 receptor agonists.
  • The safety and efficacy when used with other weight loss products have not been established.
  • Zepbound has not been studied in patients with a history of pancreatitis.

Who Should Not Use Zepbound?

Do not use Zepbound if:

  • You or any family member has ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • You have a known allergy to tirzepatide or any components of Zepbound.

Administration of Zepbound

Zepbound can be taken with or without food. It is self-administered as a subcutaneous injection in the stomach area, thigh, or upper arm once weekly, on the same day each week. Your Longevity Meds -affiliated provider will guide you on a dosing schedule, which may involve gradual dose increases every four weeks.

Do not alter your dosing schedule or discontinue Zepbound without first consulting your provider.

What to Discuss with Your Longevity Meds -Affiliated Provider Before Using Zepbound

Zepbound can interact with certain medications. Inform your provider about all medications you are taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal or dietary supplements.

Key medications to mention include:

  • Diabetes treatments (e.g., insulin or sulfonylureas like Amaryl or Glucotrol XL).
  • Oral medications (Zepbound slows gastric emptying, which may affect absorption).
  • Other GLP-1 medications (e.g., Mounjaro, Wegovy, Ozempic, Saxenda, Victoza, Byetta, or Bydureon).
  • Oral hormonal birth control (may be less effective, especially after starting or dose increases—consider non-oral or barrier methods for 4 weeks after initiation and each escalation).
  • Other weight loss products, including supplements.

Share your full medical history, especially if you have had:

  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Gastrointestinal disease
  • Kidney disease
  • Pancreatitis
  • Depression
  • Diabetic retinopathy
  • Suicidal thoughts or behavior

Discuss pregnancy, plans to become pregnant, or breastfeeding:

  • Pregnancy: Avoid Zepbound; potential risks to the unborn baby based on animal studies.
  • Females of reproductive potential: May reduce oral contraceptive effectiveness.
  • Breastfeeding: Unknown if it passes into breast milk—discuss risks and benefits with your provider.

A pregnancy exposure registry monitors outcomes for Zepbound exposure during pregnancy. Contact Eli Lilly and Company at 1-800-LillyRx (+1-401-389-7829).

Providing incomplete or inaccurate health information to obtain treatment may cause harm, including death in some cases.

Serious Side Effects to Monitor

In a medical emergency, call 911 immediately.

Rare but serious side effects may occur, especially early in treatment or with dose changes:

  • Thyroid C-Cell Tumors — Monitor for symptoms like neck lumps, hoarseness, or swallowing difficulties.
  • Severe Gastrointestinal Issues — Nausea, diarrhea, vomiting, constipation, or stomach pain (may be severe).
  • Acute Kidney Injury — From dehydration due to GI effects—stay hydrated.
  • Acute Gallbladder Disease — Upper stomach pain, jaundice, fever, or clay-colored stools.
  • Acute Pancreatitis — Severe abdominal pain, possibly radiating to the back, with or without vomiting.
  • Serious Allergic Reactions — Swelling of face/lips/tongue/throat, rash, rapid heartbeat, breathing/swallowing difficulties, or dizziness.
  • Low Blood Sugar (Hypoglycemia) — Especially with other diabetes medications; symptoms include dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
  • Diabetic Retinopathy Complications — Vision changes in those with a history.
  • Suicidal Behavior/Ideation — Monitor for mood, behavior, thought, or feeling changes.
  • Never Share Pens — Risk of infection.

Common Side Effects of Zepbound

  • Nausea
  • Diarrhea
  • Vomiting
  • Constipation
  • Indigestion
  • Injection site reactions
  • Fatigue
  • Allergic reactions
  • Belching
  • Hair loss
  • Gastroesophageal reflux disease

Report negative side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Before Using Compounded Tirzepatide

  • Your provider should demonstrate proper use.
  • Discuss diabetes medications and low blood sugar risks.
  • If using oral birth control, consider alternatives for 4 weeks after starting or dose increases.

Review with your provider:

  • Other medical conditions (e.g., pancreas/kidney issues, gastroparesis).
  • Diabetes medications.
  • History of diabetic retinopathy.
  • All other medications/supplements.
  • Pregnancy or breastfeeding plans (may harm unborn baby; unknown in breast milk).

How to Take Compounded Tirzepatide

  • Follow the Instructions for Use provided.
  • Inject subcutaneously in the abdomen, thigh, or upper arm once weekly.
  • Rotate injection sites.
  • If overdose occurs, contact your provider or Poison Control at +1 401 389 7829.
  • If overdose occurs, contact your provider or Poison Control at +1 401 389 7829.

Longevity Meds 378 Grand Ave Pawtucket, RI 02861 [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®. Longevity Meds claims no affiliation with or endorsement from the above products or entities.