Important Safety Information for Compounded Tirzepatide
Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo the same safety, effectiveness, or manufacturing review as FDA-approved drugs. Your Bluebiotech Team may recommend certain doses of compounded tirzepatide based on your medical evaluation.
What is Tirzepatide?
Tirzepatide is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced-calorie diet and increased physical activity, for adults with an initial body mass index (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., type 2 diabetes mellitus, hypertension, or dyslipidemia).
Limitations of Use
- Tirzepatide should not be used in combination with other tirzepatide-containing products, GLP-1 receptor agonists, or GIP receptor agonists.
- The safety and efficacy of tirzepatide for coadministration with other weight-loss medications have not been established.
- Tirzepatide has not been studied in patients with a history of pancreatitis.
- Tirzepatide should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
Who Should Not Use Tirzepatide?
Do not use tirzepatide if:
- You or any of your family members have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have had a serious allergic reaction to tirzepatide or any of its ingredients.
How is Tirzepatide Administered?
Tirzepatide is self-administered as a subcutaneous injection once weekly in the stomach, thigh, or upper arm. It can be taken with or without food. The Bluebiotech Team will provide a treatment plan, which may include gradually increasing doses every four weeks.
Do not change your dosing regimen or stop taking tirzepatide without consulting the Bluebiotech Team first.
What Should I Tell the Bluebiotech Team Before Using Tirzepatide?
It’s important to share your complete medical history with the Bluebiotech Team, including any current medications, prescription and over-the-counter drugs, supplements, or herbal products.
Tell the Bluebiotech Team if you have a history of:
- Type 1 or type 2 diabetes.
- Pancreatitis or gallbladder disease.
- Thyroid cancer or a family history of thyroid cancer.
- Depression or suicidal thoughts.
- Diabetic retinopathy.
- Kidney disease.
- Gastrointestinal disorders.
Pregnancy and Breastfeeding:
- Tirzepatide should not be used during pregnancy. There is a potential risk to an unborn baby based on animal studies. Discontinue tirzepatide at least two months before a planned pregnancy.
- Tell the Bluebiotech Team if you are breastfeeding, as tirzepatide’s presence in human milk is unknown.
Serious Side Effects to Monitor
If you experience any of the following side effects, seek immediate medical attention:
- Thyroid C-Cell Tumors: Symptoms include a lump or swelling in the neck, hoarseness, difficulty swallowing, or shortness of breath.
- Pancreatitis: Severe abdominal pain that may radiate to the back, with or without vomiting.
- Gallbladder Disease: Symptoms include upper abdominal pain, jaundice (yellowing of the skin or eyes), fever, or clay-colored stools.
- Severe Hypoglycemia (Low Blood Sugar): Symptoms include dizziness, confusion, sweating, or a fast heartbeat.
- Acute Kidney Injury: Dehydration from nausea, vomiting, or diarrhea may worsen kidney problems.
- Serious Allergic Reactions: Symptoms include swelling of the face, lips, or throat, rash, itching, or difficulty breathing.
- Increased Heart Rate: Report any significant increase in resting heart rate.
- Mental Health Changes: Report any signs of depression, suicidal thoughts, or sudden mood changes.
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Fatigue
- Headache
- Decreased appetite
Important Reminders
- Do not share needles or syringes to reduce the risk of infection.
- Report negative side effects to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.
This information is not comprehensive. Please consult the Bluebiotech Team for further details on safety and administration.