Important Safety Information for Compounded Retatrutide
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 retatrutide based on your medical evaluation.
What is Retatrutide?
Retatrutide is a next-generation, multi-receptor agonist targeting GLP-1, GIP, and glucagon pathways. It is being investigated for chronic weight management alongside a reduced-calorie diet and increased physical activity in adults with:
- BMI of 30 kg/m² or greater (obesity), or
- BMI of 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition, such as type 2 diabetes, hypertension, or dyslipidemia.
Limitations of Use
- Retatrutide should not be used in combination with other medications containing GLP-1 receptor agonists, GIP receptor agonists, or glucagon receptor agonists.
- The safety and efficacy of retatrutide for coadministration with other weight-loss medications have not been established.
- Retatrutide has not been studied in patients with a history of pancreatitis.
- Retatrutide should not be used in patients with type 1 diabetes mellitus or diabetic ketoacidosis.
Who Should Not Use Retatrutide?
Do not use retatrutide 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 retatrutide or any of its ingredients.
How is Retatrutide Administered?
Retatrutide 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 over time based on tolerance and efficacy.
Do not change your dosing regimen or stop taking retatrutide without consulting the Bluebiotech Team first.
What Should I Tell the Bluebiotech Team Before Using Retatrutide?
It is critical to share your complete medical history with the Bluebiotech Team, including all current medications, supplements, or herbal products.
Tell the Bluebiotech Team if you have a history of:
- Type 1 or type 2 diabetes.
- Thyroid cancer or a family history of thyroid cancer.
- Pancreatitis or gallbladder disease.
- Depression, anxiety, or suicidal thoughts.
- Diabetic retinopathy.
- Kidney disease or impaired renal function.
- Gastrointestinal disorders or delayed gastric emptying.
Pregnancy and Breastfeeding:
- Retatrutide should not be used during pregnancy, as there may be potential risks to an unborn baby based on animal studies. Discontinue retatrutide at least two months before a planned pregnancy.
- Inform the Bluebiotech Team if you are breastfeeding, as it is unknown if retatrutide is excreted in human milk.
Serious Side Effects to Monitor
Seek immediate medical attention if you experience any of the following side effects:
- 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 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 rapid heartbeat.
- Acute Kidney Injury: Dehydration caused by 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.
- Mental Health Changes: Sudden mood changes, depression, or suicidal thoughts should be reported immediately.
- Increased Heart Rate: Report a significant increase in resting heart rate.
Common Side Effects
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain
- Headache
- Fatigue
- Decreased appetite
Important Reminders
- Do not share needles or syringes to prevent 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, administration, and your treatment plan.