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the Metabolic Protocol: important safety information

Please read this carefully before starting the metabolic protocol. It does not replace the guidance of your prescribing provider.

Boxed warning. Risk of thyroid C-cell tumors. The compounded medication used in this protocol belongs to the GLP-1 receptor agonist class. In studies in rodents, medicines in this class caused thyroid C-cell tumors. It is not known whether this medication causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in people. Do not use it if you or any of your family members have ever had MTC, or if you have an endocrine condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider right away if you notice a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These can be symptoms of thyroid cancer.

What it is

The metabolic protocol uses an investigational compounded peptide in the GLP-1 receptor agonist class, prepared by a licensed US pharmacy on a valid prescription when an independent US-licensed provider decides it is appropriate for you. We do not market the compound by name: during your visit, your provider names it, explains how it acts, and reviews its complete safety information with you before anything is prescribed. Compounded medications are not reviewed or approved by the FDA for safety or effectiveness, and the medication is investigational, which means it is still being studied and is not an FDA-approved drug. Whether your provider prescribes it is their decision, based on your full history. Starting an online visit is a request for a consultation, not a guarantee of a prescription, and individual experiences vary.

Do not use if

  • You or a family member have had medullary thyroid carcinoma (MTC)
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • You have had a serious allergic reaction to GLP-1 class medicines or to any of the ingredients in your compounded preparation
  • You are pregnant, planning to become pregnant, or breastfeeding
  • Your provider has told you it is not appropriate for you based on your history

Tell your provider before starting if you have

  • Any personal or family history of thyroid cancer, MTC, or MEN 2
  • Any history of pancreatitis (inflammation of the pancreas)
  • Any problems with your gallbladder
  • Kidney problems, or any condition that can cause dehydration
  • Diabetes or low blood sugar, especially if you take insulin or a sulfonylurea
  • A history of diabetic eye disease (diabetic retinopathy) or changes in your vision
  • Any history of depression, mood changes, or thoughts of self-harm
  • Stomach or digestive conditions, including problems with digestion of food (gastroparesis)
  • All medicines, supplements, and other compounded or prescription products you take
  • If you are pregnant, planning to become pregnant, or breastfeeding

Common side effects

The most commonly reported effects are gastrointestinal: nausea, vomiting, diarrhea, constipation, stomach pain, indigestion, bloating, and reduced appetite. These are often more noticeable when you first start or when your provider adjusts your dose. Provider-guided titration is one approach your provider may use, and you should tell your provider about any side effects that bother you or that do not go away.

Serious side effects: seek care promptly

  • Inflammation of the pancreas (pancreatitis): severe stomach pain that may spread to your back, with or without vomiting, that will not go away
  • Gallbladder problems: pain in your upper stomach, fever, yellowing of the skin or eyes, or clay-colored stools
  • Kidney injury from dehydration: nausea, vomiting, and diarrhea can cause fluid loss, which may lead to kidney problems
  • Low blood sugar (hypoglycemia), especially if used with insulin or a sulfonylurea: dizziness, shakiness, sweating, confusion, fast heartbeat, or feeling weak
  • Serious allergic reactions: rash, itching, swelling of the face, lips, tongue, or throat, and trouble breathing or swallowing
  • Vision changes: any new or worsening problems with your eyesight
  • Mood changes: new or worsening depression, anxiety, or any thoughts of harming yourself
  • Symptoms of a possible thyroid tumor: a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath

Storage & handling

Store your compounded medication exactly as directed on the label and by your pharmacy. It is typically kept refrigerated and protected from light. Do not freeze it, and do not use it if it has been frozen. Keep it in its original container, keep it out of the reach of children and pets, and do not use it after the beyond-use date on the label. Dispose of needles and supplies in an approved sharps container. If you have any questions about storage or handling, message your provider or the pharmacy.

This page is general education and is not medical advice, and it is not a complete list of risks, side effects, or interactions. The compounded medication in this protocol is investigational and is prepared by a licensed US pharmacy on a valid prescription. Your provider names the compound and reviews its complete safety information with you during your visit. It is not reviewed or approved by the FDA for safety or effectiveness. Dr Holistic is a technology platform, not a healthcare provider, and your independent US-licensed provider decides whether any treatment is appropriate for you. Always read the information that comes with your prescription and follow your provider's instructions. Report any side effects to your provider, and report side effects to the FDA at 1-800-FDA-1088.

The assessment made available on the Dr Holistic website does not create a doctor-patient relationship between the individual completing the assessment and Dr Holistic. Dr Holistic is not a healthcare provider. Dr Holistic acts primarily as a technology platform to connect you with third-party licensed healthcare professionals and pharmacies. Treatment is only provided when prescribed by a licensed provider. Compounded medications are not reviewed by the FDA for safety or efficacy. Read our Safety Information and Terms of Use for important information.