This Medications Safety Information page (this "Page") describes important safety information about the prescription medications that may be dispensed in connection with the Telehealth Services delivered through findmydirectdoctor.com. The Telehealth Services are provided by OpenLoop Healthcare Partners, PC and its affiliated professional corporations (collectively, the "Healthcare Provider"), and medication is dispensed by pharmacies engaged by the Healthcare Provider (the "Dispensing Pharmacies"). This Page is incorporated into and forms part of the FindMyDirectDoctor Terms of Service and should be read together with Section 21 of the Terms of Service (Compounded Medication Disclosures).

This Page is provided for general informational purposes only. It is not medical advice, does not create a provider-patient relationship with FindMyDirectDoctor, and does not substitute for the Healthcare Provider's clinical evaluation, prescribing decision, or medication counseling. If you have a specific question about your prescription, your dose, side effects you are experiencing, or whether to start, continue, or stop a medication, contact the Healthcare Provider through your member portal or by the methods in Section 9 of this Page. If you are experiencing a medical emergency, dial 911 or your local emergency number.

Depending on clinical eligibility determined by the Healthcare Provider's licensed clinician, medications that may be prescribed through the Telehealth Services include, but are not limited to, the following categories:

• Compounded injectable GLP-1 receptor agonists, including compounded injectable semaglutide and compounded injectable tirzepatide (a dual GLP-1 and GIP receptor agonist), for medical weight management.
• Compounded oral GLP-1 receptor agonists, including compounded oral semaglutide and compounded oral tirzepatide, dispensed as tablets, troches, or other oral preparations. Oral compounded GLP-1 medications carry the same FDA approval status and the same FDA-related disclosures as the injectable compounded GLP-1 medications described in Section 2 below.
• Branded GLP-1 medications, including, where available and clinically appropriate, FDA-approved branded products such as Wegovy (injectable semaglutide), Ozempic (injectable semaglutide), Rybelsus (oral semaglutide), Mounjaro (injectable tirzepatide), or Zepbound (injectable tirzepatide), manufactured by Novo Nordisk or Eli Lilly. Rybelsus is the only FDA-approved oral GLP-1 product currently marketed in the United States; oral tirzepatide is not available in an FDA-approved form, and any oral tirzepatide preparation dispensed under the Telehealth Services is compounded.
• Other compounded or branded therapies that the Healthcare Provider may offer outside the weight-management program, including, where clinically appropriate and where the prescribing clinician is licensed in your state, testosterone replacement therapy, peptide therapies, and longevity therapies. Safety information specific to those medications is provided separately by the Healthcare Provider at the time of prescription.

The safety information in Sections 3 through 7 of this Page applies to both injectable and oral GLP-1 medications, except as specifically noted. Route of administration differs (injectable medications are administered subcutaneously; oral medications are swallowed), but the underlying mechanism of action and the principal safety considerations - including the boxed warning, contraindications, common and serious side effects, and pregnancy precautions - are class effects that apply across formulations. Storage and handling instructions differ by route of administration and are described in Section 7 below.

Compounded medications are prepared by state-licensed 503A compounding pharmacies engaged by the Healthcare Provider. Compounded medications are not approved by the U.S. Food and Drug Administration ("FDA") and have not been evaluated by the FDA for safety, effectiveness, or quality. The compounding facilities engaged by the Healthcare Provider are regulated under federal and state law, but the FDA does not review individual compounded products before they are dispensed.

Compounded GLP-1 medications (including compounded semaglutide and compounded tirzepatide) are not generic versions of Ozempic, Wegovy, Rybelsus, Mounjaro, or Zepbound, which are FDA-approved brand-name medications manufactured by Novo Nordisk or Eli Lilly. Compounded medications are distinct preparations.

In addition, the bioavailability, clinical efficacy, and pharmacokinetic profile of compounded oral GLP-1 preparations - including compounded oral semaglutide, compounded oral tirzepatide, and sublingual troches - have not been established by adequate and well-controlled clinical studies. The FDA-approved oral semaglutide product (Rybelsus) achieves systemic absorption through a proprietary absorption-enhancer formulation that is not used in compounded preparations. Clinical outcomes from compounded oral GLP-1 preparations may differ materially from outcomes reported for FDA-approved injectable or oral GLP-1 products, and individual results vary.

The FDA has issued public alerts regarding non-active salt forms of semaglutide (such as semaglutide sodium and semaglutide acetate). The Healthcare Provider's compounding pharmacies use the active base form of semaglutide only.

The availability of compounded GLP-1 medications is conditional on FDA drug-shortage status under Section 503A(b) of the Federal Food, Drug, and Cosmetic Act. When a branded GLP-1 medication is removed from the FDA's shortage list, the Healthcare Provider's compounding partners may no longer be permitted to prepare that compounded formulation, and the Healthcare Provider may discontinue that medication option without notice.

The FDA-approved labeling for branded semaglutide products (Ozempic, Wegovy, Rybelsus) and branded tirzepatide products (Mounjaro, Zepbound) carries a boxed warning regarding the risk of thyroid C-cell tumors. In rodent studies, these medications caused thyroid C-cell tumors (including medullary thyroid carcinoma) at clinically relevant exposures. Whether semaglutide or tirzepatide causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans is not known, because the human relevance of the rodent findings has not been determined.

The FDA-approved labeling for branded semaglutide and tirzepatide products lists these medications as contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). The Healthcare Provider applies the same contraindication screening to compounded formulations of semaglutide and tirzepatide. Symptoms of a thyroid tumor may include a mass or lump in the neck, difficulty swallowing, shortness of breath, or persistent hoarseness. The Healthcare Provider's clinician will screen for these contraindications during clinical intake. If you develop any of these symptoms while taking a GLP-1 medication, contact the Healthcare Provider promptly and seek clinical evaluation.

The most common side effects of GLP-1 receptor agonists (semaglutide and tirzepatide), based on FDA-approved labeling for the branded reference products, include nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, and indigestion. Injection-site reactions are an additional common side effect for injectable formulations only and do not apply to oral GLP-1 medications. These side effects are most pronounced during dose escalation and typically diminish over time.

Serious side effects that have been reported with GLP-1 receptor agonists include, but are not limited to:

• Acute pancreatitis (including hemorrhagic or necrotizing pancreatitis, which may be fatal)
• Acute kidney injury and worsening of chronic kidney disease, often associated with severe dehydration from vomiting or diarrhea
• Hypersensitivity reactions, including anaphylaxis and angioedema
• Gallbladder disease, including cholelithiasis (gallstones) and cholecystitis
• Hypoglycemia, particularly when used with insulin or insulin secretagogues
• Diabetic retinopathy complications in patients with pre-existing diabetic retinopathy
• Depression, suicidal thoughts, or suicidal behavior (monitor for the emergence or worsening of these symptoms and discontinue the medication if they occur)

This list is not exhaustive. For a complete list of side effects, consult the FDA-approved prescribing information for the relevant branded product (available at accessdata.fda.gov) and discuss any side effects you experience with the Healthcare Provider's clinician.

Stop using the medication and seek immediate medical care, or call 911, if you experience any of the following:

• Severe abdominal pain that does not go away, with or without vomiting (possible pancreatitis)
• A lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath (possible thyroid tumor)
• Severe allergic reaction symptoms, including swelling of the face, lips, tongue, or throat, severe rash, fainting, or difficulty breathing
• Symptoms of severe dehydration (markedly reduced urination, severe weakness, confusion)
• Sudden, severe vision changes
• Persistent vomiting that prevents you from keeping fluids down

GLP-1 receptor agonists are contraindicated in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), and in patients with a history of serious hypersensitivity reaction to a GLP-1 receptor agonist or any of its components. FDA-approved labeling advises caution in patients with a history of pancreatitis or with severe gastrointestinal disease, including gastroparesis, where these medications have not been adequately studied. The Healthcare Provider's clinician will evaluate your medical history for these conditions at intake.

Pregnancy and Breastfeeding. GLP-1 receptor agonists are not recommended during pregnancy and should be discontinued at least two months before a planned pregnancy. Use during breastfeeding has not been adequately studied. If you become pregnant, suspect you may be pregnant, or are planning to become pregnant while taking a GLP-1 medication, contact the Healthcare Provider's clinician immediately for guidance.

Drug Interactions. GLP-1 receptor agonists slow gastric emptying and may affect the absorption of other oral medications. Disclose all prescription medications, over-the-counter medications, and supplements to the Healthcare Provider's clinician at the time of intake and at each follow-up.

The Healthcare Provider's clinician determines all clinical eligibility, including contraindications, during clinical intake and ongoing clinical care. Final prescribing decisions are made in the clinician's independent professional medical judgment.

Storage - Injectable GLP-1 medications. Injectable GLP-1 medications, including compounded injectable forms, are typically stored refrigerated between 36 to 46 degrees Fahrenheit (2 to 8 degrees Celsius) prior to first use, and may be kept at room temperature (below 86 degrees Fahrenheit or 30 degrees Celsius) for a limited period after first use. Specific storage and beyond-use-date information is provided on the medication's label and accompanying patient instructions. Do not freeze. Do not use if the medication has been frozen.

Storage - Oral GLP-1 medications. Oral GLP-1 medications, including FDA-approved Rybelsus tablets and compounded oral semaglutide and tirzepatide preparations, are typically stored at controlled room temperature (between 68 to 77 degrees Fahrenheit, or 20 to 25 degrees Celsius) in their original blister pack or dispensing container, away from moisture and direct light. Specific storage instructions and beyond-use dates are provided on the medication label and accompanying patient instructions.

Administration - Oral GLP-1 medications. Branded Rybelsus tablets are taken on an empty stomach in the morning with no more than 4 ounces of plain water; you should wait at least 30 minutes before eating, drinking other liquids, or taking other oral medications, in accordance with the FDA-approved labeling. Compounded oral GLP-1 preparations may have different administration instructions depending on formulation (for example, sublingual troches dissolve under the tongue and do not require water). Follow the specific administration instructions provided with your medication and the directions of the Healthcare Provider's clinician. Do not crush, split, or chew tablets unless specifically directed.

Handling - Injectable forms. Inspect the medication before each use. Do not use if the solution appears cloudy, discolored, or contains particles, or if the packaging is damaged.

Sharps Disposal - Injectable forms only. Used needles and syringes must be disposed of in an FDA-cleared sharps disposal container or, where one is not available, a heavy-duty plastic household container with a tight-fitting puncture-resistant lid. Do not throw loose needles and syringes in household trash, and do not flush them down the toilet. For local sharps disposal options, refer to safeneedledisposal.org. Sharps disposal does not apply to oral GLP-1 medications.

The Healthcare Provider's current partner Dispensing Pharmacies include the following entities. The Healthcare Provider may add or remove Dispensing Pharmacies at any time without notice based on supply, clinical, regulatory, or operational considerations:

• RedRock Pharmacy, 1240 E 100 S #220, St. George, UT 84790 / (801) 433-9500
• Health Warehouse, 7107 Industrial Rd., Florence, KY 41042 / (800) 748-7001
• Precision Medicine, 2657 Merrick Road, Bellmore, NY 11710 / (516) 833-6262
• Triad Rx, 26258 Pollard Road, Daphne, AL 36526 / (251) 380-7630

If you experience a side effect, an unexpected reaction, or a quality concern with a medication dispensed under the Telehealth Services, report it to the Healthcare Provider through any of the following channels:

• Member portal: Log in to your member account and use the clinical-concern or messaging function.
• Email: [email protected].
• Phone: (855) 597-1248 (24 hours a day, 7 days a week).

You may also report side effects directly to the FDA's MedWatch program, the FDA's safety information and adverse-event reporting program for human medical products:

• Online at fda.gov/medwatch.
• By phone at 1-800-FDA-1088 (1-800-332-1088).

If you are experiencing a medical emergency, dial 911 or your local emergency number. Do not wait to contact patient support.

The decision to prescribe a compounded or branded medication is made by the Healthcare Provider's clinician in the clinician's independent professional medical judgment, based on a telehealth consultation and your medical history. Not all patients will qualify for compounded medications, and the clinician may determine that a different course of treatment is appropriate. No specific weight loss or other clinical outcome is guaranteed, and individual results vary.

FindMyDirectDoctor may update this Page at any time. When we make changes, we will post the updated Page with a revised "Last Updated" date. The current FDA-approved prescribing information for any branded reference product, and the FDA's most current public guidance regarding compounded GLP-1 medications, controls in the event of any inconsistency with this Page.

This Page is incorporated into and forms part of the FindMyDirectDoctor Terms of Service. Your use of the Telehealth Services and any reliance on the information in this Page is governed by the Terms of Service, including without limitation the disclaimers of warranty, limitation of liability, indemnification, binding individual arbitration, class action and representative action waiver, governing law, venue, and one-year limitations period set forth therein. To the extent of any conflict between this Page and the Terms of Service, the Terms of Service govern. Any dispute arising from or relating to this Page is subject to Section 20 of the Terms of Service (Resolution of Disputes and Governing Law).

For clinical or medication-specific questions, contact the Healthcare Provider's patient support using the methods in Section 9. For questions about this Page itself, contact FindMyDirectDoctor at [email protected] or by U.S. mail at FindMyDirectDoctor, LLC, 3225 McLeod Dr, Suite 100, Las Vegas, NV 89121.