Safety Information

What Nuvara is and what this page covers

Nuvara is an educational and informational platform that connects interested users with licensed healthcare providers and a US compounding pharmacy through an affiliated partner network. Nuvara does not itself provide medical care, diagnose or treat any condition, prescribe or dispense medication, or fulfill prescriptions.

This Safety Information page describes the standards we expect of our affiliated partner network and the general safety considerations that apply to the peptide and compounded GLP-1 therapies referenced on the Site. It is not a substitute for professional medical advice. Your prescribing clinician will review the full risks, benefits, and monitoring requirements with you before you start any protocol.

Our approach to safety

We believe there is no one-size-fits-all approach to health and wellness, and that personalized, physician-supervised care is critical to good outcomes. Our role is to make it easier for you to find that care — we vet the partners we connect you with, we hold them to clear standards, and we are transparent about what Nuvara does and does not do.

Three commitments anchor how we work with our affiliated partner network:

• We only operate in specialties where we can provide meaningful access. We will not enter a new space simply because it is popular. When we do enter a space, we do so with clinical input and at a scale that can meet user needs consistently.
• We rely on licensed clinicians to practice medicine. A prescribing clinician — not Nuvara — decides whether a given therapy is right for you.
• We expect our pharmacy partners to meet high safety and quality standards. See the "Compounding pharmacy standards" section below for the specifics.

Clinical standards

The offerings described on the Site are developed with input from licensed clinical teams and reflect the current state of evidence for peptide and compounded therapies. Clinical understanding of these compounds continues to evolve, and our partner network updates protocols as new evidence emerges.

Information on the Site — including descriptions of peptide mechanisms and general product information — is for educational purposes only. It is not tailored to any individual and should not be relied upon in place of advice from your own healthcare provider.

Leaving medical judgment to licensed providers

Every therapy described on the Site is a prescription product that requires a valid prescription from a licensed healthcare provider. Nuvara does not and cannot make clinical decisions for you.

When you engage with an affiliated provider through Nuvara, that provider:

• Reviews your medical history, current medications, and goals.
• Determines, in their sole clinical judgment, whether a particular therapy is appropriate for you.
• May decline to prescribe a therapy if they determine it is not appropriate, or refer you to in-person care or an alternative not available through the Nuvara partner network.
• Provides informed consent, dosing guidance, and ongoing monitoring as part of your protocol.

Compounding pharmacy standards

The medications referenced on the Site are prepared by US licensed compounding pharmacies that are held to the following standards:

• Ingredient quality. Active pharmaceutical ingredients must meet specifications set by the United States Pharmacopeia (USP) or other applicable quality standards.
• Compounding standards. Facilities follow USP compounding standards (including USP 795 for non-sterile compounding and USP 797 for sterile compounding) and applicable FDA regulations governing pharmacy compounding under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act.
• Sterility testing. Sterile medications — including GLP-1 therapies and other injectable peptides — undergo sterility testing prior to release.
• Cold-chain handling. Injectable medications are shipped in temperature-controlled packaging when required for product stability.
• Use-by labeling. Each prescription includes clear use-by dating and instructions for storage after opening.

Compounded medications are not the same as FDA-approved branded drugs. Compounded products are prepared by a licensed pharmacy in response to an individual prescription and are not FDA-approved. In some cases, FDA-approved branded versions of a given compound also exist and may be appropriate for some patients; your prescribing clinician will help you understand the differences and determine what fits your situation.

Peptide therapies — general safety information

Peptide therapies are prescription medications that signal or support specific biological pathways. Most peptides available through Nuvara's partner network are generally well tolerated, but they are not risk-free. Side effects may include:

• Injection-site reactions (redness, soreness, bruising, or mild itching at the injection site).
• Gastrointestinal discomfort, such as nausea, changes in appetite, or digestive changes.
• Headache, fatigue, or flushing, particularly during the initial cycle.
• Mild water retention or changes in insulin sensitivity, depending on the specific peptide.

Rare but more serious risks include allergic reactions. Peptide protocols are not appropriate for everyone — see the "Who should not use these therapies" section below. Your prescribing clinician will review the full risk profile of your specific protocol with you before you start.

GLP-1 therapies — important safety information

Compounded GLP-1 therapies (including compounded semaglutide and compounded tirzepatide) carry specific risks and are not appropriate for everyone. Please review the following before speaking with a prescribing clinician:

Not the same as FDA-approved branded drugs

Compounded semaglutide and compounded tirzepatide are prepared by licensed US compounding pharmacies in response to an individual prescription. They are not the same as FDA-approved branded drug products containing these compounds, and they are not interchangeable with them. FDA-approved branded versions exist and may be appropriate for some patients.

Known and potential risks

GLP-1 therapies are associated with the following risks, among others:

• Thyroid C-cell tumors. Based on findings in animal studies, GLP-1 receptor agonists may be associated with a risk of thyroid C-cell tumors. Whether these drugs cause thyroid C-cell tumors in humans is not known. GLP-1 therapies should not be used in individuals with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
• Pancreatitis. GLP-1 therapies have been associated with pancreatitis. Discontinue use and seek medical care if you experience severe abdominal pain.
• Gallbladder disease. GLP-1 therapies may increase the risk of gallstones and other gallbladder conditions.
• Kidney injury. Acute kidney injury has been reported, particularly in the context of dehydration from vomiting, diarrhea, or reduced fluid intake.
• Hypoglycemia. Low blood sugar may occur, especially when GLP-1 therapies are combined with insulin, sulfonylureas, or other glucose-lowering medications.
• Allergic and hypersensitivity reactions. Serious allergic reactions, including anaphylaxis and angioedema, have been reported.
• Gastrointestinal side effects. The most common side effects are gastrointestinal — nausea, vomiting, diarrhea, constipation, reflux, and reduced appetite. These typically ease after the first few weeks as your body adjusts.

Full prescribing discussion, informed consent, and ongoing monitoring are part of every GLP-1 protocol arranged through Nuvara's partner network.

Who should not use these therapies

Peptide and GLP-1 therapies may not be appropriate for individuals who:

• Are pregnant, planning to become pregnant, or breastfeeding.
• Have a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (for GLP-1 therapies).
• Have a history of pancreatitis, gallbladder disease, or severe gastrointestinal disease.
• Have active malignancy.
• Have certain endocrine, pituitary, or other chronic medical conditions.
• Have known allergies or hypersensitivities to the active ingredients or excipients.
• Are taking medications that may interact adversely with the therapy (for example, certain diabetes medications when combined with GLP-1 therapies).

Your prescribing clinician will review your full medical history, current medications, and any relevant lab results before recommending a protocol. Additional contraindications may apply to specific compounds.

Common and serious side effects

All prescription therapies carry some risk of side effects. The following are general patterns; specific side effects vary by compound and dosage.

Common side effects

• Injection-site reactions (redness, soreness, bruising, itching).
• Nausea, changes in appetite, or other gastrointestinal symptoms.
• Headache, fatigue, or vivid dreams (for sleep-focused peptides).
• Mild water retention, flushing, or changes in insulin sensitivity.

Rare but serious side effects

• Allergic or hypersensitivity reactions, including anaphylaxis and angioedema.
• For GLP-1 therapies specifically: pancreatitis, gallbladder disease, kidney injury, and the thyroid C-cell tumor risk described above.
• Changes in blood glucose requiring monitoring, especially in individuals taking other glucose-affecting medications.

Contact your prescribing clinician promptly if you experience unexpected or severe symptoms. Seek emergency care for signs of a severe allergic reaction (difficulty breathing, swelling of the face or throat), severe abdominal pain, or other medical emergencies.

FDA status of compounded products

Statements on this site have not been evaluated by the U.S. Food and Drug Administration. Products described on the Site are not FDA-approved drugs. Compounded medications are prepared by licensed US compounding pharmacies in response to individual prescriptions and are distinct from FDA-approved branded drug products. Compounded medications are not intended to diagnose, treat, cure, or prevent any disease.

Contact us

If you have questions about the information on this page, please contact us:

For questions about a specific medical condition, medication, or protocol, please speak with a licensed healthcare provider.