Important safety information, medication-specific disclosures, and program terms.
BioBylt Labs LLC ("BioBylt Labs," "we," "our," or "us") is a management services organization (MSO) that provides administrative, marketing, technology coordination, and non-clinical support services to facilitate patient access to telehealth consultations and prescription medications. BioBylt Labs does not practice medicine, pharmacy, nursing, or any other licensed healthcare profession. All medical consultations, prescribing decisions, and clinical judgment are performed by independently licensed healthcare providers operating on a HIPAA-compliant telehealth platform. All prescriptions are filled by licensed pharmacies engaged through the platform's pharmacy network. BioBylt Labs LLC does not prescribe, compound, dispense, or fulfill prescriptions, and does not direct, control, or interfere with the independent clinical judgment of any licensed provider or pharmacist. Eligibility for any medication is determined solely by the evaluating clinician based on an individual patient's medical history, current health status, and applicable state and federal law. BioBylt Labs makes no representation or promise that any patient will be prescribed a particular medication or any medication at all.
Information provided through the BioBylt Labs website, communications, marketing, or any associated materials is for general educational and informational purposes only. It is not intended as, and should not be interpreted as, medical advice, a professional diagnosis, a treatment plan, or a prescription. Nothing on our website creates a patient-provider relationship with BioBylt Labs. A patient-provider relationship is established only after a licensed clinician accepts you for care through the telehealth platform. Do not delay seeking medical attention or disregard professional medical advice because of information you have read on our website or in our communications. If you believe you are experiencing a medical emergency, call 911 or proceed immediately to the nearest emergency department.
The sections below summarize important safety information for the medications coordinated through BioBylt Labs at this time. This is not a complete description of risks, warnings, contraindications, or adverse reactions. The full Prescribing Information issued by the manufacturer (for FDA-approved products) or by the dispensing compounding pharmacy (for compounded preparations) is the authoritative source and will be provided with your medication.
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. Branded forms include Ozempic®, Wegovy®, and Rybelsus® (registered trademarks of Novo Nordisk A/S; BioBylt Labs is not affiliated with, endorsed by, or sponsored by Novo Nordisk A/S — see Section 5). Where the semaglutide coordinated through the platform is a compounded preparation, additional disclosures under "Compounded Product Notice" below apply. Important Safety Information — Thyroid C-Cell Tumors. In rodent studies, semaglutide caused dose- and duration-dependent thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). Whether semaglutide causes thyroid C-cell tumors, including MTC, in humans is unknown. Do not use semaglutide if you or any family member has a history of medullary thyroid carcinoma or if you have been diagnosed with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Contact your clinician promptly if you develop symptoms that may indicate a thyroid tumor, such as a new lump or swelling in the neck, persistent hoarseness, trouble swallowing, or shortness of breath.
Warnings and Precautions. The warnings and precautions listed for semaglutide in Section 3.1 also apply to tirzepatide, including but not limited to: acute pancreatitis, acute gallbladder disease, hypoglycemia (particularly with concurrent insulin or sulfonylurea use), acute kidney injury from dehydration, serious hypersensitivity reactions including anaphylaxis and angioedema, diabetic retinopathy complications, mental health changes including new or worsening depression or suicidal ideation, severe gastrointestinal disease, and pulmonary aspiration risk during anesthesia or deep sedation. Disclose your complete medical history to your clinician before starting therapy. Additional considerations specific to tirzepatide:
Common Side Effects. The side-effect profile of tirzepatide is similar to that of semaglutide. Commonly reported adverse effects include nausea, vomiting, diarrhea, constipation, abdominal pain, indigestion, decreased appetite, injection site reactions, fatigue, dizziness, headache, altered taste, back pain, and elevated pancreatic enzymes on laboratory testing. Hypoglycemia may occur in patients with Type 2 diabetes, particularly when tirzepatide is combined with other glucose-lowering agents. Gastrointestinal effects are most common during dose escalation and often diminish over time. Notify your clinician if side effects are severe or persistent. Drug Interactions. As with semaglutide, tirzepatide delays gastric emptying and may affect the absorption of oral medications. Important interactions include increased hypoglycemia risk with insulin or sulfonylureas, potential effects on the absorption of narrow-therapeutic-index oral drugs (such as warfarin), potential effects on oral thyroid hormone absorption, and the reduction in oral contraceptive effectiveness described above. Disclose all prescription medications, over-the-counter products, and herbal supplements to your clinician before starting therapy. To report a suspected adverse reaction, contact the FDA MedWatch program at 1-800-FDA-1088 or [www.fda.gov/medwatch], and notify your prescribing clinician. In a medical emergency, call 911 or proceed immediately to the nearest emergency department.
Nicotinamide Adenine Dinucleotide (NAD+) is a naturally occurring coenzyme involved in cellular energy production, DNA repair, and metabolic regulation. NAD+ is coordinated through BioBylt Labs as a compounded preparation prepared by a licensed 503A compounding pharmacy pursuant to a patient-specific prescription. NAD+ in injectable or intranasal form is not an FDA-approved drug product for the uses discussed in connection with the BioBylt Labs program. Important Safety Information. Compounded NAD+ is not evaluated or approved by the FDA for the treatment, cure, or prevention of any disease. Statements regarding NAD+ reflect cellular biology and clinical experience and are not medical claims. Eligibility for NAD+ therapy is determined by a licensed clinician based on individual medical history. Do not use NAD+ if you have a known allergy or hypersensitivity to any component of the preparation. Warnings and Precautions:
Common Side Effects. Reported side effects are generally mild and transient. These may include:
Drug Interactions. Clinical interaction data for parenteral NAD+ is limited. Disclose all prescription medications, over-the-counter products, and dietary supplements to your clinician before starting NAD+ therapy. Particular caution is warranted for patients on medications affecting hepatic metabolism, on chemotherapy regimens, or on therapies affecting sirtuin, PARP, or CD38 activity. Compounded Product Notice:
To report a suspected adverse reaction, contact the FDA MedWatch program at 1-800-FDA-1088 or [www.fda.gov/medwatch], and notify your prescribing clinician. In a medical emergency, call 911 or proceed immediately to the nearest emergency department.
Any testimonials, case histories, before-and-after images, or statistical references published by BioBylt Labs reflect the experiences of specific individuals and are not representative of the results any particular patient may experience. Clinical outcomes vary based on individual physiology, medical history, adherence to the prescribed regimen, concurrent lifestyle factors, and the clinical judgment of the treating provider. BioBylt Labs does not guarantee any specific medical, aesthetic, metabolic, or performance outcome. No statement on our website or in our marketing should be interpreted as a promise of results.
BioBylt Labs LLC is not affiliated with, endorsed by, sponsored by, or otherwise connected to Novo Nordisk A/S, the owner of the registered trademarks Ozempic®, Wegovy®, Rybelsus®, Saxenda®, and Victoza®. BioBylt Labs LLC is not affiliated with, endorsed by, sponsored by, or otherwise connected to Eli Lilly and Company, the owner of the registered trademarks Mounjaro®, Zepbound®, and Trulicity®. All third-party trademarks referenced in BioBylt Labs materials are the property of their respective owners and are used only for identification and informational purposes. Certain medications prescribed through the telehealth platform may be FDA-approved for indications other than the purpose for which they are prescribed. Off-label prescribing is lawful when performed by a licensed clinician exercising independent medical judgment.
Prices displayed on our website and in marketing materials are subject to change and apply only to the BioBylt Labs membership and administrative coordination services. Membership fees do not include the cost of medications, which are billed separately by the dispensing pharmacy, nor the cost of clinical consultations, which are billed by the provider group. Prescription eligibility and medication selection are determined solely by the evaluating clinician; no fee paid to BioBylt Labs guarantees that you will receive a particular medication or any medication. BioBylt Labs memberships are billed on a recurring subscription basis. Specific billing terms, trial offers, promotional discounts, cancellation rights, and refund eligibility are set forth in our Terms of Service, Payment & Billing Consent, Refund Policy, and Offer Terms, each available at biobyltlabs.com and incorporated by reference into these disclaimers.
BioBylt Labs-coordinated care is delivered via telehealth. A telehealth encounter differs from an in-person examination; in limited situations, the absence of an in-person evaluation may affect the clinician's ability to diagnose or treat certain conditions. The evaluating clinician may determine that in-person care is required and may decline to prescribe. Telehealth services are available only in states in which the provider group is licensed. A complete description of telehealth rights, responsibilities, and limitations is included in our Telehealth Consent document, which patients acknowledge before beginning care. Prescriptions are issued pursuant to a valid patient-clinician relationship established through the platform. All prescriptions are for personal, patient-specific use and may not be shared, resold, or transferred.
BioBylt Labs and the clinicians coordinated through the platform do not provide emergency medical services. If you are experiencing a medical emergency — including but not limited to chest pain, difficulty breathing, signs of stroke, severe allergic reaction, suicidal thoughts, or any condition you believe is life-threatening — call 911 or go to the nearest emergency department immediately. If you are in a mental health crisis, you may also reach the 988 Suicide and Crisis Lifeline by calling or texting 988.
Suspected adverse reactions to any medication should be reported to the FDA's MedWatch program by telephone at 1-800-FDA-1088 or online at [www.fda.gov/medwatch]. You are encouraged to also notify your prescribing clinician and the dispensing pharmacy. Reporting safety concerns helps the FDA monitor the safety of marketed products.