Medical Weight Management
GLP-1 Therapy Informed Consent

Purpose & Program Description

Navara Health's medical weight management program provides medically supervised weight loss using GLP-1 receptor agonists (semaglutide) and dual GIP/GLP-1 receptor agonists (tirzepatide). The program is designed to address weight, metabolic, and appetite regulation in the context of:

• Hormonal status (thyroid, sex hormones, cortisol)
• Insulin resistance and metabolic adaptation
• Body composition goals
• Lifestyle, nutrition, sleep, and stress physiology

This is medical weight management — not a quick-fix or cosmetic program. Treatment includes initial evaluation, personalized dosing, ongoing provider oversight, side effect management, and refill access. Treatment approval is determined at the consultation and is not guaranteed in advance.

Medications Used

Treatment Pathways

Navara Health offers two distinct medication pathways. My provider will help me determine the best pathway based on my health history, eligibility, insurance status, and budget.

Important Pathway Notes

• Compounded medications are not interchangeable with brand-name products. Dosing units, concentrations, and formulations may differ from FDA-approved versions and from each other.
• Some compounded formulations may include additional ingredients beyond the GLP-1 active ingredient itself, including B vitamins (such as vitamin B12 and vitamin B6 / pyridoxine). These adjuncts are sometimes added to help reduce nausea or to support metabolic factors during therapy. I understand that:
  • The specific ingredients in my compounded medication will be disclosed to me at the time of prescription
  • I should disclose any known sensitivities or allergies to B vitamins, preservatives, or compounding excipients
  • Adding ingredients beyond the FDA-approved formulation is part of why compounded preparations are not interchangeable with brand-name products
  • Excessive long-term exposure to high-dose vitamin B6 has been associated with peripheral neuropathy and other adverse effects; my provider will discuss the dose and source if applicable
• The FDA has taken regulatory action regarding compounded GLP-1 medications as branded products move in and out of FDA "shortage" status. Compounding availability can change, and my prescribed compounded medication may become unavailable or be transitioned to a brand-name product mid-therapy.
• Manufacturer direct programs (Novo Nordisk Direct, Lilly Direct) have their own terms, eligibility requirements, refill cadence rules, and may discontinue eligibility for non-adherence (e.g., skipped months, dose splitting).

FDA Status, Off-Label Use & Compounding

I understand and acknowledge that:

• Brand-name Wegovy® and Zepbound® are FDA-approved for chronic weight management in adults with obesity (BMI ≥30) or overweight (BMI ≥27) with at least one weight-related condition. Use outside these criteria may be considered off-label.
• Brand-name Ozempic® and Mounjaro® are FDA-approved for Type 2 diabetes only. Use of Ozempic® or Mounjaro® for weight loss alone is off-label.
• Compounded semaglutide and tirzepatide are NOT FDA-approved for any indication, including weight loss.
• Compounded preparations do not undergo the same pre-market safety, efficacy, or manufacturing review as commercially manufactured drugs.
• Compounded semaglutide and tirzepatide are NOT the same as Ozempic®, Wegovy®, Mounjaro®, or Zepbound®.
• Long-term safety data for compounded GLP-1 medications is limited beyond what is known about the brand-name products.
• Off-label use is legal, common, and accepted in medical practice but is not specifically FDA-approved.

FDA Boxed Warning · Thyroid C-Cell Tumors

Risks & Side Effects

Contraindications & Cautions

GLP-1 therapy is contraindicated or requires caution in the following:

Absolute Contraindications

• Personal or family history of medullary thyroid carcinoma (MTC)
• Multiple Endocrine Neoplasia syndrome type 2 (MEN-2)
• Known serious hypersensitivity to semaglutide, tirzepatide, or any product component
• Pregnancy, possible pregnancy, or breastfeeding
• Active or untreated severe gastroparesis

Cautions / Relative Contraindications

• History of pancreatitis (acute or chronic)
• History of gallbladder disease
• Severe renal impairment
• Severe hepatic impairment
• Diabetic retinopathy
• History of bariatric surgery (case-by-case review)
• Severe gastrointestinal disease, including significant reflux or motility disorders
• Eating disorders (active or in recovery; requires careful clinical judgment)
• Active or recent history of depression, suicidal ideation, or other significant mental health conditions (requires monitoring)
• Planned pregnancy within 2 months (medication should be discontinued in advance)
• Use of concurrent medications that affect gastric emptying or absorption

It is my responsibility to disclose all medical conditions, medications, supplements, and recent procedures, and to notify Navara Health of any new diagnoses or significant medical events during therapy.

BMI Criteria & Voluntary Election (Below-Threshold Treatment)

FDA-approved GLP-1 receptor agonists for chronic weight management are indicated for adults with:

• BMI ≥ 30 kg/m² (obesity), or
• BMI ≥ 27 kg/m² (overweight) with at least one weight-related comorbidity such as hypertension, type 2 diabetes, dyslipidemia, obstructive sleep apnea, cardiovascular disease, or non-alcoholic fatty liver disease

I understand that use of GLP-1 receptor agonists or compounded GLP-1 medications outside these criteria is considered off-label.

• GLP-1 receptor agonists should not be used during pregnancy or breastfeeding
• Women of reproductive potential must use effective contraception while on therapy
• GLP-1 medications may reduce the effectiveness of oral contraceptives by delaying gastric absorption — non-oral contraception or backup methods should be considered, particularly during dose escalation
• If pregnancy is planned, semaglutide should be discontinued at least 2 months before attempted conception, and tirzepatide at least 1–2 months before, based on manufacturer guidance
• I will notify Navara Health immediately if I become pregnant or suspect pregnancy
• GLP-1 therapy may improve fertility in patients with PCOS or anovulation; effective contraception is essential if pregnancy is not desired

Pre-Procedure / Anesthesia Considerations

Laboratory Monitoring

Labs are not always required to start but are strongly recommended. Lab options:

• $150 flat-rate Weight Loss Lab Panel through Navara Health
• Insurance billing through Quest Diagnostics

Recommended baseline and follow-up labs may include, but are not limited to:

• CBC, CMP (including liver and kidney function, electrolytes)
• HbA1c, fasting glucose, fasting insulin
• Lipid panel
• TSH (thyroid screening)
• Lipase or amylase if pancreatic concerns
• Vitamin D, B12, ferritin (nutrient screening)
• Pregnancy testing where appropriate

I am financially responsible for all laboratory testing. Failure to complete recommended monitoring labs may result in modification or discontinuation of therapy, and refills will not be issued if labs are significantly abnormal.

Self-Administration, Storage & Supplies

Medication ships directly from the partner compounding pharmacy or the manufacturer direct program, with supplies included for compounded pathways. I acknowledge and agree that:

• I will receive written and/or video instruction on injection technique, site rotation, dose preparation, storage, and sharps disposal
• I will not administer my first dose until I have confirmed I understand the instructions
• I will store medication as directed (typically refrigerated; refer to vial or pen labeling)
• I will not share, sell, transfer, or allow another person to use any GLP-1 medication prescribed to me
• I will not split doses, microdose, or use the medication in any manner inconsistent with the prescribed protocol unless specifically directed by my provider
• I will use a proper sharps container and dispose of needles in accordance with state and local regulations
• I will not exceed the prescribed dose, frequency, or duration without prior approval
• I will keep all required follow-up appointments and complete monitoring labs
• I will contact Navara Health before the next dose if I experience an unexpected reaction, technique concern, or significant side effect

When to Stop and Call Navara Health

• Severe persistent abdominal pain (especially radiating to the back) — possible pancreatitis
• Severe nausea, vomiting, or inability to keep liquids down → dehydration risk
• New neck mass, hoarseness, persistent dysphagia, or shortness of breath
• Severe upper-right abdominal pain, fever, or yellowing of skin/eyes — possible gallbladder disease
• Significant decrease in urine output, swelling, or sudden weight changes
• New or worsening depression, anxiety, or thoughts of self-harm
• Hives, swelling of face/lips/tongue, or signs of allergic reaction
• Vision changes (relevant for diabetic patients)
• Any reaction I am uncertain about

Expected Outcomes & Limitations

• Weight loss varies significantly between individuals; results are not guaranteed
• Average reported weight loss in clinical trials is approximately 10–15% for semaglutide and 15–22% for tirzepatide over 12+ months at maintenance dose, in combination with lifestyle changes
• Outcomes depend on starting weight, adherence, lifestyle modifications, hormonal status, sleep, stress, and other factors
• Discontinuation of therapy is typically followed by gradual weight regain unless lifestyle changes are sustained; this is a chronic-disease model, not a curative treatment
• Plateaus are expected and may require dose adjustment, behavioral changes, or medication change
• Significant rapid weight loss may be accompanied by loss of lean muscle mass; resistance training and adequate protein intake are recommended
• This program is one component of a comprehensive approach that includes nutrition, movement, sleep, and stress management

Program Pricing & Financial Disclosure

Financial Terms

• GLP-1 therapy is elective; cash-pay and insurance pathways available depending on medication
• Navara Health does not bill insurance for compounded medications or consultations; superbills may be provided
• For brand-name medications, prior authorization assistance is available at $99 (approval not guaranteed)
• Payment is due at the time of service or medication ordering
• No refunds are issued once medication has been prepared, opened, or shipped, or once an injection has been administered
• Pre-paid accelerator packages are non-refundable except as expressly stated in writing
• Pricing, refund policies, and shipping practices for the dispensing pharmacy or manufacturer direct program are governed by those entities and are outside Navara Health's control
• If I become ineligible for therapy after a package purchase (e.g., contraindication discovered at consultation), the unused medication portion may be refunded or applied to alternative services at the practice's discretion

Manufacturer Direct Program Compliance

For patients on the Novo Nordisk Direct (Wegovy®) or Lilly Direct (Zepbound®) pathway, I understand and agree:

• Manufacturer programs require continuous monthly refills
• Dose splitting, microdosing, or "stretching" medication is not permitted
• Skipped months may result in loss of program eligibility, determined by the manufacturer
• Loss of manufacturer eligibility is not within Navara Health's control
• Re-enrollment after loss of eligibility may not be possible or may require restarting at higher cash-pay pricing

Communication & HIPAA Authorization

I authorize Navara Health to communicate with me regarding scheduling, pharmacy coordination, refills, lab results, monitoring, and follow-up through:

• The secure HIPAA-compliant patient portal
• Email to the address I have provided
• SMS / text message to the mobile number I have provided
• Telephone calls to the number I have provided

I understand that email and SMS are not fully secure channels. I may revoke authorization for any specific channel in writing to contact@navarahealthtx.com, except where required for legally mandated notices.

Assumption of Risk & Release of Liability

I voluntarily assume all known, unknown, and unforeseen risks associated with GLP-1 therapy, including risks specific to compounded medications and risks related to manufacturer direct program eligibility. To the fullest extent permitted by law, I agree to release, indemnify, and hold harmless Navara Health, PLLC, Jessica Boggs APRN, the medical director, and all affiliated providers, nurses, staff, contractors, and agents from liability for:

• Adverse reactions or complications
• Side effects
• Unexpected outcomes, plateaus, or weight regain after discontinuation
• Treatment failure or lack of benefit
• Long-term or delayed effects not yet known to medicine
• Effects related to FDA regulatory changes affecting compounding availability
• Loss of manufacturer direct program eligibility

This release does not apply to cases of gross negligence or willful misconduct, and does not waive any right that cannot lawfully be waived under the laws of my state of residence.

Dispute Resolution & Binding Arbitration

Any dispute, controversy, or claim arising out of or relating to this Consent, the prescribing of GLP-1 therapy, or the practitioner-patient relationship — including any claim of medical malpractice, billing dispute, or breach of contract — shall first be addressed by good-faith negotiation between the parties.

If the matter cannot be resolved through negotiation within thirty (30) days, the parties agree to submit the dispute to binding arbitration administered by a recognized arbitration body (such as the American Arbitration Association) under its applicable rules, with the arbitration to take place in Dallas County, Texas, unless otherwise required by the laws of the patient's state of residence.

The parties acknowledge that by agreeing to arbitration, they are waiving the right to a jury trial. This provision does not waive any right that cannot lawfully be waived under the patient's state law. Either party retains the right to seek injunctive or equitable relief in court where appropriate.

Governing Law & Severability

This Consent shall be governed by and construed under the laws of the State of Texas, except where the laws of the patient's state of residence require otherwise. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.

Emergency & Adverse Event Reporting

Non-emergent adverse events should be reported to Navara Health through the patient portal or by calling 469-653-3124. Suspected drug-related adverse events may also be reported to the FDA MedWatch program at 1-800-FDA-1088 or fda.gov/medwatch.