Safety Information

Last updated: June 2, 2026

This page provides safety, side effect, and risk disclosure information for every prescription protocol offered by Maximus. It is intended to help prospective and current clients make informed decisions and to serve as a reference for clinicians, support staff, and anyone evaluating Maximus products.

This page is not a substitute for medical advice from your prescribing clinician. It does not replace the Medication Guide provided with your prescription, nor does it cover every possible risk or drug interaction. Always discuss your full medical history with your provider before starting or changing a protocol.

If you are experiencing a medical emergency, call 911 immediately. If you suspect a serious or life-threatening reaction to a medication, call 911 or your local emergency number. Do not delay emergency care.

To contact your care team: message your prescriber through the Maximus dashboard, or email support@maximustribe.com.

How to Use This Page

This page is organized by protocol category. Each section covers the products within that category, including who should not use them (contraindications), required warnings, common and serious side effects, drug interactions, and monitoring requirements. If you are looking for information about a specific product, scroll to the relevant category or use your browser's search function (Ctrl+F or Cmd+F) to find it by name.

General Risks: Telehealth and Compounded Medications

Telehealth limitations

Maximus delivers care through a telehealth platform. Telehealth has inherent limitations compared to in-person care: your clinician cannot perform a physical examination, diagnostic accuracy depends on the completeness and accuracy of the information you provide, and telehealth is limited to conditions that can be appropriately evaluated and treated remotely. If your clinician determines that in-person evaluation is needed, they will refer you accordingly.

Compounded medications

Several Maximus products are dispensed as compounded medications prepared by FDA-registered 503A or 503B compounding pharmacies. Compounded medications are not FDA-approved for safety, efficacy, or quality. Compounding pharmacies are licensed and regulated at the state and federal level, but compounded drugs do not undergo the same pre-market review process as FDA-approved drugs. Maximus partners exclusively with LegitScript-certified US pharmacies. Where a product is compounded vs. FDA-approved, this is disclosed in the relevant protocol section below.

State availability

Not all Maximus products are available in every state. Availability varies by product and state regulation. Check the individual product page on maximustribe.com for current availability, or contact support.

Testosterone Optimization — Safety Information

Products in this section: Enclomiphene (standalone), Enclomiphene + Tadalafil, Enclomiphene + Tadalafil + Vardenafil, Oral Testosterone, Testosterone Cream, Injectable Testosterone. For Tadalafil- and Vardenafil-specific safety detail, also see the Blood Flow / Sexual Health section.

Protocol overview

These are prescription medications used under physician supervision to address clinically diagnosed low testosterone. Maximus offers oral, topical, and injectable forms of testosterone, and also offers enclomiphene, a selective estrogen receptor modulator (SERM) that stimulates the body's own testosterone production through the HPG axis rather than supplying exogenous hormone directly.

Who should not use these products (contraindications)

Do not use testosterone products if you have:

Known or suspected prostate cancer [FDA class labeling, 2/28/2025]
Known or suspected breast cancer [FDA class labeling]
A hypersensitivity to testosterone, sesame oil (injectable), castor oil (cream base), or other product components [product-specific PI]
You are a woman who is or may become pregnant, or breastfeeding — testosterone is Pregnancy Category X [FDA class labeling]

Enclomiphene is not FDA-approved as a standalone drug. The closest FDA-labeled analog (clomiphene citrate) is contraindicated in liver disease, abnormal uterine bleeding, and in any individual with a hypersensitivity to the compound. [Clomid PI]

For products containing Tadalafil or Vardenafil (Enclomiphene+ combinations): do not use if you take nitrate medications for chest pain or heart conditions. Combining PDE5 inhibitors with nitrates can cause a severe, potentially fatal drop in blood pressure. [FDA labeling for PDE5 inhibitors]

Boxed warnings

⚠️ TOPICAL TESTOSTERONE (CREAM) — SECONDARY EXPOSURE WARNING: Secondary exposure to testosterone has occurred in children and women who have come into skin-to-skin contact with application sites on male users. Cases in children have resulted in inappropriate virilization, including enlargement of the genitalia and advanced bone age. Wash hands thoroughly after application, cover application sites with clothing, and avoid skin-to-skin contact with women and children until the site is washed or covered. [FDA class labeling for topical testosterone products]

No other boxed warning currently applies to testosterone products following the February 28, 2025, FDA class-wide labeling action that removed the prior cardiovascular boxed warning based on TRAVERSE trial data.

Warnings and precautions

Blood pressure increase — class-wide warning added February 28, 2025. Monitor blood pressure before and during treatment. [FDA class labeling]
Polycythemia (elevated red blood cell count) — hematocrit must be monitored; treatment may need to be paused or stopped if hematocrit exceeds safe thresholds. [FDA class labeling]
Worsening BPH and possible increased risk of prostate cancer — monitor PSA and prostate symptoms. [FDA class labeling]
Sleep apnea — may be initiated or worsened by testosterone therapy.
Liver effects (oral testosterone) — oral testosterone has historically been associated with hepatotoxicity. Maximus-published data (N=100, open-label, 90 days) showed zero hepatic adverse events on the specific oral formulation used, with improvement in elevated baseline liver enzymes. This does not eliminate the class-level concern. [Maximus study: oral-t-liver-safety.md, N=100, no placebo control]
Fertility effects — exogenous testosterone (injectable, cream, oral T) suppresses the HPG axis and can reduce sperm production and fertility. Enclomiphene is included in certain combination protocols in part to preserve fertility markers, but fertility preservation is not guaranteed. Injectable testosterone consistently suppresses spermatogenesis without an enclomiphene or hCG adjunct. [Maximus studies: N=79, N=45, N=34]
Edema — especially in individuals with cardiac, renal, or hepatic disease.
Hypercalcemia — possible in immobilized patients.
Gynecomastia — breast enlargement or tenderness may occur with exogenous testosterone.

Adverse reactions

Common (reported in clinical trials and post-marketing surveillance):

Enclomiphene: Headache (~3.3%), nausea (~2.1%), hot flashes (~1.7%), dizziness, mild GI symptoms, mood changes, mild acne, blurred or abnormal vision (uncommon).
Enclomiphene + Tadalafil: All enclomiphene effects above, plus nasal congestion and light-headedness (PDE5 effect), headache (~6%), dyspepsia (~5%), back pain, flushing, myalgia (~2–3% each).
Enclomiphene + Tadalafil + Vardenafil: All effects above, plus additional headache, flushing, nasal congestion, dizziness, and mild visual disturbances from the Vardenafil component.
Oral Testosterone: GI upset or diarrhea (more likely without a fat-containing meal), mild headache, mild blood pressure elevation, acne, mood changes, fatigue, decreased SHBG, possible hair loss in genetically predisposed men.
Testosterone Cream: Application site irritation, dryness, or redness, skin discoloration at application site, acne, libido changes, mood fluctuations, fluid retention, possible hair loss in genetically predisposed men.
Injectable Testosterone: Acne, injection site pain/swelling/bruising, libido changes, mood fluctuations, fluid retention, elevated blood pressure, elevated hematocrit/hemoglobin/PSA, testicular shrinkage, gynecomastia, night sweats.

Serious (seek immediate medical attention):

Chest pain, shortness of breath, sudden severe headache, slurred speech, or weakness/numbness on one side of the body (signs of cardiovascular event or stroke)
Signs of blood clot: leg swelling, leg pain, redness (DVT/PE — rare)
Allergic reaction: rash, swelling of face/lips/tongue, difficulty breathing
Priapism — erection lasting longer than 4 hours (applies to combinations containing Tadalafil or Vardenafil; requires immediate medical attention to prevent permanent damage)
Sudden vision loss / NAION or sudden hearing loss (PDE5 class effect, applies to Tadalafil/Vardenafil combinations)
Severe hypotension (PDE5 + nitrate interaction — contraindicated)
Visual disturbances from enclomiphene (warrants discontinuation and provider evaluation)
Polycythemia / dangerously elevated hematocrit
QT prolongation (Vardenafil-specific; avoid in patients with cardiac arrhythmias or on QT-prolonging medications)
Hypersensitivity or anaphylactoid reactions (rare; oil vehicle in injectables)

Hair loss note: Testosterone can convert to DHT, which may accelerate male-pattern hair loss in genetically predisposed men. This applies to all exogenous testosterone products and to enclomiphene (which increases endogenous testosterone). Clinicians can discuss protective options such as dutasteride if hair loss is a concern.

Drug interactions and monitoring

Anticoagulants (warfarin and others) — testosterone may increase anticoagulant effect; INR monitoring required.
Insulin and oral antidiabetics — testosterone may reduce blood glucose and change insulin requirements.
Corticosteroids, ACTH — increased risk of edema.
Hepatically cleared drugs (oral testosterone specifically) — possible interaction; consult your prescriber.
Nitrates (all forms) — contraindicated with Tadalafil and Vardenafil. Combination can cause severe, potentially fatal hypotension.
Alpha-blockers — risk of hypotension when combined with PDE5 inhibitors.
QT-prolonging medications — Vardenafil may prolong the QT interval; cardiac history screening required.

Required monitoring on Maximus testosterone protocols:

Baseline labs: Total Testosterone, SHBG or Free T, LH, FSH, PSA, Hematocrit
Follow-up labs at 4 weeks after dose change
Annual labs at minimum thereafter
Blood pressure monitoring consistent with February 2025 class labeling

Use in specific populations

Pregnancy: Contraindicated. Testosterone is Category X. Women who are or may become pregnant must not use testosterone products or come into contact with application sites (cream).
Lactation: Contraindicated.
Pediatric: Not indicated. Risk of advanced bone age and virilization.
Geriatric: Increased risk of prostate-related effects; clinical judgment required.
Hepatic impairment: Use with caution, particularly oral testosterone.
Renal impairment: Edema risk.

Compounded vs. FDA-approved status

Injectable testosterone at Maximus doses is dispensed from FDA-registered 503A or 503B compounding pharmacies depending on the prescription. Oral testosterone products dispensed by Maximus are compounded formulations and are not FDA-approved as finished products. Testosterone cream as dispensed by Maximus is compounded. Enclomiphene is not FDA-approved as a standalone drug in the United States; compounded enclomiphene is dispensed from 503A pharmacies based on individual prescriptions. Compounded drugs are not reviewed by FDA for safety, efficacy, or quality prior to dispensing. Maximus partners with LegitScript-certified US pharmacies.

Blood Flow / Sexual Health — Safety Information

Products in this section: Tadalafil, Vardenafil, Sildenafil. These medications are also components of certain Enclomiphene+ combination products listed under Testosterone Optimization.

Protocol overview

PDE5 inhibitors are prescription medications that improve blood flow by relaxing smooth muscle in blood vessel walls. Maximus offers three PDE5 inhibitors with different duration, onset, and specificity profiles: Tadalafil (long-acting daily support), Vardenafil (fast onset for targeted timing), and Sildenafil (moderate onset and duration).

Who should not use these products (contraindications)

Do not use PDE5 inhibitors if you:

Take nitrate medications in any form (nitroglycerin, isosorbide mononitrate, isosorbide dinitrate, amyl nitrite/poppers) — combination can cause severe, potentially fatal hypotension [FDA labeling]
Have a hypersensitivity to Tadalafil, Vardenafil, Sildenafil, or any product component
Take alpha-blockers and have not been stabilized on the alpha-blocker dose (risk of severe hypotension)
Have been advised by your clinician to avoid sexual activity due to cardiovascular risk

Vardenafil-specific: Avoid if you have a history of cardiac arrhythmias, congenital QT prolongation, or are taking QT-prolonging medications. Vardenafil carries a QT prolongation risk that Tadalafil and Sildenafil do not. [FDA labeling]

Warnings and precautions

Cardiovascular risk — sexual activity itself carries cardiac risk. Patients with pre-existing cardiovascular disease should discuss risks with their prescriber before using PDE5 inhibitors.
Hypotension — PDE5 inhibitors lower blood pressure. Use caution if already taking antihypertensives.
Priapism — erection lasting more than 4 hours requires immediate medical attention to prevent permanent damage. Risk is elevated in patients with sickle cell disease, multiple myeloma, or leukemia.
Vision and hearing — rare reports of sudden vision loss (NAION) and sudden hearing loss or tinnitus have been associated with PDE5 inhibitor use. Seek immediate medical attention if these occur.

Adverse reactions

Common:

Tadalafil: Headache (~6%), dyspepsia (~5%), nasopharyngitis (~3%), back pain (~3%), flushing (~3%), myalgia (~2%), nasal congestion, light-headedness.
Vardenafil: Headache, flushing, nasal congestion, dyspepsia, dizziness, back pain, mild visual disturbances.
Sildenafil: Headache, flushing, nasal congestion, dyspepsia, dizziness, blue-tinted or color-altered vision (more common with Sildenafil than other PDE5 inhibitors due to cross-reactivity with PDE6 in the retina), transient blurred vision.

Serious (seek immediate medical attention):

Sudden vision loss or changes (NAION)
Sudden hearing loss or tinnitus
Priapism (erection lasting more than 4 hours)
Severe hypotension — especially if combined with nitrates or alpha-blockers
Allergic or hypersensitivity reactions
QT prolongation (Vardenafil-specific)

Drug interactions

Nitrates (all forms) — contraindicated. Potentially fatal hypotension.
Alpha-blockers — risk of additive hypotension. Stabilize on alpha-blocker dose before starting PDE5 inhibitor.
CYP3A4 inhibitors (ketoconazole, ritonavir, erythromycin, grapefruit juice) — may increase PDE5 inhibitor levels. Dose adjustment may be needed.
Other antihypertensives — additive blood pressure lowering. Monitor.
QT-prolonging medications — avoid combining with Vardenafil.

Compounded vs. FDA-approved status

PDE5 inhibitors dispensed by Maximus may be compounded formulations. Compounded drugs are not reviewed by FDA for safety, efficacy, or quality prior to dispensing. Tadalafil, Vardenafil, and Sildenafil are well-established FDA-approved drug classes. Maximus partners with LegitScript-certified US pharmacies.

Weight Management — Compounded GLP-1 — Safety Information

Products in this section: Tirzepatide (compounded), Semaglutide (compounded). Both are administered as once-weekly injections. For FDA-approved branded GLP-1 products (Wegovy®, Ozempic®, Mounjaro®, Zepbound® KwikPen®, Foundayo™), see the Weight Management — Branded GLP-1 section below.

Protocol overview

GLP-1 receptor agonists (and dual GLP-1/GIP receptor agonists) are prescription medications that suppress appetite, regulate blood sugar, and improve metabolic markers. Tirzepatide targets both GLP-1 and GIP receptors simultaneously; Semaglutide targets GLP-1 receptors. Both require physician supervision and personalized dosing.

Who should not use these products (contraindications)

Do not use GLP-1 or GLP-1/GIP receptor agonists if you have:

A personal or family history of medullary thyroid carcinoma (MTC) [see Boxed Warning below]
Multiple Endocrine Neoplasia syndrome type 2 (MEN2) [see Boxed Warning below]
A known hypersensitivity to Tirzepatide, Semaglutide, or any product component

Boxed warning

⚠️ THYROID C-CELL TUMORS: In rodent studies, GLP-1 receptor agonists (including Semaglutide and Tirzepatide) caused thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether these drugs cause thyroid C-cell tumors, including MTC, in humans. Tirzepatide and Semaglutide are contraindicated in patients with a personal or family history of MTC or in patients with MEN2. All patients should be screened for this history before prescribing. [FDA boxed warning — class effect for GLP-1 receptor agonists]

Warnings and precautions

Acute pancreatitis — discontinue immediately if persistent severe abdominal pain occurs, with or without vomiting. Do not restart if pancreatitis is confirmed.
Gallbladder disease — increased risk of cholelithiasis (gallstones) and cholecystitis. Substantial or rapid weight loss may further increase this risk.
Diabetic retinopathy complications — patients with type 2 diabetes and pre-existing retinopathy should be monitored, as rapid improvements in glucose control have been associated with worsening retinopathy.
Hypoglycemia — risk is low when used without concomitant insulin or sulfonylurea therapy, but patients on those medications need dose adjustments.
Tachycardia — increases in resting heart rate have been observed.
Muscle mass loss — rapid weight loss can lead to loss of lean muscle mass. Resistance training and adequate protein intake should be emphasized. DEXA monitoring may be appropriate.
Gastrointestinal events — GI side effects are the most common reason for discontinuation. Most are dose-dependent and improve with time and gradual dose titration.

Adverse reactions

Common (dose-dependent; typically peak during dose titration and improve with time):

Tirzepatide: Nausea (~18–24%), diarrhea (~12–17%), vomiting (~6–9%), constipation (~6–12%), abdominal pain/dyspepsia, decreased appetite, injection site reactions, fatigue, dizziness, burping.
Semaglutide: Nausea (~15–20%), diarrhea (~10–14%), vomiting (~5–8%), constipation (~5–8%), abdominal pain/dyspepsia, decreased appetite, injection site reactions, fatigue, dizziness, burping.

Serious (seek immediate medical attention):

Persistent severe abdominal pain (possible pancreatitis) — discontinue and seek care immediately
Signs of gallbladder disease: severe upper abdominal pain, fever, jaundice
Severe allergic reaction: rash, swelling of face/lips/tongue, difficulty breathing
Severe GI events requiring hospitalization
Signs of hypoglycemia (if on concurrent insulin or sulfonylureas): shakiness, sweating, confusion, rapid heartbeat

Drug interactions

Insulin and sulfonylureas — risk of hypoglycemia increases. Dose reduction of these medications may be needed.
Oral medications generally — GLP-1 agonists slow gastric emptying, which may affect the absorption rate of oral medications taken at the same time. Discuss timing with your prescriber.
Oral contraceptives — absorption may be affected by delayed gastric emptying. Discuss with your prescriber.

Required monitoring

Dose titration per clinician guidance. Weight, blood pressure, and metabolic markers monitored at regular intervals. HbA1c monitoring for patients with diabetes or pre-diabetes. Report any persistent GI symptoms, abdominal pain, or symptoms of gallbladder disease.

Compounded vs. FDA-approved status

Tirzepatide and Semaglutide dispensed under Maximus' compounded GLP-1 protocols are compounded formulations. Maximus uses the base form of Semaglutide only (not the salt form). Compounded medications are not FDA-approved for safety, efficacy, or quality. These compounds are also available in FDA-approved branded forms; see the Weight Management — Branded GLP-1 section below for those products, manufacturers, indications, and full prescribing information. Maximus partners with LegitScript-certified US pharmacies.

Availability: All 50 states and Washington, DC, except Alabama (AL), Mississippi (MS), and Louisiana (LA).

Weight Management — Branded GLP-1 — Safety Information

Products in this section: Zepbound® KwikPen® (tirzepatide), Wegovy® Pens (semaglutide), Wegovy® Tablets (oral semaglutide), Foundayo™ Tablets (orforglipron), Ozempic® Pens (semaglutide), Mounjaro® Pens (tirzepatide). All six are FDA-approved prescription medications dispensed in their branded form through the Maximus pharmacy partnership.

Trademark attribution: Wegovy® and Ozempic® are registered trademarks of Novo Nordisk A/S. Mounjaro®, Zepbound®, and KwikPen® are registered trademarks, and Foundayo™ is a trademark, of Eli Lilly and Company. Maximus is not affiliated with or endorsed by Novo Nordisk A/S or Eli Lilly and Company.

Protocol overview

Four of the six products in this section are FDA-approved for chronic weight management in adults with obesity or overweight with at least one weight-related medical problem (Zepbound® KwikPen®, Wegovy® Pens, Wegovy® Tablets, Foundayo™ Tablets). Two are FDA-approved for type 2 diabetes mellitus only (Ozempic® Pens and Mounjaro® Pens) and are prescribed off-label for chronic weight management at clinician discretion. An off-label disclosure block appears at the top of each of those two product subsections.

GLP-1 receptor agonists (semaglutide, orforglipron) and dual GLP-1/GIP receptor agonists (tirzepatide) suppress appetite, slow gastric emptying, regulate blood sugar, and improve metabolic markers. The Important Safety Information (ISI) and full prescribing information published by the manufacturer is the controlling document for any individual prescription and is linked inside each product subsection below.

Who should not use these products (contraindications)

Do not use any branded GLP-1 receptor agonist or GLP-1/GIP receptor agonist if you have:

A personal or family history of medullary thyroid carcinoma (MTC) [see Boxed Warning below]
Multiple Endocrine Neoplasia syndrome type 2 (MEN2) [see Boxed Warning below]
A known hypersensitivity to the active ingredient (semaglutide, tirzepatide, or orforglipron) or any product excipient

Drug-specific contraindications and additional warnings appear inside each product subsection below.

Boxed warning (class effect)

⚠️ THYROID C-CELL TUMORS: In rodent studies, GLP-1 receptor agonists (including semaglutide, tirzepatide, and orforglipron) caused thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether these drugs cause thyroid C-cell tumors, including MTC, in humans. Semaglutide, tirzepatide, and orforglipron are contraindicated in patients with a personal or family history of MTC or in patients with MEN2. All patients should be screened for this history before prescribing. [FDA boxed warning — class effect for GLP-1 receptor agonists]

Class warnings and precautions

Acute pancreatitis — discontinue immediately if persistent severe abdominal pain occurs, with or without vomiting. Do not restart if pancreatitis is confirmed.
Acute gallbladder disease — increased risk of cholelithiasis (gallstones) and cholecystitis. Substantial or rapid weight loss may further increase this risk. Reports include cases requiring hospitalization.
Acute kidney injury — typically secondary to dehydration from GI side effects (vomiting, diarrhea, decreased fluid intake). Maintain hydration; report persistent vomiting or signs of dehydration.
Severe gastrointestinal disease and delayed gastric emptying — these drugs slow gastric emptying. Use with caution in patients with severe pre-existing GI disease, gastroparesis, or a history of bowel obstruction.
Pulmonary aspiration during anesthesia or deep sedation — delayed gastric emptying may increase the risk of retained gastric contents and aspiration. Inform any anesthesiologist or surgeon that you are taking a GLP-1 receptor agonist; dose hold or pre-procedural fasting adjustments may be required.
Hypoglycemia — risk is low without concomitant insulin or sulfonylurea therapy, but patients on those medications need dose adjustments.
Increased heart rate (tachycardia) — increases in resting heart rate have been observed. Persistent resting tachycardia warrants evaluation.
Hypersensitivity reactions — including anaphylaxis and angioedema. Discontinue and seek immediate medical attention if a severe allergic reaction occurs.
Suicidal behavior and ideation — a class signal has been reported with weight-management GLP-1 receptor agonists. Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, or unusual changes in mood and behavior; discontinue if these emerge.
Diabetic retinopathy complications (in patients with type 2 diabetes) — rapid improvements in glucose control have been associated with worsening retinopathy. Patients with T2D and pre-existing retinopathy should be monitored.
Muscle mass loss — rapid weight loss can lead to loss of lean muscle mass. Resistance training and adequate protein intake should be emphasized. DEXA monitoring may be appropriate.
Gastrointestinal events — GI side effects are the most common reason for discontinuation. Most are dose-dependent and improve with time and gradual dose titration.

Class adverse reactions

Common (dose-dependent; typically peak during dose titration and improve with time):

Nausea, vomiting, diarrhea, constipation
Abdominal pain, dyspepsia (indigestion), bloating, belching, heartburn
Decreased appetite
Injection-site reactions (injectable products only): redness, bruising, pain, swelling
Fatigue
Dizziness
Headache
Hair loss (lower incidence; reported with semaglutide and orforglipron in particular)

Serious (seek immediate medical attention):

Persistent severe abdominal pain, with or without vomiting (possible pancreatitis) — discontinue and seek care immediately
Signs of gallbladder disease: severe upper-abdominal pain, fever, jaundice (yellowing of skin or eyes)
Severe allergic reaction: rash, swelling of face/lips/tongue, difficulty breathing
Severe GI events requiring hospitalization
Signs of acute kidney injury: decreased urination, swelling of legs/feet, fatigue, shortness of breath
Signs of hypoglycemia (if on concurrent insulin or sulfonylureas): shakiness, sweating, confusion, rapid heartbeat
New or worsening depression, suicidal thoughts or behavior, or unusual mood changes
Sudden vision changes (in patients with type 2 diabetes and pre-existing retinopathy)

Class drug interactions

Insulin and sulfonylureas — risk of hypoglycemia increases. Dose reduction of these medications may be needed.
Oral medications generally — GLP-1 receptor agonists slow gastric emptying, which may affect the absorption rate of oral medications taken at the same time. Discuss timing with your prescriber.
Oral contraceptives (tirzepatide products specifically — Mounjaro®, Zepbound® KwikPen®) — tirzepatide may decrease oral contraceptive effectiveness, especially after the first dose and after each dose escalation. Switch to a non-oral contraceptive method or use a barrier method for 4 weeks after starting and for 4 weeks after each dose escalation.
Oral contraceptives (semaglutide and orforglipron products) — absorption may be affected by delayed gastric emptying. Discuss with your prescriber.

Required monitoring

Dose titration per clinician guidance and the manufacturer-labeled titration schedule. Weight, blood pressure, and metabolic markers monitored at regular intervals. HbA1c monitoring for patients with diabetes or pre-diabetes. Report any persistent GI symptoms, abdominal pain, symptoms of gallbladder disease, decreased urination, or new or worsening mood symptoms.

Availability (all six branded SKUs): All 50 states and Washington, DC, except Alabama (AL), Mississippi (MS), and Louisiana (LA). Per-drug state availability is being confirmed with the dispensing pharmacy; contact support for the latest per-product state list.

Zepbound® KwikPen® (tirzepatide injection) — Eli Lilly

FDA-approved indications: Chronic weight management in adults with obesity (BMI 30 or higher) or overweight (BMI 27 or higher) with at least one weight-related medical condition. Moderate-to-severe obstructive sleep apnea in adults with obesity. Zepbound® is the first and only FDA-approved prescription medicine for moderate-to-severe OSA in adults with obesity.

Form and dosing: Once-weekly subcutaneous injection in the abdomen, thigh, or upper arm. Six dose strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. The 2.5 mg dose is a treatment-initiation dose, not for maintenance. Step up every 4 weeks under clinician guidance. The KwikPen® form factor holds four weekly doses per pen; the single-dose vial is the alternative form factor. Take on the same day each week, with or without food.

Drug-specific notes: Tirzepatide may decrease oral contraceptive effectiveness; see the class drug interactions above. Concurrent use with other tirzepatide products or any GLP-1 receptor agonist is not recommended.

Full prescribing information: pi.lilly.com/us/zepbound-uspi.pdf

Wegovy® Pens (semaglutide injection) — Novo Nordisk

FDA-approved indications: Chronic weight management in adults with obesity (BMI 30 or higher) or overweight (BMI 27 or higher) with at least one weight-related medical condition. Reduction of the risk of major adverse cardiovascular events (heart attack, stroke, or cardiovascular death) in adults with established cardiovascular disease and obesity or overweight. Wegovy® is the only weight-management medication with this cardiovascular risk-reduction indication.

Form and dosing: Once-weekly subcutaneous injection in the abdomen, thigh, or upper arm. Pre-filled, color-coded, single-use pens at five standard dose strengths (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) plus the Wegovy HD 7.2 mg higher-dose maintenance pen. Standard titration starts at 0.25 mg and steps up every 4 weeks. Take on the same day each week, any time of day, with or without food.

Drug-specific notes: Pre-filled pens; no priming or assembly. The 7.2 mg HD pen is a higher-dose maintenance option for clients who plateau on standard maintenance, not part of the standard titration ladder.

Full prescribing information: wegovy.com/prescribing-information.html

Wegovy® Tablets (oral semaglutide) — Novo Nordisk

FDA-approved indication: Chronic weight management in adults with obesity (BMI 30 or higher) or overweight (BMI 27 or higher) with at least one weight-related medical condition. The first and only FDA-approved oral semaglutide for chronic weight management.

Form and dosing: Once-daily oral tablet. Start at 1.5 mg. Step up every 30 days as tolerated to 25 mg maintenance.

⚠️ ADMINISTRATION REQUIREMENT (drug-specific): Take Wegovy® Tablets on an empty stomach with up to 4 ounces of water. Wait at least 30 minutes before eating, drinking other liquids, or taking other oral medications. Swallow the tablet whole; do not crush, cut, chew, or dissolve. Food, other liquids, and other oral medications in the stomach can interfere with absorption and reduce the drug's effectiveness.

Drug-specific notes: Clients who cannot reliably accommodate the 30-minute empty-stomach window every day should discuss alternative oral options with their clinician.

Full prescribing information: wegovy.com/prescribing-information.html

Foundayo™ Tablets (orforglipron) — Eli Lilly

FDA-approved indication: Chronic weight management in adults with obesity (BMI 30 or higher) or overweight (BMI 27 or higher) with at least one weight-related medical condition. Foundayo™ contains orforglipron, a different molecule from semaglutide and tirzepatide. The MTC/MEN2 boxed warning, class warnings, and class adverse reactions above apply.

Form and dosing: Once-daily oral tablet at the dose and titration schedule specified by your clinician per the manufacturer label. Commercial dose strengths: 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg. Foundayo™ does not require an empty-stomach administration window; take with or without food at the same time each day.

Full prescribing information: Refer to the Foundayo™ manufacturer prescribing information published by Eli Lilly; the canonical URL will be added once confirmed by the dispensing pharmacy. Until then, ask your prescriber for the manufacturer Medication Guide and ISI.

Ozempic® Pens (semaglutide injection) — Novo Nordisk

⚠️ OFF-LABEL USE DISCLOSURE: Ozempic® is FDA-approved for type 2 diabetes. Your Maximus clinician may prescribe Ozempic® off-label for chronic weight management based on your medical history and clinical evaluation. Off-label prescription is legal but is not an FDA-approved indication for this drug.

FDA-approved indications: Type 2 diabetes mellitus in adults (as an adjunct to diet and exercise to improve glycemic control). Reduction of the risk of major adverse cardiovascular events (heart attack, stroke, cardiovascular death) in adults with type 2 diabetes and established cardiovascular disease. Reduction of the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. Ozempic® is not FDA-approved for chronic weight management.

Form and dosing: Once-weekly subcutaneous injection in the abdomen, thigh, or upper arm. Pen colors and dose strengths: red label (0.25 mg / 0.5 mg), blue label (1 mg), yellow label (2 mg). Start at 0.25 mg; step up after at least 4 weeks. Take on the same day each week, with or without food.

Drug-specific notes: Because Ozempic® is FDA-approved for use in a population that includes patients with type 2 diabetes and pre-existing diabetic retinopathy, the diabetic retinopathy warning in the class warnings above applies on this product regardless of the indication being treated. Not for use in patients with type 1 diabetes.

Full prescribing information: ozempic.com/important-safety-information.html

Mounjaro® Pens (tirzepatide injection) — Eli Lilly

⚠️ OFF-LABEL USE DISCLOSURE: Mounjaro® is FDA-approved for type 2 diabetes. Your Maximus clinician may prescribe Mounjaro® off-label for chronic weight management based on your medical history and clinical evaluation. Off-label prescription is legal but is not an FDA-approved indication for this drug. For weight loss as a primary indication, ask your clinician about Zepbound® (same active ingredient, weight-loss indicated).

FDA-approved indication: Type 2 diabetes mellitus in adults and pediatric patients aged 10 years and older (as an adjunct to diet and exercise to improve glycemic control). Mounjaro® is not FDA-approved for chronic weight management.

Form and dosing: Once-weekly subcutaneous injection in the abdomen, thigh, or upper arm. Six dose strengths in single-dose pre-filled auto-injector pens: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg. The 2.5 mg dose is a treatment-initiation dose, not for glycemic control or maintenance. Step up every 4 weeks under clinician guidance. Take on the same day each week, with or without food.

Drug-specific notes: Tirzepatide may decrease oral contraceptive effectiveness; see the class drug interactions above. Because Mounjaro® is FDA-approved for use in a population that includes patients with type 2 diabetes and pre-existing diabetic retinopathy, the diabetic retinopathy warning in the class warnings above applies on this product regardless of the indication being treated. Not for use in patients with type 1 diabetes. Concurrent use with other tirzepatide products (including Zepbound®) or any GLP-1 receptor agonist is not recommended.

Full prescribing information: pi.lilly.com/us/mounjaro-uspi.pdf

Growth Hormone Secretagogues — Safety Information

Products in this section: Tesamorelin, Sermorelin. Both are administered as subcutaneous injections.

Protocol overview

Growth hormone secretagogues are prescription medications that stimulate the body's own growth hormone (GH) production rather than introducing exogenous growth hormone. GH triggers the liver to produce IGF-1, which delivers downstream benefits including fat mobilization, tissue repair, and metabolic improvement. The body's natural negative feedback mechanisms help prevent overproduction. These are not exogenous growth hormone.

Who should not use these products (contraindications)

Do not use growth hormone secretagogues if you have:

Active malignancy (cancer) — GH/IGF-1 axis stimulation may theoretically promote tumor growth
A history of pituitary tumor (Tesamorelin-specific contraindication)
A family history of two or more first degree relatives with similar or identical types of cancer.
A known hypersensitivity to Tesamorelin, Sermorelin, or any product component

Warnings and precautions

Glucose intolerance / elevated blood sugar — GH-axis stimulation can modestly impair insulin sensitivity and glucose tolerance, especially in patients with prediabetes, diabetes, visceral adiposity, or high baseline insulin resistance. Tesamorelin has documented trial and label signals for elevated HbA1c/diabetes-range conversion, so check fasting glucose and HbA1c at baseline and periodically during treatment; the risk appears lower or less well documented with sermorelin.
Fluid retention and edema — can be clinically significant, particularly with Tesamorelin. The 5-days-on, 2-days-off dosing schedule for Tesamorelin is designed to mitigate this. Patients with pre-existing edema or heart failure should be closely monitored.
Theoretical tumor growth stimulation — GH and IGF-1 are growth-promoting hormones. Contraindicated with active malignancy.
Fasting matters for effectiveness — insulin and growth hormone are antagonistic. Inject fasted (2+ hours after eating) for optimal response.

Adverse reactions

Tesamorelin — Common:

Injection site reactions (redness, pain, swelling)
Water retention (can be significant; mitigated by 5-on/2-off dosing)
Wrist or hand numbness/tingling (water compressing carpal tunnel)
Joint pain or stiffness (arthralgia)
Myalgia
Post-injection flushing
Headache, dizziness, nausea

Sermorelin — Common:

Injection site reactions (~25–33% initially; nearly always resolves within 2–3 weeks)
Injection site itchiness (normal; resolves with repeated exposure)
Minimal water retention
Headaches, dizziness, flushing
Mild nausea (typically during initial adjustment)
Mild joint stiffness or puffiness in hands/wrists (GH effect; often resolves with dose adjustment)
Mild fatigue (early weeks)

Serious (contact your provider immediately):

Glucose intolerance or significantly elevated blood sugar
Clinically significant peripheral edema
Allergic or hypersensitivity reactions (rash, itching, swelling)
Chest pain or tightness (rare; stop medication and seek evaluation)
Difficulty breathing (rare)
Blurred vision (rare)
Sleep disturbances

Drug interactions

Insulin and oral antidiabetics — GH axis activation may impair glucose metabolism, potentially requiring dose adjustments of diabetes medications.
Glucocorticoids — may reduce the GH response to secretagogues.
Other hormone therapies — discuss all current hormonal medications with your prescriber.

Compounded vs. FDA-approved status

Tesamorelin is FDA-approved as Egrifta for HIV-associated lipodystrophy. However, Tesamorelin dispensed by Maximus for other indications is a compounded formulation. Sermorelin was previously FDA-approved (as Geref) but has been discontinued as an FDA product; all current Sermorelin is compounded. Compounded drugs are not reviewed by FDA for safety, efficacy, or quality prior to dispensing. Maximus partners with LegitScript-certified US pharmacies.

Hair Regrowth — Safety Information

Products in this section: All-in-One Gel (dutasteride + minoxidil + tretinoin + fexofenadine), Oral Minoxidil, Oral Dutasteride, Oral Finasteride, Minoxidil+ Gel, Dutasteride+ Gel, and combination protocols.

Protocol overview

Maximus offers a full spectrum of hair regrowth protocols using clinically validated ingredients (minoxidil, finasteride, dutasteride, tretinoin) in oral and topical formulations. Protocol selection is based on hair loss pattern, severity, and individual preference for oral vs. topical delivery.

Who should not use these products (contraindications)

Dutasteride and Finasteride (oral or topical): Women who are or may become pregnant must not use or handle broken/crushed tablets of oral dutasteride or finasteride. These drugs are Pregnancy Category X — they can cause feminization of a male fetus. Women should also avoid contact with semen from men using dutasteride. [FDA labeling]
Oral Minoxidil: Contraindicated with recent myocardial infarction or pheochromocytoma. [FDA labeling]
Known hypersensitivity to any active ingredient or product component.

Boxed warning

⚠️ DUTASTERIDE AND FINASTERIDE — PREGNANCY RISK: Dutasteride and Finasteride are Pregnancy Category X. These medications can cause birth defects (feminization of male fetus) if a pregnant woman is exposed. Women who are or may become pregnant should not handle broken or crushed tablets, and should avoid contact with the application site of topical formulations. Men using dutasteride should not donate blood until 6 months after the last dose, due to the risk of the drug reaching a pregnant woman through blood transfusion. [FDA labeling]

Adverse reactions by product

All-in-One Gel (topical dutasteride + minoxidil + tretinoin + fexofenadine):

Common: Application site irritation, dryness, or redness; mild transient shedding (expected as part of hair cycle reset); mild skin peeling or flaking (tretinoin component); increased sunburn sensitivity at application site (tretinoin; use sunscreen on exposed scalp).
Serious (rare): Severe scalp or skin allergic reaction. Maximus published data (N=15) reported zero sexual, mood, or cognitive side effects with the topical formulation. Serum DHT decreased only 20.4% (vs. 90–95% with oral dutasteride), confirming limited systemic absorption.

Oral Minoxidil:

Common: Hypertrichosis (excessive body hair growth, ~15–24%, dose-dependent); transient shedding (16–22%); lightheadedness (1.7%); fluid retention (1.3–2%); tachycardia (0.9%); headache; periorbital edema.
Serious (rare): Significant fluid retention or edema (especially with renal impairment); reflex tachycardia or worsening of pre-existing cardiac conditions; pericardial effusion (rare at hair loss doses); severe hypotension.
Note: Oral minoxidil was originally developed as a blood pressure medication. Low-dose use for hair loss is off-label.

Oral Dutasteride:

Common: Decreased libido (~3–5%), erectile dysfunction (~5%), ejaculation disorders/decreased volume (~1–4%), gynecomastia/breast tenderness (~1.5%), mood changes/depression, dizziness.
Serious: Persistent sexual dysfunction after discontinuation; clinically significant depression or suicidal ideation (rare); PSA suppression (~50% — affects prostate cancer screening; inform all providers reviewing PSA results).

Oral Finasteride:

Common: Decreased libido (~1–5%), erectile dysfunction (~3–5%), decreased semen volume (~1–3%), breast tenderness (~0.4% at 1mg dose), mood changes, headache.
Serious: Persistent sexual dysfunction, depression, and cognitive symptoms after discontinuation — rare but documented, frequency debated); clinically significant depression or suicidal ideation (rare, less than 1 in 1,000); PSA suppression (~50%); possible reduced fertility while on treatment.

Topical gels (Minoxidil+ Gel, Dutasteride+ Gel):

Common: Application site irritation, dryness, redness; mild transient shedding; skin peeling/flaking (tretinoin component).
Topical formulations are designed to minimize systemic exposure compared to their oral counterparts.

Fertility note (all 5-alpha reductase inhibitors): Dutasteride and Finasteride may reduce sperm count and semen quality. Discuss with your clinician if you are planning to conceive.

Blood donation restriction: Men taking oral dutasteride should not donate blood until 6 months after the last dose.

Compounded vs. FDA-approved status

The All-in-One Gel, Minoxidil+ Gel, and Dutasteride+ Gel are compounded formulations. Oral Finasteride is FDA-approved for hair loss (as Propecia). Oral Dutasteride is FDA-approved for BPH (as Avodart); its use for hair loss is off-label. Oral Minoxidil is FDA-approved as a blood pressure medication; its use for hair loss is off-label. Compounded drugs are not reviewed by FDA for safety, efficacy, or quality prior to dispensing. Maximus partners with LegitScript-certified US pharmacies.

Mood, Stress & Sleep — Safety Information

Products in this section: Oxytocin Calming Cream.

Protocol overview

Oxytocin Calming Cream is a topical cream containing bioidentical oxytocin delivered via proprietary transdermal technology. It creates a skin-level reservoir providing slow, sustained release over 12–16 hours. This is a novel delivery method for a naturally occurring hormone. Patent pending.

Who should not use this product (contraindications)

Pregnant women should avoid contact with the product.
Individuals with heart failure, chronic kidney disease, low sodium levels, or fluid balance conditions should be evaluated by a provider before use.

Warnings and precautions

Transference risk — avoid direct skin contact with children and pets within the first 2 hours of application. Cover the application site or wash it off after 2 hours. Choose alternative application sites (shoulder, behind knee, inner thigh) if children or pets are in the household.
Hyponatremia / water retention — rare and primarily associated with IV oxytocin administration; theoretical risk with chronic high-dose topical use.
Cardiovascular effects — rare, primarily at pharmacological doses and with other methods of administration.

Adverse reactions

Common:

Mild application site irritation (especially on freshly shaved skin; resolves by rotating sites)
Mild headache
Mild nausea

Maximus clinical data (N=152 observation sets, 60 days) reported zero sedative side effects, zero morning grogginess, and zero tolerance or withdrawal symptoms.

Serious (rare):

Transference to children or pets within 2 hours of application
Hyponatremia or water retention (theoretical with topical use)
Cardiovascular effects at pharmacological doses (rare)

Drug interactions

No significant drug interactions have been documented for topical oxytocin at the doses used. As with any new medication, inform your prescriber of all medications you are currently taking.

Compounded vs. FDA-approved status

Oxytocin Calming Cream is a compounded medication. There is no FDA-approved topical oxytocin product for mood, stress, or sleep indications. Compounded medications are not FDA-approved for safety, efficacy, or quality. Maximus partners with LegitScript-certified US pharmacies.

Foundational Nutrition — Safety Information

Products in this section: Building Blocks (prescription-strength multivitamin).

Protocol overview

Building Blocks is a prescription-strength, bioavailable multivitamin formulated to support hormone production, energy, metabolism, and recovery. It is designed specifically to complement Maximus protocols and delivers vitamins and minerals at concentrations with superior absorption compared to over-the-counter multivitamins. Once-daily dosing. Available as an add-on to any Maximus subscription.

Key ingredients include Vitamin D3 (10,000 IU), Magnesium (200mg), Zinc (15mg), Vitamin K2 (MK-4), Leucine (483mg), Benfotiamine, and B-vitamins in bioavailable forms (including Pyridoxal 5-Phosphate and flush-free Nicotinamide).

Who should not use this product (contraindications)

Clients on warfarin (Coumadin) or other vitamin K antagonist anticoagulants should consult their provider before starting. The Vitamin K2 (MK-4) component can interfere with anticoagulant therapy and may require INR management. [Standard drug-nutrient interaction]
Known hypersensitivity to any ingredient in the formulation.
Individuals with granulomatous disease (e.g., sarcoidosis), primary hyperparathyroidism, or renal impairment should consult their provider before use due to the high-dose Vitamin D3 content.

Warnings and precautions

Vitamin K2 and anticoagulant therapy — Vitamin K2 may reduce the effectiveness of warfarin and other vitamin K antagonists. Clients on these therapies must inform their prescriber and monitor INR closely.
High-dose Vitamin D3 (10,000 IU) — may require periodic 25-OH Vitamin D monitoring in some individuals. Risk of hypervitaminosis D is rare with appropriate dosing but warrants monitoring in patients with granulomatous disease, primary hyperparathyroidism, or renal impairment.

Adverse reactions

Common: Mild GI upset or nausea, especially if taken on an empty stomach. These are typical of multivitamin supplements and generally resolve when taken with food.

Serious (rare):

Hypervitaminosis D — rare with appropriate dosing, but possible with the 10,000 IU Vitamin D3 content in susceptible individuals. Symptoms may include nausea, vomiting, weakness, and kidney problems.
Clinically significant drug interaction with warfarin/Coumadin from the Vitamin K2 component, requiring INR management.
Allergic reactions are possible with any supplement.

Drug interactions

Warfarin / Coumadin — Vitamin K2 may reduce anticoagulant effect. INR monitoring required. This is the most clinically significant interaction for this product.
Thyroid medications (levothyroxine) — calcium, iron, and other minerals can interfere with thyroid medication absorption. Separate dosing by at least 4 hours.
Antibiotics (tetracyclines, fluoroquinolones) — minerals can reduce antibiotic absorption. Separate dosing by at least 2 hours.

Compounded vs. FDA-approved status

Building Blocks is a prescription-strength multivitamin. Dietary supplements and prescription vitamins are not subject to the same FDA pre-market approval process as prescription drugs. This product is not intended to diagnose, treat, cure, or prevent any disease.

Diagnostics (Lab Testing) — Safety Information

Products in this section: At-Home Testosterone Test Kit, Optimal Panel, Maximal Panel, Essential Panel.

Overview

Maximus offers at-home lab testing kits for monitoring hormone levels and related biomarkers. The At-Home Testosterone Test Kit uses the Tasso+ device (FDA 510(k) cleared) for painless at-home blood collection. Results are reviewed by Maximus clinicians.

Risks of phlebotomy / blood collection

Bruising at the collection site
Minor pain or discomfort during or after collection
Infection at the draw site (very rare with proper technique and sealed devices)
Lightheadedness or fainting (vasovagal response — sit or lie down during collection if you are prone to this)

Limitations of lab testing

Lab results are a snapshot and may vary based on time of day, hydration, diet, exercise, illness, and other factors.
Lab tests are not a substitute for a comprehensive medical evaluation.
False positives and false negatives are possible with any laboratory test. Abnormal results should be confirmed and interpreted by a clinician.
At-home collection devices collect smaller blood volumes than traditional venipuncture, which may limit the range of tests that can be performed.

Adverse Event Reporting

If you experience a serious side effect or adverse event while using a Maximus product, you can report it through the following channels:

Maximus support: Email support@maximustribe.com or message your prescriber through the Maximus dashboard.
FDA MedWatch: You can report serious adverse events directly to the FDA through the MedWatch program online, or by calling 1-800-FDA-1088. Branded FDA-approved drugs (Wegovy®, Ozempic®, Mounjaro®, Zepbound® KwikPen®, Foundayo™) may also be reported directly to the manufacturer; contact information appears in the manufacturer Medication Guide that ships with each prescription.

Reporting an adverse event does not replace calling 911 for emergencies. If you believe you are experiencing a medical emergency, call 911 immediately.

Glossary

Adverse reaction / adverse event: An unwanted or harmful effect that occurs during or after use of a medication.
Compounded medication: A medication prepared by a pharmacy to meet an individual patient's specific needs. Compounded drugs are not FDA-approved for safety, efficacy, or quality.
Contraindication: A condition or factor that makes a particular treatment inadvisable or dangerous.
DHT (dihydrotestosterone): A hormone derived from testosterone that contributes to male-pattern hair loss and prostate growth.
GLP-1 (glucagon-like peptide-1): A hormone that regulates appetite, blood sugar, and insulin secretion.
GIP (glucose-dependent insulinotropic polypeptide): A hormone that works with GLP-1 to regulate appetite and metabolism.
Hematocrit: The percentage of red blood cells in your blood. Elevated hematocrit increases the risk of blood clots.
HPG axis (hypothalamic-pituitary-gonadal axis): The hormonal signaling pathway that regulates testosterone production.
IGF-1 (insulin-like growth factor 1): A hormone produced by the liver in response to growth hormone. Delivers benefits including fat metabolism, tissue repair, and recovery.
ISI (Important Safety Information): The manufacturer-published safety summary that accompanies every FDA-approved prescription drug. The ISI and the full prescribing information are the controlling documents for any prescription; this safety page is a plain-language summary that points readers to the manufacturer ISI for each branded product.
MTC (medullary thyroid carcinoma): A rare thyroid cancer originating in the thyroid C-cells. Personal or family history of MTC is a contraindication to GLP-1 receptor agonists.
MEN2 (Multiple Endocrine Neoplasia syndrome type 2): An inherited syndrome that predisposes to medullary thyroid carcinoma and other endocrine tumors. MEN2 is a contraindication to GLP-1 receptor agonists.
NAION (non-arteritic anterior ischemic optic neuropathy): A rare condition involving sudden vision loss, associated with PDE5 inhibitor use.
Off-label use: Prescription of an FDA-approved drug for an indication, population, dose, or route of administration that is not on the drug's FDA-approved label. Off-label prescription is legal in the United States and is common in clinical practice when the prescribing clinician judges it appropriate.
Orforglipron: An oral GLP-1 receptor agonist molecule. Active ingredient in Foundayo™ Tablets. Distinct from semaglutide and tirzepatide.
OSA (obstructive sleep apnea): A sleep disorder in which the airway repeatedly collapses during sleep, interrupting breathing. Zepbound® KwikPen® is FDA-approved for moderate-to-severe OSA in adults with obesity.
PDE5 inhibitor: A class of medications that improve blood flow by inhibiting the PDE5 enzyme, relaxing blood vessel walls.
Priapism: A prolonged, painful erection lasting more than 4 hours that requires immediate medical treatment.
PSA (prostate-specific antigen): A protein produced by the prostate. Elevated PSA can indicate prostate conditions including cancer.
Semaglutide: A GLP-1 receptor agonist molecule. Active ingredient in Wegovy® Pens, Wegovy® Tablets, and Ozempic® Pens.
SERM (selective estrogen receptor modulator): A class of medications that affect estrogen receptors. Enclomiphene is a SERM that stimulates natural testosterone production.
Tirzepatide: A dual GIP and GLP-1 receptor agonist molecule. Active ingredient in Zepbound® KwikPen® and Mounjaro® Pens.
503A / 503B pharmacy: Federal designations for compounding pharmacies under the Federal Food, Drug, and Cosmetic Act. 503A pharmacies compound based on individual prescriptions; 503B pharmacies operate as outsourcing facilities with more FDA oversight.

Change Log

June 2, 2026 — v1.1: Added Weight Management — Branded GLP-1 — Safety Information section covering Zepbound® KwikPen®, Wegovy® Pens, Wegovy® Tablets, Foundayo™ Tablets, Ozempic® Pens, and Mounjaro® Pens. Renamed the prior GLP-1 H2 to "Weight Management — Compounded GLP-1 — Safety Information" and updated the "Compounded vs. FDA-approved status" subsection wording to remove the inline same-active-ingredient phrasing (cross-linked to the new branded section instead). Added Glossary entries for ISI, MTC, MEN2, Off-label use, Orforglipron, OSA, Semaglutide, and Tirzepatide. Updated Adverse Event Reporting to mention manufacturer reporting channels for branded products. Clinical review by [reviewer initials]. Legal/compliance review by [reviewer initials].
May 5, 2026 — v1.0: Initial publication. All protocol sections created and populated. Clinical review by [reviewer initials]. Legal/compliance review by [reviewer initials].

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