Important Safety Information

Thisdocument provides Important Safety Information for prescription and compoundedmedications that may be available through Alyve, Inc.'s affiliated providernetwork. It covers indications, contraindications, potential side effects, druginteractions, and use in special populations. This document is forinformational purposes only and does not replace the clinical judgment of yourprescribing provider.

Patientsare encouraged to report adverse drug reactions to their prescribing provider,their dispensing pharmacy, and the FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

In case of amedical emergency, call 911 or go to the nearest emergency room immediately.

GeneralDisclaimers

PlatformRole

Alyve,Inc. is a managed services organization (MSO) that provides clinicalinfrastructure and care coordination services. Alyve, Inc. does not practicemedicine, provide medical advice, or dispense medications. All prescribingdecisions are made exclusively by independent, licensed healthcare providersoperating through affiliated professional medical entities in the states wherethey are licensed to practice.

PrescriptionMedications

Prescriptionmedications are only available following a completed telehealth consultationand a clinical determination of appropriateness by a licensed provider. Whetherto prescribe, and what to prescribe, is entirely within the provider'sindependent clinical judgment and subject to applicable laws and regulations.

CompoundedMedications

Sometreatments available through affiliated providers may involve compoundedmedications prepared by licensed, USA-based compounding pharmacies. Compoundedmedications may be appropriate when commercially available alternatives do notmeet a patient's clinical needs.

Important:Compounded medications have not been reviewed or approved by the FDA forsafety, effectiveness, or quality. They are not FDA-approved drug products.Your provider will discuss the risks and benefits of compounded medicationswith you during your consultation.

GLP-1Weight Management — Compounded Semaglutide

Compoundedsemaglutide is not an FDA-approved drug product. FDA shortage status forbranded semaglutide may affect the availability of compounded versions. Yourprovider will advise you on current availability.

BLACK BOXWARNING

Semaglutideand other GLP-1 receptor agonists are contraindicated in patients with apersonal or family history of medullary thyroid carcinoma (MTC) or MultipleEndocrine Neoplasia syndrome type 2 (MEN 2). In animal studies, GLP-1 receptoragonists caused thyroid C-cell tumors. The relevance to humans is unknown.

SeekImmediate Medical Attention For:

•    Severe nausea, vomiting, ordiarrhea resulting in dehydration or inability to keep fluids down.

•    Signs of kidney problems:decreased urination or swelling in the legs.

•    Thyroid tumor symptoms:neck lump or swelling, hoarseness, trouble swallowing, or shortness of breath.

•    Pancreatitis: persistent,severe abdominal or back pain, with or without vomiting.

•    Gallbladder disease: upperabdominal pain, fever, jaundice, or nausea.

•    Liver problems: jaundice,elevated liver enzymes, or hepatitis signs.

•    Diabetic retinopathyprogression: new or worsening vision changes.

•    Low blood sugar signs:dizziness, weakness, shakiness, headache, sweating, confusion, or rapidheartbeat.

•    Worsening depression,behavioral changes, or thoughts of self-harm or suicide.

•    Do not share thismedication with anyone else.

DrugInteractions

Semaglutidemay interact with insulin, oral diabetes medications (especiallysulfonylureas), and other glucose-lowering therapies, increasing the risk ofhypoglycemia. It may also affect the absorption rate of oral medications due toeffects on gastric emptying. Inform your provider of all medications, supplements,and herbal products you are taking.

Use inSpecial Populations

Donot use during pregnancy or while breastfeeding. Use effective contraceptionduring treatment. Safety and efficacy have not been established in pediatricpatients.

GLP-1Weight Management — Compounded Tirzepatide

Compoundedtirzepatide is not an FDA-approved drug product. FDA shortage status forbranded tirzepatide may affect the availability of compounded versions.

WARNING —THYROID TUMOR RISK

Tirzepatidehas been associated with thyroid C-cell tumors in animal studies. Do not use ifyou or any first-degree family member has a history of medullary thyroidcarcinoma or MEN 2.

SeriousSide Effects — Seek Medical Attention For:

•    Persistent or severeabdominal discomfort (possible pancreatitis).

•    Signs of kidney problemsfrom dehydration secondary to gastrointestinal symptoms.

•    Gallbladder disease: upperabdominal pain, jaundice, fever, or stool color changes.

•    Allergic reactions: facialswelling, hives, difficulty breathing, or rapid heartbeat.

•    Hypoglycemia: dizziness,sweating, confusion, shakiness, or rapid heartbeat.

•    New or worsening visualchanges.

•    Mood changes, depression,or thoughts of self-harm.

CommonSide Effects

Nausea,diarrhea, vomiting, constipation, abdominal pain, indigestion, injection sitereactions, fatigue, belching, hair loss, and heartburn.

DrugInteractions

Increasedhypoglycemia risk when combined with insulin or sulfonylureas. May reduce theeffectiveness of oral contraceptives — discuss alternative contraception withyour provider.

Use inSpecial Populations

Donot use during pregnancy or while breastfeeding. Use effective contraceptionduring treatment.

Wegovy®and Ozempic® (Branded Semaglutide)

BLACK BOX WARNING— Same as compounded semaglutide above. All semaglutide-containing productscarry the same class warnings.

CommonSide Effects

Nausea,constipation, vomiting, diarrhea, abdominal pain, headache, indigestion,injection site reactions, dizziness, back pain, altered taste, decreasedappetite, bloating, belching, fatigue, nasopharyngitis, and GERD.

Use inSpecial Populations

Donot use if pregnant, trying to become pregnant, or breastfeeding. Use effectivecontraception during treatment.

Zepbound™and Mounjaro® (Branded Tirzepatide)

Branded tirzepatide is indicated for chronic weight management (BMI ≥30, or ≥27 with weight-related comorbidity) and for the treatment of type 2 diabetes mellitus.

WARNING —THYROID TUMOR RISK. Same as compounded tirzepatide above.

Do NotUse If You Have:

•    Diabetic ketoacidosis, Type1 diabetes, or clinically significant diabetic retinopathy.

•    Personal or family historyof MEN 2 or medullary thyroid carcinoma.

•    Active pancreatitis orkidney disease requiring dialysis.

SeriousSide Effects

•    Severe gastrointestinalproblems.

•    Kidney failure fromdehydration.

•    Gallbladder disease.

•    Pancreatitis.

•    Serious allergic reactions.

•    Hypoglycemia (especiallywith sulfonylureas or insulin).

•    Vision changes in type 2diabetes patients.

•    Depression or suicidalideation — monitor mood changes throughout treatment.

OralContraceptive Interaction

Usesupplemental contraception for four weeks after treatment initiation and fourweeks after each dose increase.

HormoneReplacement Therapy — Testosterone (Men)

Testosteroneproducts prescribed through this platform are intended for adult males withclinically diagnosed hypogonadism or testosterone deficiency. These statementsapply to both FDA-approved and compounded testosterone preparations.

SeriousWarnings

•    Polycythemia (elevated redblood cell count): may increase risk of blood clots, stroke, and heart attack.Regular monitoring of hematocrit is required.

•    Cardiovascular risk:testosterone therapy may increase cardiovascular risk in certain patientpopulations. Discuss your cardiac history with your provider.

•    Sleep apnea: may worsenexisting sleep apnea or cause new-onset sleep apnea.

•    Venous thromboembolism:increased risk of deep vein thrombosis (DVT) and pulmonary embolism has beenreported.

•    Prostate: testosterone maystimulate the growth of existing prostate cancer. PSA monitoring is required.Do not use if you have or are suspected to have prostate cancer.

•    Infertility: exogenoustestosterone suppresses natural testosterone production and sperm production. Maycause infertility. Discuss fertility preservation with your provider beforestarting treatment.

•    Pediatric exposure risk:testosterone gels and creams can be transferred to children through skincontact and may cause premature puberty. Keep application sites covered andwash hands thoroughly after application.

CommonSide Effects

Acne,oily skin, increased body or facial hair, mood changes or irritability,injection site reactions (for injectable forms), fluid retention, headache, anddecreased testicular size.

Contraindications

Knownor suspected prostate or breast cancer. Serious cardiovascular conditions.Polycythemia. Pregnancy (females). Do not use if you are trying to fatherchildren without first discussing fertility implications with your provider.

MonitoringRequirements

Regularblood tests to monitor testosterone levels, hematocrit, PSA, and liver functionare required throughout treatment. Your provider will establish a monitoringschedule at the initiation of therapy.

HormoneReplacement Therapy — Estradiol and Progesterone (Women)

Thesestatements apply to both FDA-approved and compounded estradiol andprogesterone/progestin preparations.

ImportantSafety Information

Hormonereplacement therapy (HRT) for women involves the use of estrogen alone (inwomen without a uterus) or estrogen combined with progestogen (in women with auterus). The following risks have been associated with systemic HRT:

•    Cardiovascular disease: HRTmay increase the risk of stroke, blood clots (DVT/pulmonary embolism), andheart attack, particularly in older women or those with pre-existingcardiovascular risk factors.

•    Breast cancer: Combinedestrogen-progestogen therapy has been associated with a modest increase inbreast cancer risk with long-term use. Estrogen-only therapy may have adifferent risk profile. Discuss your personal risk with your provider.

•    Endometrial cancer:Estrogen used without progestogen in women with a uterus increases the risk ofendometrial cancer. Progestogen is typically co-prescribed to protect theuterine lining.

•    Abnormal vaginal bleeding:Report any unexpected vaginal bleeding to your provider immediately.

•    Blood clots: Oral estrogenhas a higher thrombotic risk compared to transdermal (patch or gel) forms.Discuss the preferred route of administration with your provider based on yourrisk profile.

Contraindications

Knownor suspected estrogen-dependent cancers (including certain breast and uterinecancers). Active or recent history of DVT, pulmonary embolism, stroke, or heartattack. Known hypersensitivity to estradiol, progesterone, or any component ofthe formulation. Pregnancy. Undiagnosed abnormal genital bleeding.

CommonSide Effects

Breasttenderness, bloating, nausea, headaches, mood changes, and irregular spottingor bleeding (particularly in the first months of therapy). Patch or cream formsmay cause local skin irritation at the application site.

MonitoringRequirements

Regularfollow-up visits including breast exams, mammography (as appropriate), bloodpressure monitoring, and gynecological evaluation are recommended throughouttreatment. Your provider will establish a monitoring schedule.

PeptideTherapies — General Notice

Peptidetherapies offered through this platform are compounded preparations and havenot been reviewed or approved by the FDA for safety, effectiveness, or quality.These are prescribed at the independent clinical discretion of your providerfor off-label or wellness applications. The statements in this section have notbeen evaluated by the FDA.

BPC-157(Body Protection Compound)

BPC-157is a synthetic peptide derived from a protein found in gastric juice, usedoff-label in certain regenerative and recovery protocols. It is notFDA-approved for any indication.

Reportedbenefits in preclinical and limited clinical contexts include support fortissue healing, tendon and ligament recovery, and gastrointestinal protection.Clinical evidence in humans is limited and ongoing.

Commonside effects reported include nausea, dizziness, and injection site reactions.No large-scale safety data in humans is available. Patients with a history ofcancer should consult their oncologist before use, as some preclinical datasuggests potential pro-angiogenic effects. Do not use if pregnant orbreastfeeding.

ThymosinAlpha-1 (Tα-1)

ThymosinAlpha-1 is a peptide with immune-modulating properties, used off-label incertain immune support and longevity protocols. It is not FDA-approved for usein the United States.

Reportedbenefits include immune system support and potential anti-inflammatory effects.Clinical evidence in the United States is limited; it is approved for use insome other countries for viral hepatitis and immune deficiency conditions.

Generallywell-tolerated. Common side effects include local injection site reactions. Usewith caution in patients with autoimmune conditions or those takingimmunosuppressive medications. Do not use if pregnant or breastfeeding.

ThymosinBeta-4 (TB-500)

ThymosinBeta-4 is a naturally occurring peptide with potential roles in tissue repair,wound healing, and anti-inflammatory activity. It is not FDA-approved for anyindication and is not approved for use in athletic competition.

Preclinicaldata suggests potential benefit in wound healing and cardiac and neurologicaltissue repair. Human clinical evidence is very limited.

Commonside effects include injection site reactions and mild fatigue. Long-termsafety data in humans is unavailable. Do not use if pregnant or breastfeeding.Patients with a history of cancer should consult their oncologist before use.

NAD+(Nicotinamide Adenine Dinucleotide)

NAD+ infusionsand injections are not FDA-approved drug products for any indication. Thestatements in this section have not been evaluated by the FDA.

NAD+is a coenzyme involved in cellular energy metabolism. It is used off-label inlongevity, anti-aging, and neurological support protocols. NAD+ therapy may beadministered via intravenous infusion, intramuscular injection, or subcutaneousinjection depending on the clinical protocol.

CommonSide Effects (Particularly with IV Administration)

•    Flushing, warmth, andredness during infusion.

•    Nausea, stomach cramping,or discomfort during infusion.

•    Chest tightness or pressure(typically transient and resolves with slower infusion rate).

•    Muscle cramping duringinfusion.

•    Fatigue or light-headednessfollowing infusion.

•    Injection site reactionsfor non-IV routes.

Contraindicationsand Precautions

Usewith caution in patients with a history of cancer, autoimmune conditions, orsignificant cardiovascular or hepatic disease. The safety of NAD+ therapyduring pregnancy and breastfeeding has not been established. Inform yourprovider of all medications you are taking.

DrugInteractions

Potentialinteractions with certain medications affecting cellular metabolism exist butare not well-characterized. Disclose all medications, supplements, and herbalproducts to your provider before starting NAD+ therapy.

IVMicronutrient Therapy and MIC/Lipo-B Injections

IVmicronutrient therapies and lipotropic injections are not FDA-approved drugproducts for any specific indication. These are provided as compoundedpreparations under the supervision of a licensed provider.

IVmicronutrient therapies (including Myers' Cocktail and similar formulations)typically contain combinations of vitamins, minerals, and amino acidsadministered intravenously. MIC (Methionine, Inositol, Choline) and Lipo-Binjections are lipotropic compounds sometimes used in conjunction with weightmanagement programs.

CommonSide Effects

•    Injection or infusion sitereactions: pain, bruising, or inflammation.

•    Flushing, warmth, ortingling during IV infusion.

•    Nausea or stomachdiscomfort.

•    Vitamin B12 injections:mild injection site pain, itching, or redness.

•    Rare: allergic reactions —seek medical attention if you experience hives, swelling, difficulty breathing,or rapid heartbeat.

Contraindicationsand Precautions

Patientswith kidney disease, heart failure, or fluid retention conditions shouldconsult their primary care provider before receiving IV fluid-based therapies.High-dose vitamin supplementation may interact with certain medications.Disclose all medications and supplements to your provider before treatment.

Sermorelin

Sermorelin is agrowth hormone-releasing hormone (GHRH) analogue. These statements have notbeen evaluated by the FDA. This product is not intended to diagnose, treat,cure, or prevent any disease.

CommonSide Effects

•    Mild fatigue or dizziness,particularly early in treatment.

•    Injection: localized pain,redness, or swelling at the injection site.

•    ODT (oral dissolvingtablet) form: temporary changes in taste or transient dry mouth.

LessCommon Side Effects

Itching,difficulty swallowing, flushing, headache, drowsiness, hyperactivity, orrestlessness. Contact your provider if any side effects are persistent orconcerning.

Contraindications

•    Known hypersensitivity tosermorelin or any component of the formulation.

•    Pregnancy or activeplanning to become pregnant.

•    Breastfeeding.

•    Active malignancy or ahistory of cancer not in confirmed remission.

DrugInteractions

Glucocorticoids(e.g., prednisone) may attenuate the growth hormone-stimulating effects ofsermorelin. Thyroid hormone medications may alter hormonal balance andinterfere with laboratory monitoring. Disclose all medications and supplementsto your provider.

Finasteride(Hair Loss)

Finasterideis FDA-approved for the treatment of male-pattern hair loss (androgeneticalopecia) in adult men. It is not approved for use in women or children. Womenwho are pregnant or may become pregnant should not handle crushed or brokenfinasteride tablets due to the risk of fetal harm (Category X in pregnancy).

CommonSide Effects

•    Decreased libido.

•    Erectile dysfunction.

•    Decreased ejaculatoryvolume.

•    Breast tenderness orenlargement (gynecomastia).

SeriousSide Effects

•    Post-finasteride syndrome:some patients report persistent sexual, neurological, or physical side effectsfollowing discontinuation. The FDA has updated finasteride labeling to reflectthis.

•    Worsening depression orsuicidal ideation — report any mood changes to your provider immediately.

•    Allergic reactions: rash,hives, or facial swelling.

Vardenafiland Tadalafil (PDE5 Inhibitors — Erectile Dysfunction)

CommonSide Effects

•    Headache, facial flushing,and nasal congestion.

•    Dyspepsia or indigestion.

•    Back pain and muscle aches(more common with tadalafil).

•    Visual disturbancesincluding blurred vision or altered color perception.

SeriousSide Effects Requiring Immediate Medical Attention

•    Severe hypotension:dangerous blood pressure drop, particularly when combined with nitratemedications.

•    Cardiovascular events:increased risk of myocardial infarction, stroke, or arrhythmias in patientswith pre-existing cardiovascular conditions.

•    Priapism: prolongederection lasting more than four hours, which constitutes a medical emergency.

•    Sudden hearing loss.

•    Non-arteritic anteriorischemic optic neuropathy (NAION): sudden vision loss (rare).

Contraindications

Donot use concurrently with nitrate medications (nitroglycerin, isosorbidemononitrate, isosorbide dinitrate) — may cause severe, potentially fatalhypotension. Do not use with other PDE5 inhibitors. Use with caution or avoidentirely if you have severe cardiovascular disease, have recently suffered astroke or myocardial infarction, or have resting hypotension.

Glutathione(IV / Injection / Intranasal)

Glutathione is a naturallyoccurring antioxidant tripeptide used off-label in compounded IV, intramuscular,subcutaneous, and intranasal formulations for oxidative stress support, skinhealth, detoxification protocols, and neurological wellness. It is notFDA-approved for these indications as a compounded preparation.

Common Side Effects

Injection site reactions (pain,redness, swelling). With IV administration: transient flushing, warmth, ortingling. Intranasal formulations may cause mild nasal irritation or temporaryaltered sense of smell. Rare: allergic reactions including hives, facialswelling, or difficulty breathing — seek immediate medical attention if theseoccur.

Contraindications andPrecautions

Known hypersensitivity toglutathione or any component of the formulation. Use with caution in patientswith asthma (rare cases of bronchospasm with nebulized forms reported). Safetyduring pregnancy and breastfeeding has not been established. Disclose allmedications and supplements to your provider, as high-dose antioxidant therapymay theoretically interact with certain chemotherapy agents.

MethyleneBlue

Methylene blue is used off-labelin compounded oral and low-dose IV formulations for cognitive support,mitochondrial function, and neuroprotective protocols. At prescription doses itis a potent monoamine oxidase inhibitor (MAOI). It is FDA-approved only for thetreatment of methemoglobinemia at higher doses. These statements have not beenevaluated by the FDA for the off-label indications described here.

SERIOUS WARNING — SerotoninSyndrome Risk

Methylene blue inhibits monoamineoxidase and can precipitate potentially life-threatening serotonin syndromewhen combined with serotonergic medications. Do NOT use methylene blue if youare taking any of the following: SSRIs (e.g., sertraline, fluoxetine,escitalopram), SNRIs (e.g., venlafaxine, duloxetine), MAOIs, tricyclicantidepressants, tramadol, triptans, linezolid, or St. John’s Wort. Symptoms ofserotonin syndrome include agitation, confusion, rapid heart rate, high bloodpressure, muscle twitching, and fever — seek emergency care immediately ifthese occur.

Common Side Effects

Blue or green discoloration ofurine and stool (expected and harmless at low doses). Nausea, vomiting, orabdominal discomfort. Headache or dizziness. Skin or mucous membranediscoloration at higher doses. With IV administration: injection site pain andtransient blood pressure changes.

Contraindications

Known hypersensitivity tomethylene blue. G6PD (glucose-6-phosphate dehydrogenase) deficiency — methyleneblue may cause hemolytic anemia in G6PD-deficient patients. Concurrent use ofserotonergic medications (see warning above). Pregnancy and breastfeeding —safety not established. Renal impairment — use with caution as methylene blueis renally excreted.

GHK-Cu(Copper Peptide)

Listed underPeptide Therapies

GHK-Cu (glycyl-l-histidyl-l-lysinecopper) is a naturally occurring copper-binding peptide used in compoundedinjectable and topical formulations for skin rejuvenation, wound healing, hairfollicle support, and anti-inflammatory applications. It is not FDA-approvedfor any of these indications. The statements in this section have not beenevaluated by the FDA.

Common Side Effects

Injection site reactions (redness,mild swelling, or discomfort). Topical formulations may cause transient skinirritation, redness, or tingling at the application site. Temporary blue-greenskin tint at the injection site may occur due to the copper component andtypically resolves within hours. Large-scale human safety data is limited.

Contraindications andPrecautions

Known hypersensitivity to copperor any peptide component. Use with caution in patients with Wilson’s disease orother copper metabolism disorders. Patients with a history of cancer shouldconsult their oncologist before use, as some preclinical data suggests pro-angiogenicactivity. Do not use during pregnancy or breastfeeding. Safety in pediatricpopulations has not been established.

Phentermine(Controlled Substance — Schedule IV)

Phentermine is an FDA-approvedSchedule IV controlled substance indicated as a short-term adjunct to areduced-calorie diet and exercise program for the treatment of obesity in adultpatients with an initial BMI of 30 kg/m² or greater, or 27 kg/m² or greater inthe presence of at least one weight-related comorbidity. It is a sympathomimeticamine with amphetamine-like activity. Phentermine is prescribed only throughaffiliated licensed providers in states where they are authorized to prescribeSchedule IV controlled substances via telehealth, in compliance with applicableDEA regulations and state law.

SERIOUS WARNINGS

Cardiovascular risk: phentermineincreases heart rate and blood pressure. Do not use if you have a history ofcardiovascular disease, coronary artery disease, arrhythmia, stroke, oruncontrolled hypertension. Pulmonary hypertension: rare but serious cases ofprimary pulmonary hypertension have been reported with phentermine use.Valvular heart disease: cases of serious regurgitant cardiac valvular diseasehave been reported, primarily affecting the mitral, aortic, and/or tricuspidvalves. Drug dependence: phentermine has potential for abuse and dependenceconsistent with its Schedule IV classification. Prescribing is limited toshort-term use (typically up to 12 weeks).

Common Side Effects

Dry mouth, insomnia, irritability,constipation, elevated heart rate, increased blood pressure, headache,dizziness, and decreased appetite. Some patients report restlessness ornervousness.

Contraindications

History of cardiovascular disease,stroke, arrhythmia, or uncontrolled hypertension. Hyperthyroidism. Glaucoma.History of drug abuse. Concurrent use of MAOIs (contraindicated — risk ofhypertensive crisis) or within 14 days of MAOI discontinuation. Pregnancy andbreastfeeding. Agitated states.

Drug Interactions

MAOIs: concurrent use may causehypertensive crisis — contraindicated. Serotonergic medications: increased riskof serotonin syndrome. Other stimulants or sympathomimetic amines: additivecardiovascular effects. Insulin and oral hypoglycemic agents: phentermine mayalter glycemic control — dose adjustments may be needed in diabetic patients.Alcohol: may increase the risk of adverse cardiovascular effects.

Low DoseNaltrexone (LDN)

Low Dose Naltrexone (LDN) refersto naltrexone prescribed at doses significantly below the FDA-approved range(typically 1.5–4.5 mg, compared to the FDA-approved 50 mg dose for opioid usedisorder). LDN is used off-label in compounded formulations for immunemodulation, chronic pain, inflammatory conditions, and general wellnessprotocols. It is not FDA-approved for these off-label indications. Naltrexoneitself is not a controlled substance. These statements have not been evaluatedby the FDA for the off-label indications described here.

Common Side Effects

Vivid dreams or sleep disturbances(most common, particularly in the first 2–4 weeks of treatment). Nausea,particularly when initiating treatment. Headache. Fatigue or low energy,typically transient. Most side effects resolve as the body adjusts to themedication.

CRITICAL WARNING — OpioidInteractions

Naltrexone is an opioidantagonist. Even at low doses, it will block the effects of opioid medicationsand can precipitate acute opioid withdrawal in patients who areopioid-dependent. Do NOT use LDN if you are currently taking any opioidmedications (including prescription pain medications, buprenorphine, ormethadone) or if you have taken opioids within the past 7–10 days. Acute opioidwithdrawal can be dangerous and requires immediate medical attention.

Contraindications

Current use of opioid medicationsor opioid agonist therapy (buprenorphine, methadone). Acute opioid dependenceor withdrawal. Acute hepatitis or hepatic failure — naltrexone is hepaticallymetabolized and has been associated with hepatotoxicity at higher doses; usewith caution in patients with liver disease. Pregnancy and breastfeeding —safety not established. Hypersensitivity to naltrexone or any component of theformulation.

Drug Interactions

All opioid medications: blockedeffect and potential precipitation of withdrawal — contraindicated.Thioridazine: combination may cause drowsiness. Disulfiram: caution advisedwith concurrent use, particularly in patients with hepatic concerns. Discloseall medications — including over-the-counter medications containing opioidssuch as cough syrups — to your provider before starting LDN.

GLP-1Compounded Medication — FDA Regulatory Disclosure

Important: The availability of compounded semaglutide and tirzepatide is directly tied to the FDA's designation of shortage status for the branded equivalents (Wegovy®, Ozempic®, Zepbound™, Mounjaro®). When FDA removes a medication from the shortage list, compounding pharmacies may no longer be permitted to compound that medication. Treatment plans utilizing compounded GLP-1 medications are subject to change or discontinuation based on FDA regulatory actions outside the control of Alyve, Inc. or affiliated providers.

Byinitiating treatment with a compounded GLP-1 medication, you acknowledge that:

•    Compounded semaglutide andtirzepatide are not FDA-approved drug products.

•    The availability of yourcompounded medication may change at any time based on FDA shortage statusdeterminations.

•    If your compoundedtreatment becomes unavailable, your provider may recommend an alternative,including branded medications or a different treatment approach.

•    Any transition in yourtreatment will be managed by your provider based on your individual clinicalneeds.

•    Alyve, Inc. cannotguarantee the continuous availability of any compounded GLP-1 medication.

AdverseEvent Reporting and Contact Information

Toreport a suspected adverse reaction to any medication, contact:

•    The FDA MedWatch program at1-800-FDA-1088 or www.fda.gov/medwatch.

•    Your prescribing providerdirectly through the patient portal.

•    Your dispensing pharmacy.

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Disclaimer

This documentis provided for informational purposes only. It does not constitute medicaladvice and is not a substitute for consultation with a licensed healthcareprovider. Alyve, Inc., as a managed services organization, does not providemedical advice. All clinical decisions are made by independent, licensedhealthcare providers. The statements in this document have not beenindependently reviewed or approved by the FDA unless otherwise noted.