General Safety Information

Emergencies. If you are experiencing a medical emergency, call 911 or go to the nearest emergency department. Do not use Pure Nova Health (“PNH”) for urgent or emergent care.

What this page is (and isn’t). This page summarizes important risks, boxed warnings (if any), use in specific populations, and known drug interactions for therapies discussed or prescribed via PNH. It is educational only and not a substitute for advice from your licensed clinician or pharmacist. Always read the FDA Prescribing Information/Medication Guide and your pharmacy’s patient insert.

Role of PNH. PNH is a technology and administrative platform; we do not practice medicine or dispense medications. All diagnosis, treatment, and prescribing are performed exclusively by independent, licensed clinicians. Dispensing is performed by licensed pharmacies. Completing an intake or visit does not guarantee a prescription, a specific product, dose, timing, or refills.

Compounded & off-label products. Some prescriptions may be filled as compounded medications by licensed U.S. compounding pharmacies to meet individual needs. Compounded drugs are not FDA-approved for safety or effectiveness. Clinicians may also prescribe certain medications off-label when, in their professional judgment, potential benefits outweigh risks.

Tell your clinician about:

  • All medicines and supplements you take (Rx, OTC, vitamins, herbals), alcohol and nicotine use, and any drug allergies.
  • Medical history including kidney, liver, pancreas, gallbladder, heart, blood pressure, endocrine/thyroid, eye/retina, psychiatric/neurologic, seizure, bleeding/clotting, cancer/tumor, or prior bariatric or GI surgery.
  • If you are pregnant, planning pregnancy, or breastfeeding; some medicines require effective contraception and/or a washout period before conception.

General interaction watch-list. Insulin and sulfonylureas (hypoglycemia risk), warfarin (INR changes), thyroid hormone (absorption timing), antidepressants (SSRIs/SNRIs/MAOIs), stimulants, seizure meds, PDE-5 inhibitors and nitrates/riociguat (dangerous hypotension), decongestants, and St. John’s Wort.

Administration & sharps. Use only as instructed. Rotate injection sites. Never share injection pens, needles, or vials. Dispose of sharps in an FDA-cleared sharps container.

Monitoring. Your clinician may order labs (e.g., A1c, fasting glucose, lipids, CMP, CBC, thyroid studies, pregnancy tests) and clinical follow-up (e.g., BP/HR, weight, vision, mood, adverse events). Complete all requested monitoring.

Driving & machinery. If you experience dizziness, visual changes, marked GI distress, sedation, or hypoglycemia, do not drive or operate machinery.

Alcohol. Alcohol can worsen dizziness, GI effects, and glycemic instability. Ask your clinician for personalized guidance.

Surgery/anesthesia. Some medicines (e.g., GLP-1/GIP agents) may need to be held before anesthesia due to aspiration risk. Inform your surgeon/anesthesiologist in advance.

Reporting adverse events. Report side effects to your clinician and dispensing pharmacy. You can also report suspected adverse reactions to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.

Trademarks. Product names and trademarks (e.g., Ozempic®, Wegovy®, Mounjaro®, Zepbound®, Qsymia®) belong to their respective owners. Reference does not imply affiliation or endorsement.

Section 1: Weight-Loss Therapies

This section covers prescription and compounded medications used for weight management. Some are FDA-approved for specific indications. Others are used off-label or prepared as compounded medications. Compounded drugs are not FDA-approved; safety and effectiveness have not been evaluated by the FDA. All medications must be prescribed by a licensed clinician based on your individual health profile. Not all therapies are suitable for every patient. Use only as directed by your clinician.

Semaglutide

Boxed Warning
Risk of thyroid C-cell tumors. Contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients on symptoms of thyroid tumors (neck mass, dysphagia, dyspnea, persistent hoarseness). Not for Type 1 diabetes or DKA. Semaglutide is not indicated for type 1 diabetes or treatment of diabetic ketoacidosis.

Do NOT use if:

  • You or a family member has MTC or you have MEN 2
  • You have had a serious hypersensitivity reaction to semaglutide or its ingredients
  • You are pregnant or breastfeeding
  • You are using another GLP-1 receptor agonist (to avoid duplication of therapy)

Precautions / Tell your clinician if you:

  • Have pancreatitis (past or current)
  • Have gallbladder disease (risk of gallstones/cholecystitis)
  • Have gastroparesis or severe GI disease (delayed gastric emptying worsens symptoms)
  • Have diabetic retinopathy (rapid glucose lowering may worsen eye disease)
  • Have kidney disease or dehydration risk (severe GI side effects can precipitate acute kidney injury)
  • Are on warfarin (gastric emptying delay may affect INR)
  • Are on thyroid hormone or multiple oral drugs (semaglutide slows absorption)
  • Have a history of suicidal thoughts or psychiatric illness (rare mood changes reported)
  • Drink significant amounts of alcohol (↑ risk pancreatitis/hypoglycemia)

Drug Interactions

  • Insulin / sulfonylureas → ↑ risk of hypoglycemia (dose adjustment may be required)
  • Warfarin → monitor INR
  • Levothyroxine and other oral meds → absorption may be delayed (take at consistent times)
  • Other weight-loss medications → safety not established in combination
  • Alcohol → can worsen hypoglycemia and pancreatitis risk

Common Side Effects
Nausea, vomiting, diarrhea, constipation, abdominal pain, indigestion, bloating, decreased appetite, fatigue, headache, dizziness, injection-site reactions. Often dose-related and most common during titration.

Serious Side Effects (Seek medical attention immediately)
Pancreatitis (persistent severe abdominal pain ± vomiting), gallbladder disease (right upper abdominal pain, jaundice, fever, clay-colored stools), kidney injury (sudden ↓ urination, swelling in legs, fatigue), severe allergic reaction (swelling of face/tongue/throat, trouble breathing, rash), vision changes (blurred vision, worsening retinopathy), thyroid mass symptoms (lump in neck, hoarseness, difficulty swallowing/breathing).

Pregnancy & Contraception
Contraindicated in pregnancy (fetal risk). Stop ≥ 2 months before conception (long half-life). Use effective contraception while taking semaglutide. Not recommended while breastfeeding (unknown if excreted in human milk).

Special Populations

  • Pediatrics (<12 yrs): safety/efficacy not established
  • Adolescents (12–17 yrs): Wegovy® approved for obesity, but requires monitoring (growth, puberty, psychosocial impact)
  • Older adults (65+): similar efficacy, but GI and kidney risks may be more pronounced
  • Renal/hepatic impairment: use caution; monitor closely

Administration
Inject subcutaneously in abdomen, thigh, or upper arm once weekly, same day each week, with or without food. If ≤ 5 days late, inject ASAP; if > 5 days late, skip and resume on next scheduled day. Do not inject intramuscularly or intravenously. Rotate injection sites weekly.

Storage
Before use: refrigerate (36°F–46°F / 2°C–8°C). Do not freeze. Protect from light. After first use (pens): refrigerate or store at room temp (≤86°F / 30°C) for up to 56 days. Do not use if solution is cloudy, discolored, or contains particles. Keep out of reach of children/pets. Dispose of pens/needles in FDA-cleared sharps container.

Monitoring
 Baseline: A1c, fasting glucose, renal function, pregnancy test (if applicable). Ongoing: weight, A1c, renal function if GI side effects, vision exams if retinopathy, adherence/tolerability. Counsel patients on recognizing pancreatitis, gallbladder disease, thyroid tumors, dehydration.

Regulatory Note
 Ozempic® (for type 2 diabetes) and Wegovy® (for obesity) are FDA-approved. Compounded semaglutide is not FDA-approved; safety and efficacy not reviewed by FDA.

Adverse Event Reporting
 Report side effects to your clinician and dispensing pharmacy. Report to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. For emergencies, call 911

Tirzepatide

Boxed Warning
Risk of thyroid C-cell tumors. Contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Educate patients on warning signs of thyroid tumors (lump in neck, persistent hoarseness, difficulty swallowing/breathing). Not for Type 1 diabetes or DKA. Tirzepatide is not indicated for type 1 diabetes or treatment of diabetic ketoacidosis.

Do NOT use if:

  • You or a family member has MTC or you have MEN 2
  • You have had a serious hypersensitivity reaction to tirzepatide or its ingredients
  • You are pregnant or breastfeeding
  • You are using another GLP-1 receptor agonist or GIP/GLP-1 therapy (to avoid duplication)

Precautions / Tell your clinician if you:

  • Have a history of pancreatitis
  • Have gallbladder disease (increased risk of gallstones/cholecystitis)
  • Have gastroparesis or severe GI disease (delayed gastric emptying can worsen symptoms)
  • Have diabetic retinopathy (rapid A1c lowering may worsen eye disease)
  • Have kidney disease or are at risk of dehydration (severe nausea/vomiting can precipitate acute kidney injury)
  • Take warfarin (delayed gastric emptying may affect INR)
  • Are on thyroid hormone or other oral medications (absorption may be slowed)
  • Have a history of suicidal thoughts, depression, or psychiatric illness (rare but reported)
  • Drink significant amounts of alcohol (↑ pancreatitis and hypoglycemia risk)

Drug Interactions

  • Insulin / sulfonylureas → ↑ risk of hypoglycemia (may need dose reduction)
  • Warfarin → monitor INR
  • Oral contraceptives → tirzepatide delays gastric emptying, which may reduce contraceptive effectiveness, especially during dose escalation (use backup contraception for 4 weeks after initiation and 4 weeks after each dose increase)
  • Levothyroxine and other oral drugs → absorption may be delayed (take consistently at the same times)
  • Other weight-loss medications → not studied in combination
  • Alcohol → ↑ risk of hypoglycemia and pancreatitis

Common Side Effects
 Nausea, vomiting, diarrhea, constipation, abdominal pain, decreased appetite, fatigue, headache, dizziness, indigestion, injection-site reactions. These are usually dose-related and most frequent during titration.

Serious Side Effects (Seek medical attention immediately)

  • Pancreatitis: persistent severe abdominal pain (± vomiting)
  • Gallbladder disease: right upper abdominal pain, jaundice, fever, clay-colored stools
  • Kidney injury: sudden ↓ urination, swelling in legs, fatigue
  • Severe allergic reaction: swelling of face/tongue/throat, difficulty breathing, rash
  • Vision changes: blurred vision, floaters, worsening retinopathy
  • Thyroid tumor symptoms: lump in neck, hoarseness, difficulty swallowing/breathing

Pregnancy & Contraception

  • Contraindicated in pregnancy (fetal risk).
  • Stop at least 2 months before planned conception (long half-life).
  • Women of childbearing potential should use effective contraception; oral contraceptives may be less effective during initiation and dose increases → use backup contraception during these times.
  • Not recommended while breastfeeding (unknown if excreted in human milk).

Special Populations

  • Pediatrics (<18 yrs): safety and efficacy not established
  • Older adults (65+): similar efficacy, but GI side effects and renal risks may be more pronounced
  • Renal/hepatic impairment: use caution; monitor closely

Administration
 Inject subcutaneously into abdomen, thigh, or upper arm once weekly, same day each week, with or without food. If ≤ 4 days late, inject ASAP; if > 4 days late, skip and resume on next scheduled day. Do not inject intramuscularly or intravenously. Rotate injection sites weekly.

Storage
 Before use: refrigerate (36°F–46°F / 2°C–8°C). Do not freeze. Protect from light. After first use: can store in refrigerator or at room temperature (≤86°F / 30°C) for up to 21 days. Do not use if solution is cloudy, discolored, or contains particles. Keep out of reach of children/pets. Dispose of pens/needles in an FDA-cleared sharps container.

Monitoring

  • Baseline: A1c, fasting glucose, renal function, pregnancy test (if applicable)
  • Ongoing: weight, A1c, renal function if significant GI symptoms, retinopathy exams, adherence/tolerability
  • Counseling: teach patients how to recognize symptoms of pancreatitis, gallbladder disease, thyroid tumors, and dehydration; reinforce contraception precautions

Regulatory Note

  • Mounjaro® (for type 2 diabetes) and Zepbound® (for obesity) are FDA-approved.
  • Compounded tirzepatide is not FDA-approved; safety and efficacy not reviewed by the FDA.

Adverse Event Reporting
 Report side effects to your clinician and dispensing pharmacy. Report to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. For emergencies, call 911.

Phentermine + Topiramate

Boxed Warning / Key Alerts

  • Teratogenic risk (Topiramate): Contraindicated in pregnancy due to risk of oral clefts and other fetal harm. Women of childbearing potential must use effective contraception.
  • Sympathomimetic effects (Phentermine): May ↑ heart rate and blood pressure; contraindicated in patients with significant cardiovascular disease.

Do NOT use if:

  • You are pregnant or planning pregnancy
  • You have glaucoma
  • You have a history of hyperthyroidism
  • You are taking or recently discontinued a monoamine oxidase inhibitor (MAOI)
  • You have serious cardiovascular disease (uncontrolled hypertension, coronary artery disease, arrhythmias, stroke, heart failure)
  • You have had a serious hypersensitivity reaction to phentermine, topiramate, or formulation ingredients

Precautions / Tell your clinician if you:

  • Have a history of depression, anxiety, or mood disorders (topiramate may worsen psychiatric symptoms)
  • Have a history of suicidal thoughts or behaviors (antiepileptic drugs including topiramate have been associated with increased risk of suicidal ideation)
  • Have seizure disorder (dose changes may increase seizure risk)
  • Have kidney stones or metabolic acidosis risk (topiramate can increase risk of nephrolithiasis and acidosis)
  • Have metabolic acidosis risk factors (chronic diarrhea, kidney disease, respiratory disorders) — topiramate can cause or worsen metabolic acidosis
  • Have osteopenia/osteoporosis (long-term use may reduce bone mineral density)
  • Have liver or kidney impairment (dose adjustments may be needed)
  • Have alcohol use disorder (topiramate increases CNS side effect risk)

Drug Interactions

  • MAOIs: contraindicated; risk of hypertensive crisis
  • Oral contraceptives: topiramate may reduce efficacy → use backup contraception
  • CNS depressants (alcohol, benzodiazepines, opioids): ↑ sedation, cognitive impairment
  • Carbonic anhydrase inhibitors: ↑ kidney stone risk
  • Anticonvulsants: potential additive CNS side effects

Common Side Effects
 Dry mouth, constipation, insomnia, paresthesia (tingling), dizziness, altered taste, fatigue, mood changes, cognitive difficulties (memory, attention issues).

Serious Side Effects (Seek medical attention immediately)

  • Pregnancy exposure → fetal harm (oral clefts, growth restriction)
  • Suicidal thoughts or new psychiatric symptoms
  • Vision changes or acute angle-closure glaucoma
  • Cardiovascular events (palpitations, chest pain, syncope)
  • Seizures with abrupt discontinuation of topiramate
  • Metabolic acidosis → unexplained fatigue, irregular heartbeat, confusion, rapid breathing

Pregnancy & Contraception

  • Contraindicated in pregnancy (boxed warning).
  • Stop immediately if pregnancy occurs.
  • Women must use effective contraception while taking this therapy.
  • Not recommended while breastfeeding.

Special Populations

  • Pediatrics (<12 yrs): not established; Qsymia® is FDA-approved for ≥12 yrs with obesity (BMI ≥95th percentile).
  • Older adults: may be more sensitive to CNS and cardiovascular side effects.
  • Renal/hepatic impairment: dose reduction required in moderate impairment; avoid in severe disease.

Administration

  • Taken orally once daily in the morning (to reduce insomnia risk).
  • Swallow whole; do not crush, chew, or split capsules.
  • If discontinued, taper gradually to reduce seizure risk.

Storage

  • Store at room temperature (68°F–77°F / 20°C–25°C).
  • Protect from light and moisture.
  • Keep out of reach of children.

Monitoring

  • Baseline: pregnancy test, blood pressure, heart rate, electrolytes, serum bicarbonate
  • Ongoing: weight, mood/psychiatric status, heart rate, metabolic labs, adherence
  • Monitor for cognitive/mood changes, signs of acidosis, and pregnancy risk

Regulatory Note

  • Qsymia® (phentermine/topiramate ER) is FDA-approved for chronic weight management in adults and certain adolescents.
  • Compounded formulations are not FDA-approved; safety and efficacy not reviewed by the FDA.

Adverse Event Reporting
 Report side effects to your clinician and pharmacy. Report to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. For emergencies, call 911.

Tesamorelin

Boxed Warning / Key Alerts

  • Malignancy risk: Tesamorelin stimulates growth hormone release and may promote growth of existing cancers. Contraindicated in patients with active malignancy.
  • Glucose intolerance: Tesamorelin can increase fasting glucose and HbA1c, and may unmask or worsen diabetes. Monitor closely.
  • Hypersensitivity: Serious allergic reactions have occurred; avoid use if you’ve had hypersensitivity to tesamorelin or formulation ingredients.
  • Not for general weight loss: Egrifta SV® is FDA-approved only for HIV-associated lipodystrophy, not for obesity, anti-aging, or performance enhancement.

Do NOT use if:

  • You have an active malignancy or unexplained mass
  • You are pregnant or breastfeeding
  • You have had serious hypersensitivity reactions to tesamorelin or its ingredients
  • You have pituitary tumors or hypothalamic-pituitary axis disruption (surgery, irradiation, trauma)

Precautions / Tell your clinician if you:

  • Have diabetes or pre-diabetes (tesamorelin may worsen hyperglycemia)
  • Have a history of malignancy (requires heightened surveillance)
  • Have retinopathy or other endocrine disorders
  • Are taking corticosteroids, which can blunt tesamorelin’s effectiveness

Drug Interactions

  • Corticosteroids: may reduce tesamorelin’s effect
  • Other growth hormone therapies or secretagogues: additive risks (IGF-1 elevation, glucose changes)
  • Antidiabetic medications: doses may need adjustment to prevent hypoglycemia

Common Side Effects
 Injection site reactions (pain, redness, itching, swelling), joint pain, muscle aches, tingling/numbness, fatigue, headache, nausea, increased sweating.

Serious Side Effects (Seek medical attention immediately)

  • Severe allergic reaction (trouble breathing, swelling, rash)
  • Worsening diabetes or new hyperglycemia
  • Intracranial hypertension (persistent headache, vision changes, vomiting)
  • Fluid retention (rapid weight gain, edema, shortness of breath)
  • Potential stimulation of malignancy growth or recurrence

Pregnancy & Contraception

  • Contraindicated in pregnancy (may harm fetus).
  • Not recommended while breastfeeding.
  • Women of childbearing potential should use effective contraception.

Special Populations

  • Pediatrics (<18 yrs): not studied, avoid use.
  • Older adults: greater risk of fluid retention and glucose intolerance.
  • Diabetics: require close monitoring of blood sugar and HbA1c.

Administration

  • Subcutaneous injection once daily (abdomen preferred).
  • Rotate injection sites to prevent irritation.
  • Do not inject intravenously.

Storage

  • Store refrigerated (36°F–46°F / 2°C–8°C).
  • Protect from light.
  • Reconstituted solution: use immediately or refrigerate and discard after 24 hours (follow compounding pharmacy instructions).
  • Do not freeze.

Monitoring

  • Baseline: blood glucose, HbA1c, IGF-1, cancer history assessment.
  • Ongoing: IGF-1 levels, blood glucose, cancer surveillance, fluid retention, allergic reactions, neurological symptoms.

Regulatory Note

  • Egrifta SV® (tesamorelin) is FDA-approved only for the treatment of HIV-associated lipodystrophy.
  • Tesamorelin is not FDA-approved for weight loss, anti-aging, or performance uses.
  • Compounded tesamorelin formulations are not FDA-approved; their safety and efficacy have not been reviewed by the FDA.

Adverse Event Reporting
 Report side effects to your clinician and compounding pharmacy. Report to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. For emergencies, call 911.

Tesamorelin + Ipamorelin

Boxed Warning / Key Alerts

  • Not FDA-approved: This combination is compounded for investigational/off-label use. Safety, effectiveness, sterility assurance, and lot-to-lot consistency have not been reviewed by the FDA.
  • Malignancy risk (theoretical/precautionary): Both agents stimulate the GH/IGF-1 axis (via GHRH and GHRP mechanisms). Avoid in patients with active malignancy and use extreme caution with any history of cancer.
  • Glucose effects: May increase fasting glucose/insulin resistance via elevated IGF-1/GH. Individuals with diabetes or prediabetes require close monitoring and potential medication adjustments.
  • Hypersensitivity: Risk of allergic reactions to peptide or excipients (including diluents/preservatives).

Do NOT use if:

  • You have active cancer, an unexplained mass, or proliferative retinopathy.
  • You are pregnant or breastfeeding.
  • You’ve had a serious hypersensitivity to tesamorelin, ipamorelin, or formulation ingredients.
  • You have known pituitary tumors, intracranial lesions, or significant hypothalamic–pituitary axis disruption (e.g., post-surgical, post-radiation, traumatic).

Use with caution / Tell your clinician if you:

  • Have diabetes, prediabetes, metabolic syndrome, or a history of gestational diabetes.
  • Have risk factors or history of malignancy, colon polyps, or endometrial/breast/prostate disease.
  • Have a history of intracranial hypertension, migraines, or vision changes.
  • Have sleep apnea, fluid retention, carpal tunnel, or edema with prior GH-axis therapy.
  • Use glucocorticoids (may blunt response) or thyroid medication (axis interactions possible).

Drug / Therapy Interactions

  • Antidiabetic agents (insulin, sulfonylureas, GLP-1s, SGLT2s, metformin): glycemic control may change; dose adjustments/monitoring may be required.
  • Systemic corticosteroids: may antagonize anabolic/IGF-1 effects.
  • Other GH, GHRH, or GHRP products (e.g., sermorelin, CJC-1295, MK-677): avoid stacking due to additive IGF-1 elevation and adverse-event risk (edema, glucose intolerance, CTS-like symptoms).
  • Estrogens/androgens/thyroid hormone: may alter IGF-1 and binding proteins; monitor when initiating or changing doses.
  • Anticoagulants/antiplatelets: no direct interaction expected; monitor if unexplained bruising/edema occurs.

Common Side Effects

  • Injection-site reactions: pain, redness, itching, swelling.
  • Neuromuscular: joint stiffness/arthralgia, myalgia, paresthesias/tingling (CTS-like), muscle cramps.
  • General: flushing, fatigue, headache, insomnia or vivid dreams, increased sweating.
  • GI: nausea, abdominal discomfort, appetite changes.

Serious Side Effects (seek medical attention immediately)

  • Severe hypersensitivity: facial/tongue/throat swelling, hives, wheeze, difficulty breathing.
  • Intracranial hypertension: persistent/worsening headache, visual disturbances, vomiting.
  • Marked fluid retention: rapid weight gain, swelling of hands/feet, shortness of breath.
  • Worsening glycemic control: polyuria, polydipsia, unexplained fatigue; hyperglycemia or ketosis in at-risk patients.
  • Potential tumor stimulation/recurrence in patients with prior malignancy (precautionary).

Pregnancy, Contraception, & Lactation

  • Contraindicated in pregnancy; may affect fetal growth via IGF-1.
  • Not recommended during breastfeeding (unknown excretion/effects).
  • Use effective contraception while on therapy and notify your clinician immediately if pregnancy occurs.

Special Populations

  • Pediatrics (<18 yrs): not studied; do not use.
  • Older adults: greater propensity for edema, CTS-like symptoms, glucose intolerance—start low and monitor.
  • Renal/hepatic impairment: limited data—use cautiously with closer monitoring of fluid status and metabolism.

Administration

  • Route: subcutaneous injection (do not inject IV).
  • Sites: abdomen (avoid 2 inches around navel), thigh, or upper arm; rotate sites to minimize irritation.
  • Timing: often administered once daily at bedtime (to align with physiologic GH pulse), or as directed by your prescriber.
  • Aseptic technique: use alcohol prep, new sterile needle/syringe; follow pharmacy instructions for needle gauge and volumes.

Dosing

  • Patient-specific. Compounded strengths vary. Do not self-titrate. Follow the exact dose, timing, and any cycling protocol provided by your prescriber.

Storage & Handling

  • Unreconstituted vials: refrigerate 2–8°C (36–46°F); protect from light; do not freeze.
  • Diluent: use only the diluent provided/specified by the pharmacy (often bacteriostatic saline unless contraindicated).
  • After reconstitution: store refrigerated; follow pharmacy beyond-use date (commonly 7–28 days depending on formulation/preservative).
  • Inspection: do not use if solution is cloudy, discolored, or contains particulates.
  • Travel: keep cold with insulated packaging/ice packs; avoid temperature excursions.
  • Disposal: place used needles/syringes in an approved sharps container; follow local regulations.

Monitoring (what we check and why)

  • Baseline: fasting glucose or A1c; IGF-1; cancer history and appropriate screenings (per age/sex); blood pressure; edema exam; sleep apnea risk.
  • Follow-up: IGF-1 (avoid supra-physiologic elevation), fasting glucose/A1c, weight and fluid status, CTS-like symptoms, headaches/vision, lipid profile (if clinically indicated).
  • If diabetic/prediabetic: home glucose logs initially; adjust antidiabetic meds as needed.
  • If prior malignancy: ensure up-to-date oncology clearance and surveillance plan.

Patient Safety Guidance

  • Report persistent headaches/vision changes, hand numbness, or rapid swelling/weight gain.
  • Do not combine with other GH-axis agents unless explicitly prescribed.
  • Maintain adequate hydration and sleep hygiene; avoid excessive alcohol.
  • If you miss a dose, do not double the next dose; follow your prescriber’s instructions.

Regulatory / Clinical Use Note

  • Tesamorelin is FDA-approved only for HIV-associated lipodystrophy when used as Egrifta SV® monotherapy.
  • Ipamorelin is not FDA-approved for any indication.
  • This combination is not FDA-approved; quality and sterility depend on the compounding pharmacy’s compliance with USP <795>/<797>/<800> and state law. Discuss pharmacy credentials with your clinician.

Adverse Event Reporting

  • Notify your clinician and dispensing pharmacy about any side effects.
  • You can report adverse events to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • For emergencies, call 911.

Disclaimer
 This information is educational and does not replace medical advice. Decisions about use, dose, duration, and monitoring must be made by you and your licensed clinician based on your medical history, exam, labs, and goals.

Tesofensine

Boxed Warning / Key Alerts

  • Not FDA-approved: Tesofensine is an investigational monoamine reuptake inhibitor studied for weight loss. Safety and efficacy have not been established by the FDA.

  • Cardiovascular risk: May increase blood pressure and heart rate due to sympathomimetic effects.

  • Psychiatric risk: May increase risk of mood changes, anxiety, agitation, or suicidal thoughts.

Do NOT use if:

  • You have uncontrolled hypertension, arrhythmias, coronary artery disease, or other serious cardiovascular disease
  • You are pregnant or breastfeeding
  • You have a history of seizure disorders
  • You are taking or recently discontinued monoamine oxidase inhibitors (MAOIs) (risk of hypertensive crisis)
  • You have had a serious hypersensitivity reaction to tesofensine or formulation ingredients

Precautions / Tell your clinician if you:

  • Have a history of depression, anxiety, or psychiatric illness
  • Have substance use disorder (stimulant-like potential)
  • Have diabetes (monitor closely; effects on appetite/glucose tolerance not fully defined)
  • Have thyroid disease (sympathomimetic activity may affect metabolism)
  • Take other stimulants or appetite suppressants
  • Have liver or kidney impairment (metabolism and excretion not fully studied)

Drug Interactions

  • MAOIs: contraindicated (risk of hypertensive crisis)
  • SSRIs, SNRIs, TCAs: risk of serotonin syndrome
  • Stimulants / sympathomimetics: additive cardiovascular risk
  • Alcohol: may increase CNS side effects
  • Antihypertensives: may reduce efficacy due to tesofensine’s pressor effects

Common Side Effects
 Dry mouth, constipation, insomnia, increased heart rate, anxiety, nausea, headache, sweating, dizziness, irritability.

Serious Side Effects (Seek medical attention immediately)

  • Cardiovascular events: chest pain, palpitations, syncope, severe hypertension
  • Neurologic events: seizures, confusion, agitation
  • Psychiatric effects: new or worsening depression, suicidal ideation, hallucinations
  • Serotonin syndrome: agitation, tremor, hyperthermia, muscle rigidity (if combined with serotonergic drugs)
  • Severe allergic reaction: swelling of face/tongue/throat, rash, difficulty breathing

Pregnancy & Contraception

  • Contraindicated in pregnancy (fetal risk unknown, stimulant class risk expected).
  • Women must use effective contraception.
  • Not recommended while breastfeeding (excretion into milk unknown).

Special Populations

  • Pediatrics (<18 yrs): not studied; do not use
  • Older adults: may be more sensitive to cardiovascular and psychiatric risks
  • Renal/hepatic impairment: not studied; avoid use until safety clarified

Administration

  • Oral, compounded capsules (dose varies by formulation; no standardized FDA-approved dosing).
  • Take in the morning to minimize insomnia.
  • Avoid evening doses.

Storage

  • Store at room temperature (68°F–77°F / 20°C–25°C).
  • Keep out of reach of children and pets.

Monitoring

  • Baseline: blood pressure, heart rate, psychiatric history
  • Ongoing: weight, BP/HR at each visit, psychiatric evaluation, adherence/tolerability
  • Monitor for insomnia, anxiety, or misuse potential

Regulatory Note

  • Tesofensine is not FDA-approved in the U.S. for any indication.
  • All use is off-label and investigational when prescribed by compounding pharmacies.

Adverse Event Reporting
 Report side effects to your clinician and pharmacy. Report to FDA MedWatch at 1-800-FDA-1088 or www.fda.gov/medwatch. For emergencies, call 911.

Section 2: Peptides for Healing & Performance

BPC-157 + TB-500

This section covers compounded peptide therapies. None are FDA-approved for anti-aging, healing, or performance uses. Safety and effectiveness have not been evaluated by the FDA. All therapies are investigational, compounded medications that require a prescription from a licensed clinician. Use only as directed under medical supervision.

Boxed Warning

  • Human safety data are extremely limited. Most evidence comes from preclinical animal studies, not controlled human clinical trials.

  • Not FDA-approved for any indication. All human use is compounded and investigational.

  • Potential risks include unknown long-term effects, immune reactions, contamination or sterility issues with compounded formulations, and unpredictable safety when peptides are combined.

  • Contraindicated in pregnancy, breastfeeding, pediatrics, and patients with active malignancy.

  • Must not be used as a substitute for standard medical or surgical care.

Do NOT use if:

  • You are pregnant or breastfeeding (unknown fetal/infant risk).

  • You are under 18 years old (safety not established).

  • You have active cancer or history of malignancy without clearance from an oncologist (theoretical risk of growth-promoting effects).

  • You have a known hypersensitivity to peptide formulations or excipients.

Precautions / Tell your clinician if you:

  • Have autoimmune disease (risk of immune modulation).

  • Have a history of blood clots or vascular disease (angiogenesis may increase thrombotic risk).

  • Are immunocompromised.

  • Are using other investigational peptides (additive or overlapping effects possible).

  • Have liver or kidney disease (metabolism and clearance are not established).

  • Are taking medications that affect wound healing, angiogenesis, or immune function.

Drug Interactions (based on theoretical and preclinical data)

  • Corticosteroids → may blunt wound healing or immune-modulating effects.

  • Anticoagulants/antiplatelet drugs → theoretical additive risk if angiogenesis is enhanced.

  • Immunosuppressants → unpredictable immune-modulating interactions.

  • Other investigational peptides → additive or unknown synergistic risks.

Common Side Effects (reported anecdotally, not well-studied)

  • Injection site reactions: redness, swelling, pain, itching.

  • Nausea, headache, dizziness.

  • Fatigue or flu-like symptoms (reported more frequently with TB-500).

  • Increased appetite or changes in mood.

  • Water retention or mild swelling.

Serious Side Effects (Seek medical attention immediately)

  • Signs of allergic reaction: swelling of face/lips/tongue, difficulty breathing, rash.

  • Chest pain, shortness of breath, leg swelling (possible clotting event).

  • Unexplained rapid weight gain or significant edema.

  • Severe or persistent fatigue, dizziness, or immune-related reactions.

Pregnancy & Contraception

  • Contraindicated in pregnancy and breastfeeding.

  • Unknown fetal/infant risks due to growth and angiogenesis effects.

  • Women of childbearing potential should use effective contraception during use.

Special Populations

  • Pediatric: not recommended; no safety/efficacy data.

  • Older adults: use caution; data lacking. Possible higher risk of edema or vascular complications.

  • Immunocompromised patients: avoid use unless under direct supervision of a specialist.

  • Cancer survivors: avoid without explicit oncologist approval.

Administration

  • Administered by subcutaneous injection into fatty tissue (abdomen, thigh, or upper arm).

  • Frequency, dosing, and duration are not standardized; must be directed by a licensed clinician.

  • Rotate injection sites to reduce irritation.

  • Do not self-compound or purchase from unverified suppliers due to high contamination risk.

Storage

  • Refrigerate at 36–46°F (2–8°C). Do not freeze. Protect from light.

  • Keep in original vial until ready for use.

  • Discard if solution is cloudy, discolored, contains particles, or is past the beyond-use date.

  • Keep out of reach of children and pets.

Monitoring (no standardized guidelines, but clinicians may track)

  • Blood counts and inflammatory markers.

  • Blood pressure, weight, and signs of fluid retention.

  • Glucose or metabolic labs if patient has risk factors.

  • Signs of allergic or immune reactions.

  • Periodic cancer screening per age and risk profile.

Regulatory Note

  • Neither BPC-157 nor TB-500 is FDA-approved.

  • Both peptides are only available through compounding pharmacies.

  • Safety and efficacy for wound healing, recovery, or performance enhancement have not been established.

  • Use is investigational and off-label only.

Adverse Event Reporting

  • Report side effects to your prescribing clinician and the dispensing pharmacy.

  • Report adverse events to FDA MedWatch: www.fda.gov/medwatch or 1-800-FDA-1088.

  • Seek emergency care (call 911) for severe allergic reactions, chest pain, difficulty breathing, or other urgent symptoms.

CJC-1295 + Ipamorelin

Boxed Warning

  • Long-term safety in humans is unknown.

  • Both peptides stimulate the growth hormone/IGF-1 axis → potential to promote tumor growth in patients with existing cancers.

  • Contraindicated in patients with active malignancy.

  • May cause fluid retention, carpal tunnel syndrome, insulin resistance, or edema.

  • Must not be used as a substitute for FDA-approved therapies for growth hormone deficiency or other conditions.

Do NOT use if:

  • You have active cancer or history of malignancy without clearance from an oncologist.

  • You are pregnant or breastfeeding.

  • You are under 18 years old (safety not established).

  • You have had a hypersensitivity reaction to peptide formulations.

Precautions / Tell your clinician if you:

  • Have diabetes, prediabetes, or metabolic syndrome (risk of increased fasting glucose and insulin resistance).

  • Have cardiovascular disease, hypertension, or history of edema.

  • Have sleep apnea (may worsen with GH/IGF-1 stimulation).

  • Have autoimmune disease or are immunocompromised.

  • Are taking corticosteroids, insulin, or other GH-axis therapies (possible drug interactions).

Drug Interactions (theoretical and based on mechanism)

  • Insulin or antidiabetics → may increase risk of hypoglycemia or worsen insulin resistance.

  • Corticosteroids → may blunt effects or alter glucose metabolism.

  • Other GH-axis therapies (GH, GHRPs, GHRHs) → additive or unpredictable stimulation of IGF-1.

  • Immunosuppressants → interactions unknown.

Common Side Effects

  • Injection site reactions: redness, swelling, pain.

  • Headaches, flushing, lightheadedness.

  • Increased hunger (ghrelin-mimetic effect of ipamorelin).

  • Fatigue, mood changes, or sleep disturbances.

  • Water retention, joint pain, or tingling in extremities.

Serious Side Effects (Seek medical attention immediately)

  • Severe or persistent edema, swelling in legs or hands.

  • Chest pain, shortness of breath, or irregular heartbeat.

  • Severe allergic reaction: swelling of face/lips/tongue, difficulty breathing, rash.

  • Gynecomastia (breast tissue changes in men).

  • Signs of hyperglycemia or uncontrolled diabetes (excessive thirst, frequent urination, unexplained weight loss).

Pregnancy & Contraception

  • Contraindicated in pregnancy and breastfeeding.

  • Unknown fetal/infant risks due to hormonal and IGF-1 stimulation.

  • Women of childbearing potential should use effective contraception.

Special Populations

  • Pediatric: not recommended (safety not established).

  • Older adults: higher risk of edema, insulin resistance, and carpal tunnel symptoms.

  • Patients with metabolic disease: require careful monitoring of glucose and HbA1c.

  • Cancer survivors: avoid unless cleared by oncology.

Administration

  • Subcutaneous injection into abdomen, thigh, or upper arm.

  • Typically dosed once daily or several times per week (per clinician).

  • Rotate injection sites to minimize irritation.

  • Use only under the supervision of a licensed clinician.

Storage

  • Store refrigerated at 36–46°F (2–8°C). Do not freeze. Protect from light.

  • Keep in original vial until ready for use.

  • Discard if solution is cloudy, discolored, contains particles, or past the beyond-use date.

  • Keep out of reach of children and pets.

Monitoring (suggested, no standardized protocols)

  • Fasting glucose, HbA1c, and insulin levels.

  • IGF-1 levels (to avoid excessive elevation).

  • Lipid profile, weight, and blood pressure.

  • Screening for edema, carpal tunnel symptoms, or gynecomastia.

  • Cancer screening per age-appropriate guidelines.

Regulatory Note

  • Neither CJC-1295 nor Ipamorelin is FDA-approved for any indication.

  • All human use is compounded, investigational, and off-label only.

  • The safety and efficacy of this combination have not been studied in controlled human trials.

Adverse Event Reporting

  • Report side effects to your prescribing clinician and dispensing pharmacy.

  • Report adverse events to FDA MedWatch: www.fda.gov/medwatch or 1-800-FDA-1088.

  • Call 911 for emergencies such as severe allergic reaction, chest pain, or difficulty breathing.

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Sermorelin

Boxed Warning

  • Withdrawn FDA approval: Sermorelin (Geref®) was FDA-approved in the past for pediatric growth hormone deficiency, but the approval was discontinued for commercial reasons. It is now available only as a compounded product.

  • Not FDA-approved for anti-aging, weight loss, or performance uses.

  • Long-term safety in adults is unknown.

  • Stimulates growth hormone/IGF-1 axis → potential to promote tumor growth in patients with existing cancers.

  • Contraindicated in patients with active malignancy.

  • Must not be used as a substitute for FDA-approved growth hormone therapies.

Do NOT use if:

  • You have active cancer or a history of malignancy without clearance from an oncologist.

  • You are pregnant or breastfeeding.

  • You are under 18 years old, unless specifically prescribed for pediatric GH deficiency by a specialist.

  • You have had a hypersensitivity reaction to Sermorelin or formulation excipients.

Precautions / Tell your clinician if you:

  • Have diabetes, prediabetes, or metabolic syndrome (risk of altered glucose tolerance).

  • Have cardiovascular disease, hypertension, or edema.

  • Have sleep apnea (may worsen with GH stimulation).

  • Have autoimmune disease or are immunocompromised.

  • Are taking corticosteroids, insulin, or other GH-axis therapies.

Drug Interactions

  • Glucocorticoids (steroids): may blunt GH response to Sermorelin.

  • Insulin or antidiabetics: Sermorelin may alter glucose tolerance; adjustments may be needed.

  • Other GH-axis therapies (GH, GHRPs, GHRHs): additive stimulation possible, unpredictable effects.

  • Immunosuppressants: interactions unknown.

Common Side Effects

  • Injection site reactions: redness, pain, swelling.

  • Flushing, headache, dizziness.

  • Nausea, fatigue, or mood changes.

  • Sleep disturbances or increased appetite.

Serious Side Effects (Seek medical attention immediately)

  • Severe allergic reaction: swelling of face/lips/tongue, difficulty breathing, rash.

  • Rapid weight gain, significant edema, or swelling in extremities.

  • Chest pain, palpitations, or shortness of breath.

  • Signs of hyperglycemia or worsening diabetes (excessive thirst, frequent urination, unexplained weight loss).

Pregnancy & Contraception

  • Contraindicated in pregnancy and breastfeeding.

  • Unknown fetal/infant risks due to hormonal and IGF-1 stimulation.

  • Women of childbearing potential should use effective contraception.

Special Populations

  • Pediatric: previously FDA-approved for GH deficiency but now discontinued; compounded forms are investigational only.

  • Older adults: higher risk of edema, glucose intolerance, and carpal tunnel symptoms.

  • Patients with metabolic disease: require monitoring of glucose and HbA1c.

  • Cancer survivors: avoid unless cleared by oncology.

Administration

  • Subcutaneous injection, typically in abdomen, thigh, or upper arm.

  • Usually administered once daily at bedtime to mimic physiologic GH secretion.

  • Rotate injection sites to minimize irritation.

  • Use only under supervision of a licensed clinician.

Storage

  • Store refrigerated at 36–46°F (2–8°C). Do not freeze. Protect from light.

  • Keep in original vial until ready for use.

  • Discard if solution is cloudy, discolored, contains particles, or past beyond-use date.

  • Keep out of reach of children and pets.

Monitoring (suggested, no standardized protocols)

  • Fasting glucose, HbA1c, and insulin.

  • IGF-1 levels (to avoid excessive stimulation).

  • Lipid profile, blood pressure, and body weight.

  • Cancer screening per age/risk profile.

  • Sleep apnea screening if symptomatic.

Regulatory Note

  • Sermorelin was once FDA-approved for pediatric GH deficiency but is no longer marketed as an FDA-approved product.

  • All current formulations are compounded, investigational, and off-label only.

  • Safety and efficacy for adult anti-aging, weight loss, or performance purposes have not been established.

Adverse Event Reporting

  • Report side effects to your prescribing clinician and pharmacy.

  • Report adverse events to FDA MedWatch: www.fda.gov/medwatch or 1-800-FDA-1088.

  • Call 911 for emergencies such as chest pain, severe allergic reaction, or difficulty breathing.

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IGF-1 LR3

Boxed Warning

  • Not FDA-approved for any indication. All human use is compounded, investigational, and off-label.

  • Long-term safety is unknown. IGF-1 LR3 is a synthetic analog of insulin-like growth factor-1 with an extended half-life.

  • May promote tumor growth in patients with existing cancers due to IGF-1–mediated cell proliferation.

  • Contraindicated in patients with active malignancy.

  • Risk of hypoglycemia due to insulin-like activity.

  • Must not be used as a substitute for FDA-approved therapies for growth disorders, diabetes, or other conditions.

Do NOT use if:

  • You have active cancer or history of malignancy without oncologist clearance.

  • You are pregnant or breastfeeding.

  • You are under 18 years old (safety not established).

  • You have had a hypersensitivity reaction to IGF-1 products or peptide formulations.

Precautions / Tell your clinician if you:

  • Have diabetes, prediabetes, or metabolic syndrome (risk of hypoglycemia or altered glucose control).

  • Have cardiovascular disease, hypertension, or edema.

  • Have history of intracranial hypertension, seizures, or migraines (IGF-1 may worsen symptoms).

  • Have kidney or liver disease.

  • Are taking insulin, antidiabetic medications, corticosteroids, or other GH/IGF-axis therapies.

Drug Interactions

  • Insulin or antidiabetic drugs → additive hypoglycemia risk.

  • Corticosteroids → may blunt growth-promoting effects.

  • Other GH or IGF therapies → increased risk of excessive IGF-1 activity.

  • Estrogen therapy → may alter IGF-1 response.

Common Side Effects

  • Injection site reactions: redness, swelling, pain.

  • Headache, dizziness, fatigue.

  • Nausea, muscle aches, or joint pain.

  • Increased appetite.

Serious Side Effects (Seek medical attention immediately)

  • Severe hypoglycemia: confusion, sweating, shakiness, rapid heartbeat, fainting, seizures.

  • Severe allergic reaction: swelling of face/lips/tongue, difficulty breathing, rash.

  • Intracranial hypertension: severe headache, vision changes, vomiting.

  • Rapid weight gain, significant edema, or shortness of breath.

  • Abnormal growth of organs or tissues (rare, theoretical risk with misuse).

Pregnancy & Contraception

  • Contraindicated in pregnancy and breastfeeding.

  • Unknown fetal/infant risks; theoretical risk of abnormal growth.

  • Women of childbearing potential should use effective contraception.

Special Populations

  • Pediatric: not FDA-approved; investigational use only.

  • Older adults: higher risk of edema, insulin resistance, and cardiovascular strain.

  • Patients with metabolic disease: require close glucose monitoring.

  • Cancer survivors: avoid unless cleared by oncology.

Administration

  • Administered by subcutaneous injection.

  • Frequency and dosing are not standardized; must be directed by a licensed clinician.

  • Rotate injection sites to minimize irritation.

  • Do not self-source from unverified suppliers (contamination risk).

Storage

  • Store refrigerated at 36–46°F (2–8°C). Do not freeze. Protect from light.

  • Keep in original vial until ready for use.

  • Discard if solution is cloudy, discolored, contains particles, or past the beyond-use date.

Monitoring (suggested, no standardized guidelines)

  • Blood glucose and HbA1c to detect hypoglycemia or altered tolerance.

  • IGF-1 serum levels (to avoid excessive elevation).

  • Blood pressure, weight, and signs of edema.

  • Neurologic symptoms (headache, vision changes).

  • Cancer screening per age/risk profile.

Regulatory Note

  • IGF-1 LR3 is not FDA-approved for any human use.

  • Available only through compounding pharmacies as an investigational product.

  • Safety and efficacy have not been established in controlled human trials.

Adverse Event Reporting

  • Report side effects to your prescribing clinician and dispensing pharmacy.

  • Report adverse events to FDA MedWatch: www.fda.gov/medwatch or 1-800-FDA-1088.

  • Call 911 for emergencies such as severe hypoglycemia, chest pain, or allergic reaction.

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