Important Safety Information

General Disclaimers

Platform Role

MyCare MD is a managed services organization (MSO) that provides clinical infrastructure and care coordination services. MyCare MD does not practice medicine, provide medical advice, or dispense medications. All prescribing decisions are made exclusively by independent, licensed healthcare providers operating through affiliated professional medical entities in the states where they are licensed to practice.

Prescription Medications

Prescription medications are only available following a completed telehealth consultation and a clinical determination of appropriateness by a licensed provider. Whether to prescribe, and what to prescribe, is entirely within the provider's independent clinical judgment and subject to applicable laws and regulations.

Compounded Medications

Some treatments available through affiliated providers may involve compounded medications prepared by licensed, USA-based compounding pharmacies. Compounded medications may be appropriate when commercially available alternatives do not meet a patient's clinical needs.

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

GLP-1 Weight Management — Compounded Semaglutide

Compounded semaglutide is not an FDA-approved drug product. FDA shortage status for branded semaglutide may affect the availability of compounded versions. Your provider will advise you on current availability.

Seek Immediate Medical Attention For:

• Severe nausea, vomiting, or diarrhea 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: upper abdominal pain, fever, jaundice, or nausea.
• Liver problems: jaundice, elevated liver enzymes, or hepatitis signs.
• Diabetic retinopathy progression: new or worsening vision changes.
• Low blood sugar signs: dizziness, weakness, shakiness, headache, sweating, confusion, or rapid heartbeat.
• Worsening depression, behavioral changes, or thoughts of self-harm or suicide.

Do not share this medication with anyone else.

Drug Interactions

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

Use in Special Populations

Do not use during pregnancy or while breastfeeding. Use effective contraception during treatment. Safety and efficacy have not been established in pediatric patients.

GLP-1 Weight Management — Compounded Tirzepatide

Compounded tirzepatide is not an FDA-approved drug product. FDA shortage status for branded tirzepatide may affect the availability of compounded versions.

Serious Side Effects — Seek Medical Attention For:

• Persistent or severe abdominal discomfort (possible pancreatitis).
• Signs of kidney problems from dehydration secondary to gastrointestinal symptoms.
• Gallbladder disease: upper abdominal pain, jaundice, fever, or stool color changes.
• Allergic reactions: facial swelling, hives, difficulty breathing, or rapid heartbeat.
• Hypoglycemia: dizziness, sweating, confusion, shakiness, or rapid heartbeat.
• New or worsening visual changes.
• Mood changes, depression, or thoughts of self-harm.

Common Side Effects

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

Drug Interactions

Increased hypoglycemia risk when combined with insulin or sulfonylureas. May reduce the effectiveness of oral contraceptives — discuss alternative contraception with your provider.

Use in Special Populations

Do not use during pregnancy or while breastfeeding. Use effective contraception during treatment.

Wegovy® and Ozempic® (Branded Semaglutide)

Common Side Effects

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

Use in Special Populations

Do not use if pregnant, trying to become pregnant, or breastfeeding. Use effective contraception 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.

Do Not Use If You Have:

• Diabetic ketoacidosis, Type 1 diabetes, or clinically significant diabetic retinopathy.
• Personal or family history of MEN 2 or medullary thyroid carcinoma.
• Active pancreatitis or kidney disease requiring dialysis.

Serious Side Effects

• Severe gastrointestinal problems.
• Kidney failure from dehydration.
• Gallbladder disease.
• Pancreatitis.
• Serious allergic reactions.
• Hypoglycemia (especially with sulfonylureas or insulin).
• Vision changes in type 2 diabetes patients.
• Depression or suicidal ideation — monitor mood changes throughout treatment.

Oral Contraceptive Interaction

Use supplemental contraception for four weeks after treatment initiation and four weeks after each dose increase.

Oral and Sublingual GLP-1 Formulations

Compounded orally-dissolving tablet (ODT) and sublingual GLP-1 preparations are not FDA-approved drug products. The class warnings, contraindications, and side effects described in the compounded semaglutide and compounded tirzepatide sections above apply in full to these formulations, including the thyroid C-cell tumor warning, pancreatitis risk, and gallbladder disease. The notes below cover what differs about the oral route.

Oral Semaglutide (ODT)

Absorption of orally administered semaglutide is substantially lower and more variable than injection, and is affected by food, drink, and other oral medications. Follow your provider's dosing and timing instructions precisely — taking the tablet with food or too close to other medication can materially reduce the dose your body absorbs. Do not chew, crush, or swallow a tablet intended to dissolve. Local effects may include mouth or tongue irritation, altered taste, and dry mouth in addition to the class gastrointestinal effects.

Oral Tirzepatide (ODT)

The same absorption variability and administration requirements apply. Tirzepatide acts on both GIP and GLP-1 receptors, and the oral formulation carries the same interaction with oral contraceptives described in the branded tirzepatide section — discuss a non-oral or backup contraceptive method with your provider. Local effects may include mouth or tongue irritation, altered taste, and dry mouth.

Absorption and Dose Equivalence

Oral and injectable doses are not interchangeable on a milligram basis. Never convert a dose between routes yourself. If you are switching between an oral and an injectable formulation, your provider will set the new dose and may restart titration.

Hormone Replacement Therapy — Testosterone (Men)

Testosterone products prescribed through this platform are intended for adult males with clinically diagnosed hypogonadism or testosterone deficiency. These statements apply to both FDA-approved and compounded testosterone preparations.

Serious Warnings

• Polycythemia (elevated red blood 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 patient populations. Discuss your cardiac history with your provider.
• Sleep apnea: may worsen existing sleep apnea or cause new-onset sleep apnea.
• Venous thromboembolism: increased risk of deep vein thrombosis (DVT) and pulmonary embolism has been reported.
• Prostate: testosterone may stimulate the growth of existing prostate cancer. PSA monitoring is required. Do not use if you have or are suspected to have prostate cancer.
• Infertility: exogenous testosterone suppresses natural testosterone production and sperm production. May cause infertility. Discuss fertility preservation with your provider before starting treatment.
• Pediatric exposure risk: testosterone gels and creams can be transferred to children through skin contact and may cause premature puberty. Keep application sites covered and wash hands thoroughly after application.

Common Side Effects

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

Contraindications

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

Monitoring Requirements

Regular blood tests to monitor testosterone levels, hematocrit, PSA, and liver function are required throughout treatment. Your provider will establish a monitoring schedule at the initiation of therapy.

Enclomiphene

Enclomiphene is a selective estrogen receptor modulator (SERM) used off-label to raise the body's own testosterone production by increasing pituitary release of LH and FSH. It is prescribed as a compounded preparation and is not FDA-approved for any indication. Unlike testosterone replacement, it does not suppress the testicular axis, and is sometimes chosen by patients concerned about fertility. These statements have not been evaluated by the FDA.

Common Side Effects

Headache, nausea, and hot flushes. Mood changes, including irritability or low mood. Acne and increased oiliness of the skin. Fatigue. Most effects are dose-related and reported early in treatment.

Serious Side Effects

Visual disturbances — blurred vision, floaters, light sensitivity, or afterimages — are a recognised effect of the SERM class and warrant stopping the medication and contacting your provider promptly. As a class, SERMs have been associated with venous thromboembolism; seek immediate medical attention for leg swelling or pain, chest pain, or shortness of breath.

Contraindications

Pregnancy — do not use if you are or may become pregnant. Active or prior venous thromboembolism, or a known thrombophilic disorder. Known or suspected hormone-sensitive cancer. Significant liver disease. Hypersensitivity to enclomiphene, clomiphene, or any component of the formulation.

Monitoring Requirements

Baseline and follow-up blood work including total and free testosterone, estradiol, LH and FSH, and a complete blood count. Your provider will set the interval and adjust or stop treatment based on results.

Anastrozole

Anastrozole is an aromatase inhibitor that reduces the conversion of testosterone to estradiol. It is FDA-approved for the treatment of breast cancer in postmenopausal women. Its use in men receiving hormone therapy, to manage elevated estradiol, is off-label and has not been evaluated by the FDA for that purpose.

Common Side Effects

Joint pain and stiffness. Hot flushes. Headache. Fatigue and low mood. Reduced libido or erectile difficulty, usually reflecting estradiol suppressed below the physiological range.

Contraindications and Precautions

Pregnancy and breastfeeding. Known hypersensitivity to anastrozole or any component of the formulation. Use with caution in patients with osteoporosis or osteopenia, existing lipid disorders, or significant hepatic impairment.

Monitoring Requirements

Estradiol should be measured before starting and rechecked after any dose change, using a sensitive assay. Lipids and, with prolonged use, bone mineral density should be monitored. Your provider will establish the schedule.

HCG (Human Chorionic Gonadotropin)

HCG is FDA-approved for hypogonadotropic hypogonadism in men, prepubertal cryptorchidism, and ovulation induction. It is used alongside testosterone therapy to maintain testicular size and function and to support fertility — a use that is off-label. Compounded HCG preparations are not FDA-approved products.

Common Side Effects

Injection site pain, redness, or swelling. Headache. Irritability, restlessness, or mood changes. Fluid retention and mild swelling. Breast tenderness or enlargement (gynecomastia), which reflects increased estradiol and should be reported to your provider.

Serious Side Effects

Seek medical attention for signs of a blood clot — leg pain or swelling, chest pain, shortness of breath, or sudden severe headache. In women, HCG used for ovulation induction carries a risk of ovarian hyperstimulation syndrome; severe abdominal pain or bloating, nausea and vomiting, or rapid weight gain requires urgent assessment.

Contraindications

Precocious puberty. Known or suspected androgen-dependent tumour, including prostate cancer. Pregnancy. Known hypersensitivity to HCG or any component of the formulation. Use with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma, where fluid retention may aggravate the condition.

NAD+ (Nicotinamide Adenine Dinucleotide)

NAD+ infusions and injections are not FDA-approved drug products for any indication. The statements in this section have not been evaluated by the FDA. NAD+ is a coenzyme involved in cellular energy metabolism, used off-label in longevity, anti-aging, and neurological support protocols. It may be administered via intravenous infusion, intramuscular injection, or subcutaneous injection depending on the clinical protocol.

Common Side Effects (Particularly with IV Administration)

• Flushing, warmth, and redness during infusion.
• Nausea, stomach cramping, or discomfort during infusion.
• Chest tightness or pressure (typically transient and resolves with slower infusion rate).
• Muscle cramping during infusion.
• Fatigue or light-headedness following infusion.
• Injection site reactions for non-IV routes.

Contraindications and Precautions

Use with caution in patients with a history of cancer, autoimmune conditions, or significant cardiovascular or hepatic disease. The safety of NAD+ therapy during pregnancy and breastfeeding has not been established. Disclose all medications, supplements, and herbal products to your provider, as potential interactions affecting cellular metabolism exist but are not well-characterized.

MIC / Lipo-B Injections

Lipotropic injections are not FDA-approved drug products for any specific indication. These are provided as compounded preparations under the supervision of a licensed provider. MIC (Methionine, Inositol, Choline) and Lipo-B injections are lipotropic compounds sometimes used in conjunction with weight management programs.

Common Side Effects

• Injection site reactions: pain, bruising, or inflammation.
• Nausea or stomach discomfort.
• 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.

Contraindications and Precautions

High-dose vitamin supplementation may interact with certain medications. Disclose all medications and supplements to your provider before treatment.

Sermorelin

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

Common Side Effects

• Mild fatigue or dizziness, particularly early in treatment.
• Injection: localized pain, redness, or swelling at the injection site.
• ODT (oral dissolving tablet) form: temporary changes in taste or transient dry mouth.

Less Common Side Effects

Itching, difficulty swallowing, flushing, headache, drowsiness, hyperactivity, or restlessness. Contact your provider if any side effects are persistent or concerning.

Contraindications

Known hypersensitivity to sermorelin or any component of the formulation. Pregnancy or active planning to become pregnant. Breastfeeding. Active malignancy or a history of cancer not in confirmed remission.

Drug Interactions

Glucocorticoids (e.g., prednisone) may attenuate the growth hormone-stimulating effects of sermorelin. Thyroid hormone medications may alter hormonal balance and interfere with laboratory monitoring. Disclose all medications and supplements to your provider.

Tadalafil (PDE5 Inhibitor — Erectile Dysfunction)

Common Side Effects

• Headache, facial flushing, and nasal congestion.
• Dyspepsia or indigestion.
• Back pain and muscle aches.
• Visual disturbances including blurred vision or altered color perception.

Contraindications

Do not use concurrently with nitrate medications (nitroglycerin, isosorbide mononitrate, isosorbide dinitrate) — may cause severe, potentially fatal hypotension. Do not use with other PDE5 inhibitors (including sildenafil or vardenafil obtained elsewhere). Use with caution or avoid entirely if you have severe cardiovascular disease, have recently suffered a stroke or myocardial infarction, or have resting hypotension.

PT-141 (Bremelanotide)

Bremelanotide is a melanocortin receptor agonist that acts on pathways in the central nervous system involved in sexual arousal, rather than on blood flow as PDE5 inhibitors do. It is FDA-approved under the brand name Vyleesi® for hypoactive sexual desire disorder in premenopausal women. Compounded PT-141, and its use in men or in postmenopausal women, is off-label and not FDA-approved. It is taken as needed, not daily. These statements have not been evaluated by the FDA.

Common Side Effects

Nausea is the most common effect and may be pronounced with the first doses; it typically lessens with subsequent use. Flushing. Headache. Injection site reactions. Vomiting. Fatigue.

Blood Pressure and Heart Rate

Bremelanotide causes a transient rise in blood pressure and fall in heart rate after each dose, peaking within a few hours and resolving on its own. Do not use more than one dose in 24 hours, or more than eight doses per month. It should not be used by patients with uncontrolled hypertension or known cardiovascular disease.

Skin Darkening

Focal hyperpigmentation — darkening of the skin, gums, or face — can occur, and is more likely with frequent dosing and in patients with darker skin. It does not always resolve after stopping. Report any new areas of darkening to your provider.

Contraindications

Uncontrolled hypertension. Known cardiovascular disease. Pregnancy — discontinue if pregnancy is suspected. Known hypersensitivity to bremelanotide or any component of the formulation. Use with caution in patients at high cardiovascular risk, and discuss any medication for blood pressure with your provider before starting.

Glutathione (Injection / Intranasal)

Glutathione is a naturally occurring antioxidant tripeptide used off-label in compounded intramuscular, subcutaneous, and intranasal formulations for oxidative stress support, skin health, detoxification protocols, and neurological wellness. It is not FDA-approved for these indications as a compounded preparation.

Common Side Effects

Injection site reactions (pain, redness, swelling). Intranasal formulations may cause mild nasal irritation or temporary altered sense of smell. Rare: allergic reactions including hives, facial swelling, or difficulty breathing — seek immediate medical attention if these occur.

Contraindications and Precautions

Known hypersensitivity to glutathione or any component of the formulation. Use with caution in patients with asthma (rare cases of bronchospasm with nebulized forms reported). Safety during pregnancy and breastfeeding has not been established. Disclose all medications and supplements to your provider, as high-dose antioxidant therapy may theoretically interact with certain chemotherapy agents.

Methylene Blue

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

Common Side Effects

Blue or green discoloration of urine and stool (expected and harmless at low doses). Nausea, vomiting, or abdominal discomfort. Headache or dizziness. Skin or mucous membrane discoloration at higher doses. With IV administration: injection site pain and transient blood pressure changes.

Contraindications

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

Low Dose Naltrexone (LDN)

Low Dose Naltrexone (LDN) refers to 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 use disorder). LDN is used off-label in compounded formulations for immune modulation, chronic pain, inflammatory conditions, and general wellness protocols. It is not FDA-approved for these off-label indications. Naltrexone itself is not a controlled substance. These statements have not been evaluated by 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 the medication.

Contraindications

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

Drug Interactions

All opioid medications: blocked effect and potential precipitation of withdrawal — contraindicated. Thioridazine: combination may cause drowsiness. Disulfiram: caution advised with concurrent use, particularly in patients with hepatic concerns. Disclose all medications — including over-the-counter medications containing opioids such as cough syrups — to your provider before starting LDN.

Metformin

Metformin is an FDA-approved biguanide indicated for the treatment of type 2 diabetes mellitus. Its use for metabolic support, insulin resistance without diabetes, or longevity is off-label and has not been evaluated by the FDA for those purposes.

Common Side Effects

Gastrointestinal effects are common at the start of treatment and after dose increases: diarrhea, nausea, abdominal discomfort, flatulence, and a metallic taste. These usually improve over one to two weeks and are reduced by taking the dose with food and by titrating slowly. Extended-release formulations are often better tolerated.

Vitamin B12

Long-term metformin use reduces vitamin B12 absorption and can cause deficiency, which may present as fatigue, or as numbness or tingling in the hands and feet. Periodic B12 measurement is recommended during extended use.

Contraindications

Severe renal impairment (eGFR below 30 mL/min/1.73 m²). Acute or chronic metabolic acidosis, including diabetic ketoacidosis. Known hypersensitivity to metformin. Use with caution and with renal monitoring at an eGFR of 30–45.

Drug Interactions and Procedures

Iodinated contrast imaging: metformin is typically withheld at or before the procedure and restarted only after renal function is confirmed — tell any provider ordering a CT scan or angiogram that you take metformin. Alcohol increases the risk of lactic acidosis and hypoglycemia. Carbonic anhydrase inhibitors (topiramate, acetazolamide) and certain drugs cleared by the kidneys (cimetidine, dolutegravir, ranolazine) can raise metformin levels. Combining metformin with insulin or a sulfonylurea increases the risk of hypoglycemia.

GLP-1 Compounded 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 MyCare MD or affiliated providers.

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

• Compounded semaglutide and tirzepatide are not FDA-approved drug products.
• The availability of your compounded medication may change at any time based on FDA shortage status determinations.
• If your compounded treatment becomes unavailable, your provider may recommend an alternative, including branded medications or a different treatment approach.
• Any transition in your treatment will be managed by your provider based on your individual clinical needs.
• MyCare MD cannot guarantee the continuous availability of any compounded GLP-1 medication.

Adverse Event Reporting and Contact Information

To report a suspected adverse reaction to any medication, contact:

• The FDA MedWatch program at 1-800-FDA-1088 or www.fda.gov/medwatch.
• Your prescribing provider directly through the patient portal.
• Your dispensing pharmacy.

MyCare MD LLC — support@mycare.md

Disclaimer

This document is provided for informational purposes only. It does not constitute medical advice and is not a substitute for consultation with a licensed healthcare provider. MyCare MD, as a managed services organization, does not provide medical advice. All clinical decisions are made by independent, licensed healthcare providers. The statements in this document have not been independently reviewed or approved by the FDA unless otherwise noted.