Important Safety Information

The information on this page provides a general summary of important safety considerations for certain treatments that may be available through Alexis Life.

It is not a complete list of risks, warnings, contraindications, drug interactions, or side effects and is not a substitute for individualized medical advice.

Healthcare services are provided by independent licensed healthcare professionals (“Providers”). Your Provider determines whether a treatment is medically appropriate for you.

Always review and follow the medication label, instructions supplied by the dispensing Pharmacy, and directions provided by your Provider.

If you believe you are experiencing a medical emergency, call 911 or seek immediate emergency medical care.

Compounded Medications

Some medications available through Providers using the Alexis platform may be compounded for an individual patient when determined to be medically appropriate and permitted by law.

Compounded medications are not FDA-approved. FDA does not review compounded medications before marketing for safety, effectiveness, or quality in the same manner that it reviews FDA-approved drugs.

Compounded medications are not FDA-approved generic versions of commercially available medications.

The ingredients, concentration, dosage form, strength, inactive ingredients, administration instructions, and other characteristics of a compounded medication may differ depending upon the Provider’s prescription and the dispensing Pharmacy.

Safety information derived from an FDA-approved medication containing a similar active ingredient may be relevant when evaluating potential risks, but an FDA-approved product’s clinical studies and labeling do not establish that a compounded formulation has been independently evaluated or approved by FDA.

Your Provider and dispensing Pharmacy should be your primary sources for medication-specific instructions.

Compounded Semaglutide

Semaglutide belongs to a class of medications known as GLP-1 receptor agonists.

Compounded semaglutide is not FDA-approved.

Important Thyroid Warning

Semaglutide caused thyroid C-cell tumors in animal studies. It is not known whether semaglutide causes medullary thyroid carcinoma (“MTC”) in humans.

Do not use semaglutide if:

• you have a personal history of MTC;
• you have a family history of MTC; or
• you have Multiple Endocrine Neoplasia syndrome type 2 (“MEN 2”).

Contact your Provider if you develop symptoms such as a lump or swelling in the neck, persistent hoarseness, difficulty swallowing, or difficulty breathing.

Other Important Risks

Potential serious risks associated with semaglutide and GLP-1 receptor agonist therapy include:

• inflammation of the pancreas (pancreatitis);
• gallbladder disease, including gallstones or inflammation of the gallbladder;
• dehydration and kidney injury, particularly with prolonged vomiting or diarrhea;
• severe gastrointestinal reactions;
• serious allergic reactions;
• low blood sugar, particularly when used with insulin or certain diabetes medications;
• complications related to diabetic retinopathy in certain patients with diabetes; and
• delayed stomach emptying, which may affect certain oral medications and may be relevant before anesthesia or deep sedation.

Tell your Provider about all medications, supplements, medical conditions, allergies, and previous reactions before beginning treatment.

Common Side Effects

Commonly reported effects may include:

• nausea;
• vomiting;
• diarrhea;
• constipation;
• abdominal discomfort;
• indigestion or reflux;
• decreased appetite; and
• fatigue.

Contact your Provider if symptoms are persistent, severe, worsening, or concerning.

Pregnancy

Weight-loss treatment is not appropriate during pregnancy.

Tell your Provider immediately if you are pregnant, become pregnant, are breastfeeding, or plan to become pregnant.

Your Provider should advise you regarding when treatment should be discontinued before a planned pregnancy.

Other GLP-1 Medications

Do not use semaglutide at the same time as another semaglutide-containing medication or another GLP-1/GIP medication unless specifically directed by your Provider.

Do not assume that a lower or “microdose” eliminates the risks associated with the medication.

Compounded Tirzepatide

Tirzepatide acts on GIP and GLP-1 receptors.

Compounded tirzepatide is not FDA-approved.

Important Thyroid Warning

Tirzepatide caused thyroid C-cell tumors in animal studies. It is not known whether tirzepatide causes MTC in humans.

Do not use tirzepatide if:

• you have a personal history of MTC;
• you have a family history of MTC; or
• you have MEN 2.

Contact your Provider if you develop a lump or swelling in the neck, persistent hoarseness, difficulty swallowing, or difficulty breathing.

Other Important Risks

Potential serious risks associated with tirzepatide include:

• severe gastrointestinal reactions;
• dehydration and kidney injury;
• gallbladder disease;
• pancreatitis;
• serious allergic reactions;
• low blood sugar, particularly when combined with insulin or certain diabetes medications;
• complications related to diabetic retinopathy in certain patients with diabetes; and
• delayed stomach emptying, including possible effects on absorption of oral medications and considerations before anesthesia or deep sedation.

Common Side Effects

Commonly reported effects may include:

• nausea;
• diarrhea;
• vomiting;
• constipation;
• abdominal discomfort;
• indigestion; and
• decreased appetite.

Contact your Provider if symptoms are severe, persistent, or concerning.

Pregnancy and Oral Contraceptives

Weight-loss treatment is not appropriate during pregnancy.

Tell your Provider if you are pregnant, plan to become pregnant, are breastfeeding, or use oral hormonal contraception.

Tirzepatide can affect absorption of oral medications because it delays gastric emptying. Your Provider may advise patients using oral hormonal contraceptives to use an alternative or additional contraceptive method after beginning treatment or increasing a dose.

Other GLP-1/GIP Medications

Do not combine tirzepatide with another tirzepatide-containing medication or another GLP-1/GIP medication unless specifically directed by your Provider.

Do not assume that a lower or “microdose” eliminates the risks associated with the medication.

Compounded Oral or Dissolvable GLP-1 Formulations

A compounded oral, sublingual, or dissolvable formulation is not automatically equivalent to an FDA-approved oral or injectable product containing the same named active ingredient.

Compounded dosage forms may differ in formulation, absorption, concentration, inactive ingredients, and administration instructions.

Follow the instructions provided specifically for the formulation dispensed to you.

Do not substitute administration instructions from another semaglutide or tirzepatide product.

Compounded GLP-1 Combinations

Some compounded prescriptions may contain semaglutide or tirzepatide together with another ingredient such as a vitamin, amino acid, or other compound.

The addition of another ingredient does not eliminate the risks associated with semaglutide or tirzepatide.

The compounded combination itself has not been reviewed or approved by FDA for safety, effectiveness, or quality.

Discuss each ingredient with your Provider, including allergies, medical conditions, medications, and supplements you currently use.

Sexual Health Medications

Certain Alexis treatment options may contain one or more phosphodiesterase type 5 (“PDE5”) inhibitors, such as:

• sildenafil;
• tadalafil; or
• vardenafil.

These medications can lower blood pressure.

Do Not Use With Nitrates

Do not use PDE5 inhibitors if you take nitrate medications or nitric-oxide donor medications, including medications commonly prescribed for chest pain.

Combining these medications can cause a dangerous drop in blood pressure.

Also tell your Provider if you take riociguat or another guanylate-cyclase stimulator.

Tell Your Provider Before Treatment If You Have

Tell your Provider about:

• heart disease;
• a history of heart attack or stroke;
• very high or very low blood pressure;
• significant liver or kidney disease;
• eye disease or previous sudden vision loss;
• hearing problems;
• bleeding disorders;
• anatomical conditions affecting the penis;
• a history of prolonged erections;
• alpha-blocker treatment;
• medications that affect CYP3A metabolism; and
• all other prescription medications, over-the-counter medications, supplements, and recreational substances.

Important Symptoms Requiring Prompt Medical Attention

Seek medical attention for:

• an erection lasting more than four hours;
• sudden loss or significant decrease of vision;
• sudden decrease or loss of hearing;
• severe dizziness or fainting;
• chest pain; or
• symptoms of a serious allergic reaction.

Combination Sexual-Health Formulations

Some compounded Alexis treatment options may contain more than one PDE5 inhibitor.

Compounded combinations of sildenafil, tadalafil, vardenafil, or other PDE5 inhibitors have not been FDA-approved as combination products.

The safety and effectiveness of combining multiple PDE5 inhibitors have not been established in the same manner as approved single-agent medications, and approved product labeling generally advises against combining PDE5 inhibitors or other erectile-dysfunction therapies because of the potential for additive effects, including excessive lowering of blood pressure.

Only use a compounded combination when specifically prescribed to you by your Provider.

Do not combine it with another erectile-dysfunction medication unless your Provider specifically instructs you to do so.

Longevity and Wellness Compounds

Certain treatments available through Alexis may involve compounded preparations such as NAD+, sermorelin, amino-acid or vitamin combinations, lipotropic preparations, or other customized formulations.

Many of these compounded formulations do not have an FDA-approved product with identical formulation, dosage form, concentration, route of administration, and intended use.

Accordingly:

• the compounded preparation itself is not FDA-approved;
• FDA has not independently determined that the compounded preparation is safe or effective for the purpose for which your Provider may prescribe it;
• standardized FDA-approved prescribing information may not exist for the exact compounded formulation you receive; and
• risks and interactions may depend on the formulation, dose, route of administration, your medical history, and other medications you use.

Before treatment, tell your Provider about your full medical history and all medications and supplements you use.

Follow the instructions supplied by your Provider and Pharmacy.

Do not alter your dose or administration method without discussing it with your Provider.

Allergic Reactions

Do not use a medication if you know you have a serious allergy to the active ingredient or another ingredient in the formulation.

Seek emergency medical attention for signs of a severe allergic reaction, which may include:

• difficulty breathing;
• swelling of the face, lips, tongue, or throat;
• severe rash or hives;
• severe dizziness; or
• loss of consciousness.

Medication Errors and Dosing

Compounded medications may be dispensed in concentrations or delivery systems that differ from other medications you have previously used.

Always verify:

• the medication name;
• concentration;
• prescribed dose;
• units or volume to administer;
• frequency;
• route of administration; and
• storage instructions

before using the medication.

If you are uncertain how to measure or administer a dose, do not guess. Contact your Provider or dispensing Pharmacy before administering the medication.

Never share prescription medication, needles, syringes, injection devices, or other prescription supplies with another person.

Surgery, Procedures, and Anesthesia

Tell your surgeon, anesthesiologist, dentist, or other healthcare professional about all medications you are using before any scheduled procedure.

Certain medications, including GLP-1/GIP therapies, can delay gastric emptying and may affect considerations surrounding anesthesia or deep sedation.

Your healthcare professionals should determine whether medication needs to be adjusted or temporarily stopped.

Side Effects and Adverse Events

This page does not contain every possible side effect or drug interaction.

Contact your Provider if you experience new, persistent, severe, or concerning symptoms.

You may also contact the dispensing Pharmacy with questions concerning:

• the formulation;
• preparation;
• labeling;
• storage;
• medication appearance; or
• dispensing.

If you believe you are experiencing a medical emergency, call 911 or seek emergency medical care.

Important

Do not start, stop, increase, decrease, combine, or otherwise change a prescription medication without consulting your Provider.

Your Provider’s individualized instructions and the Pharmacy label supplied with your medication control over general information on this page.

Florida Weight-Loss Consumer Notice

The following notice is provided in accordance with the Florida Commercial Weight-Loss Practices Act where applicable.

You Have a Right To:

1. Ask questions about the potential health risks of this program and its nutritional content, psychological support, and educational components.
2. Receive an itemized statement of the actual or estimated price of the weight-loss program, including extra products, services, supplements, examinations, and laboratory tests.
3. Know the actual or estimated duration of the program.
4. Know the name, address, and qualifications of the dietitian or nutritionist who has reviewed and approved the weight-loss program as required by applicable Florida law.

Questions regarding your Alexis program may be directed to:

Alexis Life LLC

[email protected]