Medications Safety Information

Compound Semaglutide Safety Information

Your medical provider may recommend compounded semaglutide based on a medical review. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness, or quality standards. This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider. Compounded drugs are permitted to be prescribed under federal law but are not FDA-approved and do not undergo safety, effectiveness, or manufacturing review. Your provider may recommend certain doses of compounded semaglutide based on your medical evaluation.

Indications and Use

Compounded semaglutide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight (overweight), who may also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity. Compounded semaglutide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of 27 kg/m² or higher. Compounded semaglutide should not be used with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines. It is not known if compounded semaglutide is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if compounded semaglutide can be used in people who have had pancreatitis. It is not known if compounded semaglutide is safe and effective for use in children under 18 years of age.

Important Safety Information: Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if compounded semaglutide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. Do not use compounded semaglutide if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Limitations of Use

Compounded semaglutide should not be used in combination with other semaglutide-containing products or any other GLP-1/GIP receptor agonist medicines. The safety and efficacy of coadministration with other products for weight loss have not been established. Compounded semaglutide has not been studied in patients with a history of pancreatitis. Note: Compounded medications are not FDA approved and do not have indications for treatment as an FDA approved medication would.

Who Should Not Use Compounded Semaglutide?

Do not use compounded semaglutide if:

• You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to compounded semaglutide.

How Should Compounded Semaglutide Be Administered?

You can take compounded semaglutide with or without food. The pre-filled vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks. You should not change your dosing regimen or stop taking compounded semaglutide as prescribed without discussing with your provider first.

What Should I Tell My Provider Before Using Compounded Semaglutide?

Compounded semaglutide has certain drug interactions. It's important to tell your provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

Some medications to watch out for include:

• Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL). Compounded semaglutide causes a delay in gastric emptying, so it has the potential to impact the absorption of medications taken by mouth at the same time.
• Other GLP-1/GIP medications, including Wegovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
• Other products for weight loss, including dietary supplements.

In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior

Pregnancy and Breastfeeding

• If you are pregnant: Compounded semaglutide should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
• If you are of reproductive potential: Discontinue compounded semaglutide at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
• If you are breastfeeding: Compounded semaglutide was found in the milk of lactating rats. At this time, we do not recommend taking compounded semaglutide if you are breastfeeding or bottle-feeding with breastmilk.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

Side Effects

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use semaglutide. If any of these effects last or get worse, tell your provider or pharmacist promptly. Many people using this medication do not have serious side effects. Vomiting/diarrhea that doesn't stop may result in dehydration. Contact your provider promptly if you notice any symptoms of dehydration, such as unusual dry mouth/thirst or dizziness/lightheadedness.

Tell your provider right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), vision changes, fast heartbeat, mental/mood changes (such as depression, thoughts of suicide), or signs of low blood sugar.

Get medical help right away if you have any very serious side effects, including: signs of pancreas or gallbladder disease (such as nausea/vomiting that doesn't stop, severe stomach/abdominal pain) or symptoms of a serious allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing).

This is not a complete list of possible side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Serious Side Effects to Monitor

• Thyroid C-Cell Tumors: In mice and rats, semaglutide caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether compounded semaglutide causes thyroid C-cell tumors in humans.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
• Acute Gallbladder Disease: Compounded semaglutide may cause gallbladder problems, including gallstones. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
• Low Blood Sugar (Hypoglycemia): Compounded semaglutide may lower blood glucose. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
• Acute Kidney Injury: Diarrhea, nausea, and vomiting may cause dehydration which may worsen kidney problems. Drink plenty of water to help reduce your chance of dehydration.
• Serious Allergic Reactions: Stop using compounded semaglutide right away if you experience swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
• Diabetic Retinopathy: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
• Suicidal Behavior and Ideation: Pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings.
• Never Share a Vial/Needle/Syringe: Sharing poses a risk of infection.

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

Legal Disclaimers

Compounded semaglutide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality. Zepbound and Mounjaro are registered trademarks of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S. Byetta and Bydureon are registered trademarks of Amylin Pharmaceuticals, Inc.

Compound Tirzepatide Safety Information

Your medical provider may recommend compounded tirzepatide based on a medical review. Compounded drugs are not FDA approved and are not evaluated for safety, effectiveness, or quality standards. This document is a summary of product information and does NOT have all possible information and potential side effects of the product. This is not medical advice and does not substitute advice from your health care provider.

Indications and Use

Compounded tirzepatide is an injectable prescription medicine that may help adults and adolescents with obesity and excess weight, who may also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity. Compounded tirzepatide is a synthetic glucagon-like peptide-1 (GLP-1) receptor agonist used for chronic weight management for people with an initial BMI of 27 kg/m² or higher.

Important Safety Information: Warning: Risk of Thyroid C-Cell Tumors

In studies with mice and rats, tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if compounded tirzepatide will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. Do not use compounded tirzepatide if you or any of your family have ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Limitations of Use

Compounded tirzepatide should not be used in combination with other tirzepatide-containing products or any other GLP-1/GIP receptor agonist medicines. The safety and efficacy of coadministration with other products for weight loss have not been established. Compounded tirzepatide has not been studied in patients with a history of pancreatitis.

Who Should Not Use Compounded Tirzepatide?

• You or any of your family have ever had medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You have a known allergic reaction to compounded tirzepatide.

How Should Compounded Tirzepatide Be Administered?

The pre-filled vial is self-administered with a needle and syringe as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your provider will guide you on a treatment regimen that may include an increase in dose every four weeks. You should not change your dosing regimen or stop taking compounded tirzepatide as prescribed without discussing with your provider first.

What Should I Tell My Provider Before Using Compounded Tirzepatide?

Compounded tirzepatide has certain drug interactions. Tell your provider all medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.

In particular, tell your provider if you have a past history of:

• Type 1 or type 2 diabetes
• Thyroid cancer
• Pancreatitis
• Kidney disease
• Diabetic retinopathy
• Depression
• Suicidal thoughts or behavior

Pregnancy and Breastfeeding

• If you are pregnant: Compounded tirzepatide should not be used during pregnancy.
• If you are of reproductive potential: Discontinue at least 2 months before a planned pregnancy.
• If you are breastfeeding: Compounded tirzepatide was found in the milk of lactating rats. We do not recommend taking compounded tirzepatide if you are breastfeeding.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

Side Effects

Nausea, vomiting, stomach upset, diarrhea, tiredness, dizziness, or constipation may occur. Nausea usually lessens as you continue to use tirzepatide. Get medical help right away for signs of pancreas or gallbladder disease or a serious allergic reaction.

This is not a complete list of possible side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Serious Side Effects to Monitor

• Thyroid C-Cell Tumors: Compounded tirzepatide is contraindicated in patients with a family history of MTC or MEN 2.
• Inflammation of Pancreas (Acute Pancreatitis): Monitor for severe abdominal pain that does not go away, sometimes radiating to the back.
• Acute Gallbladder Disease: Tell your provider right away if you have pain in your upper stomach, jaundice, fever, or clay-colored stools.
• Low Blood Sugar (Hypoglycemia): Monitor your blood sugar if you also take other glucose control medications.
• Acute Kidney Injury: Drink plenty of water to help reduce your chance of dehydration.
• Serious Allergic Reactions: Stop using compounded tirzepatide right away if you experience symptoms of a serious allergic reaction.
• Diabetic Retinopathy: Tell your provider right away if you experience changes in vision.
• Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
• Suicidal Behavior and Ideation: Pay attention to any mental health changes.
• Never Share a Vial/Needle/Syringe: Sharing poses a risk of infection.

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

Legal Disclaimers

Compounded tirzepatide is not approved by the FDA. The FDA does not evaluate compounded products for safety, effectiveness, or quality. Zepbound and Mounjaro are registered trademarks of Eli Lilly and Company. Ozempic, Wegovy, Saxenda, and Victoza are registered trademarks of Novo Nordisk A/S.

Zepbound® (tirzepatide) Safety Information

In rats, Zepbound® (tirzepatide) caused thyroid tumors, including thyroid cancer. It is not known if Zepbound® (tirzepatide) will cause thyroid tumors or medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. Do not use Zepbound® (tirzepatide) if you or any of your family have ever had MTC or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA-Approved Use

Zepbound® (tirzepatide) is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial BMI of 30 kg/m² or greater (obesity) or 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition.

Who Should Not Use Zepbound®?

• You or any family member have ever had medullary thyroid carcinoma (MTC) or MEN 2.
• You have a known allergic reaction to Zepbound® (tirzepatide).

Drug Interactions

• Medications for diabetes, including insulin or sulfonylureas.
• Hormonal birth control: Zepbound® may decrease efficacy. Use a non-oral or barrier method for 4 weeks after starting and after each dose escalation until reaching a maintenance dose.
• Other GLP-1 medications including Wegovy®, Ozempic®, Saxenda®, Mounjaro®, Victoza®, Byetta®, or Bydureon®.

Most Common Side Effects

• Nausea, diarrhea, vomiting, constipation, stomach pain, indigestion
• Injection site reactions, fatigue, allergic reactions, belching, hair loss
• Gastroesophageal reflux disease (heartburn)

You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. This information is not comprehensive. Please see the full Prescribing Information for complete safety information.

Disclaimer: Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Ozempic®, WeGovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk. Healis Health has no affiliation with Novo Nordisk or Eli Lilly. The compounded products available as part of Healis Health's Weight Loss Program are not made by Novo Nordisk or Eli Lilly or any company affiliated with them.

Wegovy® (Semaglutide) Safety Information

In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® (semaglutide) will cause thyroid tumors or MTC in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. Do not use Wegovy® (semaglutide) if you or any of your family have ever had MTC or MEN 2.

FDA-Approved Use

Wegovy® (semaglutide) is a GLP-1 receptor agonist for chronic weight management along with a reduced calorie diet and increased physical activity for people with an initial BMI of 30 kg/m² or greater (obesity) or 27 kg/m² or greater (overweight) with at least one weight-related comorbid condition.

Pregnancy and Breastfeeding

• If you are pregnant: Wegovy® (semaglutide) should not be used during pregnancy.
• If you are of reproductive potential: Discontinue at least 2 months before a planned pregnancy.
• If you are breastfeeding: Talk to your provider about the risks before using Wegovy®.
• Pregnancy registry: Contact Novo Nordisk at 1-800-727-6500.

Most Common Side Effects

• Nausea, diarrhea, vomiting, constipation, abdominal pain, headache
• Fatigue, dyspepsia, dizziness, abdominal distension, flatulence
• Gastroenteritis, gastroesophageal reflux disease
• Hypoglycemia in patients with type 2 diabetes

Contact Novo Nordisk Inc. at 1-833-934-6891 or FDA MedWatch at 1-800-FDA-1088 / fda.gov/medwatch.

Disclaimer: Ozempic®, WeGovy® and Saxenda® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. Healis Health has no affiliation with Novo Nordisk or Eli Lilly. The compounded products available as part of Healis Health's Weight Loss Program are not made by Novo Nordisk or Eli Lilly.

Mounjaro® (tirzepatide) Safety Information

Mounjaro® (tirzepatide) injection may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. Do not use Mounjaro® (tirzepatide) injection if you or any of your family have ever had MTC or MEN 2.

FDA-Approved Use

Mounjaro® (tirzepatide) injection is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). It is not for use in people with type 1 diabetes. It is not known if Mounjaro® is safe and effective for use in children under 18 years of age.

How Should I Take Mounjaro®?

The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Change your injection site each week. Your Healis provider will guide you on a treatment regimen that may include dose increases every four weeks.

Drug Interactions

• Medications for diabetes including insulin or sulfonylureas.
• Oral hormonal contraceptives: Mounjaro® may decrease efficacy. Use a non-oral or barrier method for 4 weeks after starting and after each dose escalation.
• Other GLP-1 medications including Zepbound®, Wegovy®, Ozempic®, Saxenda®, Victoza®, Byetta®, or Bydureon®.

Pregnancy and Breastfeeding

• If you are pregnant: Mounjaro® should not be used during pregnancy.
• If you are of reproductive potential: Use a non-oral or barrier contraceptive method for 4 weeks after starting and after each dose escalation.
• If you are breastfeeding: It is not known if Mounjaro® passes into breast milk. Talk to your provider about the risks.
• Pregnancy registry: Contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

Testosterone Safety Information

Indications / Use

• Primary hypogonadism (congenital or acquired) in men.
• Hypogonadotropic hypogonadism (congenital or acquired) in men.
• Delayed puberty in adolescent males (selected cases, typically short-term).

Contraindications

• Known or suspected prostate cancer or breast cancer in men.
• Pregnancy and breastfeeding.
• Hypersensitivity to testosterone or any component of the formulation.
• Serious cardiac, hepatic, or renal disease (risk of edema).
• Elevated hematocrit (>54%).
• Untreated/uncontrolled sleep apnea.

Side Effects

• Common: Acne, oily skin, increased hair growth, gynecomastia, mood changes, hot flashes/night sweats.
• Cardiovascular: Hypertension.
• Hematologic: Polycythemia (increased hematocrit).
• Hepatic: Liver dysfunction, hepatotoxicity (more common with oral 17-alpha alkylated androgens).
• Reproductive: Reduced sperm production (infertility), testicular atrophy, erection changes.
• Other: Poor sleep, sleep apnea worsening, edema, nipple sensitivity.

Important Precautions

• Transference risk: With topical formulations, avoid skin contact with others (especially children) after application. Testosterone can be transferred by vaporization for 4–6 hours after application.
• Monitoring: Regularly monitor serum testosterone levels, hemoglobin/hematocrit, liver function, lipid profile, and PSA (prostate-specific antigen) in men.
• Risk of abuse/misuse: Testosterone can be misused for performance enhancement, leading to serious cardiovascular and psychiatric side effects.
• Pediatric use: Risk of premature closure of growth plates in children.

Administration

Testosterone can be administered as a subcutaneous or intramuscular injection, topical cream, or oral dissolvable tablet. In most cases, Healis prescribes via the subcutaneous route. Always follow the guidance of your healthcare provider before starting or adjusting any medication regimen. Rotate injection sites with each weekly injection to prevent tissue damage. Use a sharps container to dispose of all used needles.

Enclomiphene

Enclomiphene is not FDA-approved. It is used off-label for male hypogonadism and infertility. The main indications include: low testosterone with correlating symptoms, desire to preserve fertility, or avoidance of testosterone products.

• Contraindications: Known hypersensitivity to enclomiphene or related compounds; liver disease; pituitary or hypothalamic tumors; elevated prolactin levels.
• Side Effects: Hot flashes/night sweats, mood swings, headache, visual disturbances, nausea, testicular discomfort, thromboembolic risk (rare).