Important Safety Information

Emergency Notice

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

This page summarizes important safety considerations for treatments that may be discussed through Elantris. It is not a substitute for medical advice, diagnosis, treatment, prescribing information, pharmacy instructions, or consultation with a licensed healthcare provider.

Advertising and Service Role

Advertisements and website materials from Elantris are intended to describe Elantris services and may include examples, actors, illustrations, or customer experiences. Individual results vary and are not guaranteed.

Elantris provides technology, administrative, and coordination services. Elantris does not practice medicine, prescribe medication, dispense medication, manufacture medication, or operate as a pharmacy. Licensed healthcare providers determine whether treatment is appropriate, and licensed pharmacies are responsible for dispensing medications when prescriptions are issued.

Prescriptions and Treatment Availability

Prescription treatments require evaluation by a licensed healthcare provider. A provider may determine that a treatment is not appropriate for you. Access to any prescription, treatment plan, medication, pharmacy, dose, or product is not guaranteed.

Tell your provider about all medical conditions, allergies, medications, supplements, pregnancy or breastfeeding status, and prior reactions to medications before starting treatment.

Compounded Medications

Some providers may prescribe compounded medications when clinically appropriate. Compounded medications are prepared by licensed compounding pharmacies for individual patients. They are not FDA-approved and FDA does not review compounded products for safety, effectiveness, or manufacturing quality in the same way as FDA-approved drugs.

Compounded products may differ from commercially available FDA-approved products in ingredients, concentration, route, dosage form, packaging, inactive ingredients, or instructions. Follow only the instructions provided by your provider and pharmacy.

Reporting Side Effects

Report side effects or adverse reactions promptly to your healthcare provider and the pharmacy that dispensed your medication. You may also report suspected adverse reactions to FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088.

GLP-1 and Related Weight Management Treatments

GLP-1 and related medications, including semaglutide and tirzepatide, may be used for chronic weight management in certain adults when prescribed by a licensed healthcare provider and used with nutrition, physical activity, and other lifestyle changes.

These medications may not be appropriate for everyone. Your provider should evaluate your medical history, current medications, risk factors, and treatment goals.

Semaglutide Safety Considerations

Semaglutide is a GLP-1 receptor agonist. FDA-approved semaglutide products include boxed warnings and important warnings. Compounded semaglutide products are not FDA-approved.

Do not use semaglutide if:

• You or a family member has had medullary thyroid carcinoma.
• You have Multiple Endocrine Neoplasia syndrome type 2.
• You have had a serious allergic reaction to semaglutide or any ingredient in the product.
• You are pregnant, planning pregnancy, or breastfeeding unless your provider specifically advises otherwise.

Semaglutide may cause serious side effects, including:

• Possible thyroid tumors, including cancer.
• Pancreatitis.
• Gallbladder problems.
• Low blood sugar, especially when used with insulin or medications that increase insulin.
• Kidney problems related to dehydration from nausea, vomiting, or diarrhea.
• Serious allergic reactions.
• Diabetic retinopathy complications in people with type 2 diabetes.
• Increased heart rate.
• Mood changes, depression, or suicidal thoughts.

Common side effects may include nausea, vomiting, diarrhea, constipation, stomach pain, indigestion, headache, fatigue, dizziness, gas, bloating, belching, heartburn, and injection-site reactions.

Seek medical help promptly for severe abdominal pain, signs of allergic reaction, symptoms of low blood sugar, vision changes, severe dehydration, yellowing of the skin or eyes, or new or worsening mood changes.

Tirzepatide Safety Considerations

Tirzepatide is a GIP and GLP-1 receptor agonist. FDA-approved tirzepatide products include boxed warnings and important warnings. Compounded tirzepatide products are not FDA-approved.

Do not use tirzepatide if:

• You or a family member has had medullary thyroid carcinoma.
• You have Multiple Endocrine Neoplasia syndrome type 2.
• You have had a serious allergic reaction to tirzepatide or any ingredient in the product.
• You are pregnant, planning pregnancy, or breastfeeding unless your provider specifically advises otherwise.

Tirzepatide may cause serious side effects, including:

• Possible thyroid tumors, including cancer.
• Severe gastrointestinal reactions.
• Pancreatitis.
• Gallbladder problems.
• Low blood sugar, especially when used with insulin or medications that increase insulin.
• Kidney problems related to dehydration from nausea, vomiting, or diarrhea.
• Serious allergic reactions.
• Diabetic retinopathy complications in people with type 2 diabetes.
• Mood changes, depression, or suicidal thoughts.

Common side effects may include nausea, vomiting, diarrhea, constipation, stomach pain, indigestion, injection-site reactions, fatigue, allergic reactions, belching, hair loss, and heartburn.

Tell your provider if you use insulin, sulfonylureas, diabetes medications, oral contraceptives, or any medication that may be affected by delayed stomach emptying.

Injection and Dosing Safety

Use medication only as prescribed. Do not change your dose, dosing schedule, injection method, or stop treatment without speaking with your provider.

For injectable medications, follow the instructions from your provider and pharmacy. Use clean technique, rotate injection sites, do not share needles or syringes, and dispose of sharps safely.

Pregnancy, Breastfeeding, and Fertility

Weight management medications may not be appropriate during pregnancy or breastfeeding. If you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed, tell your provider before starting or continuing treatment.

Some medications may need to be stopped before a planned pregnancy. Your provider should advise you based on the specific medication and your medical history.

Oral Medications and Tablets

Some oral medications or tablets may be offered or discussed as part of a treatment plan. These products may have different risks, interactions, timing requirements, food restrictions, and contraindications than injectable treatments.

Follow pharmacy instructions exactly. Tell your provider about all medications and supplements you take, including over-the-counter products.

Wellness Injections and Non-GLP Products

Certain wellness injections, supplements, or compounded products may be discussed through Elantris. These products may not be FDA-approved to diagnose, treat, cure, or prevent disease.

Potential risks can include injection-site reactions, allergic reactions, lightheadedness, nausea, headache, flushing, fatigue, infection, dosing errors, and interactions with medications or medical conditions. Your provider should determine whether these products are appropriate for you.

Drug Interactions

Tell your provider and pharmacist about all prescription medications, over-the-counter medications, vitamins, supplements, and herbal products you use.

Some medications may affect blood sugar, hydration, heart rate, mood, digestion, absorption of oral medications, or other treatment risks. Your provider may need to adjust your plan or monitor you more closely.

Not Comprehensive

This page is not comprehensive and may not include every risk, contraindication, interaction, or side effect. Always read medication guides, pharmacy instructions, prescription labels, and provider instructions. Contact your healthcare provider with questions before starting, stopping, or changing any treatment.

Contact

Questions about Elantris services may be sent to privacy@elantris.com.