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GLP-1 safety information

Pepti compounds semaglutide and tirzepatide. The safety information below is summarized from the FDA-approved prescribing information for these active ingredients. Please read it carefully and discuss it with your healthcare provider before starting treatment.

If at any point during treatment you experience any of the serious side effects described below, contact your healthcare provider immediately or call 911.

Compounded medications are not FDA-approved. A licensed provider determines whether treatment is appropriate, and results may vary. The information on this page is summarized from FDA-approved prescribing information and medication guides for semaglutide- and tirzepatide-containing products and is provided for educational purposes; it is not a substitute for medical advice from your provider.

Active ingredient · GLP-1 receptor agonist

Semaglutide

Pepti compounds semaglutide, a GLP-1 receptor agonist. The safety information below is summarized from the FDA-approved prescribing information for semaglutide and should be reviewed carefully with your provider before starting treatment.

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS — In rodents, semaglutide causes thyroid C-cell tumors. It is unknown whether semaglutide causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of semaglutide-induced rodent thyroid C-cell tumors has not been determined. Semaglutide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

How it's used

Semaglutide is used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight with at least one weight-related condition. Your prescribing physician determines whether semaglutide is appropriate for you, along with your dose and schedule.

Limitations of Use:

  • •Should not be used together with other semaglutide-containing products or with any other GLP-1 receptor agonist.
  • •Has not been studied in patients with a history of pancreatitis.
  • •The safety and effectiveness of semaglutide in combination with other products for weight management have not been established.

Contraindications

Do not use semaglutide if you have:

  • •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • •Known hypersensitivity to semaglutide or to any of the excipients in the formulation.

Administration

Administered by subcutaneous injection in the abdomen, thigh, or upper arm once weekly, on the same day each week, at any time of day, with or without meals. Rotate injection sites with each dose.

Before starting treatment

  • •Disclose all current medications, including insulin and insulin secretagogues (sulfonylureas), oral medications, and oral hormonal contraceptives.
  • •Disclose any history of pancreatitis, gallbladder disease, severe gastrointestinal disease (including gastroparesis), diabetic retinopathy, suicidal behavior or ideation, and kidney problems.
  • •Notify your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding.

Serious side effects to monitor

Semaglutide may cause serious side effects, including:

Thyroid tumors, including thyroid cancer

Watch for a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath.

Inflammation of the pancreas (pancreatitis)

Severe pain in the stomach area that will not go away, with or without vomiting, which may radiate to the back.

Gallbladder problems

Pain in the upper stomach, fever, yellowing of skin or eyes, or clay-colored stools.

Low blood sugar (hypoglycemia)

Especially when used with insulin or sulfonylureas. Watch for dizziness, blurred vision, confusion, sweating, and fast heartbeat.

Kidney problems (kidney failure)

Severe nausea, vomiting, and diarrhea can lead to dehydration and kidney problems.

Serious allergic reactions

Swelling of the face, lips, tongue, or throat; breathing problems; severe rash; or fainting. Get medical help right away.

Changes in vision (diabetic retinopathy)

Changes in vision during treatment should be reported to your provider.

Depression or thoughts of suicide

Monitor for new or worsening depression, mood changes, or suicidal thoughts and contact your provider right away.

Increased heart rate

Tell your provider if you have a racing heartbeat at rest.

If you experience any of these symptoms, contact your healthcare provider or call 911.

Common side effects

The most common side effects of semaglutide include:

NauseaDiarrheaVomitingConstipationStomach painHeadacheTirednessIndigestionDizzinessBloatingBurpingGasHeartburn

Active ingredient · GIP and GLP-1 receptor agonist

Tirzepatide

Pepti compounds tirzepatide, a dual GIP and GLP-1 receptor agonist. The safety information below is summarized from the FDA-approved prescribing information for tirzepatide and should be reviewed carefully with your provider before starting treatment.

Boxed Warning

WARNING: RISK OF THYROID C-CELL TUMORS — In male and female rats, tirzepatide causes a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors after lifetime exposure. It is unknown whether tirzepatide causes such tumors in humans, including medullary thyroid carcinoma (MTC). Tirzepatide is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness).

How it's used

Tirzepatide is used as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or who are overweight in the presence of at least one weight-related condition. Your prescribing physician determines whether tirzepatide is appropriate for you, along with your dose and schedule.

Limitations of Use:

  • •Should not be used together with other tirzepatide-containing products or with any GLP-1 receptor agonist.
  • •Has not been studied in patients with a history of pancreatitis.
  • •The safety and effectiveness of tirzepatide in combination with other products for weight management have not been established.

Contraindications

Do not use tirzepatide if you have:

  • •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
  • •Known serious hypersensitivity to tirzepatide or to any of the excipients in the formulation.

Administration

Administered by subcutaneous injection in the abdomen, thigh, or upper arm once weekly, on the same day each week, with or without meals. Rotate injection sites with each dose.

Before starting treatment

  • •Disclose all current medications, including insulin and insulin secretagogues (sulfonylureas), oral medications, and oral hormonal contraceptives.
  • •Disclose any history of pancreatitis, gallbladder disease, severe gastrointestinal disease (including gastroparesis), diabetic retinopathy, suicidal behavior or ideation, and kidney problems.
  • •Notify your healthcare provider if you are pregnant, plan to become pregnant, or are breastfeeding. Tirzepatide may cause fetal harm.

Serious side effects to monitor

Tirzepatide may cause serious side effects, including:

Thyroid tumors, including thyroid cancer

Watch for a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath.

Inflammation of the pancreas (pancreatitis)

Severe pain in the stomach area that will not go away, with or without vomiting. The pain may radiate to the back.

Severe stomach problems

Stomach problems, sometimes severe, including delayed gastric emptying, have been reported.

Kidney problems (kidney failure)

Severe diarrhea, nausea, and vomiting can cause dehydration and may cause kidney problems.

Serious allergic reactions

Swelling of the face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; or fainting. Get medical help right away.

Gallbladder problems

Pain in the upper stomach, fever, yellowing of skin or eyes, or clay-colored stools.

Low blood sugar (hypoglycemia)

Risk is higher when used with insulin or sulfonylureas. Watch for dizziness, blurred vision, confusion, sweating, and fast heartbeat.

Changes in vision (diabetic retinopathy)

Tell your provider if you have changes in vision during treatment.

Depression or thoughts of suicide

Pay attention to new or worsening changes in mood, behavior, or thoughts, and contact your provider right away.

If you experience any of these symptoms, contact your healthcare provider or call 911.

Common side effects

The most common side effects of tirzepatide include:

NauseaDiarrheaVomitingConstipationStomach (abdominal) painIndigestionDecreased appetiteInjection site reactionsFatigueBurpingHeartburn

Report an adverse event

If you experience a negative side effect, tell your prescribing provider. You may also report side effects to the FDA directly: call FDA MedWatch at 1-800-FDA-1088 or visit www.fda.gov/medwatch. To reach Pepti, use our contact page.

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