Tesamorelin Safety Information

Tesamorelin is a synthetic analog of growth hormone-releasing hormone (GHRH) that stimulates the pituitary gland to produce and secrete growth hormone. It has been studied for its effect on visceral adipose tissue, the deep abdominal fat surrounding the organs.

At Belle, Tesamorelin is offered in compounded injectable form, prescribed when deemed clinically appropriate by a licensed healthcare provider. Please review the following important safety information before beginning treatment.

What Is Tesamorelin?

Tesamorelin is FDA-approved for one specific condition: the reduction of excess abdominal fat in adults with HIV-associated lipodystrophy. Use of compounded tesamorelin for general body composition, weight-related goals, or wellness purposes is off-label and has not been evaluated or approved by the FDA for those uses. It is not intended to diagnose, treat, cure, or prevent any disease.

Always consult your healthcare provider before beginning any injectable regimen, especially if you have pre-existing health conditions.

Who Should Not Use Tesamorelin

Tesamorelin should not be used by individuals who:

Are allergic to tesamorelin, mannitol, or any ingredient in the formulation

Are pregnant, may become pregnant, or are breastfeeding

Have an active malignancy (cancer)

Have a disrupted hypothalamic-pituitary axis, including pituitary tumor or surgery, head irradiation, or head trauma

Have untreated or uncontrolled chronic illness without supervision from a licensed provider

Precautions and Warnings

Inform your provider if you have or have had:

Diabetes, prediabetes, or blood sugar dysregulation. Tesamorelin can impair glucose tolerance and your provider may monitor blood sugar during treatment

Any history of cancer, including benign or malignant neoplasms. Tesamorelin raises IGF-1 levels, and the effect of sustained elevation on neoplasm risk is not established

Fluid retention, edema, or carpal tunnel syndrome

Cardiovascular conditions

Kidney or liver disease

Thyroid conditions, including hypothyroidism

Tell your provider about all medications you take, including any GLP-1 medication such as semaglutide or tirzepatide, insulin, or other diabetes treatments.

Common Side Effects

Most side effects associated with tesamorelin are mild and temporary. They may include:

Injection site redness, itching, swelling, or discomfort

Joint pain or muscle pain

Swelling in the hands, feet, or lower legs

Numbness or tingling, particularly in the hands

Nausea or vomiting

Rash or itching

Muscle stiffness

If you experience any severe or prolonged symptoms, notify your provider immediately.

Serious Reactions (Rare)

In rare cases, patients may experience:

Hypersensitivity or allergic reaction

New or worsening glucose intolerance, or new-onset diabetes

Significant fluid retention

Worsening of pre-existing conditions

Stop treatment and seek medical attention immediately if you experience trouble breathing, chest pain, or swelling of the face, lips, or throat.

Use and Administration

Use tesamorelin only as directed by your licensed provider.

Do not exceed the prescribed dosage or frequency.

Tesamorelin is administered via subcutaneous injection, on the schedule your provider sets.

Rotate injection sites to reduce the chance of local reactions.

If you miss a dose, contact your provider for guidance before resuming.

Report any adverse effects or unexpected symptoms during treatment.

Storage and Disposal

Store tesamorelin as directed on the pharmacy label, typically refrigerated and protected from light. Do not use expired products. Dispose of needles and syringes in an approved sharps container. Keep out of reach of children.