Tesamorelin Safety Information
Brand Names: Egrifta, Egrifta WR Drug Class: Growth Hormone-Releasing Factor (GRF) Analog Route: Subcutaneous injection (abdomen) FDA-Approved Indication: Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy
Important Safety Information for Tesamorelin
Please read this safety information carefully before starting tesamorelin. This page summarizes key safety data from the FDA-approved prescribing information. It does not include all possible risks, side effects, or drug interactions. Always talk to your Strut Health provider if you have questions about your treatment.
Warnings
Tesamorelin does not carry an FDA black box warning.
However, the following warnings apply:
- Do not use tesamorelin if you have any of the following:
- A disrupted hypothalamic-pituitary axis (from pituitary surgery, pituitary tumor, head irradiation, or head trauma)
- An active malignancy (cancer) of any kind -- any prior malignancy must be inactive and treatment must be complete before starting tesamorelin
- A known allergy to tesamorelin or any of its inactive ingredients
- If you are pregnant or plan to become pregnant
- Pregnancy: Tesamorelin is contraindicated during pregnancy. In animal studies, tesamorelin caused hydrocephaly (fluid on the brain) and delayed skull development in offspring. There is no benefit to visceral fat reduction during pregnancy. If you become pregnant while taking tesamorelin, stop the medication immediately and contact your doctor.
- Administration: Tesamorelin is given as a subcutaneous (under the skin) injection into the abdomen. Rotate your injection site with each dose to reduce the risk of injection site reactions. Do not inject into scar tissue, bruises, or areas that are red or irritated.
- Your doctor should check your blood glucose (blood sugar) levels before starting treatment and periodically during treatment
- Your IGF-1 (insulin-like growth factor 1) levels should be monitored -- 47% of patients in clinical trials had IGF-1 levels above the normal range at 26 weeks
- If you are diabetic, your doctor should monitor you for diabetic eye disease (retinopathy)
- If you do not see a reduction in abdominal fat after 12 weeks of treatment, your doctor may consider discontinuing tesamorelin
- Tumor and malignancy risk: Tesamorelin stimulates your body's production of growth hormone, which raises IGF-1 levels. Elevated IGF-1 may promote the growth of existing tumors. If you have a history of any treated cancer, your doctor will carefully weigh the risks and benefits before prescribing this medication. If cancer recurs during treatment, tesamorelin should be discontinued.
- Acute critical illness: Increased mortality has been reported in critically ill patients receiving growth hormone therapy following open heart surgery, abdominal surgery, multiple trauma, or acute respiratory failure. Tesamorelin should be discontinued if you become critically ill.
Before Taking This Medication
Tell your Strut Health provider about all of your medical conditions, including if you:
- Have or have had any type of cancer
- Have diabetes or prediabetes
- Have a history of pituitary gland problems
- Have a history of head injury or head/brain radiation therapy
- Have fluid retention, swelling, joint pain, or carpal tunnel syndrome
- Have liver or kidney problems
- Are pregnant, planning to become pregnant, or breastfeeding
- Are taking any prescription or over-the-counter medications, vitamins, or supplements
Age restriction: Tesamorelin is not approved for use in patients under 18 years of age. Safety and effectiveness have not been established in pediatric patients. Tesamorelin is not recommended in children or adolescents because it may cause accelerated linear growth in those with open epiphyses (growth plates).
Drug Interactions
Tesamorelin may affect how your body processes certain medications. Tell your doctor about all medications you are taking, especially:
- Corticosteroids (such as prednisone, hydrocortisone) -- Tesamorelin increases growth hormone, which may reduce your body's ability to convert cortisone to cortisol. If you are on glucocorticoid replacement therapy, your doctor may need to increase your maintenance or stress doses.
- Sex steroids (such as estrogen, testosterone) -- Growth hormone may change how your body clears these medications. Your doctor may need to adjust your dose.
- Anticonvulsants (seizure medications) -- Growth hormone may alter how these drugs are metabolized. Your doctor should monitor your levels and may adjust your dose.
- Cyclosporine (an immunosuppressant) -- Growth hormone may change how your body processes cyclosporine. Your doctor should monitor drug levels.
- Simvastatin (a cholesterol-lowering medication) -- Tesamorelin caused a minor (8%) decrease in simvastatin blood levels in clinical studies. This is generally not clinically significant, but your doctor should be aware.
- Ritonavir (an HIV protease inhibitor) -- Tesamorelin caused a minor (9%) decrease in ritonavir blood levels in clinical studies. This is generally not clinically significant, but your doctor should be aware.
General note: Because tesamorelin stimulates growth hormone production, it may modulate CYP450 enzyme activity in the liver. This can affect the clearance of many medications. Always provide your doctor with a complete list of everything you are taking.
Side Effects
Seek immediate medical attention if you experience:
- Signs of a severe allergic reaction: difficulty breathing, swelling of the face, lips, tongue, or throat, severe skin rash or hives, rapid heartbeat, dizziness, or fainting
- Hypersensitivity reactions occurred in approximately 4% of patients in clinical trials and may include itching, skin redness, flushing, hives, or rash -- if you suspect an allergic reaction, stop your injection and seek medical care immediately
Stop taking tesamorelin and contact your doctor right away if you experience:
- Symptoms of high blood sugar or new-onset diabetes: increased thirst, frequent urination, blurred vision, fatigue (in clinical trials, 5% of patients on tesamorelin developed elevated HbA1c levels compared to 1% on placebo)
- Significant or worsening swelling in your hands, feet, or ankles
- Numbness, tingling, or pain in your wrist or hand (possible carpal tunnel syndrome)
- Severe or persistent joint pain
- Signs of a new or returning cancer
- Any sudden, unexplained worsening of your health
Common side effects include:
- Injection site reactions -- redness, itching, rash, pain, swelling, irritation, or bruising at the injection site. Rotating your injection site on the abdomen may help reduce these reactions.
- Joint pain (arthralgia)
- Pain in arms or legs
- Swelling in hands or feet (peripheral edema)
- Muscle pain (myalgia)
- Numbness or tingling (paresthesia)
- Decreased sensation (hypoesthesia)
- Skin rash
- Carpal tunnel syndrome
Most fluid retention-related side effects (swelling, joint pain, carpal tunnel) are typically transient and may resolve on their own or after discontinuation of treatment.
Immune response: Approximately 50% of patients developed antibodies to tesamorelin during clinical trials. In studies, this did not affect how well the medication worked.
Disclaimers
- Off-label use: Tesamorelin (Egrifta/Egrifta WR) is FDA-approved specifically for the reduction of excess abdominal fat in HIV-infected adults with lipodystrophy. If your provider prescribes tesamorelin for visceral fat reduction outside of this approved indication, this is considered "off-label" use. Off-label prescribing is a legal and common medical practice in which a physician prescribes an FDA-approved medication for a use other than its originally approved indication, based on clinical judgment and available evidence.
- Compounded medications: If your prescription is filled as a compounded formulation of tesamorelin, please be aware that compounded medications are not FDA-approved. Compounding pharmacies are regulated by state boards of pharmacy and/or the FDA under Section 503A or 503B of the Federal Food, Drug, and Cosmetic Act, but compounded preparations have not undergone the same FDA review for safety, efficacy, and manufacturing quality as commercially manufactured, FDA-approved products.
- This page is not a substitute for medical advice. The information provided here is for educational purposes and does not replace the judgment of your prescribing physician. Your Strut Health provider has reviewed your medical history and determined that this medication may be appropriate for you. Always follow your provider's specific instructions.
- Long-term cardiovascular safety of tesamorelin has not been established in clinical studies.
.png){kind=icon}
.png){kind=icon}
.png)
.svg){kind=icon}
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)
.png)