Tesamorelin is a synthetic peptide analog of human growth hormone-releasing hormone (GHRH). It has garnered attention for its potential benefits, particularly in reducing abdominal fat in individuals with HIV-associated lipodystrophy. However, like any medication, it's crucial to understand both its potential advantages and possible side effects.
What is Tesamorelin?
Tesamorelin is a peptide comprising 44 amino acids and is a synthetic form of human growth hormone-releasing hormone (GHRH) analog. Human growth hormone (HGH) is essential for stimulating bone, cartilage, and muscle growth and increasing protein production. Tesamorelin may release HGH by binding to growth hormone-releasing hormone receptors, stimulating the somatotropic cells, causing synthetic production of the hormone. It was developed to treat lipodystrophy, a condition causing abnormal fat distribution or loss of fat tissue, often seen in HIV/AIDS patients receiving antiretroviral therapy. In 2010, the FDA approved tesamorelin for treating HIV-related lipodystrophy. The brand name version, Egrifta, is available with a prescription.
Benefits of Tesamorelin
Reduction of Visceral Adipose Tissue (VAT)
Tesamorelin is known for targeting visceral fat in the abdominal area. Treatment of HIV patients with daily tesamorelin resulted in a significant decrease in visceral adipose tissue (VAT). Studies have shown a sustained reduction of VAT by -18% over 52 weeks of treatment compared to baseline. Research has proven tesamorelin’s efficacy in improving body composition. People with abdominal fat accumulation could benefit from the peptide.
Improvement in Lipid Profiles
Clinical trials have demonstrated that tesamorelin can improve lipid profiles in individuals with HIV-associated lipodystrophy. Treatment with tesamorelin resulted in sustained decreases in triglycerides over 52 weeks. Similar sustained beneficial effects were seen for total cholesterol.
Potential Benefits for Bodybuilding and Muscle Development
Tesamorelin supports growth hormone release, which may help with lean muscle development, fat reduction, and recovery. Some athletes and bodybuilders tout tesamorelin as a beneficial booster in their regime. Tesamorelin has gained increasing attention among athletes and bodybuilders. Many consider it a safer, better alternative to OTC medication or steroids. Tesamorelin stimulates HGH production, increasing insulin-like growth factor 1 (IGF-1). IGF-1 may promote bodybuilding via satellite cells, which are skeletal muscle cell precursors. HGH and IGF-1 could decrease the breakdown of muscles.
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Other Potential Benefits
Growth hormone-releasing hormone (GHRH) secretagogues like tesamorelin could aid nerve regeneration. Athletes may choose peptides that stimulate HGH production, like tesamorelin, for other benefits.
Side Effects of Tesamorelin
While generally well-tolerated, tesamorelin can cause side effects in some individuals.
Common Side Effects
- Soreness, swelling, or fatigue at the injection site
- Muscle or joint discomfort
- Pain or numbness in the hands or wrist
- Tingling, numbness, or a pricking sensation
- Redness, itching, pain, bruising, bleeding, or swelling at the site of the injection
- Joint or muscle pain
- Pain in the arms or legs
- Vomiting
- Heartburn
- Night sweats
Most of these side effects tend to fade or become easier to manage after six weeks of treatment.
Serious Side Effects
Although rare, some serious side effects can occur:
- Rash, hives, itching, flushing of the skin
- Swelling of the face or throat
- Shortness of breath, difficulty breathing
- Fast heartbeat
- Dizziness or fainting
If any of these serious side effects occur, seek immediate medical attention.
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Other Potential Side Effects and Risks
- Glucose intolerance: Long-term tesamorelin use may cause glucose intolerance. Its impact on IGF-1 production could affect insulin levels. Changes in glucose parameters over 52 weeks were not clinically significant and similar to those after 26 weeks.
- Fluid retention: This drug may cause you to swell or keep fluid in your body.
- Increased risk of cancer: Using this medicine may increase your risk of getting cancer. Talk to your doctor if you have concerns about this risk.
- Injection site reactions: This medicine may cause injection site reactions. Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.
- Allergic reactions: This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have difficulty in swallowing, fast heartbeat, skin itching, rash, or redness, swelling of the face, throat, or tongue, or trouble breathing after receiving this medicine.
Important Considerations Before Using Tesamorelin
Before using tesamorelin injection, tell your doctor or pharmacist:
- If you are allergic to this drug, any part of this drug, or any other drugs, foods, or substances.
- About all other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- If you have ever received radiation therapy in the area of the head or brain; if you recently had a head accident or trauma; or if you have or have ever had pituitary gland surgery, a pituitary gland tumor, or any other problems related to your pituitary gland. Also tell your doctor if you have or have ever had cancer or any kind of growth or tumor. Your doctor may tell you not to use tesamorelin injection.
- If you have recently had heart or stomach surgery, or if you have or have ever had diabetes, breathing problems, or kidney or liver disease.
- If you are pregnant or plan to become pregnant. Tesamorelin may harm the fetus.
- If you are breast-feeding or plan to breast-feed. You should not breast-feed if you are infected with HIV or are using tesamorelin injection.
- If you are having surgery, including dental surgery, tell the doctor or dentist that you are using tesamorelin injection.
Contraindications
Tesamorelin is contraindicated in certain conditions:
- Allergy to tesamorelin or any of its components.
- Pregnancy: Tesamorelin can harm an unborn baby or cause birth defects.
- Breastfeeding: Women with HIV or AIDS should not breastfeed a baby.
- Active cancer or a history of cancer.
Dosage and Administration
Tesamorelin injection comes as a powder to be mixed with the liquid provided with your medication and injected subcutaneously (under the skin). It is injected once a day. Use tesamorelin injection at around the same time every day. Use tesamorelin injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. You should inject tesamorelin into the skin of your stomach area below the navel (belly button). Do not inject tesamorelin into the navel or into any scarred, reddened, irritated, infected, or bruised areas of skin. Do not inject tesamorelin into any areas with hard bumps from previous injections. Choose a different area for each injection to help prevent bruising and irritation. Keep track of the areas where you inject tesamorelin, and do not give an injection into the same spot two times in a row.
Instructions for Use
- Preparation: Your medication comes in 2 boxes: one box with tesamorelin injection vials and another with vials containing liquid to mix with the medication, needles, and syringes. Ask your pharmacist or doctor to show you how to mix and inject the medication. Be sure to ask your pharmacist or doctor if you have any questions about how to inject this medication. Prepare your dose in a syringe only when you are ready to give yourself an injection.
- Inspection: You should always look at tesamorelin injection solution (liquid) after mixing and before you inject it. The solution should be clear and colorless with no particles in it. Do not use tesamorelin injection solution if it is colored, cloudy, contains particles, or if the expiration date on the bottle has passed.
- Injection Site: Tesamorelin is injected under the skin. You will be shown how to use injections at home. This medication comes with injection instructions for safe and effective use. Follow these directions carefully. Use a different place on your stomach each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject tesamorelin into scar tissue or on skin that is bruised.
- Needle Disposal: Never reuse syringes or needles, and never share needles with another person. Do not share syringes with another person even if the needle was changed. Sharing needles and syringes can cause the spread of certain diseases, such as HIV. If you accidently prick someone with a used needle, tell him to talk to his healthcare provider right away. Dispose of any remaining tesamorelin injection, extra liquid used to mix the injection, and used needles and syringes in a puncture-resistant container made of hard plastic or metal that has a lid. Never throw used needles or syringes into the trash. Ask your doctor or pharmacist how to dispose of the puncture-resistant container and all other used materials.
Dosage Forms and Strengths
There are two Egrifta formulations (Egrifta WR and Egrifta SV) with different recommended dosages. Egrifta WR only needs to be reconstituted once a week.
- Inactive ingredients (Egrifta SV): histidine, mannitol, polysorbate 20, sucrose. Hydrochloric acid may be used to adjust the pH. The pH of Egrifta SV is between 4.5 and 7.4. After reconstitution with 0.5 mL of Sterile Water for Injection, the resultant concentration is 2 mg/0.5 mL, and the solution is clear and colorless.
- Inactive ingredients (Egrifta WR): hydrochloric acid, hydroxypropyl betadex, mannitol, sodium hydroxide. After reconstitution with 1.3 mL of Bacteriostatic Water for Injection, USP, the resultant concentration is 8 mg/mL, and the solution is clear and colorless. Bacteriostatic Water for Injection, USP contains benzyl alcohol as a preservative.
What happens when you stop using tesamorelin?
Once you stop, growth hormone levels will gradually return to baseline.
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Drug Interactions
Tesamorelin can interact with other medications. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Tesamorelin in Sports and Athletics
Tesamorelin has gained increasing attention among athletes and bodybuilders. Many consider it a safer, better alternative to OTC medication or steroids.
From an ethics perspective, tesamorelin falls under S2.2.4 of the WADA’s Prohibited List. Peptides could help burn fat and build muscle. Tesamorelin has performance-enhancement potential and may boost several areas of your fitness regime. It’s excellent for casual exercise, bodybuilding, and sports. Athletes are responsible for complying with governing bodies and anti-doping policies. Frequently checking the prohibited substances list helps avoid trouble. Some athletes may get a therapeutic use exemption (TUE) for medically approved reasons. TUEs allow the use of WADA-prohibited substances in some cases. Different sports may have unique rules for using peptides and other substances. Some countries also have national anti-doping regulations.
Future Outlook
Predicting the future of tesamorelin use in athletics and sports is challenging. Rules and regulations constantly change regarding substances. Currently, the FDA only approves tesamorelin for use in treating HIV-related lipodystrophy. The use of growth hormone (GH) in sports is also a controversial subject. Professional and public opinions on peptides are divided. Tesamorelin needs a shift in the majority’s attitude toward it. Athletes should monitor research developments and encourage further studies. The fundamental values of sports and athletics involve fair competition. Substances that enhance physical performance and change physiological processes are unfair.
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