Tesamorelin
Pronunciation: TES a moe REL in
Generic name: tesamorelin
Brand names: Egrifta SV, Egrifta WR
Dosage form: subcutaneous powder for injection (2 mg/vial), injection for subcutaneous use (11.6 mg/vial)
Drug class: Growth hormones
What is tesamorelin?
Tesamorelin is used to reduce excess stomach-area (abdominal) fat in HIV-infected adult patients with lipodystrophy. It is injected subcutaneously (under the skin) once a day.
Tesamorelin is made with growth hormone-releasing factor (GRF).
Tesamorelin for injection is the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. It is available in 2 formulations, Egrifta SV and Egrifta WR.
- Egrifta WR is a new formulation that was FDA approved on March 25, 2025. It is injected daily, but only needs weekly reconstitution.
- Egrifta WR requires less than half the administration volume of Egrifta SV (approved October 19, 2019), which is reconstituted daily.
- These 2 formulations are not substitutable because they have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements.
Tesamorelin is not a weight-loss medication and should not be used to treat obesity.
Tesamorelin side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tesamorelin and call your doctor at once if you have a serious side effect such as:
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swelling in your hands, ankles, or feet;
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pain or stiffness in your muscles or joints;
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pain in your arms or legs;
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wrist pain or numbness;
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numbness or tingling in your hands or fingers;
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pounding heartbeats or fluttering in your chest;
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high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss);
Less serious side effects may include:
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depressed mood, sleep problems (insomnia);
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night sweats;
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mild rash or itching;
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nausea, vomiting, upset stomach;
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pain, redness, itching, swelling, bruising, bleeding, or other irritation where the injection was given;
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects tothe FDA at 1-800-FDA-1088.
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Warnings
Tesamorelin can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
You should not use tesamorelin if you are allergic to it, or if you have a history of tumor or surgery of your pituitary gland, a history of head injury, or radiation treatment,
Before using tesamorelin, tell your doctor if you have heart disease, high blood pressure, kidney disease, diabetes, epilepsy, asthma, migraines, an adrenal gland disorder, or if you have ever had cancer, any type of tumor, or open heart surgery.
Also, tell your doctor about any major illness or recent trauma, or medical emergency.
Before taking this medicine
You should not use tesamorelin if you are allergic to it, or if you have:
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cancer;
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a pituitary gland disorder;
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a history of pituitary gland tumor or surgery;
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a history of head injury or radiation treatment; or
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if you are pregnant.
To make sure you can safely take tesamorelin, tell your doctor if you have any of these other conditions:
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a history of cancer or any tumor (either benign or malignant);
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heart disease, high blood pressure;
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kidney disease;
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diabetes, eye problems caused by diabetes;
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epilepsy
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asthma;
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migraine headaches;
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adrenal gland disorder;
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if you have ever had open heart surgery; or
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if you have any major illness, a recent trauma, or a medical emergency.
FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use tesamorelin if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Do not give tesamorelin to a child without medical advice.
How is tesamorelin given?
Tesamorelin is injected under the skin. You will be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
This medication comes with injection instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Tesamorelin is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.
- Tesamorelin is usually given once per day. Follow your doctor's dosing instructions very 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 into the same place two times in a row.
- Never share a tesamorelin syringe with another person, even if you change the needle. Sharing syringes or needles can allow HIV or other diseases to pass from one person to another.
There are two Egrifta formulations (Egrifta WR and Egrifta SV) with different recommended dosages. They are not substitutable.
To make sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested often. Do not miss any follow-up visits to your doctor.
Egrifta SV
Egrifta SV needs to be reconstituted daily.
Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.
Egrifta WR
Egrifta WR only needs to be reconstituted once a week. Once reconstituted, the vial will provide enough doses for 7 days.
- After mixing and injecting on the first day, keep the Egrifta WR vial in your Medication Box, at room temperature at 20°C to 25°C (68°F to 77°F).
- Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless, and without particulate matter.
- Throw away (discard) any unused Egrifta WR 7 days after mixing.
Dosing information
Usual Adult Dose for Lipodystrophy (Egrifta SV):
- 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily.
Usual Adult Dose for Lipodystrophy (Egrifta WR)
- 1.28 mg (0.16 mL of the reconstituted solution) subcutaneously once daily.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose of tesamorelin.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using tesamorelin?
Do not inject tesamorelin into scar tissue or on skin that is bruised. Do not inject directly into your navel (belly-button).
What other drugs will affect tesamorelin?
Tell your doctor about all other medicines you use, especially:
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testosterone or hormone replacement therapy;
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seizure medication;
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steroids;
This list is not complete, and many other drugs can interact with tesamorelin. 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. Keep a list of all your medicines and show it to any healthcare provider who treats you.
Storage
Egrifta SV
Store vials of tesamorelin powder in the refrigerator; do not freeze.
Store the diluent at room temperature away from moisture, heat, and light.
Throw away any unused vials after the expiration date on the label has passed.
Egrifta WR
You will be given two boxes (Medication Box and Injection Box) from the pharmacy when you get your prescription of Egrifta WR:
- Store the 11.6 mg Egrifta WR vials in the Medication Box they come in, at room temperature between 68°F to 77°F (20°C to 25°C).
- Store the Bacteriostatic Water for Injection, syringes, needles, and alcohol swabs that come in the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Egrifta WR vials out of the light. Do not freeze.
After mixing and injecting on the first day, keep the Egrifta WR vial in your Medication Box, at room temperature at 20°C to 25°C (68°F to 77°F).
- Throw away (discard) any unused Egrifta WR 7 days after mixing.
- Throw away (discard) any Bacteriostatic Water for Injection left in the bottle 28 days after first use.
- Do not use Egrifta WR after the expiration date (EXP) printed on the carton and vial labels.
Keep out of the reach of children.
Ingredients
Active ingredient: tesamorelin
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. Only 1.4 mg (0.35 mL) needs to be given for each dose.
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. Only 1.28 mg (0.16 mL) needs to be given for each dose.
Manufacturer
Egrifta SV and Egrifta WR (tesamorelin) are manufactured by Theratechnologies Inc., based in Montréal, Québec, Canada.
Tesamorelin Biosimilars
Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.
Reference products
These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for tesamorelin.
Egrifta (tesamorelin) - Theratechnologies Inc.
Formulation type | Strength |
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Single-Dose Vial | 1 mg Discontinued |
View Egrifta information in detail.
Egrifta SV (tesamorelin) - Theratechnologies Inc.
Formulation type | Strength |
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Single-Dose Vial | 2 mg |
View Egrifta SV information in detail.
References
More about tesamorelin
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