Egrifta WR
Pronunciation: e-griff-ta W-R
Generic name: tesamorelin F8
Dosage form: injection for subcutaneous use (11.6 mg/vial)
Drug class: Growth hormones
What is Egrifta WR?
Egrifta WR 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.
- Not indicated for weight loss management.
- There are no data to support improved compliance with antiretroviral HIV medications.
Egrifta (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.
- Egrifta WR is a new formulation that is injected daily, but only needs weekly reconstitution.
- It requires less than half the administration volume of Egrifta SV, 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.
Egrifta WR received FDA approval on March 25, 2025. There is no generic.
Lipodystrophy and HIV
Lipodystrophy in HIV patients involves abnormal fat distribution and metabolism. This condition manifests as either fat accumulation (lipohypertrophy) around organs, neck, and breasts (more common in women), or fat loss (lipoatrophy) in extremities and face (more common in men).
While the exact cause remains unknown, both HIV infection itself and certain antiretroviral medications contribute to its development. Lipodystrophy often accompanies metabolic complications, including high cholesterol, insulin resistance, and increased cardiovascular disease risk.
Mechanism
Egrifta WR (tesamorelin) works to reduce excess abdominal fat in HIV-infected patients with lipodystrophy through several key mechanisms:
- It is a synthetic analog of growth hormone-releasing hormone (GHRH), which stimulates the pituitary gland to produce and release growth hormone.
- The increased growth hormone levels help reduce visceral adipose tissue (VAT), which is the fat that accumulates around internal organs in the abdomen.
- Growth hormone has lipolytic (fat-breaking) properties that specifically target visceral fat cells, promoting the breakdown of triglycerides in these cells.
- Egrifta helps improve insulin sensitivity and glucose metabolism, which can be disrupted in HIV patients with lipodystrophy.
The medication does not affect subcutaneous fat (the fat just under the skin), focusing instead on the metabolically active visceral fat that is associated with increased health risks. The reduction in visceral fat occurs gradually over several months of treatment.
Egrifta WR belongs to the drug class called growth hormone-releasing factor (GHRF) analogs.
Side effects
The most common side effects of Egrifta WR are:
- pain in legs and arms
- muscle pain
Serious side effects and warnings
The long-term safety of Egrifta WR on the heart and blood vessels (cardiovascular) is unknown.
It is unknown if Egrifta WR is safe and effective in children and should not be used in children because it is unknown how it may affect open or closed bone growth plates (epiphyses).
Egrifta WR may cause the following serious side effects:
- Increased risk of new cancer in HIV positive patients or reactivation of cancer. Stop using Egrifta WR if any cancer symptoms come back.
- Increased levels of your insulin-like growth factor-1 (IGF-1). Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking Egrifta WR..
- Swelling (fluid retention). Egrifta WR can cause swelling in some parts of your body. Call your healthcare provider if you have swelling, an increase in joint pain or pain or numbness in your hands or wrist (carpal tunnel syndrome). Joint pain and swelling of your arms, hands, legs and feet are common side effects but may sometimes be serious.
- Increase in blood sugar (glucose) levels or diabetes. Your healthcare provider will check your blood sugar before you start taking Egrifta WR and during treatment..
- Serious allergic reactions. Some people using Egrifta WR may have an allergic reaction. Stop using this medicine and get emergency medical help right away if you have any of the following symptoms:
- a rash over your body
- hives
- swelling of your face or throat
- shortness of breath or trouble breathing
- fast heartbeat
- itching
- feeling of faintness or fainting
- reddening or flushing of the skin.
- Injection site reactions. Injection site reactions are a common side effect of Egrifta WR but may sometimes be serious. Change (rotate) your injection site to help lower your risk for injection site reactions. Call your healthcare provider for medical advice if you have any of the following symptoms around the area of the injection site:
- redness
- itching
- pain
- irritation
- bruising or bleeding
- rash
- swelling
- Increased risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing (respiratory) problems has occurred when taking certain amounts of growth hormone.
These are not all the possible side effects of Egrifta WR. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or Thera Patient Support toll-free at 1-833-23THERA (1-833-238-4372).
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Before taking
Do not use Egrifta WRif you:
- have a pituitary gland tumor, have had pituitary gland surgery, have other problems related to your pituitary gland, or have
- had radiation treatment to your head or a head injury.
- have active cancer. Any previous cancer should be inactive, and any previous cancer treatment should be complete before starting Egrifta WR.
- are allergic to tesamorelin or any of the ingredients in Egrifta WR.
Before using Egrifta WR, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had cancer
- have problems with your blood sugar or diabetes. Some people with diabetes who use Egrifta WRmay develop or may have worsening eye problems.
- have scheduled heart or stomach surgery
- have breathing problems
- are pregnant or plan to become pregnant
- are breastfeeding or plan to breastfeed.
Pregnancy
Egrifta WRcan harm your unborn baby. If you become pregnant, stop using Egrifta WR and talk with your healthcare provider.
Breastfeeding
It is not known if Egrifta WR passes into your breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to their baby.
Talk with your healthcare provider about the best way to feed your baby if you are using Egrifta WR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Egrifta WR?
Read the detailed Instructions for Use that comes with Egrifta WR before you start using it. Your healthcare provider will show you how to inject it.
- Use it exactly as your healthcare provider tells you to use it.
- Inject Egrifta WR under the skin (subcutaneously) of your stomach area (abdomen).
- Change (rotate) the injection site on your stomach area with each dose.
- Do not inject into scar tissue, bruises, or your belly button.
- There are two Egrifta formulations (Egrifta WR and Egrifta SV) with different recommended dosages. They are not substitutable.
Do not share your Egrifta WR syringe or needles with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
Dosing information
The dose of Egrifta WR is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously once daily.
- Use only the diluent provided, Bacteriostatic Water for Injection, USP, to reconstitute Egrifta WR.
- Reconstitute one vial of lyophilized powder with 1.3 mL of diluent. Move the vial in a circle (swirl) to mix all the powder and liquid. Do not shake.
- Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless, and without particulate matter.
- One reconstituted vial provides daily doses for 7 days. Discard unused solution of Egrifta WR 7 days after mixing.
What other drugs will affect this medicine?
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take
- Cytochrome P450-metabolized drugs, such as statins, warfarin, theophylline, some SSRIs like sertraline and citalopram, and codeine. Your healthcare provider will need to monitor you for potential interactions with Egrifta WR.
- Glucocorticoids, such as prednisone, prednisolone, dexamethasone, methylprednisolone, and hydrocortisone: Patients receiving glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses following initiation of Egrifta WR.
This is not a complete list of interactions. See the Egrifta WR Prescribing Information for a complete list.
Storage
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 WRvial 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 (as an acetate salt)
Inactive ingredients: hydrochloric acid, hydroxypropyl betadex, mannitol, sodium hydroxide
Egrifta WR does not contain preservative. Bacteriostatic Water for Injection contains benzyl alcohol as a preservative.
Manufacturer
Egrifta WR(tesamorelin) is manufactured by Theratechnologies Inc., based in Montréal, Québec, Canada.
Biological Products Related to Egrifta
Find detailed information on biosimilars for this medication.
References
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