Egrifta SV
Pronunciation: e-griff-ta S-V
Generic name: tesamorelin F4
Dosage form: subcutaneous powder for injection (2 mg)
Drug class: Growth hormones
What is Egrifta SV?
Egrifta SV 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 SV is an older formulation that requires daily reconstitution and administration.
- 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 SV received FDA approval on October 19, 2019. There is no generic.
Mechanism
Egrifta SV (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 SV belongs to the drug class called growth hormone-releasing factor (GHRF) analogs.
Side effects
The most common side effects of Egrifta SV are:
- pain in legs and arms
- muscle pain
Serious side effects and warnings
The long-term safety of Egrifta SV on the heart and blood vessels (cardiovascular) is unknown.
It is unknown if Egrifta SV 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 SV may cause the following serious side effects:
- Increased risk of new cancer in HIV positive patients or reactivation of cancer. Stop using Egrifta SV 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 SV..
- Swelling (fluid retention). Egrifta SV 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 wrists (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 SV and during treatment.
- Serious allergic reactions. Some people using Egrifta SV 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 SV 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 SV. 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).
Related/similar drugs
Myalept
Myalept (metreleptin) is used to treat complications caused by leptin deficiency in people who have ...
Genotropin
Genotropin is a human growth hormone used to treat growth failure in children and adults who lack ...
Ozempic
Learn about Ozempic (semaglutide) for type 2 diabetes treatment, weight management, cardiovascular ...
Humatrope
Humatrope injection (somatropin) is a human growth hormone used to treat growth failure in children ...
Ngenla
Ngenla is a long-acting human growth hormone used to treat children aged 3 and older who are not ...
Norditropin
Norditropin is used to treat growth hormone deficiency (GHD) in adults and children and other ...
Norditropin FlexPro
Norditropin FlexPro is used for adult human growth hormone deficiency, idiopathic short stature ...
Nutropin
Nutropin is used for adult human growth hormone deficiency, growth retardation, chronic renal ...
Nutropin AQ
Nutropin AQ (somatropin) is an injectable preparation that may be used to treat children with ...
Before taking
Do not use Egrifta SV if 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 SV
- are allergic to tesamorelin or any of the ingredients in Egrifta SV.
Before using Egrifta SV, 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 SV may 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 SV can harm your unborn baby. If you become pregnant, stop using Egrifta SV and talk with your healthcare provider.
Breastfeeding
It is not known if Egrifta SV 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 SV. 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 SV?
Read the detailed Instructions for Use that comes with Egrifta SV 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 SV 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 SV and Egrifta SV) with different recommended dosages. They are not substitutable.
Do not share your Egrifta SV 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.
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.
Dosing information
Usual Adult Dose for Lipodystrophy: 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily.
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 SV
- 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 SV.
This is not a complete list of interactions. See the Egrifta SV Prescribing Information for a complete list.
Storage
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.
Keep out of the reach of children.
Ingredients
Active ingredient: tesamorelin
Inactive ingredients: 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.
Manufacturer
Egrifta SV (tesamorelin) is manufactured by Theratechnologies Inc., based in Montréal, Québec, Canada.
Egrifta 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 Egrifta.
Egrifta (tesamorelin) - Theratechnologies Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 1 mg Discontinued |
View Egrifta information in detail.
Egrifta SV (tesamorelin) - Theratechnologies Inc.
Formulation type | Strength |
---|---|
Single-Dose Vial | 2 mg |
View Egrifta SV information in detail.
References
More about Egrifta (tesamorelin)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (20)
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: growth hormones
- En español
Patient resources
Professional resources
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.