Egrifta Wr (tesamorelin acetate)
Growth Hormone Modulators Subcutaneous Kit
Last reviewed · Source: First Databank (FDB) drug data
Overview
Tesamorelin acetate is a synthetic analog of human growth hormone-releasing factor (GHRF).
Tesamorelin acetate is a synthetic analog of human growth hormone-releasing factor (GHRF), which stimulates the synthesis and release of endogenous growth hormone (GH) from pituitary somatotroph cells. Tesamorelin contains the 44 amino acid sequence of human GHRF that retains its biologic activity, but has been modified to include a hydrophobic side chain at the N-terminal, which improves stability over the naturally occurring peptide. This structural modification prevents enzymatic degradation by dipeptidyl peptidase-4 (DPP-4) and increases potency of the drug.
The mechanism of action of tesamorelin is not fully understood, but is thought to be related to an increased secretion of GH, which is found to be deficient in human immunodeficiency virus (HIV)-infected patients with lipodystrophy. GH produces anabolic and lipolytic effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes. The primary effect of GH is stimulation of skeletal and visceral growth, while other functions include modulation of protein, lipid, and carbohydrate metabolism; stimulation of fat mobilization; and promotion of body fat redistribution from an abdominal to a more peripheral distribution.
Some, but not all, of these effects are mediated by insulin-like growth factor1 (IGF-1).
Tesamorelin has been shown in vitro to bind to and stimulate GHRF receptors with similar potency to that of the native protein. Like endogenous GHRF, tesamorelin acts on pituitary somatotroph cells to stimulate the synthesis and pulsatile release of GH, which in turn increases the secretion of IGF-1 by the liver and peripheral tissues. Tesamorelin does not appear to substantially affect levels of other pituitary hormones (i.e., thyroid-stimulating hormone (TSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), prolactin).
USES: This medication is used to reduce excess fat in the stomach area (abdomen) in people with HIV infection who have changes in the way their body fat is distributed. Some HIV drugs may cause this side effect (increased fat in the upper back and stomach areas, decreased fat in the arms and legs). Tesamorelin works by causing your body to make more growth hormone.
This medication should not be used for weight loss.
Generic name: tesamorelin acetate
Pronunciation: (TES-a-moe-REL-in)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Egrifta Wr
Indications
The following indications are listed for Egrifta Wr:
- Lipodystrophy Associated With Human Immunodeficiency Virus Infection
Dosing
Dosage of tesamorelin acetate is expressed in terms of tesamorelin.
The administration, preparation, and dosage recommendations only apply to the 2-mg per vial formulation of tesamorelin acetate (Egrifta SV(R)) currently available in the US; the previously available 1-mg per vial formulation (Egrifta(R)) had different administration and dosage recommendations.
Tesamorelin acetate is administered by subcutaneous injection into the abdomen once daily. Injection sites should be rotated to different areas of the abdomen to reduce the risk of injection site reactions. Injections should not be made into scarred or bruised sites or into the navel.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Egrifta Wr 11.6 Mg Vial | Maintenance | Inject 1.28 mg by subcutaneous route once daily in the abdomen, rotating injection sites daily. |
| Egrifta Wr 11.6Mg Four-Vl Kit | Maintenance | Inject 1.28 mg by subcutaneous route once daily in the abdomen, rotating injection sites daily. |
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma.
*Active malignancy. Any preexisting malignancy should be inactive and its treatment complete before initiating tesamorelin therapy.
*Known hypersensitivity to tesamorelin acetate or any ingredient in the formulation.
*Pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and may result in fetal harm.
- Hypothalamic-pituitary insufficiency
- Lactation
- Malignancy
- Pituitary insufficiency
- Pregnancy
- Radiation therapy of cranium
- Transsphenoidal hypophysectomy
There are no severe contraindications for this drug.
- Acute respiratory failure
- Diabetes mellitus
- Edema
Adverse reactions
Adverse effects reported in >5% of patients receiving tesamorelin were arthralgia, injection site erythema, injection site pruritus, extremity pain, peripheral edema, and myalgia.
There are no severe adverse reactions for this drug.
More Frequent
- Arthralgia
- Body fluid retention
- Hyperglycemia
- Injection site erythema
- Injection site sequelae
- Myalgia
- Peripheral edema
Less Frequent
- Abdominal pain with cramps
- Carpal tunnel syndrome
- Depression
- Dyspepsia
- Flushing
- Hypertension
- Hypoesthesia
- Insomnia
- Musculoskeletal pain
- Nausea
- Night sweats
- Pain
- Pain in extremities
- Palpitations
- Paresthesia
- Pruritus of skin
- Skin rash
- Urticaria
- Vomiting
Precautions
No enhanced messaging available.
Safety and efficacy of tesamorelin acetate have not been established in pediatric patients. Tesamorelin therapy in pediatric patients with open epiphyses may result in linear growth acceleration and excessive growth. The manufacturer states that tesamorelin acetate is not indicated for use in pediatric patients with open or closed epiphyses.
Tesamorelin is contraindicated in pregnancy. Visceral adipose tissue increases during pregnancy as a result of normal metabolic and hormonal changes. Modification of this process with tesamorelin offers no known clinical benefit and can result in fetal harm.
It is not known whether tesamorelin is distributed into human milk and its effects on milk production and the breastfed infant also are not known. Because of the risk of adverse effects in the infant and the risk of HIV transmission (in HIV-negative infants) and the development of viral resistance (in HIV-positive patients), HIV-infected women receiving tesamorelin should not breast-feed infants.
The manufacturer makes no specific dosage recommendations for geriatric patients.
The manufacturer states that there is no information on the use of tesamorelin in patients older than 65 years of age with HIV-associated lipodystrophy.
ICD codes
| Code | Type | Description |
|---|---|---|
| Lipodystrophy associated with human immunodeficiency virus infection | ||
| E88.14 | ICD10CM | HIv-associated lipodystrophy |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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