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Drug overview for EGRIFTA WR (tesamorelin acetate):
Generic name: TESAMORELIN ACETATE (TES-a-moe-REL-in)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Tesamorelin acetate is a synthetic analog of human growth hormone-releasing factor (GHRF).
No enhanced Uses information available for this drug.
Generic name: TESAMORELIN ACETATE (TES-a-moe-REL-in)
Drug class: Growth Hormone Modulators
Therapeutic class: Endocrine
Tesamorelin acetate is a synthetic analog of human growth hormone-releasing factor (GHRF).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for EGRIFTA WR (tesamorelin acetate) have been approved by the FDA:
Indications:
Lipodystrophy associated with human immunodeficiency virus infection
Professional Synonyms:
None.
Indications:
Lipodystrophy associated with human immunodeficiency virus infection
Professional Synonyms:
None.
The following dosing information is available for EGRIFTA WR (tesamorelin acetate):
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 | DOSING INSTRUCTIONS |
|---|---|---|
| EGRIFTA WR 11.6 MG VIAL | Maintenance | Adults inject 1.28 mg by subcutaneous route once daily in the abdomen, rotating injection sites daily. |
| EGRIFTA WR 11.6MG FOUR-VL KIT | Maintenance | Adults inject 1.28 mg by subcutaneous route once daily in the abdomen, rotating injection sites daily. |
No generic dosing information available.
The following drug interaction information is available for EGRIFTA WR (tesamorelin acetate):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for EGRIFTA WR (tesamorelin acetate):
Drug contraindication overview.
*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.
*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.
There are 7 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Hypothalamic-pituitary insufficiency |
| Lactation |
| Malignancy |
| Pituitary insufficiency |
| Pregnancy |
| Radiation therapy of cranium |
| Transsphenoidal hypophysectomy |
There are 0 severe contraindications.
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Acute respiratory failure |
| Diabetes mellitus |
| Edema |
The following adverse reaction information is available for EGRIFTA WR (tesamorelin acetate):
Adverse reaction overview.
Adverse effects reported in >5% of patients receiving tesamorelin were arthralgia, injection site erythema, injection site pruritus, extremity pain, peripheral edema, and myalgia.
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 0 severe adverse reactions.
There are 26 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Arthralgia Body fluid retention Hyperglycemia Injection site erythema Injection site sequelae Myalgia Peripheral edema |
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 |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for EGRIFTA WR (tesamorelin acetate):
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.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
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 states that there is no information on the use of tesamorelin in patients older than 65 years of age with HIV-associated lipodystrophy.
The following prioritized warning is available for EGRIFTA WR (tesamorelin acetate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for EGRIFTA WR (tesamorelin acetate)'s list of indications:
| Lipodystrophy associated with HIV | |
| E88.1 | Lipodystrophy, not elsewhere classified |
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