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Tesamorelin: Drug information

Tesamorelin: Drug information
(For additional information see "Tesamorelin: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Egrifta SV;
  • Egrifta [DSC]
Brand Names: Canada
  • Egrifta [DSC]
Pharmacologic Category
  • Growth Hormone Releasing Factor
Dosing: Adult

Note: Egrifta 1 mg vials have been discontinued in the United States for >1 year.

HIV-associated lipodystrophy

HIV-associated lipodystrophy: SubQ:

1 mg vial: 2 mg once daily.

2 mg vial: 1.4 mg once daily.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Adjustment for Toxicity: Adult

Consider discontinuing with persistent elevations of IGF-1 (eg, >3 standard deviation scores). Discontinue if symptoms of hypersensitivity occur.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. The incidence of adverse reactions generally decreases with treatment continued beyond 26 weeks.

10%:

Immunologic: Antibody development (47% to 50%; neutralizing: 5% to 10%)

Local: Injection site reaction (17% to 25%)

Neuromuscular & skeletal: Arthralgia (13%)

1% to 10%:

Cardiovascular: Peripheral edema (6%), palpitations (1%)

Central nervous system: Paresthesia (5%), hypoesthesia (4%), pain (2%), carpal tunnel syndrome (1%)

Dermatologic: Skin rash (4%), pruritus (2%), night sweats (1%)

Gastrointestinal: Vomiting (3%), dyspepsia (2%)

Hematologic & oncologic: Diabetes mellitus (5%), elevated glycosylated hemoglobin (5%)

Hypersensitivity: Hypersensitivity reaction (4%)

Neuromuscular & skeletal: Limb pain (6%), myalgia (6%), muscle rigidity (2%), musculoskeletal pain (2%), increased creatine phosphokinase in blood specimen (1%), joint swelling (1%), muscle strain (1%)

Contraindications

Hypersensitivity to tesamorelin or any component of the formulation; disruption of hypothalamic-pituitary-axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation, or head trauma; active malignancy; pregnancy.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Hypersensitivity reactions (eg, pruritus, erythema, flushing, urticaria, rash) may occur. If hypersensitivity is suspected, discontinue and instruct patient to seek immediate medical attention.

• Fluid retention: Use may result in peripheral edema manifested by increased skin turgor and musculoskeletal discomfort. May be transient or resolve upon treatment discontinuation.

• Injection-site reactions: Injection-site reactions (including erythema, pruritus, pain, irritation, and bruising) may occur. Rotating the site of injection to different areas of the abdomen may reduce incidence of reactions.

Disease-related concerns:

• Diabetes: May increase risk of development of diabetes due to glucose intolerance. Evaluate glucose status prior to treatment initiation; monitor periodically for glucose metabolism changes. Patients with diabetes should be monitored for the development or worsening of retinopathy due to increased IGF-1 levels.

• Malignancy: Release of endogenous growth hormone and increased serum IGF-1 may increase the risk for development or reactivation of malignancies. Use is contraindicated in patients with active malignancies; treatment for prior malignancy should be completed prior to initiation of tesamorelin. IGF-1 levels should be monitored during treatment; consider discontinuing with persistent IGF-1 elevations (eg, >3 standard deviation scores). Discontinue treatment with any evidence of recurrent malignancy.

• Acute critical illness: Growth hormone is associated with an increased risk of mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery, trauma, or acute respiratory failure. Consider discontinuing in critically ill patients.

Special populations:

• Pediatric: Should not be used in children due to risk of excess growth (gigantism); do not use in children with open or closed epiphyses.

Other warnings/precautions:

• Appropriate use: Not indicated for weight loss management. Due to a lack of long-term cardiovascular safety/benefit data, carefully consider whether continuation of treatment is warranted in patients who do not demonstrate efficacy (based on degree of reduction of visceral adipose tissue). There are no data supporting improved compliance of antiretroviral therapy with concomitant tesamorelin.

Product Availability

Egrifta 1 mg vials have been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Subcutaneous:

Egrifta SV: 2 mg (1 ea)

Solution Reconstituted, Subcutaneous [preservative free]:

Egrifta: 1 mg (1 ea [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Egrifta SV Subcutaneous)

2 mg (per each): $291.68

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution Reconstituted, Subcutaneous:

Egrifta: 1 mg ([DSC])

Administration: Adult

SubQ: The abdomen is the preferred site of administration; rotate site within the abdomen. Avoid injection into scar tissue, bruises, or the navel.

Use: Labeled Indications

HIV-associated lipodystrophy: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy

Medication Safety Issues
Sound-alike/look-alike issues:

Tesamorelin may be confused with temsirolimus

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Cortisone: Tesamorelin may decrease serum concentrations of the active metabolite(s) of Cortisone. Risk C: Monitor therapy

Macimorelin: Products that Affect Growth Hormone may diminish the diagnostic effect of Macimorelin. Risk X: Avoid combination

PredniSONE: Tesamorelin may decrease serum concentrations of the active metabolite(s) of PredniSONE. Risk C: Monitor therapy

Pregnancy Considerations

Use is contraindicated in pregnant patients.

During pregnancy, there is an increased deposition of visceral adipose tissue due to metabolic and hormonal changes. Tesamorelin decreases the deposition of visceral fat and could potentially cause harm to the unborn fetus. If pregnancy occurs during treatment, discontinue tesamorelin.

Breastfeeding Considerations

It is not known if tesamorelin is present in breast milk.

The Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients in the United States with HIV when safer infant feeding options are available (HHS [perinatal] 2023).

Monitoring Parameters

Serum IGF-1 levels should be monitored at baseline and during therapy due to the potential increased risk of malignancy from sustained elevation of IGF-1 levels. Serum glucose (prior to treatment initiation); monitor periodically for glucose metabolism changes. Monitor for retinopathy in patients with diabetes. Visceral adipose tissue (by waist circumference or CT scan). Monitor for fluid retention.

Mechanism of Action

Tesamorelin binds to pituitary growth hormone-releasing factor (GRF) receptors and stimulates the secretion of endogenous growth hormone which has anabolic and lipolytic properties. Growth hormone exerts its effects by interacting with receptors on target cells such as osteoblasts, myocytes, hepatocytes, and adipocytes to promote the reduction of total fat mass. These effects are primarily mediated by IGF-1 produced in the liver and in peripheral tissues.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 1 mg vial: Healthy adults: 9.4 ± 3.1 L/kg, HIV-infected patients: 10.5 ± 6.1 L/kg; 2 mg vial: Healthy adults: 4.8 ± 1.9 L/kg.

Bioavailability: SubQ: Healthy adults: <4%.

Half-life elimination: 1 mg vial: Healthy adults: 26 minutes, HIV-infected patients: 38 minutes; 2 mg vial: Healthy adults: 8 minutes.

Time to peak: 9 minutes.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (MX) Mexico: Egrifta;
  • (PR) Puerto Rico: Egrifta
  1. Egrifta (tesamorelin) [prescribing information]. Montreal, Quebec, Canada: Theratechnologies; July 2019.
  2. Egrifta SV (tesamorelin) [prescribing information]. Montreal, Quebec, Canada: Theratechnologies; October 2019.
  3. Falutz J, Mamputu JC, Potvin D, et al, “Effects of Tesamorelin (TH9507), a Growth Hormone-Releasing Factor Analog, in Human Immunodeficiency Virus-Infected Patients With Excess Abdominal Fat: A Pooled Analysis of Two Multicenter, Double-Blind Placebo Controlled Phase 3 Trials With Safety Extension Data,” J Clin Endocrinol Metab, 2010, 95(9):4291-304. [PubMed 20554713]
  4. Sivakumar T, Mechanic O, Fehmie DA, et al, “Growth Hormone Axis Treatments for HIV-Associated Lipodystrophy: A Systematic Review of Placebo-Controlled Trials,” HIV Med, 2011, 12(8):453-62. [PubMed 21265979]
  5. Stanley TL, Chen CY, Branch KL, et al, “Effects of a Growth Hormone-Releasing Hormone Analog on Endogenous GH Pulsatility and Insulin Sensitivity in Healthy Men,” J Clin Endocrinol Metab, 2011, 96(1):150-8. [PubMed 20943777]
  6. Stanley TL, Falutz J, Mamputu JC, et al, “Effects of Tesamorelin on Inflammatory Markers in HIV Patients With Excess Abdominal Fat: Relationship With Visceral Adipose Reduction,” AIDS, 2011, 25(10):1281-8. [PubMed 21516030]
  7. US Department of Health and Human Services (HHS) Panel on Treatment of HIV During Pregnancy and Prevention of Perinatal Transmission. Recommendations for the use of antiretroviral drugs during pregnancy and interventions to reduce perinatal HIV transmission in the United States. https://clinicalinfo.hiv.gov/en/guidelines/perinatal/whats-new-guidelines. Updated January 31, 2023. Accessed February 23, 2023.
Topic 16092 Version 152.0

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