Version July 2025
Dosage guidance
Dosage form information: Available as two different formulations (2 mg vial or 11.6 mg vial); do not substitute one vial for the other. Use caution during product selection, preparation, and administration.
HIV-associated lipodystrophy: SUBQ:
2 mg vial: 1.4 mg once daily.
11.6 mg vial: 1.28 mg once daily.
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions are reported in adults who have been treated with the 1 mg/vial formulation of tesamorelin.
10%:
Immunologic: Antibody development (47% to 50%; neutralizing: 5% to 10%)
Local: Injection-site reaction (17% to 25%; including bleeding at injection site, erythema at injection site, injection-site pruritus, irritation at injection site, pain at injection site, rash at injection site, swelling at injection site, urticaria at injection site)
Neuromuscular & skeletal: Arthralgia (13%)
1% to 10%:
Cardiovascular: Palpitations (1%), peripheral edema (6%)
Dermatologic: Night sweats (1%), pruritus (2%), skin rash (4%)
Endocrine & metabolic: Elevated glycosylated hemoglobin (HbA1c ≥6.5%: 5%)
Gastrointestinal: Dyspepsia (2%), vomiting (3%)
Hypersensitivity: Hypersensitivity reaction (4%)
Nervous system: Carpal tunnel syndrome (1%), hypoesthesia (4%), pain (2%), paresthesia (5%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (1%), joint swelling (1%), limb pain (6%), muscle rigidity (2%), muscle strain (1%), musculoskeletal pain (2%), myalgia (6%)
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.
Concerns related to adverse effects:
• Fluid retention: Use may result in arthralgia, carpal tunnel syndrome, or edema manifested by increased skin turgor and musculoskeletal discomfort. May be transient or resolve upon treatment discontinuation.
• 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.
• 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:
• 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.
• Diabetes: May increase risk of development of diabetes due to glucose intolerance. Consider discontinuing therapy in patients that develop diabetes or glucose intolerance and do not show a clear treatment response.
• Malignancy: Release of endogenous growth hormone and increased serum IGF-1 may increase the risk for development or reactivation of malignancies. Treatment for prior malignancy should be completed prior to initiation of tesamorelin. Consider discontinuing with persistent IGF-1 elevations (eg, >3 standard deviation scores). Discontinue treatment with any evidence of recurrent malignancy.
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.
Dosage form specific concerns:
• Interchangeability: Tesamorelin is available in two different formulations (2 mg vial or 11.6 mg vial) and is not interchangeable. Verify product label to prevent medication errors; dosing, preparation, and storage are different.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Subcutaneous:
Egrifta SV: 2 mg (1 ea)
No
Solution (reconstituted) (Egrifta SV Subcutaneous)
2 mg (per each): $306.24
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.
SUBQ: The abdomen is the preferred site of administration; rotate site within the abdomen (at least 2 inches from the navel). Avoid injection into hard bumps (from previous injections), scar tissue, bruises, or the navel. Also refer to manufacturer's labeling for detailed administration information.
HIV-associated lipodystrophy: Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy.
Tesamorelin may be confused with temsirolimus
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).
None known.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Cortisone: Tesamorelin may decrease active metabolite exposure of Cortisone. Risk C: Monitor
Macimorelin: Coadministration of Products that Affect Growth Hormone and Macimorelin may alter diagnostic results. Risk X: Avoid
PredniSONE: Tesamorelin may decrease active metabolite exposure of PredniSONE. Risk C: Monitor
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.
It is not known if tesamorelin is present in breast milk.
Breastfeeding is not recommended by the manufacturer.
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.
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.
Distribution: Vd: Healthy adults: 4.8 ± 1.9 L/kg.
Bioavailability: SUBQ: Healthy adults: <4% (1 mg vial [DSC]).
Half-life elimination: 2 mg vial: Healthy adults: 8 minutes; 11.6 mg vial: Healthy adults: 11 minutes.
Time to peak: 0.15 hours.
