(tes a moe REL in)
- Tesamorelin Acetate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Subcutaneous [preservative free]:
Egrifta: 1 mg (1 ea); 2 mg (1 ea [DSC])
Brand Names: U.S.
- Growth Hormone Releasing Factor
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.
Vd: Healthy adults: 9.4 ± 3.1 L/kg; HIV-infected patients: 10.5 ± 6.1 L/kg
Time to Peak
Healthy adults: 26 minutes; HIV-infected patients: 38 minutes
Use: Labeled Indications
HIV-associated lipodystrophy: Reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
Hypersensitivity to tesamorelin, mannitol, 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 (newly diagnosed or recurrent); pregnancy
HIV-associated lipodystrophy: SubQ: 2 mg once daily
Refer to adult dosing.
Dosing: Renal Impairment
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Dosing: Adjustment for Toxicity
Consider discontinuing with persistent elevations of IGF-1 (eg, >3 standard deviation scores). Discontinue if symptoms of hypersensitivity occur.
Use provided diluent only. Reconstitute 2 mg vial with 2.1 mL diluent; gently roll vial for 30 seconds to mix; do not shake. When using 1 mg vials, reconstitute the first 1 mg vial with 2.2 mL diluent; gently roll vial (do not shake) for 30 seconds to mix; reconstitute the second 1 mg vial with the entire solution from first vial; gently roll vial (do not shake) for 30 seconds to mix. Use reconstituted solution immediately after prepared.
SubQ: The abdomen is the preferred site of administration; rotate site within the abdomen. Avoid injection into scar tissue, bruises, or the navel.
Store intact vials refrigerated at 2°C to 8°C (36°F to 46°F). Protect from light and store in original container until time of use. Store diluent, (sterile water for injection), syringes, and needles at 20°C to 25°C (68°F to 77°F). Use reconstituted solution immediately after prepared; do not refrigerate or freeze. Discard if not used immediately.
Cortisone: Tesamorelin may decrease serum concentrations of the active metabolite(s) of Cortisone. Consider therapy modification
Macimorelin: Growth Hormone Products may diminish the diagnostic effect of Macimorelin. Avoid combination
PredniSONE: Tesamorelin may decrease serum concentrations of the active metabolite(s) of PredniSONE. Consider therapy modification
The incidence of adverse reactions generally decreases with treatment continued beyond 26 weeks.
Immunologic: Antibody development (IgG: 48% to 50%)
Local: Injection site reaction (6% to 25%)
Neuromuscular & skeletal: Arthralgia (13%)
1% to 10%:
Cardiovascular: Peripheral edema (2% to 6%), hypertension (1% to 2%), chest pain (1%), flushing (1%), palpitations (1%)
Central nervous system: Paresthesia (2% to 5%), hypoesthesia (2% to 4%), carpal tunnel syndrome (2%), depression (2%), pain (2%), peripheral neuropathy (2%), insomnia (1%)
Dermatologic: Injection site pruritus (2% to 8%), skin rash (4%), urticaria at injection site (2%), pruritus (1% to 2%), night sweats (1%), rash at injection site (1%), urticaria (1%)
Endocrine & metabolic: Diabetes mellitus (5%), hyperglycemia
Gastrointestinal: Nausea (4%), vomiting (2% to 3%), dyspepsia (2%), abdominal pain (1%)
Hematologic & oncologic: Elevated glycosylated hemoglobin (5%), local hemorrhage (injection site: 2%)
Hypersensitivity: Hypersensitivity reaction (1% to 4%)
Immunologic: Antibody development (neutralizing; tesamorelin: 10%; hGHRH: 5%)
Local: Erythema at injection site (1% to 9%), pain at injection site (4%), irritation at injection site (3%), swelling at injection site (2%)
Neuromuscular & skeletal: Limb pain (3% to 6%), myalgia (1% to 6%), increased creatine phosphokinase (2%), muscle rigidity (2%), musculoskeletal pain (2%), joint stiffness (2%), joint swelling (1%), muscle spasm (1%), strain (1%)
<1%, postmarketing, and/or case reports: Anemia, abscess (abdominal, appendix, perianal), basal cell carcinoma, benign prostatic hypertrophy, bipolar mood disorder, bone fracture (humerus, rib), bronchitis (viral), cardiac failure, cellulitis, cerebellar syndrome, coronary arteriosclerosis, dehydration, diarrhea, drug dependence, impaired glucose tolerance, intestinal obstruction (small), malignant neoplasm of rectum, mental status changes, mobility disorder, pneumonia, retinopathy (chorioretinopathy), sepsis, trigeminal neuralgia, upper respiratory tract infection
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; incidence decreases with treatment continued beyond 26 weeks. Rotating the site of injection to different areas of the abdomen may reduce incidence of reactions.
• 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).
• 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.
• Pediatric: Should not be used in children due to risk of excess growth (gigantism) when epiphyses are open.
• 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 is no data supporting improved compliance of antiretroviral therapy with concomitant tesamorelin.
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.
Pregnancy Risk Factor
Studies in animals have shown evidence of fetal abnormalities and use is contraindicated in pregnant women. 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.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience muscle pain, muscle weakness, itching, nausea, or vomiting. Have patient report immediately to prescriber signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), tachycardia, severe dizziness, passing out, shortness of breath, severe joint pain, painful extremities, burning or numbness feeling, arrhythmia, injection site pain, redness, edema, itching, bleeding, or irritation, mood changes, depression, or swelling of arms or legs (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
More about tesamorelin
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- Drug class: growth hormones
Other brands: Egrifta