{"site":"Tesamorelin Co","url":"https://tesamorelinco.com","format":"evidence-manifest/v1","claim_count":68,"claims":[{"id":"TSM-001","text":"FDA approved tesamorelin (Egrifta, Theratechnologies) on November 10, 2010 under application 022505; the former NDA was deemed a Biologic License Application on March 23, 2020.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/entity","https://tesamorelinco.com/faq","https://tesamorelinco.com/comparison","https://tesamorelinco.com"]},{"id":"TSM-002","text":"The approved indication is the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy; it is tesamorelin's only FDA-approved use.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/entity","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid","https://tesamorelinco.com"]},{"id":"TSM-003","text":"Label Limitations of Use: long-term cardiovascular safety has not been established, and the label instructs prescribers to consider risk and benefit of continuing in patients without a visceral adipose tissue reduction.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid"]},{"id":"TSM-004","text":"The label states tesamorelin is not indicated for weight loss management because it has a weight neutral effect.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com","https://tesamorelinco.com/comparison"]},{"id":"TSM-005","text":"The label states there are no data to support improved compliance with antiretroviral therapies in HIV-positive patients taking tesamorelin.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-006","text":"Tesamorelin is FDA-approved (Egrifta) to reduce excess abdominal fat in adults with HIV-associated lipodystrophy. Use for general fat loss or anti-aging is off-label, and 'research' tesamorelin vials are not the approved product.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/entity","https://tesamorelinco.com","https://tesamorelinco.com/copy","https://tesamorelinco.com/faq"]},{"id":"TSM-007","text":"Three formulations have been approved under BLA 022505: original EGRIFTA (1 mg/vial, 2010), EGRIFTA SV (2 mg/vial, 2019 supplements), and EGRIFTA WR (11.6 mg/vial, supplement approved March 25, 2025). The WR label states EGRIFTA WR and EGRIFTA SV are not substitutable.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools"]},{"id":"TSM-008","text":"Compounded drugs are not FDA-approved; FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid"]},{"id":"TSM-009","text":"Both marketed tesamorelin products (EGRIFTA SV and EGRIFTA WR) are prescription drugs.","source_url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.application_number:%22BLA022505%22&limit=1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid"]},{"id":"TSM-010","text":"Tesamorelin is a synthetic analog of human growth hormone-releasing factor comprising the full 44-amino-acid GRF sequence with a hexenoyl moiety (a C6 chain with a double bond at position 3) attached to the N-terminal tyrosine; it is prepared as an acetate salt, molecular formula C221H366N72O67S (free base), molecular weight 5135.9 Da (PubChem CID 16137828 lists 5136).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"chemical-reference","grade_label":"Chemical reference","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/entity","https://tesamorelinco.com/comparison"]},{"id":"TSM-011","text":"The trans-3-hexenoyl modification makes tesamorelin resistant to dipeptidyl aminopeptidase-IV (DPP-4) deactivation: it slowed in vitro degradation in rat, dog, and human plasma and prolonged in vivo elimination kinetics compared with natural hGRF(1-44).","source_url":"https://pubmed.ncbi.nlm.nih.gov/17214611/","grade":"animal","grade_label":"Animal","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/comparison","https://tesamorelinco.com/faq"]},{"id":"TSM-012","text":"Tesamorelin binds and stimulates human GRF receptors with potency similar to endogenous GRF; GHRH acts on pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone, which is both anabolic and lipolytic, with some effects mediated by IGF-1 produced in the liver and peripheral tissues.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/comparison","https://tesamorelinco.com/tools"]},{"id":"TSM-013","text":"Tesamorelin stimulates growth hormone secretion and subsequently increases IGF-1 and IGFBP-3; trials observed no clinically significant changes in other pituitary hormones (TSH, LH, ACTH, prolactin).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools"]},{"id":"TSM-014","text":"Tesamorelin's mean elimination half-life is 8 minutes (healthy subjects, single 1.4 mg EGRIFTA SV dose) and 11 minutes with the EGRIFTA WR formulation; the original 2010 label reported 26 minutes in healthy subjects and 38 minutes in HIV-infected patients after 14 consecutive days of the 2 mg dose.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools"]},{"id":"TSM-015","text":"Absolute bioavailability of subcutaneous tesamorelin is less than 4% (2 mg dose, healthy adults); median Tmax is 0.15 hours (about 9 minutes); mean volume of distribution is 4.8 L/kg; AUC was 34% higher in HIV-infected patients than in healthy subjects.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-016","text":"The EGRIFTA SV dose is 1.4 mg (0.35 mL of reconstituted solution) injected subcutaneously once daily into the abdomen, rotating injection sites; do not inject into scar tissue, bruises, or the navel.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-017","text":"EGRIFTA SV reconstitution per label: reconstitute one 2 mg vial with 0.5 mL of the provided Sterile Water for Injection (2 mg per 0.5 mL), mix by rolling the vial gently for 30 seconds without shaking, inject 0.35 mL immediately, and discard any unused solution; do not freeze or refrigerate the reconstituted solution.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-018","text":"Each EGRIFTA SV single-dose vial contains 2 mg tesamorelin (about 2.2 mg tesamorelin acetate) with histidine, mannitol, polysorbate 20, and sucrose; the reconstituted solution must be clear and colorless without particulate matter.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools"]},{"id":"TSM-019","text":"EGRIFTA SV vials are stored at room temperature (20 to 25 C; excursions 15 to 30 C permitted) protected from light in the original box; the package contains 30 single-dose vials with diluent, syringes, and needles for a 30-day supply.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-020","text":"The original EGRIFTA formulation (2010) dosed 2 mg once daily from 1 mg single-use vials reconstituted to 1 mg/mL, and unreconstituted vials required refrigerated storage at 2 to 8 C.","source_url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022505s000lbl.pdf","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-021","text":"EGRIFTA WR (approved March 2025) supplies 11.6 mg single-patient-use vials reconstituted weekly with 1.3 mL Bacteriostatic Water for Injection to 8 mg/mL; the dose is 1.28 mg (0.16 mL) once daily, one vial provides 7 daily doses, and the vial is discarded 7 days after mixing; vials store at room temperature.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+WR%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-022","text":"Systemic exposure (Cmax and AUC) is similar between the 1.4 mg EGRIFTA SV dose, the 1.28 mg EGRIFTA WR dose, and the original 2 mg EGRIFTA dose; the newer formulations deliver equivalent exposure at lower nominal doses.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-023","text":"Phase 3 Study 1 (NCT00123253) randomized 412 HIV-infected adults with lipodystrophy and excess abdominal fat 2:1 to tesamorelin 2 mg or placebo subcutaneously daily for 26 weeks; the primary endpoint was percent change in visceral adipose tissue measured by CT at the L4-L5 level.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18057338/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com"]},{"id":"TSM-024","text":"In Study 1, visceral adipose tissue decreased 15.2% with tesamorelin versus a 5.0% increase with placebo at 26 weeks (P<0.001); by the label's statistical model the changes were -18% versus +2% (treatment difference -20 percentage points, 95% CI -24 to -15; absolute -27 vs +4 cm2).","source_url":"https://pubmed.ncbi.nlm.nih.gov/18057338/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com"]},{"id":"TSM-025","text":"In Phase 3 Study 2, visceral adipose tissue decreased 10.9% (-21 cm2) with tesamorelin versus 0.6% (-1 cm2) with placebo over the 6-month efficacy phase (P<0.0001); the label reports -14% versus -2% (treatment difference -12 percentage points, 95% CI -16 to -7).","source_url":"https://pubmed.ncbi.nlm.nih.gov/20101189/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-026","text":"In the pooled phase 3 analysis (806 randomized: 543 tesamorelin, 263 placebo), VAT decreased -24 versus +2 cm2 at week 26 (P<0.001; treatment effect -15.4%), while abdominal subcutaneous fat was preserved (-2 vs +2 cm2, P=0.08; treatment effect -0.6%).","source_url":"https://pubmed.ncbi.nlm.nih.gov/20554713/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com"]},{"id":"TSM-027","text":"Tesamorelin improved lipids in the phase 3 program: pooled triglycerides fell -37 versus +6 mg/dL (P<0.001) and the cholesterol to HDL ratio improved; in Study 1 triglycerides decreased 50 mg/dL versus a 9 mg/dL increase with placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/20554713/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-028","text":"IGF-1 rises substantially on tesamorelin: pooled mean +108 versus -7 ng/mL at 26 weeks (P<0.001); the label reports treatment differences of +122 and +105 ng/mL in Studies 1 and 2; in the NEJM report IGF-1 increased 81.0% versus a 5.0% decrease on placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/20554713/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-029","text":"Tesamorelin is weight neutral in its trials: label-reported weight change at 26 weeks was -0.4 kg (Study 1) and +0.5 kg (Study 2) versus 0.0 and +0.3 kg with placebo.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com","https://tesamorelinco.com/comparison"]},{"id":"TSM-030","text":"Waist circumference decreased about 2 to 3 cm with tesamorelin versus about 1 cm with placebo at 26 weeks in the phase 3 studies.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-031","text":"At week 26, trunk fat fell about 1 kg with tesamorelin while lean body mass rose about 1.2 to 1.3 kg (versus small opposite changes on placebo).","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-032","text":"Patient-reported belly appearance distress and physician-rated belly profile improved significantly with tesamorelin versus placebo (pooled P=0.002 and P<0.001).","source_url":"https://pubmed.ncbi.nlm.nih.gov/20554713/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-033","text":"Continuing tesamorelin through 52 weeks maintained the VAT reduction: -35 cm2 (-17.5%) versus original baseline in the pooled T-T group (P<0.001), reported as a sustained change of about -18% in the Study 1 extension.","source_url":"https://pubmed.ncbi.nlm.nih.gov/20554713/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-034","text":"Visceral fat returns after stopping: patients re-randomized from tesamorelin to placebo at week 26 regained VAT (+25 cm2, +22% in Study 1; +24 cm2, +16% in Study 2 by week 52) while those continuing did not (+3 cm2, 0%; -11 cm2, -5%); the extension publication states that upon discontinuation VAT reaccumulated and effects do not last beyond the duration of treatment.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com"]},{"id":"TSM-035","text":"IGF-1 falls back when tesamorelin stops: in the extension phase, patients switched to placebo saw IGF-1 drop -137 and -135 ng/mL (Studies 1 and 2) versus -59 and -25 ng/mL in those continuing.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools"]},{"id":"TSM-036","text":"The phase 2 dose-ranging trial (61 HIV-infected patients, 12 weeks) found dose-related IGF-1 increases (+48% at 1 mg, +65% at 2 mg), a significant trunk fat reduction at 2 mg (-9.2% vs +0.8% placebo, P=0.014), preserved subcutaneous fat, and a VAT change (-15.7% at 2 mg) that did not reach significance versus placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/16052083/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools"]},{"id":"TSM-037","text":"In a 50-patient randomized trial (Stanley 2014, NCT01263717), 6 months of tesamorelin 2 mg reduced visceral fat (treatment effect -42 cm2, 95% CI -71 to -14, P=.005) and modestly reduced liver fat (net treatment effect -2.9% lipid-to-water ratio, P=.003); fasting glucose rose at 2 weeks (treatment effect +7 mg/dL, P=.03) but glucose changes were not significant at 6 months.","source_url":"https://pubmed.ncbi.nlm.nih.gov/25038357/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-038","text":"In the NIH-funded Stanley 2019 trial (NCT02196831; 61 people with HIV and NAFLD, 12 months), tesamorelin reduced hepatic fat fraction by an absolute -4.1% (95% CI -7.6 to -0.7, P=0.018), a 37% relative reduction; 35% of tesamorelin patients versus 4% on placebo reached a hepatic fat fraction below 5% (P=0.0069), with no difference in glucose or HbA1c at 12 months.","source_url":"https://pubmed.ncbi.nlm.nih.gov/31611038/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-039","text":"Tesamorelin is not FDA-approved for NAFLD or liver disease; the liver findings come from research trials in people with HIV, and the study authors call for further work on histology and long-term effects.","source_url":"https://pubmed.ncbi.nlm.nih.gov/31611038/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-040","text":"In the 20-week SMART trial (NCT00257712; 152 adults aged 55 to 87, 66 with mild cognitive impairment), tesamorelin 1 mg daily had a favorable effect on cognition (intent-to-treat P=.03; executive function P=.005), increased IGF-1 by 117% (remaining within the physiological range), and reduced percent body fat by 7.4%; adverse events, mostly mild, were reported by 68% versus 36% on placebo.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22869065/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools"]},{"id":"TSM-041","text":"A 30-person imaging substudy of the SMART trial found 20 weeks of tesamorelin increased brain GABA levels in all three sampled regions, increased NAAG in dorsolateral frontal cortex, and decreased myo-inositol in posterior cingulate.","source_url":"https://pubmed.ncbi.nlm.nih.gov/23689947/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-042","text":"The cognition findings are preliminary: a single 20-week trial program whose authors state that longer-duration treatment trials are needed; tesamorelin has no approval for cognition, brain aging, or dementia prevention.","source_url":"https://pubmed.ncbi.nlm.nih.gov/22869065/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-043","text":"The only randomized tesamorelin trial in a general (non-HIV) population studied 60 abdominally obese adults with reduced growth hormone secretion for 12 months: VAT fell (treatment effect -35 cm2, P=0.003), carotid intima-media thickness and CRP improved, triglycerides fell, subcutaneous fat was unchanged, IGF-1 rose (+92 ug/L treatment effect), and glucose measures did not change.","source_url":"https://pubmed.ncbi.nlm.nih.gov/23015655/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools"]},{"id":"TSM-044","text":"There is no FDA-approved tesamorelin use outside HIV-associated lipodystrophy: the trials in general obesity, NAFLD, and cognition did not lead to approvals, and prescriptions for belly fat or anti-aging in people without HIV lipodystrophy are off-label uses of a drug approved for a different population.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid","https://tesamorelinco.com"]},{"id":"TSM-045","text":"In an exploratory secondary analysis of the phase 3 trials, tesamorelin responders showed increased trunk muscle density (coefficients 1.56 to 4.86 Hounsfield units across four muscle groups, P<0.005) and increased muscle area versus placebo over 26 weeks.","source_url":"https://pubmed.ncbi.nlm.nih.gov/31237318/","grade":"human-trial","grade_label":"Human trial","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-046","text":"Tesamorelin is contraindicated in: disruption of the hypothalamic-pituitary axis (hypophysectomy, hypopituitarism, pituitary tumor or surgery, head irradiation or head trauma); active malignancy; known hypersensitivity to tesamorelin or excipients; and pregnancy.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid"]},{"id":"TSM-047","text":"The label's neoplasm precaution: tesamorelin induces growth hormone, a known growth factor; do not treat patients with active malignancy; any preexisting malignancy should be inactive with treatment complete before starting; discontinue if there is evidence of recurrent malignancy; weigh the increased background risk of malignancy in HIV-positive patients.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/decision_aid"]},{"id":"TSM-048","text":"The label directs IGF-1 monitoring during therapy and advises considering discontinuation for persistent elevations (for example SDS above 3): at 26 weeks, 47% of tesamorelin patients had IGF-1 above 2 SDS and 36% above 3 SDS (seen as early as 13 weeks); at 52 weeks the figures were 34% and 23%.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools","https://tesamorelinco.com"]},{"id":"TSM-049","text":"Fluid retention can occur during therapy, related to induced GH secretion, manifesting as edema, arthralgia, and carpal tunnel syndrome; these are transient or resolve on discontinuation per the label.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-050","text":"Glucose intolerance can develop on tesamorelin: 5% of treated patients versus 1% on placebo developed HbA1c of 6.5% or higher by week 26 (hazard ratio 3.3, CI 1.4 to 9.6); the label says to evaluate glucose before starting, monitor periodically during therapy, and monitor diabetic patients for development or worsening of retinopathy.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq","https://tesamorelinco.com/tools"]},{"id":"TSM-051","text":"Hypersensitivity reactions (pruritus, erythema, flushing, urticaria, rash) occurred in 4% of tesamorelin-treated patients in clinical trials; the label advises prompt medical attention and immediate discontinuation if suspected.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-052","text":"Injection site reactions (erythema, pruritus, pain, irritation, bruising) occurred in 25% of tesamorelin patients versus 14% on placebo during the first 26 weeks; the label recommends rotating injection sites across the abdomen to reduce them.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-053","text":"The label carries the growth hormone class caution on acute critical illness: increased mortality has been reported after pharmacologic growth hormone in patients critically ill from open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure; because tesamorelin stimulates GH production, the label says to consider discontinuing it in critically ill patients.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/comparison"]},{"id":"TSM-054","text":"Most common adverse reactions (over 5%): arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia. Combined 26-week rates versus placebo (543 vs 263 patients): injection site reactions 17% vs 6%, arthralgia 13% vs 11%, pain in extremity 6% vs 5%, myalgia 6% vs 2%, peripheral edema 6% vs 2%, paresthesia 5% vs 2%; 740 patients received tesamorelin in trials overall.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-055","text":"In the NEJM trial report, overall adverse events did not differ significantly between groups, but more tesamorelin patients withdrew because of an adverse event.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18057338/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-056","text":"Pregnancy is a contraindication: modifying visceral fat offers no benefit in pregnancy and could cause fetal harm; in pregnant rats, tesamorelin caused hydrocephaly in offspring at about 2 to 4 times clinical exposure and delayed skull ossification at 0.1 to 1 times; rabbits showed no adverse developmental effects up to about 500 times clinical exposure.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"animal","grade_label":"Animal","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-057","text":"Safety and effectiveness are not established in pediatric patients (risk of linear growth acceleration with open epiphyses; not indicated in children), and there is no information on use in patients over 65.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-058","text":"Lifetime carcinogenicity studies in rodents have not been conducted with tesamorelin; mutagenicity tests (Ames, mammalian cell, mouse bone marrow) were negative, and rat fertility was unaffected at doses up to about clinical exposure.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"animal","grade_label":"Animal","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-059","text":"Drug interactions: GH may alter clearance of CYP450-metabolized drugs (corticosteroids, sex steroids, anticonvulsants, cyclosporine), so the label advises monitoring; co-administration studies showed only small pharmacokinetic changes for simvastatin (8% AUC decrease) and ritonavir (9% AUC, 11% Cmax decreases); patients on glucocorticoid replacement may need dose increases because GH inhibits 11beta-HSD-1, especially with cortisone acetate and prednisone.","source_url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22EGRIFTA+SV%22&limit=1","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/faq"]},{"id":"TSM-060","text":"In preclinical toxicology, repeat daily tesamorelin markedly increased GH and IGF-1 in pigs, rats, and dogs; dogs showed a more pronounced anabolic effect and reversible adverse effects (liver and kidney findings, anemia, clinical chemistry and organ weight changes) attributed to prolonged supraphysiologic GH/IGF-1 exposure; dog elimination half-life was 21 to 45 minutes.","source_url":"https://pubmed.ncbi.nlm.nih.gov/17214611/","grade":"animal","grade_label":"Animal","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-061","text":"Sermorelin is a 29-amino-acid analogue of human GHRH, the shortest fragment with full biological activity of the parent hormone; it specifically stimulates growth hormone secretion from the anterior pituitary.","source_url":"https://pubmed.ncbi.nlm.nih.gov/18031173/","grade":"review","grade_label":"Review or guideline","used_on":["https://tesamorelinco.com/comparison","https://tesamorelinco.com/faq"]},{"id":"TSM-062","text":"GHRH(1-29) (sermorelin) has an elimination half-life of about 4.3 minutes after intravenous administration in normal men, with rapid clearance.","source_url":"https://pubmed.ncbi.nlm.nih.gov/7962295/","grade":"human-trial","grade_label":"Human trial","used_on":["https://tesamorelinco.com/comparison","https://tesamorelinco.com/faq"]},{"id":"TSM-063","text":"In a 16-week randomized trial of a nightly GHRH(1-29) analog in adults aged 55 to 71, IGF-1 rose within 2 weeks but returned toward baseline by 16 weeks despite continued injections.","source_url":"https://pubmed.ncbi.nlm.nih.gov/9141536/","grade":"human-rct","grade_label":"Human RCT","used_on":["https://tesamorelinco.com/comparison","https://tesamorelinco.com/tools"]},{"id":"TSM-064","text":"Somatropin (recombinant human growth hormone) labels titrate dose against serum IGF-1 concentrations and direct dose decreases when IGF-1 exceeds the age- and gender-specific normal range; the somatropin label also reports significantly increased mortality (42% vs 19%) when GH was given to non-GH-deficient patients with acute critical illness.","source_url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1058e17c-9261-459c-a3e6-fae38d196c14","grade":"fda-label","grade_label":"FDA label","used_on":["https://tesamorelinco.com/comparison","https://tesamorelinco.com/tools","https://tesamorelinco.com/faq"]},{"id":"TSM-065","text":"A systematic review of growth hormone in the healthy elderly (18 study populations, 220 GH-treated completers) found small body-composition changes (fat mass -2.1 kg, lean mass +2.1 kg, no weight change), significantly more soft tissue edema, arthralgias, carpal tunnel syndrome, and gynecomastia, and somewhat more new diabetes and impaired fasting glucose; the authors conclude GH cannot be recommended as an anti-aging therapy and note its distribution as an anti-aging agent is illegal in the United States.","source_url":"https://pubmed.ncbi.nlm.nih.gov/17227934/","grade":"review","grade_label":"Review or guideline","used_on":["https://tesamorelinco.com/comparison","https://tesamorelinco.com/faq","https://tesamorelinco.com/monograph"]},{"id":"TSM-066","text":"Published injection-technique recommendations for subcutaneous therapy: the shortest needles (4 mm pen, 6 mm syringe) are safe and less painful as first-line, and systematic site rotation keeps lipohypertrophy, which can distort absorption, from developing.","source_url":"https://pubmed.ncbi.nlm.nih.gov/27594187/","grade":"review","grade_label":"Review or guideline","used_on":["https://tesamorelinco.com/monograph","https://tesamorelinco.com/tools"]},{"id":"TSM-067","text":"Tesamorelin remains under active study: as of August 2026, ClinicalTrials.gov lists recruiting phase 2 trials of tesamorelin as an exercise adjunct for physical function in HIV (NCT06554717, target 100 participants) and for functional recovery after peripheral nerve injury (NCT03150511, target 36).","source_url":"https://clinicaltrials.gov/api/v2/studies/NCT06554717","grade":"regulatory","grade_label":"Regulatory record","used_on":["https://tesamorelinco.com/monograph"]},{"id":"TSM-068","text":"This site's tesamorelin reference layer contains 34 fetch-verified unique sources (17 peer-reviewed, 17 government), a 14-row species-labeled study table (12 human rows), and 13 sourced FAQs; these counts are derived from the pack arrays and must be recomputed whenever an array changes.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022505","grade":"derived","grade_label":"Derived from cited data","used_on":["https://tesamorelinco.com","https://tesamorelinco.com/copy"]}]}