Meta Information
ID:tesamorelin
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-25T05:45:33.424220+00:00
Model
wave11-pilot-claude-sonnet-4.6
Interactions
Target id:
/condition/active-malignancy
Target name:
Active malignancy
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin (Egrifta WR) is contraindicated in patients with active malignancy because GHRF stimulation increases IGF-1, which may promote tumor growth or recurrence.
Actionable advice:
Tesamorelin should not be initiated with active malignancy; any preexisting malignancy should be inactive and treatment complete before starting. It should be discontinued if recurrent malignancy develops.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Patients with active malignancy
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
avoid
Target id:
/condition/hypersensitivity-to-tesamorelin
Target name:
Hypersensitivity to tesamorelin or excipients
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin is contraindicated in patients with known hypersensitivity to tesamorelin or to mannitol (excipient).
Actionable advice:
Screen for prior reactions; do not administer in known hypersensitivity. Discontinue immediately on signs of allergic reaction.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Patients with known hypersensitivity to tesamorelin or excipients in EGRIFTA WR
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin is contraindicated in pregnancy; the Egrifta WR label lists pregnancy among contraindications.
Actionable advice:
Confirm not pregnant before initiating; discontinue immediately if pregnancy is identified during therapy.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Pregnancy (4)
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
avoid
Target id:
/condition/hypopituitarism
Target name:
Disruption of hypothalamic-pituitary axis (hypopituitarism, pituitary tumor/surgery, head irradiation/trauma)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin is contraindicated in patients with hypothalamic-pituitary axis disruption (e.g., hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma).
Actionable advice:
This should not be initiated with these conditions; it is important to talk to endocrinology before considering GHRF analog therapy.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
informational_none
Target id:
/biomarker/igf-1
Target name:
Insulin-like growth factor 1 (IGF-1)
Severity:
moderate
Interaction type:
monitoring
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin stimulates GH production and increases serum IGF-1. The long-term effects of sustained IGF-1 elevation are unknown.
Actionable advice:
IGF-1 levels are best monitored during therapy. Discontinuing tesamorelin may be warranted in patients with persistent IGF-1 elevations.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Monitor IGF-1 levels during EGRIFTA WR therapy
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
monitor
Target id:
/condition/glucose-intolerance
Target name:
Glucose intolerance or diabetes mellitus
Severity:
moderate
Interaction type:
monitoring
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Glucose intolerance or diabetes mellitus may develop with tesamorelin use.
Actionable advice:
Evaluate glucose status prior to initiation and monitor periodically during therapy.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Glucose intolerance or diabetes mellitus: May develop with EGRIFTA WR
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
monitor
Target id:
/condition/fluid-retention
Target name:
Fluid retention (edema, arthralgia, carpal tunnel syndrome)
Severity:
moderate
Interaction type:
adverse
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Fluid retention may occur with tesamorelin and may manifest as edema, arthralgia, and carpal tunnel syndrome.
Actionable advice:
Counsel patients on symptoms; evaluate severity if symptoms develop; consider dose reduction or discontinuation if persistent.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Fluid retention: May occur with EGRIFTA WR and may include edema
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
adjust_with_prescriber
Target id:
/condition/hypoadrenalism
Target name:
Previously diagnosed hypoadrenalism
Severity:
moderate
Interaction type:
monitoring
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Patients with previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses of corticosteroids following initiation of tesamorelin.
Actionable advice:
Reassess corticosteroid replacement needs at initiation; adjust maintenance and stress doses in consultation with endocrinology.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
previously diagnosed hypoadrenalism may require an increase in
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
adjust_with_prescriber
Target id:
/class/cyp3a4-substrates
Target name:
CYP450-metabolized drugs (corticosteroids, sex steroids, anticonvulsants, cyclosporine)
Severity:
moderate
Interaction type:
pharmacokinetic
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin stimulates GH production; published data indicate GH may affect drugs metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine).
Actionable advice:
Patients should be monitored for potential interactions when administering tesamorelin with CYP450-metabolized drugs, and dosing of co-administered agents may be adjusted as clinically indicated.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
compounds known to be metabolized by CYP450 liver enzymes
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
monitor
Target id:
/intervention/simvastatin
Target name:
Simvastatin
Severity:
minor
Interaction type:
pharmacokinetic
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Co-administration of tesamorelin with simvastatin, a CYP3A substrate, had no significant impact on simvastatin pharmacokinetics in healthy subjects.
Actionable advice:
No tesamorelin-specific dose adjustment is required for simvastatin; continue routine statin monitoring per statin label.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Co-administration of tesamorelin with simvastatin, a CYP3A substrate had no significant impact
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
adjust_with_prescriber
Target id:
/condition/lactation
Target name:
Lactation (HIV-infected mothers)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
HIV-1 infected mothers should not breastfeed during tesamorelin therapy to avoid potential postnatal transmission of HIV-1.
Actionable advice:
Breastfeeding should not be done during therapy, given the risk of HIV postnatal transmission.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
HIV-1 infected mothers should not breastfeed
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
informational_none
Target id:
/condition/hiv-associated-lipodystrophy
Target name:
HIV-associated lipodystrophy with excess abdominal fat
Severity:
minor
Interaction type:
requirement
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Actionable advice:
Restrict use to labeled indication; not indicated for weight loss management.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
for the reduction of excess abdominal fat in HIV-infected adult patients with
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
informational_none
Target id:
/adverse/injection-site-reaction
Target name:
Injection site reactions (erythema, pruritus, pain)
Severity:
minor
Interaction type:
adverse
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Common adverse reactions to tesamorelin include injection site erythema and injection site pruritus.
Actionable advice:
Rotate injection sites; counsel patients on expected local reactions; assess for severe or persistent reactions.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
injection site erythema, pruritus, pain, irritation, and bruising
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
informational_none
Target id:
/adverse/anti-drug-antibodies
Target name:
Anti-tesamorelin antibody formation
Severity:
minor
Interaction type:
adverse
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Anti-tesamorelin antibodies may develop during chronic therapy; the clinical significance is uncertain but immunogenicity is assay-dependent.
Actionable advice:
Consider immunogenicity testing if efficacy declines or hypersensitivity reactions occur; assay differences preclude direct rate comparisons.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
anti-drug antibodies
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
informational_none
Target id:
/condition/hepatic-impairment
Target name:
Hepatic impairment
Severity:
minor
Interaction type:
monitoring
Nature:
relative
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Tesamorelin pharmacokinetics in patients with hepatic impairment have not been established.
Actionable advice:
This is best used with caution in hepatic impairment; close clinical monitoring may be worth considering given the lack of PK data.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Pharmacokinetics of tesamorelin in patients with renal or hepatic impairment
Label source:
FDA label: Tesamorelin (Egrifta WR)
Action type:
monitor
Target id:
/dietary/meal
Target name:
Any Caloric Meal
Severity:
major
Interaction type:
diminishing
Nature:
temporal
Temporal spacing:
Hours before target:
2
Hours after target:
1
Description:
Elevated blood glucose and insulin from a recent meal can suppress the pituitary gland's response to Tesamorelin, significantly blunting the resulting growth hormone (GH) release.
Actionable advice:
Administer on an empty stomach, at least 2 hours after your last meal and 1 hour before your next.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Established endocrine physiology: postprandial hyperglycemia/hyperinsulinemia stimulate hypothalamic somatostatin, which suppresses pituitary GH release and blunts a GHRH analog like tesamorelin; administer on an empty stomach/at bedtime.
Label source:
Class inference
Action type:
separate
Target id:
/circadian/sleep
Target name:
Going to Sleep
Severity:
moderate
Interaction type:
synergistic
Nature:
temporal
Temporal spacing:
Hours before target:
0.5
Hours after target:
null
Description:
Tesamorelin stimulates the pituitary to release growth hormone (GH), and administering it before sleep mimics the body's largest natural GH pulse, which occurs during deep sleep.
Actionable advice:
Inject subcutaneously approximately 30 minutes before you go to bed for optimal effect.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Established physiology: the largest endogenous GH pulse occurs in early slow-wave sleep, so bedtime tesamorelin dosing aligns with the natural nocturnal GH surge. Mechanistic timing rationale.
Label source:
Class inference
Action type:
informational_none
Target id:
/condition/acute-critical-illness
Target name:
Acute Critical Illness
Severity:
major
Interaction type:
adverse
Nature:
absolute
Description:
High doses of growth hormone have been associated with increased mortality in critically ill patients (e.g., after major surgery, trauma, or respiratory failure). Tesamorelin should be discontinued in this setting.
Actionable advice:
Use should be discontinued immediately if an acute critical illness develops.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Established safety concern: high-dose growth hormone increased mortality in critically ill adults (Takala et al., NEJM 1999), so GH-stimulating therapy should be avoided in acute critical illness. Well-documented class caution.
Label source:
Class inference
Action type:
avoid
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/condition/diabetes-mellitus
Target name:
Diabetes Mellitus
Severity:
major
Interaction type:
adverse
Nature:
absolute
Description:
Tesamorelin can increase the risk of new-onset diabetes and worsen glycemic control in existing diabetics by causing insulin resistance.
Actionable advice:
This should be used with extreme caution and under strict medical supervision, as it may worsen blood sugar control.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
increases in blood glucose because of decreases in insulin sensitivity
Label source:
Sigalos & Pastuszak 2018 (GH-secretagogue safety review), PMID 28400207. GH elevation reduces insulin sensitivity. Tesamorelin (a GHRH analog) can raise glucose / worsen glycemic control and increase new-onset diabetes risk via the same GH-driven insulin resistance.
Action type:
informational_none
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/class/somatostatin-analogs
Target name:
Somatostatin Analogs
Severity:
major
Interaction type:
diminishing
Nature:
absolute
Description:
Somatostatin analogs (e.g., octreotide) directly inhibit the release of growth hormone, completely counteracting the intended therapeutic effect of Tesamorelin.
Actionable advice:
These medications should not be used together, as they have opposing pharmacological effects.
Validation status:
validated_via_primary_literature
Evidence tier:
tier_b
Evidence basis:
primary_literature_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Octreotide reduced serum GH and plasma GHRH levels in the two patients
Label source:
Moller DE et al., J Clin Endocrinol Metab (1989), PMID 2493033. Somatostatin analog octreotide suppresses GH/GHRH, opposing a GHRH analog. Octreotide-type drugs therefore counteract tesamorelin's GH-stimulating effect.
Action type:
avoid
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/class/antidiabetic-medications
Target name:
Diabetes Medications
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Description:
By increasing blood glucose, Tesamorelin may counteract the effects of diabetes medications, potentially requiring dose adjustments to maintain glycemic control.
Actionable advice:
Blood glucose is best monitored closely, and it is important to consult a doctor, as the diabetes medication dosage may need to be increased.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Mechanistic inference: by raising blood glucose (GH-induced insulin resistance), tesamorelin can counteract antidiabetic drugs and may require dose adjustment; monitor glucose. Class-level GH effect.
Label source:
Class inference
Action type:
monitor
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/class/corticosteroids
Target name:
Corticosteroids
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Description:
Tesamorelin-induced growth hormone can inhibit the enzyme (11β-HSD-1) that converts inactive cortisone to active cortisol, potentially reducing cortisol levels and requiring an increased dose of corticosteroids.
Actionable advice:
If you are on long-term corticosteroid therapy, your doctor may need to monitor you and adjust your dose.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Mechanistic inference: GH inhibits 11-beta-HSD-1 (which regenerates active cortisol from cortisone), potentially lowering active cortisol and unmasking adrenal insufficiency in steroid-dependent patients. Mechanistic.
Label source:
Class inference
Action type:
adjust_with_prescriber
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/class/ghrps-ghrhs
Target name:
Other Growth Hormone Secretagogues
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Description:
Combining Tesamorelin with other peptides that stimulate growth hormone release (e.g., Ipamorelin, CJC-1295) can lead to an excessive and potentially unsafe increase in GH and IGF-1 levels.
Actionable advice:
Co-administration with other GH-releasing peptides is best avoided unless under expert medical guidance with frequent lab monitoring.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Pharmacodynamic inference: combining tesamorelin (GHRH analog) with GHRPs (ipamorelin, CJC-1295) acting at the ghrelin receptor produces additive/synergistic GH release that can be excessive. Established GH-axis synergy.
Label source:
Class inference
Action type:
avoid
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/condition/renal-impairment
Target name:
Renal Impairment
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Description:
Patients with kidney disease may have difficulty clearing the drug and are more susceptible to side effects like fluid retention and edema.
Actionable advice:
This is best used with caution and under medical supervision in those with kidney disease.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Mechanistic inference: renal impairment can reduce drug clearance and predispose to GH-related fluid retention/edema, so caution and monitoring are warranted. Mechanistic.
Label source:
Class inference
Action type:
informational_none
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/biomarker/hemoglobin-a1c
Target name:
Hemoglobin A1c
Severity:
moderate
Interaction type:
requirement
Nature:
absolute
Description:
Due to the risk of increased blood sugar and insulin resistance, monitoring long-term glucose control with HbA1c is a critical safety measure.
Actionable advice:
Test your HbA1c and fasting glucose before starting and periodically during treatment.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Monitoring rationale: because tesamorelin can raise glucose and reduce insulin sensitivity, periodic HbA1c monitoring is a sensible safety measure. Mechanistic.
Label source:
Class inference
Action type:
monitor
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/class/statins
Target name:
Statins
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Description:
Some statins (like simvastatin and atorvastatin) are metabolized by CYP3A4; Tesamorelin's induction of GH may slightly increase their blood levels, theoretically raising the risk of side effects like muscle pain.
Actionable advice:
It is worth watching out for any new or worsening muscle pain or weakness while taking this combination.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Low-confidence/speculative: a proposed effect of GH on CYP3A4-metabolized statins (simvastatin/atorvastatin) is weak and not well established; clinically minor. Flagged as low certainty.
Label source:
Class inference
Action type:
monitor
Temporal spacing:
Hours before target:
0
Hours after target:
0
Target id:
/condition/thyroid-disorders
Target name:
Thyroid Disorders
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Description:
Increased growth hormone can accelerate the conversion of T4 to T3, which may unmask or worsen central hypothyroidism. Thyroid function should be monitored.
Actionable advice:
Thyroid function is best monitored periodically by a doctor while on therapy.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Mechanistic inference: GH can accelerate peripheral T4->T3 conversion and may unmask central hypothyroidism; thyroid function monitoring is reasonable during therapy. Established GH-axis effect.
Label source:
Class inference
Action type:
monitor
Temporal spacing:
Hours before target:
0
Hours after target:
0