Need help or have questions about your order? Call 510-991-8265Questions about your order? Call 510-991-8265

Sign InShop GLPs
Shop GLPs

Egrifta (Tesamorelin) Mental Health and Mood Impact

By
Published Updated Last reviewed
5 linked public sourcesEditorial, sourcing, and corrections policy

At a glance

  • Approved use / excess abdominal fat in HIV-infected adults with lipodystrophy [1]
  • Psychiatric warnings in the Egrifta SV and Egrifta WR labels / none [1][2]
  • Boxed warning / none [1][2]
  • Body image in the phase 3 trials / self-assessed, secondary endpoint [3][4]
  • IGF-1 at week 26, pooled phase 3 / plus 108 ng/mL vs minus 7 ng/mL on placebo [5]

What the labels say about mood

The Egrifta SV and Egrifta WR labels share seven warnings and precautions: neoplasms, elevated IGF-1, fluid retention, glucose intolerance or diabetes, hypersensitivity, injection-site reactions and mortality in acute critical illness [1][2]. Mood, depression, anxiety and cognition are not among them, and neither label has a boxed warning [1][2].

IGF-1

Tesamorelin stimulates pituitary release of the body's own growth hormone, raising IGF-1 and IGFBP-3 [1]. In the pooled phase 3 analysis IGF-1 rose 108 ng/mL on tesamorelin against a 7 ng/mL fall on placebo at week 26 [5]. The label says the effects of prolonged IGF-1 elevation are unknown and asks prescribers to monitor IGF-1 and consider discontinuing with persistent elevations, for example above 3 SDS, particularly if the efficacy response is not robust [1].

Interactions with other medicines

The label states that growth hormone may modulate CYP450-mediated clearance and may alter clearance of drugs handled by CYP450 enzymes, naming corticosteroids, sex steroids, anticonvulsants and cyclosporine; antidepressants are not among them [1].

Frequently asked questions

Does tesamorelin cause depression?
Depression and mood change are not among the seven warnings and precautions in the Egrifta SV or Egrifta WR label [1][2].
Can tesamorelin improve mood?
Tesamorelin is approved only for reducing excess abdominal fat in HIV-infected adults with lipodystrophy; mood is not an approved use [1]. Self-assessed body image was a secondary endpoint in both phase 3 trials [3][4].
Does tesamorelin interact with antidepressants?
The label says growth hormone may alter the clearance of drugs metabolized by CYP450 liver enzymes and names corticosteroids, sex steroids, anticonvulsants and cyclosporine; antidepressants are not among the drugs it names [1]. Simvastatin, a CYP3A substrate, showed no significant change in exposure when given with tesamorelin [1].

References

  1. U.S. National Library of Medicine, DailyMed. Egrifta SV (tesamorelin) for injection, 2 mg vial prescribing information. Egrifta SV (tesamorelin) for injection, 2 mg vial label
  2. U.S. National Library of Medicine, DailyMed. Egrifta WR (tesamorelin) for injection, 11.6 mg vial prescribing information. Egrifta WR (tesamorelin) for injection, 11.6 mg vial label
  3. Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, et al. Metabolic effects of a growth hormone-releasing factor in patients with HIV. N Engl J Med. 2007;357(23):2359-70. Metabolic effects of a growth hormone-releasing factor in patients with HIV
  4. Falutz J, Potvin D, Mamputu JC, Assaad H, Zoltowska M, Michaud SE, et al. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension. J Acquir Immune Defic Syndr. 2010;53(3):311-22. Effects of tesamorelin, a growth hormone-releasing factor, in HIV-infected patients with abdominal fat accumulation: a randomized placebo-controlled trial with a safety extension
  5. Falutz J, Mamputu JC, Potvin D, Moyle G, Soulban G, Loughrey H, 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. 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
Evidence overview for Egrifta (Tesamorelin) Mental Health and Mood Impact