Egrifta (Tesamorelin) ACL / Ligament Rehabilitation Protocol

Is tesamorelin approved for ACL or ligament injury?

No. Egrifta is a growth hormone-releasing factor analog indicated for reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy [1]. The label states that long-term cardiovascular safety has not been established and that the drug is not indicated for weight loss because its effect on weight is neutral [1]. Ligament healing is outside that indication. FDA states that prescribers generally may use an approved drug for an unapproved use, and that FDA has not determined the drug is safe and effective for that use [2].

What tesamorelin does

Tesamorelin binds and stimulates human GRF receptors on pituitary somatotroph cells, so the pituitary makes and releases more of the body's own growth hormone, which then raises IGF-1 and IGFBP-3 [1]. It is a peptide, not growth hormone [1].

Approved doses and what the labels say to watch for

The Egrifta SV label gives a dose of 1.4 mg injected subcutaneously into the abdomen once daily, rotating sites. The Egrifta WR label gives 1.28 mg once daily, and the labels state the two are not substitutable [1][3]. The pivotal trials used 2 mg daily of the original 1 mg/vial product [1].

• IGF-1. The label tells prescribers to monitor IGF-1 and consider stopping if levels stay high (for example above 3 SDS), especially if fat loss is not robust. In the trials, 47% of patients treated 26 weeks had IGF-1 above 2 SDS and 36% above 3 SDS; at 52 weeks the figures were 34% and 23% [1].
• Glucose. HbA1c of 6.5% or higher developed in 5% on tesamorelin versus 1% on placebo by week 26 (hazard ratio 3.3, 95% CI 1.4 to 9.6), and the label asks for glucose evaluation before and during treatment [1].
• Fluid retention, injection sites and hypersensitivity. Edema, joint pain and carpal tunnel syndrome are labeled warnings; arthralgia was 13% versus 11% on placebo and peripheral edema 6% versus 2%. Injection-site reactions occurred in 25% versus 14%, and hypersensitivity reactions in 4%, with the label advising patients to seek immediate medical attention and stop treatment if one is suspected [1].
• Neoplasms. The label says that any preexisting malignancy should be inactive and its treatment complete before starting tesamorelin, and that treatment should be discontinued if malignancy recurs [1].

Contraindications are disruption of the hypothalamic-pituitary axis, active malignancy, known hypersensitivity to tesamorelin or its excipients, and pregnancy [1][3].

ACL rehabilitation after reconstruction

The Dutch ACL rehabilitation guideline, based on 90 studies, sets out three criterion-based postoperative phases guided by strength, hop, movement-quality and psychological tests, and states that rehabilitation should continue 9 to 12 months [5]. It describes rehabilitation phases and testing; it gives no tesamorelin dose or drug-based protocol for ligament healing.

Drug testing in athletes

WADA names tesamorelin in section S2.2.4 among growth hormone-releasing factors, prohibited at all times, and it appears on the 2026 and 2027 Prohibited Lists [4][6]. For athletes subject to WADA rules, taking tesamorelin during ACL rehabilitation would be prohibited in and out of competition.