Egrifta (Tesamorelin) for Adults 65 and Older: Transitioning to Geriatric Care

What the labels say about patients over 65

Both current labels address older patients in one line. The Egrifta SV Geriatric Use section reads: 'There is no information on the use of EGRIFTA SV in patients greater than 65 years of age' [1]. The Egrifta WR label says the same for its formulation [2].

The two multicenter, randomized, double-blind, placebo-controlled approval studies enrolled patients aged 18 to 65 with HIV-associated lipodystrophy and excess abdominal fat [1][2]. Their exclusion criteria included type 1 or type 2 diabetes, prior insulin or oral glucose-lowering treatment, a history of malignancy, and hypopituitarism [1][2].

Is the dose different after 65?

The labels' dosing sections give a single dose. Egrifta SV is 1.4 mg, given as 0.35 mL of the reconstituted 2 mg per 0.5 mL solution, subcutaneously into the abdomen once daily [1]. Egrifta WR is 1.28 mg, given as 0.16 mL of the reconstituted 8 mg/mL solution, once daily [2]. The labels state the two products are not substitutable because dose, number of vials, reconstitution and storage all differ [2].

The pivotal trials used 2 mg daily of the original 1 mg-per-vial product. FDA accepted the 1.4 mg Egrifta SV dose because its exposure was similar to the 2 mg dose used with the earlier formulation [1]. Kinetics in kidney impairment, liver impairment, children and the elderly are not established [1].

What the labels ask for at any age

The labels describe these monitoring points and warnings.

• IGF-1. The label directs monitoring of IGF-1, a growth factor, and says to consider discontinuing with persistent elevation, for example above 3 SDS, particularly if fat loss is not robust [1].
• Glucose. HbA1c of at least 6.5% developed in 5% on tesamorelin vs 1% on placebo by week 26 (hazard ratio about 3.3; 95% CI 1.4 to 9.6). The label says to evaluate glucose before and during therapy [1].
• Other labeled warnings. Edema, joint pain and carpal tunnel syndrome can occur; peripheral edema was 6% vs 2% on placebo, arthralgia 13% vs 11%, and myalgia 6% vs 2% [1]. Active malignancy is a contraindication, and the label says to discontinue if malignancy recurs [1][2].

The label states long-term cardiovascular safety has not been established [1].

What happens when treatment stops

In the extension phases, patients who had received tesamorelin for 26 weeks and were then switched to placebo regained visceral fat. From week 26 to week 52, visceral adipose tissue changed by 22% in Study 1 and 16% in Study 2 for those switched to placebo, versus 0% and a 5% reduction in those who continued tesamorelin [1].