The approved use is narrow
The approved use is to reduce excess belly fat in adults who have HIV and lipodystrophy, as of September 28, 2026.
The US agency that reviews medicines is the Food and Drug Administration (FDA).
HIV is the name of a virus.
Lipodystrophy means a change in where the body holds fat; it can occur during HIV treatment.
Bring the reason you are looking into this medicine to the visit. Describe the change in your own words, even if you do not yet have a name for it.
Belly fat and body weight are different
Tesamorelin is not approved for weight loss, according to the September 2026 labels.
In the main trials, the change in body weight was small even when deep belly fat fell.
Deep belly fat means the fat around the organs.
Ask what result the clinician would be trying to change. A change on the scale and a change in deep belly fat are separate goals.
Ask what an off-label use means
Off-label means prescribing an approved medicine for a purpose its label does not approve. For tesamorelin, that means a purpose other than its belly-fat use in the September 28, 2026 labels.
The sources recorded for this guide do not settle whether a clinician may prescribe it for your proposed purpose. Ask the clinician which prescribing rules apply to that use.
Ask which studies fit your situation, what they measured, and what remains unknown. Keep the answer with the proposed treatment goal.
Name the goal before the drug
Tesamorelin's label separates its belly-fat use from weight loss.
Source notes
- FDA approval record
The record sets out the original treatment purpose.
- Current label on DailyMed
The use and limits are in the opening section.