Egrifta prescribing information covers excess abdominal fat in adults with HIV-associated lipodystrophy. HIV is a virus that weakens immune defenses; lipodystrophy means a change in where the body stores fat. It is not a general weight-loss medicine. The WR label specifies daily injections and highlights cancer history, pregnancy, blood sugar, and hormone levels.
Egrifta WR and Egrifta SV have different doses, preparation steps, and storage rules. Their directions cannot be swapped.
Which Egrifta prescribing information is current?
The current DailyMed WR record says “Revised: 3/2025.” The FDA label PDF carries the same revision month. FDA's March 25, 2025 letter records the WR formulation's approval.
As of October 1, 2026, the day this article was written, DailyMed lists both WR and the older SV label as updated July 29, 2026. Their prescribing-information revision dates remain March 2025 and February 2024, respectively. The listing update is not a new clinical label revision.
Section 1: the indication and its limits
An indication is the use written into the label. WR's concerns HIV-associated fat changes. The research measured visceral fat, the fat deep around abdominal organs.
Section 1 sets three boundaries:
- “Long-term cardiovascular safety of EGRIFTA WR has not been established.” That means long-term safety for the heart and blood vessels remains unsettled.
- It is “not indicated for weight loss management” because its overall weight effect is neutral.
- There are “no data to support improved compliance” with antiretroviral therapy, the medicines that treat HIV. Egrifta does not replace those medicines.
The evidence included a 412-person trial by Falutz and colleagues in the New England Journal of Medicine in 2007. A 2010 pooled analysis in the Journal of Clinical Endocrinology & Metabolism combined two trials involving 806 adults. Both concerned HIV-related abdominal fat, not general obesity; the tesamorelin clinical-trials guide explains their results.
As of October 1, 2026, the day this article was written, a review published July 31, 2026 has combined four trials involving 909 people with HIV. It found less visceral fat with tesamorelin than placebo, an inactive comparison treatment, but described long-term safety and durability data as limited. It does not add a labeled use.
Section 2: dose and administration
Section 2 lists 1.28 mg under the skin once daily for WR. The label describes abdominal injections with site rotation, avoiding the navel, bruises, and scar tissue. A prescriber sets the actual dose and provides product-specific training.
Reconstitution means mixing the freeze-dried powder with its supplied liquid. One prepared 11.6 mg WR vial provides seven daily doses; weekly preparation does not mean weekly injection.
The label reports similar drug exposure, meaning the amount reaching the bloodstream over time, between WR's 1.28 mg and the original formulation's 2 mg. WR and SV are not substitutable.
Section 4: who must not receive it
A contraindication is a reason the medicine must not be used. WR lists four:
- Disruption of the hypothalamic-pituitary axis, the signaling system between the brain and its hormone-releasing gland. Listed causes include gland removal, reduced pituitary function, a pituitary tumor or surgery, head radiation, or head injury.
- Active malignancy, meaning active cancer. Any previous cancer must be inactive and its treatment complete before therapy starts.
- A known allergy to tesamorelin or WR's inactive ingredients.
- Pregnancy, because changing this fat offers no pregnancy benefit and could harm the fetus.
Past cancer still requires a careful assessment of possible benefit against the risk of recurrence. It is a separate question from active cancer.
Section 5: the warnings that need follow-up
Tesamorelin prompts release of growth hormone and raises IGF-1, a growth signal made by the liver. The label calls for monitoring because the effects of prolonged high levels are unknown. Persistent, substantial elevation can prompt reconsideration, especially without a clear treatment response.
Blood sugar needs checking before treatment and periodically afterward. By week 26, about 1 in 20 treated participants, or 5%, reached an HbA1c of at least 6.5%, versus 1% on placebo. HbA1c measures average blood sugar over roughly three months; the label used that threshold to identify diabetes. People with diabetes also need attention to possible damage at the back of the eye.
Fluid retention can cause swelling, joint discomfort, and carpal tunnel symptoms, caused by pressure on a wrist nerve. Allergic reactions occurred in 4% of treated trial participants. The label advises prompt medical attention for any suspected allergic reaction and says treatment should be stopped.
The label also warns about injection-site reactions and critically ill patients. The latter warning comes from increased deaths with administered growth hormone in other studies; it is not a death rate observed in Egrifta's trials. The prescriber weighs whether treatment should continue during critical illness.
Section 6: the adverse-reaction table
Adverse reactions are side effects recorded in the studies. WR's safety assessment draws on trials of the original Egrifta formulation. Table 1 combines the first 26 weeks, with 543 treated participants and 263 receiving placebo. Selected rows are:
| Reaction | Egrifta | Placebo |
|---|---|---|
| Injection-site reaction | 17% | 6% |
| Joint pain | 13% | 11% |
| Pain in an arm or leg | 6% | 5% |
| Muscle pain | 6% | 2% |
| Swelling in the limbs | 6% | 2% |
| Tingling | 5% | 2% |
| Reduced sensation | 4% | 2% |
| Rash | 4% | 2% |
Section 5.6 separately reports injection-site reactions in 25% versus 14%. These are different figures within the same label; 17% versus 6% belongs specifically to Table 1. Neither predicts personal experience. The tesamorelin side-effects guide covers the wider safety evidence.
Sections 7 and 8: medicines and special populations
Growth hormone may change how the liver clears some medicines. The label names corticosteroids, medicines that copy adrenal hormones, plus sex hormones, seizure medicines, and cyclosporine, which suppresses immune activity. Steroid replacement for low adrenal hormone production may need prescriber adjustment.
Pregnancy is contraindicated, and the label advises against breastfeeding during treatment. There are no human milk data. Safety and effectiveness in children are not established, and there is no information on patients older than 65.
Studies of how the drug moves through the body have not established its behavior in people with kidney or liver impairment. That gap does not establish a dose adjustment.
Section 16: how WR is supplied and stored
The WR package has four 11.6 mg vials in a medication box and a separate box with mixing liquid and injection supplies. It covers 28 days.
The label specifies room temperature, 68°F to 77°F, with light protection for unmixed medication. Prepared WR also stays at room temperature and has a seven-day discard window. Its instructions exclude refrigeration and freezing after mixing. These rules belong to WR, not every product containing tesamorelin.
What the label does not cover
Promise's tesamorelin is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. Egrifta's label does not establish a compounded preparation's concentration, storage, directions, or clinical results.
A tesamorelin/ipamorelin preparation adds a second compound. WR's label does not cover that pairing or establish its dose or outcomes.
As of October 1, 2026, the day this article was written, an FDA letter dated August 24, 2026 names online tesamorelin and tesamorelin/ipamorelin products as unapproved new drugs. It concerns their products and marketing. A prescribed route connects the patient with a named prescriber, a licensed U.S. compounding pharmacy, and a path for reporting problems.
A licensed provider may still prescribe a compounded formulation; that decision is between the patient and the doctor. At Promise, a licensed provider reviews every request, and not everyone qualifies. The questions to ask before tesamorelin guide helps organize that conversation around medical history, medicines, and monitoring.
