Tesamorelin

Pronunciation: tes-a-MOR-e-lin.

Generic name
tesamorelin
Brand names
Egrifta SV, Egrifta WR, Egrifta
Drug class
Growth hormone-releasing factor (GRF/GHRH) analogue
Form
Injection kit -- lyophilised powder for reconstitution with supplied sterile water
Route
Subcutaneous injection
Legal status
Prescription-only where authorised (United States, Canada). Not authorised as a licensed medicine in the European Union, United Kingdom, Australia, or New Zealand.

Availability and supply rules vary by country

Trade names by country: United States · Canada

Australia: · Full directory

What tesamorelin is and how it works

Tesamorelin is a prescription-only injectable medicine used to reduce excess abdominal fat in adults with HIV-associated lipodystrophy (an abnormal fat redistribution linked to HIV and its treatment). It is given once daily by injection under the skin. (1)

Take tesamorelin exactly as your prescriber directs, at the same time each day, reconstituting each dose immediately before use. It does not cause general weight loss and is not intended as a weight-loss treatment -- it specifically targets excess abdominal (visceral) fat linked to HIV-associated lipodystrophy.

Mechanism of action: how tesamorelin works

Tesamorelin is a synthetic analogue of growth hormone-releasing factor (GRF/GHRH) that binds human GRF receptors, stimulating the synthesis and pulsatile release of endogenous growth hormone. Its lipolytic (fat-reducing) and anabolic effects are mediated partly through increased IGF-1. (1)

What tesamorelin is used for

Excess abdominal fat in HIV-associated lipodystrophy

Used to reduce excess abdominal fat in adults with HIV infection who have lipodystrophy (abnormal body fat redistribution). It is not indicated for general weight loss, since it has a weight-neutral effect overall, and there is no evidence it improves adherence to antiretroviral therapy. Long-term cardiovascular safety has not been established. (1)

Before taking tesamorelin

Do not take / not appropriate for

  • Do not use tesamorelin if you have a disruption of the hypothalamic-pituitary axis, such as from pituitary gland removal, a pituitary tumour or its surgery, or head irradiation or trauma affecting this area. (all countries) (1)
  • Do not use tesamorelin if you have an active cancer (malignancy). (all countries) (1)
  • Do not use tesamorelin if you have had a serious allergic reaction to it or any of its ingredients. (all countries) (1)
  • Do not use tesamorelin during pregnancy -- it is contraindicated, since animal studies showed harm to the developing baby and there is no benefit to reducing abdominal fat during pregnancy. (pregnancy) (1)

Tell your clinician about

  • Any personal history of cancer, including any prior or recurrent malignancy.
  • Any history of pituitary gland problems, pituitary surgery, or head injury/radiation.
  • Diabetes, prediabetes, or a family history of diabetes, since tesamorelin can worsen blood sugar control.
  • Any history of carpal tunnel syndrome, joint pain, or fluid retention.
  • All other medicines you take, especially corticosteroids and other medicines processed by the liver.
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1)

How to take tesamorelin

  • Inject under the skin of the abdomen once a day, rotating the exact spot each time and avoiding scar tissue, bruises, or the navel area.
  • Reconstitute each dose immediately before use by gently rolling the vial with the supplied sterile water for about 30 seconds -- never shake it.
  • Use the reconstituted solution right away and discard any that is left over; never freeze or refrigerate the mixed solution.
(1)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

Contact your prescriber for guidance if you miss a dose, rather than doubling a later dose.

Overdose

Contact your prescriber or seek urgent medical attention if you think you have used too much tesamorelin. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Joint pain (arthralgia) and muscle pain (myalgia).

What to notice: Joint pain (arthralgia) and muscle pain (myalgia).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Injection site redness and itching, occurring in about 1 in 4 people using tesamorelin.

What to notice: Injection site redness and itching, occurring in about 1 in 4 people using tesamorelin.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Pain in the arms or legs and swelling (peripheral oedema).

What to notice: Pain in the arms or legs and swelling (peripheral oedema).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Headache, rash, indigestion, tingling or numbness (paraesthesia), muscle strain, night sweats, and palpitations.

What to notice: Headache, rash, indigestion, tingling or numbness (paraesthesia), muscle strain, night sweats, and palpitations.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)

Serious warnings

Signs of a serious allergic reaction — emergency

Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash or hives.

Action: Seek emergency medical help immediately. (1)

New or worsening high blood sugar — high caution

Symptoms: Increased thirst, frequent urination, or unusually high blood sugar readings.

Action: Tell your prescriber promptly; blood sugar is monitored before and during treatment because of an increased risk of developing diabetes. (1)

Signs of cancer recurrence — high caution

Symptoms: Any new or unusual symptom that could suggest a cancer has returned.

Action: Contact your prescriber promptly; treatment is stopped by a clinician if there is evidence of recurrent malignancy. (1)

Signs of carpal tunnel syndrome or significant fluid retention — high caution

Symptoms: Numbness or tingling in the hand and fingers, or new joint pain and swelling.

Action: Tell your prescriber; these effects are usually transient or resolve after stopping, but should still be assessed. (1)

Interactions

  • Corticosteroid (glucocorticoid) replacement medicines may need a dose increase after starting tesamorelin -- tell your prescriber about any steroid medicine you take. (1)
  • Tesamorelin can change how the body processes some other medicines (including certain steroids, sex hormones, seizure medicines, and ciclosporin) -- tell your prescriber about all medicines you take so they can monitor for this. (1)
  • Simvastatin can be combined with tesamorelin with only minimal changes observed to either medicine's levels. (1)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Contraindicated. Animal studies showed harm to the developing baby, and there is no benefit to reducing abdominal fat during pregnancy that would outweigh this risk. (1) (2) (3) (4) (5) (6)

Breastfeeding

Mothers with HIV are generally advised not to breastfeed, because of the risk of HIV transmission to the infant and potential effects of the medicine -- discuss with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Not established for use in children in the source reviewed for this dossier. (1) (2) (3) (4) (5) (6)

Elderly

No specific age-based dose adjustment is described in the source reviewed; individual monitoring applies regardless of age. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Not specifically detailed in the source reviewed for this dossier; tell your prescriber about any liver problems. (1) (2) (3) (4) (5) (6)

Renal_impairment

Not specifically detailed in the source reviewed for this dossier; tell your prescriber about any kidney problems. (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Assessment for active malignancy or hypothalamic-pituitary axis disruption
  • Baseline blood sugar (HbA1c)
  • Baseline IGF-1 level

During treatment

  • Periodic blood sugar monitoring, given the increased risk of developing diabetes.
  • Periodic IGF-1 level checks.
  • Watching for signs of cancer recurrence.
  • Watching injection sites for reactions, and watching for joint pain, swelling, or carpal tunnel symptoms.
(1)

Storage

Store vials, sterile water, syringes, and needles at room temperature 20-25°C (68-77°F), protected from light, in the original box. Use the reconstituted solution immediately -- never freeze or refrigerate it, and discard any unused portion.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.

United States

Indication: Reduction of excess abdominal fat in HIV-infected adults with lipodystrophy

Dose summary: 1.4 mg (0.35 mL reconstituted) subcutaneously once daily into the abdomen, rotating injection sites. Reconstitute 1 vial of lyophilised powder with the supplied sterile water by gently rolling (never shaking) for about 30 seconds; administer immediately and discard any unused solution.

Renal context: Not established in the source reviewed for this dossier. (1)

Canada

Indication: Treatment of excess visceral adipose tissue in treatment-experienced adult HIV-infected patients with lipodystrophy

Dose summary: Approved as 1 mg/vial and 2 mg/vial presentations; indication requires waist circumference >=95 cm (men) or >=94 cm (women) and CT-confirmed visceral adipose tissue >30 cm^2.

Renal context: Not detailed in the source reviewed for this dossier. (2)

Mechanism of action

Hepatic guidance

Not specifically detailed in the source reviewed for this dossier.

Overdose note

Overdose data are limited in the source reviewed; manage per general supportive principles and local poison-control guidance, with attention to blood sugar and fluid status. (1)

Frequently asked questions

Is tesamorelin (Egrifta) available in the US, UK, Europe, Canada, Australia, and New Zealand?

It is approved and available in the United States and Canada. It is not authorised as a licensed medicine in the European Union (the marketing authorisation application was withdrawn in 2012), the United Kingdom (no MHRA licence -- available only as an unlicensed import on a named-patient basis, if at all), Australia (not on the ARTG -- accessible only through the TGA Special Access Scheme), or New Zealand (Medsafe states no medicines are approved there containing this substance). (1) (2) (3) (4) (5) (6)

Will tesamorelin help me lose weight generally?

No. Tesamorelin is not indicated for general weight loss and has an overall weight-neutral effect -- it specifically targets excess abdominal (visceral) fat associated with HIV-related lipodystrophy. (1)

Who should not use tesamorelin?

Tesamorelin should not be used if you have had a pituitary gland tumour, pituitary surgery, or head radiation, since it works through the pituitary-hypothalamic pathway that these conditions can disrupt. It should also not be used if you have an active cancer or are pregnant. Because HIV itself raises background cancer risk, your prescriber will carefully weigh this before starting treatment. (1)

What is the mechanism of action of tesamorelin?

Tesamorelin is a synthetic analogue of growth hormone-releasing factor (GRF/GHRH) that binds human GRF receptors, stimulating the synthesis and pulsatile release of endogenous growth hormone. Its lipolytic (fat-reducing) and anabolic effects are mediated partly through increased IGF-1. (1)

What is the generic name of Tesamorelin?

The generic name is tesamorelin. It is sold under brand names including Egrifta SV, Egrifta WR, Egrifta. (1)

What class of drug is tesamorelin?

Tesamorelin is classed as: Growth hormone-releasing factor (GRF/GHRH) analogue. (1)

References

  1. EGRIFTA SV (tesamorelin) for injection -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Theratechnologies Inc. · United States · accessed 2026-07-30 · source 1
  2. Egrifta (tesamorelin for injection) -- Health Canada approvalHealth Canada (Notice of Compliance / Summary Basis of Decision) · Canada · accessed 2026-07-30 · source 2
  3. Ferrer Internacional S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin)European Medicines Agency (EMA) · European Union · accessed 2026-07-30 · source 3
  4. Tesamorelin/Egrifta holds no UK marketing authorisation from the MHRAUnited Kingdom -- no MHRA marketing authorisation found; unlicensed-medicine import status · United Kingdom · accessed 2026-07-30 · source 4
  5. Egrifta (tesamorelin) not approved by the TGA; accessible only via the Special Access SchemeTherapeutic Goods Administration (TGA), Australia -- not on the ARTG; Special Access Scheme only · Australia · accessed 2026-07-30 · source 5
  6. Medsafe Medicines Classification Committee submission: Classification Status of Peptide-based Performance and Image Enhancing Drugs (includes tesamorelin)Medsafe (New Zealand regulator) -- Medicines Classification Committee submission document · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient tesamorelin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Egrifta SV / Egrifta WR (1)FDA approved currently labeled · 2 mg/vial (reconstituted to 1.4 mg dose), 1 mg/vial · Theratechnologies Inc.

Canada

  • EGRIFTA
View brands in additional countries.