Tesamorelin Injection
Tesamorelin is a growth hormone-releasing factor analog used to reduce excess abdominal fat in HIV-infected adults with lipodystrophy.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Tesamorelin Injection: Patient Information Guide
A plain-language walkthrough of Tesamorelin Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Tesamorelin injection is approved for one specific use in adults:
- EGRIFTA WR is indicated to reduce excess abdominal fat in HIV-infected adults who have developed lipodystrophy — an abnormal buildup of visceral (deep belly) fat linked to HIV and antiretroviral therapy.
- EGRIFTA WR is not approved for general weight loss management — it has a weight-neutral overall effect.
- There are no data showing it improves adherence to HIV medications.
- Long-term cardiovascular safety of EGRIFTA WR has not been established.
⚙️How it works▾
Tesamorelin is a synthetic analog of growth hormone-releasing factor (GHRF) — a hormone the brain normally uses to tell the pituitary gland to make growth hormone. By binding to the same receptors as natural GHRF, tesamorelin triggers the pituitary to release growth hormone in pulses, similar to how the body does it naturally. Growth hormone then acts on fat cells (adipocytes), muscle, liver, and other tissues, promoting fat breakdown — particularly the deep abdominal fat that accumulates with HIV-related lipodystrophy. Some of these effects are also mediated through IGF-1, a secondary growth factor produced mainly in the liver in response to growth hormone.
💊How it's taken▾
EGRIFTA WR is given as a once-daily subcutaneous (under-the-skin) injection into the abdomen. The powder must be mixed with the specific diluent provided before each use; one prepared vial provides doses for 7 consecutive days and must be discarded after that.
- Rotate injection sites around the abdomen with each dose.
- Do not inject into scar tissue, bruises, or the navel.
- Store the reconstituted solution at room temperature and do not freeze it.
- EGRIFTA WR and EGRIFTA SV are not interchangeable — they have different strengths, reconstitution steps, and dosing; follow the instructions for your specific product.
🤒Side effects — in detail▾
The most commonly reported side effects with tesamorelin include:
- Joint pain (arthralgia)
- Injection site redness, itching, or pain
- Pain in the arms or legs
- Muscle aches (myalgia)
- Swelling in the legs or feet (peripheral edema)
- Tingling or numbness (paresthesia or hypoesthesia)
- Rash
- Upset stomach (dyspepsia)
More serious reactions — including significant swelling, carpal tunnel syndrome (numbness/weakness in the hand and wrist), high blood sugar, allergic reactions, and injection site reactions — should be reported to your doctor promptly. Injection site reactions are common (about 1 in 4 patients) but can be reduced by rotating sites.
⚠️Warnings & precautions▾
- Cancer risk: Tesamorelin stimulates growth hormone, a growth factor. It must not be used in anyone with active cancer. Those with a history of cancer need careful evaluation before starting. Stop immediately if cancer returns.
- High IGF-1 levels: The medication raises IGF-1 (a growth factor) in the blood. Long-term effects of elevated IGF-1 are unknown. Regular monitoring is required, and the drug may be stopped if levels stay persistently high.
- Blood sugar / diabetes: Tesamorelin can cause glucose intolerance or raise the risk of type 2 diabetes. Blood sugar should be checked before and during treatment. Patients with diabetes should also be monitored for worsening of diabetic eye disease (retinopathy).
- Fluid retention: Swelling, joint pain, and carpal tunnel syndrome can occur due to increased growth hormone levels — usually transient or resolving after stopping treatment.
- Serious allergic reactions: Occurred in about 4% of patients in trials. Seek emergency care immediately for hives, flushing, rash, or breathing difficulty.
- Critical illness: Growth hormone-stimulating drugs have been linked to increased deaths in critically ill patients. This medication may need to be stopped during serious illness or major surgery.
- Pregnancy: Contraindicated — can cause fetal harm.
🔀What it interacts with▾
Tesamorelin can affect how some other medications work, mainly because it raises growth hormone levels, which influence liver enzymes:
- CYP450-metabolized drugs (including corticosteroids, sex hormones, anti-seizure medications, and cyclosporine) — growth hormone can alter how these drugs are cleared from the body; your doctor should monitor you if you take any of these.
- Cortisone acetate and prednisone — these steroid medications rely on a specific enzyme (11βHSD-1) to become active in the body; tesamorelin may reduce that enzyme's activity, making these drugs less effective; a dose increase may be needed.
- Simvastatin — a small reduction in simvastatin exposure was seen in studies, though it was not considered clinically significant.
- Ritonavir — a small reduction in ritonavir levels was observed; your HIV specialist should be aware.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor about any history of cancer — active malignancy is a contraindication; past cancer requires careful benefit-risk discussion.
- Tell your doctor if you have pituitary gland problems, have had head surgery, brain radiation, or a serious head injury — these conditions make tesamorelin contraindicated.
- Tell your doctor if you have diabetes, pre-diabetes, or a history of high blood sugar — close monitoring is required.
- Tell your doctor about all medications you take, especially steroids, cholesterol drugs, HIV medications, anti-seizure drugs, or cyclosporine.
- Pregnancy: Do not use tesamorelin if you are pregnant — it is contraindicated and can harm the fetus. Discontinue immediately if pregnancy occurs during treatment.
- Breastfeeding: Do not breastfeed while using EGRIFTA WR. HIV-positive mothers are advised not to breastfeed regardless of tesamorelin use.
- Children: Safety and effectiveness in pediatric patients have not been established; not approved for use in children.
- Older adults (65+): No safety information is available for patients over 65.
- Kidney or liver problems: Pharmacokinetics in patients with renal or hepatic impairment have not been studied; discuss with your doctor.
📡Pharmacodynamics — effects in the body▾
Tesamorelin stimulates the pituitary gland to secrete growth hormone, which in turn raises levels of IGF-1 (insulin-like growth factor-1) and IGFBP-3 in the blood — both markers of growth hormone activity. In clinical trials, it did not cause meaningful changes in other pituitary hormones such as thyroid-stimulating hormone, luteinizing hormone, ACTH, or prolactin, suggesting its effects are relatively focused on the growth hormone axis.
🔬Pharmacokinetics — how your body processes it▾
Tesamorelin is given by subcutaneous (under-the-skin) injection and is absorbed quickly, reaching peak blood levels in about 9 minutes. Its absolute bioavailability (the fraction that reaches the bloodstream) is less than 4% after injection, and it is eliminated from the body very rapidly — with a half-life of only about 11 minutes. Because the body clears it so quickly, it must be given daily to maintain its effect. HIV-infected patients absorb about 34% more of the drug on average compared to healthy individuals. No formal studies of how the body metabolizes (breaks down) tesamorelin have been conducted in humans, and its pharmacokinetics in people with kidney or liver disease, children, or older adults have not been established.
📦How to store it▾
Store EGRIFTA WR 11. protect from light; excursions permitted to 15°C to 30°C (59°F to 86°F) . Store the Injection box (containing Bacteriostatic Water for Injection, syringes, needles and alcohol swabs) at room temperature at 20°C to 25°C (68°F to 77°F).
📄 Written from Tesamorelin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Tesamorelin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is this medication supposed to do for me? ▾
How do I give myself the injection, and does it hurt? ▾
What side effects should I actually be worried about versus just expected to put up with? ▾
Will this medication affect my blood sugar or diabetes? ▾
Can I take this if I'm pregnant or thinking about getting pregnant? ▾
Are there any other medications I need to be careful about combining with this? ▾
Is Tesamorelin Injection available over the counter? ▾
When was Tesamorelin Injection first available? ▾
💬 Answers drafted from Tesamorelin Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
📊 Tesamorelin Injection across the U.S. market
How Tesamorelin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Kit (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
📈 How widely Tesamorelin Injection is used
A general measure of how commonly Tesamorelin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Tesamorelin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Tesamorelin Injection prescribed? Of the 1,596 medications we measure, Tesamorelin Injection ranks #1,422 by Medicaid prescriptions — more than 11% of them.
Utilization by Tesamorelin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
tesamorelin 2 MG Injection
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1044587
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Tesamorelin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Tesamorelin Injection NDCs with Medicaid activity.
🔍 Compare Tesamorelin Injection products
A representative set of FDA-listed product records for Tesamorelin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|
| 💊Kits | |||
| Subcutaneous | Theratechnologies Inc. × 5 listings | BLA | View NDC → |
Showing 5 of 5 products — FDA National Drug Code Directory. See every product, package size and price: browse all 5 Tesamorelin Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Tesamorelin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Tesamorelin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Tesamorelin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 1044584 1 dose form · 3 strengths
-
Dose form (SCDF) Injection RxCUI 1719678No current FDA listing
Look up RxCUI 1044584 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Tesamorelin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Tesamorelin Injection belongs to the Growth Hormone Releasing Factor Analog class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Theratechnologies Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.