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EGRIFTA WR tesamorelin Kit — NDC 62064-0381-04 package photo
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EGRIFTA WR tesamorelin Kit — NDC 62064-381-04 (Billing 62064-0381-04)

by Theratechnologies Inc. · 1 KIT in 1 BOX * 1.3 mL in 1 VIAL * 30 mL in 1 BOTTLE

This is a package of EGRIFTA WR tesamorelin Kit from Theratechnologies Inc., marketed since Jul 2025 and currently FDA-listed. It is this product's only package size.

NDC 62064-0381-04
🏷️ FDA NDC (as labeled) 62064-381-04 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62064-381-04
Product NDC 62064-381
11-digit billing NDC 62064038104
NCPDP billing unit EA — each (per item)
RxCUI 2719314, 2719316
Application # BLA022505
SPL Set ID 839334d3-8c1d-4c26-9036-2ab524a6ea75
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-07-15
Route SUBCUTANEOUS
Dosage form KIT
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 087937
GCN 57988
HICL code 037268
Ingredient (HICL) Tesamorelin Acetate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P1
Therapeutic class — intermediate (HIC2) Anteriorpituitary Hormones
HIC3 code P1H
Therapeutic class — specific (HIC3) Growth Hormone Releasing Hormone(Ghrh) And Analogs
AHFS code 68:30.04.00
AHFS class Somatotropin Agonists
FDB label name EGRIFTA WR 11.6MG FOUR-VL KIT
FDB brand name Egrifta Wr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 087937
  • GCN: 57988
  • HICL (First Databank): 037268
  • AHFS class code: 68:30.04.00
  • RxCUI (RxNorm): 2719314
Why two NDCs? The FDA registers this code as 62064-381-04 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 62064-0381-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Growth Hormone Releasing Factor Analog class.

Pharmacologic class Growth Hormone Releasing Factor Analog
Drug family (ATC) Somatropin and somatropin agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name EGRIFTA WR 11.6MG FOUR-VL KIT Ingredient Tesamorelin Acetate
📗 Our plain-language guide HelloPharmacist
  • Tesamorelin (EGRIFTA WR) is specifically designed to reduce the excess deep belly fat that can build up in HIV-positive people — a condition called lipodystrophy. It's not a genera...
  • What exactly is this medication supposed to do for me?
  • You'll inject it just under the skin of your abdomen once a day — that's called a subcutaneous injection. Before each injection, you mix the powder with the special liquid (diluent...
  • How do I give myself the injection, and does it hurt?
📖 Read our full Tesamorelin Injection guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $10,353.08 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
62064-0381-04 You're viewing this Main listing 1 KIT in 1 BOX * 1.3 mL in 1 VIAL * 30 mL in 1 BOTTLE 2025-07-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Egrifta Wrthis 62064-0381-04 Theratechnologies 1 kit — — FDA listed —
Egrifta Sv 62064-0241-30 Theratechnologies 1 kit — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2025
First FDA approval
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2037
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Mar 2037. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 25, 2025 ⏳ ~10.5 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Egriftatesamorelin Egrifta SVtesamorelin Egrifta WRtesamorelin
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2025 2027 2029 2031 2033 2035 2037
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateMar 25, 2037
Common questions
Is there a biosimilar for EGRIFTA WR 11.6MG FOUR-VL KIT?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTheratechnologies Inc.
FDA applicationBLA022505 (BLA)
Labeler code62064
First marketedJul 2025
Product typeHuman Prescription Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 156 words ▾

1 INDICATIONS AND USAGE EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.

EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR. EGRIFTA WR is a growth hormone-releasing factor (GHRF) analog indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

( 1 ) Limitations of use: Long-term cardiovascular safety of EGRIFTA WR has not been established. ( 1 ) Not indicated for weight loss management. ( 1 ) There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA WR (tesamorelin) for injection 11.6 mg per vial formulation. For recommendations for tesamorelin for injection 2 mg per vial formulation, see the EGRIFTA SV prescribing information. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements.

EGRIFTA WR and EGRIFTA SV are not substitutable. ( 2.1 ). The dose of EGRIFTA WR is 1.28 mg (0.16 mL of the reconstituted solution) injected subcutaneously once daily.

( 2.1 ) Inject EGRIFTA WR into the abdomen, rotating injection sites. ( 2.1 , 5.6 ) Use only the diluent provided, Bacteriostatic Water for Injection, USP, to reconstitute EGRIFTA WR. ( 2.2 ) Reconstitute one vial of lyophilized powder with 1.3 mL of diluent.

Move the vial in a circle (swirl) to mix all the powder and liquid. Do not shake. ( 2.2 ) Inspect the reconstituted vial visually for particulate matter and discoloration.

Use only if the solution is clear, colorless and without particulate matter. ( 2.2 ) One reconstituted vial provides daily doses for 7 days. Discard unused solution of EGRIFTA WR vial 7 days after mixing.

( 2.2 )

2.1Recommended Dosage and Administration Instructions There are two EGRIFTA formulations (EGRIFTA WR and EGRIFTA SV) with different recommended dosages. These two formulations and strengths have differences in the dosage, the number of vials required to prepare a dose, reconstitution instructions, and storage requirements. EGRIFTA WR and EGRIFTA SV are not substitutable.

The dosage and administration recommendations in this prescribing information only apply to EGRIFTA WR (tesamorelin) for injection 11.6 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 2 mg per vial formulation, see the EGRIFTA SV prescribing information. The recommended dosage of EGRIFTA WR is 1.28 mg subcutaneously once daily.

Inject EGRIFTA WR into the abdomen. Rotate injection sites to different areas of the abdomen [see Warnings and Precautions ( 5.6 )]. Do not inject into scar tissue, bruises or the navel.

2.2Reconstitution Procedure Instruct patients to read the Instructions for Use enclosed in the EGRIFTA WR Injection Box. Use only the diluent provided, Bacteriostatic Water for Injection, to reconstitute EGRIFTA WR. Reconstitute 1 vial of EGRIFTA WR lyophilized powder with 1.3 mL of diluent (8 mg per mL).

Move the vial in a circle (swirl) to mix all the powder and liquid. Do not shake. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

EGRIFTA WR is a clear, colorless solution. Do not use if solid particles appear or if the solution is cloudy or colored. One reconstituted EGRIFTA WR vial provides daily doses for 7 consecutive days.

One dose of EGRIFTA WR is 1.28 mg in 0.16 mL of the reconstituted solution. Store reconstituted EGRIFTA WR at room temperature at 20°C to 25°C (68°F to 77°F). Discard unused solution of EGRIFTA WR 7 days after mixing.

Do not freeze.

💊 Dosage Forms and Strengths 55 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 11.6 mg of tesamorelin as a white to off-white lyophilized powder in a single-patient-use vial for reconstitution and a diluent of 30 mL of multiple-dose Bacteriostatic Water for Injection, USP. For injection: 11.6 mg of tesamorelin as a lyophilized powder in single-patient-use vial for reconstitution. ( 3 )

⛔ Contraindications 138 words ▾

4 CONTRAINDICATIONS EGRIFTA WR is contraindicated in: Patients with disruption of the hypothalamic-pituitary axis ( 4 ) Patients with active malignancy ( 4 ) Patients with known hypersensitivity to tesamorelin or excipients in EGRIFTA WR ( 4 ) Pregnancy ( 4 ) EGRIFTA WR is contraindicated in: Patients with disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. Patients with active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy [see Warnings and Precautions ( 5.1 )] .

Patients with known hypersensitivity to tesamorelin or the excipients in EGRIFTA WR [see Warnings and Precautions ( 5.5 )]. Pregnant women because modifying visceral adipose tissue offers no benefit in a pregnant woman and could result in fetal harm [see Use in Specific Populations ( 8.1 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA WR . Discontinue EGRIFTA WR if there is any evidence of recurrent malignancy. ( 5.1 ) Elevated IGF-1: EGRIFTA WR stimulates GH production and increases serum IGF-1, a growth factor.

The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA WR therapy. Consider discontinuing in patients with persistent elevations.

( 5.2 ) Fluid retention: May occur with EGRIFTA WR and may include edema, arthralgia, and carpal tunnel syndrome. ( 5.3 ) Glucose intolerance or diabetes mellitus: May develop with EGRIFTA WR use. Evaluate glucose prior to and during therapy.

( 5.4 ) Hypersensitivity reactions: Have occurred in clinical trials. Advise patients to seek immediate medical attention and discontinue treatment if suspected. ( 5.5 ) Increased mortality in patients with acute critical illness: Consider discontinuation in critically ill patients .

( 5.7 )

5.1Increased Risk of Neoplasms New Malignancy Carefully consider the decision to start treatment with EGRIFTA WR based on the increased background risk of malignancies in HIV-positive patients. Active Malignancy EGRIFTA WR induces the release of endogenous growth hormone (GH), a known growth factor. Do not treat patients with active malignancy with EGRIFTA WR [see Contraindications ( 4 )] .

History of Malignancy For patients with a history of non-malignant neoplasms, initiate EGRIFTA WR therapy after careful evaluation of the potential benefit of treatment. For patients with a history of treated and stable malignancies, initiate EGRIFTA WR therapy only after careful evaluation of the potential benefit of treatment relative to the risk of re-activation of the underlying malignancy. Discontinue EGRIFTA WR if there is any evidence of recurrent malignancy.

5.2Elevated IGF-1 Levels EGRIFTA WR stimulates GH production and increases serum IGF-1, a growth factor. The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA WR therapy.

Consider discontinuing EGRIFTA WR in patients with persistent elevations of IGF-1 levels (e.g., >3 SDS), particularly if the efficacy response is not robust. Among patients who received EGRIFTA for 26 weeks, 47% had IGF-1 levels greater than 2 standard deviation scores (SDS), and 36% had SDS >3, with this effect seen as early as 13 weeks of treatment. Among those patients who remained on EGRIFTA for a total of 52 weeks, at the end of treatment, 34% had IGF-1 SDS >2 and 23% had IGF-1 SDS >3.

5.3Fluid Retention Fluid retention may occur during EGRIFTA WR therapy and is thought to be related to the induction of GH secretion. This manifests as increased tissue turgor and musculoskeletal discomfort resulting in adverse reactions (e.g. edema, arthralgia, and carpal tunnel syndrome) which are either transient or resolve with discontinuation of treatment.

5.4Glucose Intolerance or Diabetes Mellitus EGRIFTA WR treatment can result in glucose intolerance. During clinical trials, the percentages of patients with elevated HbA 1c (≥ 6.5%) from baseline to Week 26 were 5% and 1% in the EGRIFTA and placebo groups, respectively. An increased risk of developing diabetes with EGRIFTA (HbA 1c level ≥ 6.5%) relative to placebo was observed [intent-to-treat hazard odds ratio of 3.3 (CI 1.4, 9.6)].

Evaluate glucose status prior to initiating EGRIFTA WR. Monitor all patients treated with EGRIFTA WR periodically to diagnose those who develop impaired glucose tolerance or diabetes. If patients treated with EGRIFTA WR develop glucose intolerance or diabetes, consider discontinuing EGRIFTA WR in patients who do not show a clear efficacy response.

EGRIFTA WR increases IGF-1, monitor patients with diabetes who are receiving treatment with TESAMORELIN for injection at regular intervals for potential development or worsening of retinopathy.

5.5Hypersensitivity React… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following important adverse reactions are also described elsewhere in the labeling: Increased risk of neoplasms [see Warnings and Precautions ( 5.1 )] Elevated IGF-1 levels [see Warnings and Precautions ( 5.2 )] Fluid retention [see Warnings and Precautions ( 5.3 )] Glucose intolerance or diabetes mellitus [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] Injection site reactions [see Warnings and Precautions ( 5.6 )] Most commonly reported adverse reactions (>5%): Arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient support ® toll free at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EGRIFTA WR (11.6 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation). Adverse reactions for the 1.28 mg dose (11.6 mg/vial formulation) of EGRIFTA WR are expected to be similar to those observed with the 2 mg dose (1 mg/vial formulation) of EGRIFTA [see Clinical Pharmacology ( 12.3 )].

Seven hundred and forty (740) HIV-infected patients with lipodystrophy and excess abdominal fat were treated with EGRIFTA in clinical trials; of these, 543 received EGRIFTA during the initial 26-week placebo-controlled phase. The most commonly reported adverse reactions were hypersensitivity reactions (e.g., rash, urticaria), edema-related reactions (e.g., arthralgia, extremity pain, peripheral edema, and carpal tunnel syndrome), hyperglycemia, and injection site reactions (injection site erythema, pruritus, pain, urticaria, irritation, swelling, and hemorrhage).

Adverse reactions that occurred more frequently with EGRIFTA relative to placebo and had an incidence ≥1% during the first 26 weeks across all studies are presented in Table 1 . Table 1. Adverse Reactions Reported in ≥ 1% and More Frequent in EGRIFTA–treated than Placebo Patients during the 26-Week Phase (Combined Studies) * Injection site reaction includes: Injection site erythema, Injection site pruritus, Injection site rash, Injection site urticaria, Injection site pain, Injection site swelling, Injection site irritation, Injection site hemorrhage.

Preferred Term Placebo (N=263) EGRIFTA (N=543) Injection site reaction* Arthralgia Pain in extremity Myalgia Edema peripheral Paresthesia Hypoesthesia Rash Dyspepsia Musculoskeletal pain Pain Pruritus Vomiting Musculoskeletal stiffness Blood creatine phosphokinase increased Carpal tunnel syndrome Joint swelling Muscle strain Night sweats Palpitations 6 11 5 2 2 2 2 2 1 1 1 1 0 0 0 0 0 0 0 0 17 13 6 6 6 5 4 4 2 2 2 2 3 2 1 1 1 1 1 1 In the EGRIFTA clinical trials, mean baseline HbA1c was 5.3% among patients in both the EGRIFTA and placebo groups.

Patients receiving EGRIFTA had an increased risk of developing diabetes (HbA1c level ≥ 6.5%) compared with placebo (5% vs. 1%), with a hazard ratio of 3.3 (CI 1.4, 9.6).

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Cytochrome P450-metabolized drugs : Monitor patients for potential interactions when administering with EGRIFTA WR . ( 7.1 ) Glucocorticoids : Patients receiving glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses following initiation of EGRIFTA WR. ( 7.2 )

7.1Cytochrome P450-Metabolized Drugs Co-administration of tesamorelin with simvastatin, a CYP3A substrate had no significant impact on the pharmacokinetics profiles of simvastatin in healthy subjects [see Clinical Pharmacology ( 12.3 )] . EGRIFTA WR stimulates GH production. Published data indicate that GH may modulate cytochrome P450 (CYP450) mediated antipyrine clearance.

These data suggest that GH may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, and cyclosporine). Monitor patients for potential interactions when administering EGRIFTA WR in combination with other drugs known to be metabolized by CYP450 liver enzymes.

7.2Glucocorticoids GH inhibits 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1), a microsomal enzyme required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. EGRIFTA WR stimulates GH production; therefore, patients receiving glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses following initiation of EGRIFTA WR. Patients treated with cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: HIV-1 infected mothers should not breastfeed to avoid potential postnatal transmission of HIV-1. ( 8.2 )

8.1Pregnancy Risk Summary EGRIFTA WR is contraindicated in pregnant women because modifying visceral adipose tissue offers no benefit in pregnant women and could result in fetal harm [see Clinical Considerations and Contraindications ( 4 )] . Administration of tesamorelin acetate to rats during organogenesis resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, based on measured drug exposure (AUC). If EGRIFTA WR is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue EGRIFTA WR.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes.

Modifying pregnancy-associated physiologic changes in visceral adipose tissue with EGRIFTA WR offers no known benefit and could result in fetal harm. Data Animal Data Tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). Actual animal dose was 1.2 mg/kg.

During organogenesis, lower doses approximately 0.1 to 1-times the clinical dose caused delayed skull ossification in rats. Actual animal doses were 0.1 to 0.6 mg/kg. No adverse developmental effects occurred in rabbits using doses up to approximately 500 times the clinical dose.

8.2Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. There are no data on the presence of tesamorelin in human milk, the effects on the breastfed child, or the effects on milk production. Because of both the potential for (1) HIV-1 infection transmission (in HIV-negative infants), (2) developing viral resistance (in HIV-positive patients), and (3) any possible adverse effects of tesamorelin, mothers should not breastfeed if they receive EGRIFTA WR.

8.4Pediatric Use The safety and effectiveness of EGRIFTA WR in pediatric patients have not been established. In pediatric patients with open epiphyses, treatment with EGRIFTA WR may result in linear growth acceleration and excessive growth. EGRIFTA WR is not indicated for use in pediatric patients with open or closed epiphyses.

8.5Geriatric Use There is no information on the use of EGRIFTA WR in patients greater than 65 years of age.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary EGRIFTA WR is contraindicated in pregnant women because modifying visceral adipose tissue offers no benefit in pregnant women and could result in fetal harm [see Clinical Considerations and Contraindications ( 4 )] . Administration of tesamorelin acetate to rats during organogenesis resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, based on measured drug exposure (AUC). If EGRIFTA WR is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue EGRIFTA WR.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes.

Modifying pregnancy-associated physiologic changes in visceral adipose tissue with EGRIFTA WR offers no known benefit and could result in fetal harm. Data Animal Data Tesamorelin acetate administration to rats during organogenesis and lactation resulted in hydrocephaly in offspring at a dose of approximately two and four times the clinical dose, respectively, based on measured drug exposure (AUC). Actual animal dose was 1.2 mg/kg.

During organogenesis, lower doses approximately 0.1 to 1-times the clinical dose caused delayed skull ossification in rats. Actual animal doses were 0.1 to 0.6 mg/kg. No adverse developmental effects occurred in rabbits using doses up to approximately 500 times the clinical dose.

🧒 Pediatric Use 51 words ▾

8.4Pediatric Use The safety and effectiveness of EGRIFTA WR in pediatric patients have not been established. In pediatric patients with open epiphyses, treatment with EGRIFTA WR may result in linear growth acceleration and excessive growth. EGRIFTA WR is not indicated for use in pediatric patients with open or closed epiphyses.

🧓 Geriatric Use 21 words ▾

8.5Geriatric Use There is no information on the use of EGRIFTA WR in patients greater than 65 years of age.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF [see Clinical Pharmacology ( 12.2 )]. Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic. GH exerts its effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes, resulting in a host of pharmacodynamic effects.

Some, but not all these effects, are primarily mediated by IGF-1 produced in the liver and in peripheral tissues.

12.2Pharmacodynamics Tesamorelin stimulates growth hormone secretion, and subsequently increases IGF-1 and IGFBP-3 levels. No clinically significant changes in the levels of other pituitary hormones, including thyroid-stimulating hormone (TSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH) and prolactin, were observed in patients receiving EGRIFTA in clinical trials.

12.3Pharmacokinetics Absorption The absolute bioavailability of tesamorelin after subcutaneous administration of a 2 mg dose of EGRIFTA (1 mg/vial formulation) was determined to be less than 4% in healthy adult subjects. Single and multiple dose pharmacokinetics have been characterized in healthy subjects and HIV-infected patients without lipodystrophy using a 2 mg dose of EGRIFTA (1 mg/vial formulation). Tesamorelin mean extent of absorption (AUC) was 34% higher in HIV-infected patients than healthy subjects.

Tesamorelin peak plasma concentration (C max ) was similar in HIV-infected patients and healthy subjects. The median peak plasma tesamorelin concentration (T max ) was 0.15 h in both populations. Following single dose of subcutaneous administration of 1.28 mg of EGRIFTA WR (11.6 mg/vial formulation) in healthy subjects, the mean [coefficient of variation (CV)] AUC 0-inf was 1172 (48%) pg.h/mL.

The mean (CV) C max value was 3831 (40%) pg/mL and the median T max was 0.15 h. The systemic exposure (C max and AUC s ) of tesamorelin is similar between the 1.28 mg dose of EGRIFTA WR (11.6 mg/vial formulation) and the 2 mg dose of EGRIFTA (1 mg/vial formulation). Distribution The mean volume of distribution (±SD) of tesamorelin following a single subcutaneous administration of the 1.28 mg dose of EGRIFTA WR (11.6 mg/vial formulation) was 4.8 ±

1.9L/kg in healthy subjects. Metabolism No formal metabolism studies have been performed in humans. Elimination Mean elimination half-life (t1/2) of tesamorelin was 11 minutes in healthy subjects after single dose subcutaneous administration of the 1.28 mg of EGRIFTA WR (11.6 mg/vial formulation).

Specific Populations Pharmacokinetics of tesamorelin in patients with renal or hepatic impairment, in pediatric patients, or in elderly patients has not been established. Drug Interactions Simvastatin The effect of multiple dose administration of EGRIFTA on the pharmacokinetics of simvastatin and simvastatin acid was evaluated in healthy subjects. Co-administration with simvastatin (a CYP3A substrate) resulted in 8% decrease in extent of absorption (AUC inf ) and 5% increase in rate of absorption (C max ) of simvastatin.

For simvastatin acid there was a 15% decrease in AUC inf and 1% decrease in C max [see Drug Interactions ( 7.1 )] . Ritonavir The effect of multiple dose administration of EGRIFTA on the pharmacokinetics of ritonavir was evaluated in healthy subjects. Co-administration with ritonavir resulted in 9% decrease in AUC inf and 11% decrease in C max of ritonavir [see Drug Interactions ( 7.1 )] .

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of a… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 114 words ▾

12.1Mechanism of Action In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF [see Clinical Pharmacology ( 12.2 )]. Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic. GH exerts its effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes, resulting in a host of pharmacodynamic effects.

Some, but not all these effects, are primarily mediated by IGF-1 produced in the liver and in peripheral tissues.

📦 How Supplied / Storage and Handling 165 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied EGRIFTA WR (tesamorelin) for injection is supplied as a white to off-white lyophilized powder in a 11.6 mg single-patient-use vial with a 30 mL multiple-dose bottle of Bacteriostatic Water for Injection, USP, as diluent. EGRIFTA WR (NDC 62064-381-04) is available in a package comprised of two boxes, containing 4 (four) 11.6 mg single-patient-use vials of EGRIFTA WR in the Medication Box and 1 (one) multiple-dose 30 mL bottles of Bacteriostatic Water for Injection, USP, diluent with a 28-day supply of disposable syringes, needles and alcohol swabs in the Injection Box.

Storage and Handling Store EGRIFTA WR 11.6 mg vial at room temperature at 20°C to 25°C (68°F to 77°F) in the original box to protect from light; excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. 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). Do not freeze.

📋 Description 207 words ▾

11 DESCRIPTION Tesamorelin is a human growth hormone-releasing factor (GRF) analog produced synthetically. It is comprised of the 44 amino acid sequence of human GRF and a hexenoyl moiety, a C6 chain with a double bond at position 3, attached to the tyrosine residue at the N-terminal part of the molecule. Tesamorelin is prepared as an acetate salt.

The molecular formula of tesamorelin acetate is C 221 H 366 N 72 O 67 S • x C 2 H 4 O 2 (x ≈ 7) and its molecular weight (as free base equivalent) is 5135.9 Da. The structural formula of tesamorelin acetate is: EGRIFTA WR (tesamorelin) for injection is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. Each single-patient-use vial of EGRIFTA WR contains tesamorelin 11.6 mg (equivalent to approximately 11.9 mg of tesamorelin acetate) and the following inactive ingredients: 145 mg hydroxypropyl betadex, 43.5 mg mannitol.

Hydrochloric acid and/or sodium hydroxide may be used to adjust the pH. The pH of EGRIFTA WR is between 4.5 and 7.4. After reconstitution with 1.3 mL of Bacteriostatic Water for Injection, USP, resultant concentration is 8 mg/mL and the solution is clear and colorless.

Bacteriostatic Water for Injection, USP contains benzyl alcohol as preservative. Structural Formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Increased Risk of Malignancy Inform patients about the increased background risk of malignancies in HIV-positive patients and for patients with a history of neoplasms, inform them about the risk of malignancy reoccurrence [see Warnings and Precautions ( 5.1 )]. Elevated IGF-1 Levels Inform patients that treatment with EGRIFTA WR increases IGF-1 levels and that they will need periodic monitoring of their IGF-1 levels [see Warnings and Precautions ( 5.2 )].

Fluid Retention Inform patients that treatment with EGRIFTA WR may cause fluid retention, resulting in adverse reactions including edema, arthralgia, and carpal tunnel syndrome [see Warnings and Precautions ( 5.3 )]. Glucose Intolerance or Diabetes Mellitus Inform patients that treatment with EGRIFTA WR may result in glucose intolerance or diabetes mellitus. Advise patients that they will need to be monitored to see if impaired glucose tolerance or diabetes mellitus develops, and that if they have pre-existing diabetes mellitus, they may need adjustments to their anti-diabetic medications [see Warnings and Precautions ( 5.4 )].

Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., rash, urticaria) may occur during treatment with EGRIFTA WR. Advise patients to seek prompt medical attention and to immediately discontinue treatment with EGRIFTA WR if a reaction occurs [see Warnings and Precautions ( 5.5 )]. Injection Site Reactions Inform patients that injection site reactions may occur with EGRIFTA WR, including injection site erythema, pruritus, pain, irritation, and bruising.

Advise patients to rotate the site of injection to reduce the risk of injection site reactions [see Warnings and Precautions ( 5.6 )]. Pregnancy Advise women to discontinue EGRIFTA WR if pregnancy occurs, as the drug offers no known benefit to pregnant women and could result in fetal harm [see Contraindications ( 4 ) and Use in Specific Populations ( 8.1 )]. Lactation Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, mothers receiving EGRIFTA WR should be instructed not to breastfeed [see Use in Specific Populations ( 8.2 )] .

Administration Counsel patients that they should never share an EGRIFTA WR syringe with another person, even if the needle is changed. Sharing of syringes or needles between patients may pose a risk of transmission of infection. EGRIFTA WR is a trademark of Theratechnologies Inc.

Manufactured by Theratechnologies Inc., 2015 Peel Street, Suite 1100, Montréal, Québec, Canada H3A 1T8 US License No. 2091 for Theratechnologies Inc. Thera technologies

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Absorption The absolute bioavailability of tesamorelin after subcutaneous administration of a 2 mg dose of EGRIFTA (1 mg/vial formulation) was determined to be less than 4% in healthy adult subjects. Single and multiple dose pharmacokinetics have been characterized in healthy subjects and HIV-infected patients without lipodystrophy using a 2 mg dose of EGRIFTA (1 mg/vial formulation). Tesamorelin mean extent of absorption (AUC) was 34% higher in HIV-infected patients than healthy subjects.

Tesamorelin peak plasma concentration (C max ) was similar in HIV-infected patients and healthy subjects. The median peak plasma tesamorelin concentration (T max ) was 0.15 h in both populations. Following single dose of subcutaneous administration of 1.28 mg of EGRIFTA WR (11.6 mg/vial formulation) in healthy subjects, the mean [coefficient of variation (CV)] AUC 0-inf was 1172 (48%) pg.h/mL.

The mean (CV) C max value was 3831 (40%) pg/mL and the median T max was 0.15 h. The systemic exposure (C max and AUC s ) of tesamorelin is similar between the 1.28 mg dose of EGRIFTA WR (11.6 mg/vial formulation) and the 2 mg dose of EGRIFTA (1 mg/vial formulation). Distribution The mean volume of distribution (±SD) of tesamorelin following a single subcutaneous administration of the 1.28 mg dose of EGRIFTA WR (11.6 mg/vial formulation) was 4.8 ±

1.9L/kg in healthy subjects. Metabolism No formal metabolism studies have been performed in humans. Elimination Mean elimination half-life (t1/2) of tesamorelin was 11 minutes in healthy subjects after single dose subcutaneous administration of the 1.28 mg of EGRIFTA WR (11.6 mg/vial formulation).

Specific Populations Pharmacokinetics of tesamorelin in patients with renal or hepatic impairment, in pediatric patients, or in elderly patients has not been established. Drug Interactions Simvastatin The effect of multiple dose administration of EGRIFTA on the pharmacokinetics of simvastatin and simvastatin acid was evaluated in healthy subjects. Co-administration with simvastatin (a CYP3A substrate) resulted in 8% decrease in extent of absorption (AUC inf ) and 5% increase in rate of absorption (C max ) of simvastatin.

For simvastatin acid there was a 15% decrease in AUC inf and 1% decrease in C max [see Drug Interactions ( 7.1 )] . Ritonavir The effect of multiple dose administration of EGRIFTA on the pharmacokinetics of ritonavir was evaluated in healthy subjects. Co-administration with ritonavir resulted in 9% decrease in AUC inf and 11% decrease in C max of ritonavir [see Drug Interactions ( 7.1 )] .

🧬 Pharmacodynamics 46 words ▾

12.2Pharmacodynamics Tesamorelin stimulates growth hormone secretion, and subsequently increases IGF-1 and IGFBP-3 levels. No clinically significant changes in the levels of other pituitary hormones, including thyroid-stimulating hormone (TSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH) and prolactin, were observed in patients receiving EGRIFTA in clinical trials.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The safety and effectiveness of EGRIFTA WR (11.6 mg/vial formulation) has been established based on adequate and well controlled studies with EGRIFTA (1 mg/vial formulation), as well as a demonstration of comparable bioavailability between the 1.28 mg EGRIFTA WR dose (11.6 mg/vial formulation) and the 2 mg EGRIFTA dose (1 mg/vial formulation) [see Clinical Pharmacology ( 12.3 )] . Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in HIV-infected patients with lipodystrophy and excess abdominal fat (abdominal lipohypertrophy).

Study 1 and Study 2 consisted of a 26-week Main Phase and a 26-week Extension Phase, respectively. Main inclusion criteria were age 18 to 65 years, a waist circumference ≥95 cm (37.4 inches) and a waist-to-hip ratio ≥0.94 for men and ≥94 cm (37.0 inches) and ≥0.88 for women, respectively, and fasting blood glucose (FBG) <150 mg/dL (8.33 mmol/L). Main exclusion criteria included BMI ≤ 20 kg/m 2 , type 1 diabetes mellitus, type 2 diabetes mellitus, previous treatment with insulin or with oral hypoglycemic or insulin-sensitizing agents, history of malignancy, and hypopituitarism.

Patients were on a stable anti-retroviral regimen for at least 8 weeks prior to randomization. Patients meeting the inclusion/exclusion criteria were randomized in a 2:1 ratio to receive a 2 mg dose of EGRIFTA (1 mg/vial formulation) or placebo subcutaneously daily for 26 weeks. The primary efficacy assessment for each of these studies was the percent change from baseline to Week 26 in visceral adipose tissue (VAT), as assessed by computed tomography (CT) scan at L4-L5 vertebral level.

Secondary endpoints included changes from baseline in patient-reported outcomes related to body image, triglycerides, ratio of total cholesterol to HDL cholesterol, IGF-1 levels, and safety parameters. Other endpoints included changes from baseline in waist circumference, abdominal subcutaneous tissue (SAT), trunk fat, and lean body mass. In both studies, EGRIFTA-treated patients completing the 26-week treatment period were re-randomized to blinded therapy with either daily placebo or a 2 mg dose of EGRIFTA (1 mg/vial formulation) for an additional 26-week treatment period (Extension Phase) in order to assess maintenance of VAT reduction and to gather long-term safety data.

For inclusion in the Extension Phase studies, subjects must have completed the Main Phase with FBG ≤ 150 mg/dL. Main Phase (Baseline to Week 26) : Study 1 (NCT 00123253) This study randomized 412 HIV-infected patients with lipodystrophy and excess abdominal fat to receive either a 2 mg dose of EGRIFTA (1 mg/vial formulation) (N=273) or placebo (N=137). At baseline for the two groups combined, mean age was 48 years; 86% were male; 75% were white, 14% were Black/African American, and 8% were Hispanic; mean weight was 90 kg; mean BMI was 29 kg/m 2 ; mean waist circumference was 104 cm; mean hip circumference was 100 cm; mean VAT was 176 cm 2 ; mean CD4 cell count was 606 cells/mm3; 69% had undetectable viral load (<50 copies/mL); and 33.7% randomized to EGRIFTA and 36.6% randomized to placebo had impaired glucose tolerance, while 5.6% randomized to EGRIFTA and 6.7% randomized to placebo had diet-controlled diabetes mellitus.

The twenty-six week completion rate in Study 1 was 80%. Study 2 (NCT 00435136) This study randomized 404 HIV-infected patients with lipodystrophy and excess abdominal fat to receive either a 2 mg dose of EGRIFTA (1 mg/vial formulation) (N=270) or placebo (N=126). At baseline for the two groups combined, mean age was 48 years; 84% were male; 77% were white, 12% were Black/African American, and 9% were Hispanic; mean weight was 88 kg; mean BMI was 29 kg/m 2 ; mean waist circumference was 105 cm; mean hip circumference was 100 cm; mean VAT was 189 cm 2 ; mean CD4 cell count was 592 cells/mm3; 83% had undetectable viral load (<50 copies/mL); and 44% randomized to EGRIFTA and 40% randomized to placebo had impaired… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 103 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Life-time carcinogenicity studies in rodents have not been conducted with tesamorelin acetate. No potential mutagenicity of tesamorelin acetate was revealed in a battery of tests including induction of gene mutations in bacteria (the Ames test), gene mutations in mammalian cells grown in vitro (hamster CHOK1 cells), and chromosomal damage in intact animals (bone marrow cells in mice). There was no effect on fertility in male or female rats following administration of tesamorelin acetate at doses up to 0.6 mg/kg (approximately equal to clinical exposure) for 28 days in males or 14 days in females.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 100 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Life-time carcinogenicity studies in rodents have not been conducted with tesamorelin acetate. No potential mutagenicity of tesamorelin acetate was revealed in a battery of tests including induction of gene mutations in bacteria (the Ames test), gene mutations in mammalian cells grown in vitro (hamster CHOK1 cells), and chromosomal damage in intact animals (bone marrow cells in mice). There was no effect on fertility in male or female rats following administration of tesamorelin acetate at doses up to 0.6 mg/kg (approximately equal to clinical exposure) for 28 days in males or 14 days in females.

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION EGRIFTA WR TM (tesamorelin) for injection for subcutaneous use 11.6 mg/vial Read the Patient Information that comes with EGRIFTA WR before you start to take EGRIFTA WR and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is EGRIFTA WR? EGRIFTA WR is a prescription medicine used to reduce the excess stomach-area (abdominal) fat in HIV-infected adult patients with lipodystrophy. EGRIFTA WR is a growth hormone-releasing factor (GHRF).

The long-term safety of EGRIFTA WR on the heart and blood vessels (cardiovascular) is not known. EGRIFTA WR is not for weight loss management. It is not known whether taking EGRIFTA WR helps improve how well you take (compliance with) antiretroviral medicines.

It is not known if EGRIFTA WR is safe and effective in children. EGRIFTA WR is not recommended to be used in children with open or closed bone growth plates (epiphyses). Who should not use EGRIFTA WR?

Do not use EGRIFTA WR if you: have a pituitary gland tumor, have had pituitary gland surgery, have other problems related to your pituitary gland, or have had radiation treatment to your head or a head injury. have active cancer. Any previous cancer should be inactive, and any previous cancer treatment should be complete before starting EGRIFTA WR. are allergic to tesamorelin or any of the ingredients in EGRIFTA WR. See the end of this leaflet for a complete list of ingredients in EGRIFTA WR. are pregnant or plan to become pregnant.

EGRIFTA WR can harm your unborn baby. If you become pregnant, stop using EGRIFTA WR and talk with your healthcare provider. What should I tell my healthcare provider before using EGRIFTA WR?

Before using EGRIFTA WR, tell your healthcare provider about all of your medical conditions, including if you: have or have had cancer. have problems with your blood sugar or diabetes. Some people with diabetes who use EGRIFTA WR may develop or may have worsening eye problems. have scheduled heart or stomach surgery. have breathing problems. are breastfeeding or plan to breastfeed. It is not known if EGRIFTA WR passes into your breast milk.

The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk with your healthcare provider about the best way to feed your baby if you are using EGRIFTA WR. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use EGRIFTA WR? Read the detailed Instructions for Use that comes with EGRIFTA WR before you start using it. Your healthcare provider will show you how to inject EGRIFTA WR.

Use EGRIFTA WR exactly as your healthcare provider tells you to use it. Inject EGRIFTA WR under the skin (subcutaneously) of your stomach-area (abdomen). Change (rotate) the injection site on your stomach-area with each dose.

Do not inject EGRIFTA WR into scar tissue, bruises or your belly button. There are two EGRIFTA formulations (EGRIFTA WR and EGRIFTA SV) with different recommended dosages. EGRIFTA WR and EGRIFTA SV are not substitutable.

Do not share your EGRIFTA WR syringe or needles with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. What are the possible side effects of EGRIFTA WR?

EGRIFTA WR may cause serious side effects, including: increase risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using EGRIFTA WR if any cancer symptoms come back. increased levels of your insulin-like growth factor-1 (IGF-1). Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking EGRIFTA WR. swelling (fluid retention).

EGRIFTA WR can cause swelling in some parts of your body. Call your healthcare… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE EGRIFTA WR TM (tesamorelin) for injection for subcutaneous use Note: This Instructions for Use contains information on how to mix and inject the EGRIFTA WR 11.6 mg vial. Read and follow the steps for weekly mixing and daily injection of EGRIFTA WR 11.6 mg vial. Your healthcare provider should show you how to mix and inject 11.6 mg vial before you inject it for the first time.

Ask your healthcare provider if you have any questions. Important Information You Need to Know Before Injecting EGRIFTA WR 11.6 mg vial For subcutaneous injection only (inject directly under the skin). There are two EGRIFTA formulations (EGRIFTA WR and EGRIFTA SV) with different recommended dosages.

EGRIFTA WR and EGRIFTA SV are not substitutable. The recommended daily dose of EGRIFTA WR is 1.28 mg (0.16 mL). One (1) EGRIFTA WR 11.6 mg vial must be mixed with 1.3 mL of the Bacteriostatic Water for Injection to prepare for 7 doses [for 7 consecutive daily injections (Day 1 to Day 7) of treatment].

Do not share your syringe or needles with other people. You may give other people a serious infection or get a serious infection from them. Do not use a syringe or needle more than 1 time.

If supplies are missing, damaged, or expired; or if you have any questions at any time during the mixing or the injection of EGRIFTA WR, call your pharmacist or toll-free at 1-833-23THERA (1-833-238-4372). Storing EGRIFTA WR Store the Medication Box at room temperature between 68°F to 77°F (20°C to 25°C) and keep the EGRIFTA WR vials out of the light. Store the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C).

Do not freeze or refrigerate EGRIFTA WR after it has been mixed with the Bacteriostatic Water for Injection. Keep EGRIFTA WR and all medicines out of the reach of children. Box Content Medication Box Supplies for 28 days: 4 single-patient use EGRIFTA WR 11.6 mg vials ( mix only 1 vial per week as per weekly mixing ) Injection Box Supplies for 28 days: 1 multiple-dose, 30 mL bottle of Bacteriostatic Water for Injection (to be used for weekly mixing) 4 sterile BD Plastipak TM 3 mL Syringes with needle attached (clear cap), for weekly mixing 33 sterile BD SafetyGlide TM syringes with needle attached (orange cap), for daily injection 1 box of 100 alcohol swabs Weekly Mixing (Day 1) Getting Started For Weekly Mixing of EGRIFTA WR, follow steps 1 through 23.

For Daily Injection (Day 1 to Day 7), follow steps 24 through 49. Step 1: Use a well-lit, clean, and flat surface as a working area. Step 2: Take out the following: (See Figure B ) One (1) vial of EGRIFTA WR 11.6 mg One (1) 30 mL bottle of Bacteriostatic Water for Injection One (1) BD Plastipak TM 3 mL Syringe with needle attached (clear cap) for Weekly Mixing One (1) alcohol swab Sharps disposal container Step 3: Wash and dry your hands well.

(See Figure C ) Step 4: Inspect the compact powder in the EGRIFTA WR vial. It should be white to off-white. (See Figure D ) Do not use the vial if the powder is discolored or has particles in it.

Get a new vial, and call your healthcare provider, pharmacist, or contact toll free at 1-833-23THERA (1-833-238-4372). Step 5: Check the expiration dates (EXP) on the: (See Figure E ) 1) EGRIFTA WR vial label 2) Bacteriostatic Water for Injection bottle Do not use if expired. Step 6: Remove the plastic caps from the vial and the bottle .

(See Figure F ) Step 7: Clean the top of both the vial and the bottle with an alcohol swab (See Figure G ). Throw away (discard) the alcohol swab after use. Preparing to Mix EGRIFTA WR Step 8: Take a BD Plastipak TM 3 mL Syringe with needle attached (clear cap) out of its packaging.

(See Figure H ) Step 9: Pull the protective clear needle cap straight off and throw it away (discard) (See Figure I ). Make sure the needle is tightly screwed to the syringe. Do not twist the needle cap.

Step 10: Pull down the plunger to reach the 1½ mark (1.5 mL) on the syringe to fill it with air. (See Figure J ) Step 11: Insert the need… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 7 words ▾

Dosage and Administration ( 2 ) 03/2025

📄 Package Label / Principal Display Panel ~1 min read ▾

Principal Display Panel - Medication Box Rx only MEDICATION BOX (Box 1 of 2) NDC 62064-381-04 4 vials EGRIFTA WR TM (tesamorelin) for injection 11.6 mg/vial For Subcutaneous Use Single-patient-use vial Sterile lyophilized powder New Formulation, Dose, Mixing Instructions, and Storage One (1) mixed EGRIFTA WR vial provides daily doses for seven (7) days EGRIFTA WR and EGRIFTA SV are not substitutable. THERA technologies medication box

Principal Display Panel - Injection Box INJECTION BOX (Box 2 of 2) For use only with EGRIFTA WR ™ (tesamorelin) for injection 11.6 mg/vial (NDC 62064-381-04) New Formulation, Dose Mixing Instructions, and Storage One (1) mixed EGRIFTA WR vial provides daily doses for seven (7) days READ BEFORE OPENING BOX This INJECTION BOX does NOT contain your EGRIFTA WR (tesamorelin) for injection 11.6 mg/vial. Make sure you also have the EGRIFTA WR 11.6 mg/vial MEDICATION BOX. CONTENTS OF INJECTION BOX: - 1 Instructions for Use and Patient Information - 1 multiple-dose, 30 mL bottle of Bacteriostatic Water for Injection - 4 sterile BD Plastipak™ 3 mL syringes with needle attached - 33 sterile BD SafetyGlide™ syringes with needle attached - 1 box of 100 alcohol swabs EGRIFTA WR and EGRIFTA SV are not substitutable.

For Weekly Mixing and Daily Injection, refer to Instructions for Use. Store at room temperature at 20°C to 25°C (68°F to 77°F). Rx only THERA technologies injection Box - no warning

Principal Display Panel - 11.6 mg Vial Label EGRIFTA WR™ (tesamorelin) for injection 11.6 mg/vial NDC 62064-381-01 Rx only STERILE Store at 20°C to 25°C (68°F to 77°F). For Subcutaneous Use Single-patient-use vial The daily recommended dose is 1.28 mg (0.16 mL). Mfd. by Theratechnologies Inc. US License No. 2091 vial

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Egrifta Wr — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Egrifta Wr. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$8.18M
Claims incl. refills
710
Beneficiaries
362
Spend / beneficiary
$22,600.45
Spend / claim
$11,523.05
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Theratechnologies Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Theratechnologies Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 62064-0241-30 · Theratechnologies 62066-0001-01 · Jones →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.