EGRIFTA SV tesamorelin Kit — NDC 62064-241-30 (Billing 62064-0241-30)
This is a package of EGRIFTA SV tesamorelin Kit from Theratechnologies Inc., marketed since Nov 2019 and currently FDA-listed. It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 080524
- GCN: 47393
- HICL (First Databank): 037268
- AHFS class code: 68:30.04.00
- RxCUI (RxNorm): 1044587
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Growth Hormone Releasing Factor Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Tesamorelin injection is used to decrease the amount of extra fat in the stomach area in adults with human immunodeficiency virus (HIV) who have lipodystrophy (increased body fat in certain areas of the body). Tesamorelin injection is not used to help with weight loss. Tesamorelin injection is in a class of medications called human growth hormone-releasing factor (GRF) analogs. It works by increasing the production of a certain natural substance that can decrease the amount of body fat.
Read the full MedlinePlus article ↗- 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?
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $425.97 | — |
| Medicare drug plans payPart D · Q2 2026 | $347.31 | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 62064-0241-30 You're viewing this Main listing | 1 KIT in 1 BOX * 30 BOTTLE in 1 TRAY / 10 mL in 1 BOTTLE * .5 mL in 1 VIAL | 2019-11-04 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Egrifta Svthis 62064-0241-30 | Theratechnologies | 1 kit | — | — | FDA listed | — |
| Egrifta Wr 62064-0381-04 | Theratechnologies | 1 kit | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Purple Book · refreshed Sep 5, 2026
- CMS NADAC weekly file
Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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.
🛈 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.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Mar 25, 2037 |
Is there a biosimilar for EGRIFTA SV 2 MG VIAL?
Why do different websites show different biosimilar dates?
Can a biosimilar launch before the last patent expires?
What does “current Purple Book estimate” mean?
What does “FDA listed” mean?
What does a patent or protection date mean here?
Where does this data come from?
- FDA Purple Book · refreshed Sep 5, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE EGRIFTA SV 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 SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
EGRIFTA SV 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 SV. EGRIFTA SV 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 SV 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 SV.
( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION The recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA 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.
( 2.1 ). The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. ( 2.1 ) Inject EGRIFTA SV into the abdomen, rotating injection sites.
( 2.1 , 5.6 ) Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. ( 2.2 ) Reconstitute one vial of lyophilized powder with 0.5 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds.
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 ) Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. ( 2.2 )
2.1Dosage and Administration • The dosage and administration recommendations in this prescribing information only apply to EGRIFTA SV (tesamorelin) for injection 2 mg per vial formulation. For dosage and administration recommendations for tesamorelin for injection 1 mg per vial formulation, see the EGRIFTA 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. • The dose of EGRIFTA SV is 1.4 mg, 0.35 mL of the reconstituted solution [see Dosage and Administration ( 2.2 )] , injected subcutaneously once daily. • Inject EGRIFTA SV into the abdomen.
Rotate injection sites to different areas of the abdomen [see Warnings and Precautions ( 5.5 )] . 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 SV Medication Box. • Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. • Reconstitute 1 vial of EGRIFTA SV lyophilized powder with 0.5 mL of diluent (2 mg per 0.5 mL). Mix by rolling the vial gently in your hands for 30 seconds. Do not shake. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Use only if the solution is clear, colorless and without particulate matter. • Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. If not used immediately, discard the reconstituted solution. Do not freeze or refrigerate the reconstituted solution.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 2 mg of tesamorelin as a white to off-white lyophilized powder in a single-dose vial and a diluent of 10 mL of Sterile Water for Injection. For injection: 2 mg in a single-dose vial with a diluent of 10 mL of Sterile Water for Injection ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS EGRIFTA SV 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 SV ( 4 ) Pregnancy ( 4 ) EGRIFTA SV 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 SV [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 ▾
5 WARNINGS AND PRECAUTIONS Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV . Discontinue EGRIFTA SV if there is any evidence of recurrent malignancy. ( 5.1 ) Elevated IGF-1: EGRIFTA SV 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 SV therapy. Consider discontinuing in patients with persistent elevations.
( 5.2 ) Fluid retention: May occur with EGRIFTA SV and may include edema, arthralgia, and carpal tunnel syndrome. ( 5.3 ) Glucose intolerance or diabetes mellitus: May develop with EGRIFTA SV 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 SV based on the increased background risk of malignancies in HIV-positive patients. Active Malignancy EGRIFTA SV induces the release of endogenous growth hormone (GH), a known growth factor. Do not treat patients with active malignancy with EGRIFTA SV [see Contraindications ( 4 )] .
History of Malignancy For patients with a history of non-malignant neoplasms, initiate EGRIFTA SV therapy after careful evaluation of the potential benefit of treatment. For patients with a history of treated and stable malignancies, initiate EGRIFTA SV therapy only after careful evaluation of the potential benefit of treatment relative to the risk of re-activation of the underlying malignancy. Discontinue EGRIFTA SV if there is any evidence of recurrent malignancy.
5.2Elevated IGF-1 Levels EGRIFTA SV 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 SV therapy.
Consider discontinuing EGRIFTA SV 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 SV 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 SV 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 SV. Monitor all patients treated with EGRIFTA SV periodically to diagnose those who develop impaired glucose tolerance or diabetes. If patients treated with EGRIFTA SV develop glucose intolerance or diabetes, consider discontinuing EGRIFTA SV in patients who do not show a clear efficacy response.
EGRIFTA SV increases IGF-1, monitor patients with diabetes who are receiving treatment with EGRIFTA SV at regular intervals for potential development or worsening of retinopathy.
5.5Hypersensitivity Reactions Hypersensi… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
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 SV (2 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation). Adverse reactions for the 1.4 mg dose (2 mg/vial formulation) of EGRIFTA SV 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 HbA 1c was 5.3% among patients in both the EGRIFTA and placebo groups.
Patients receiving EGRIFTA had an increased risk of developing diabetes (HbA 1c level ≥ 6.5%) compared with placebo (5% vs. 1%), with a hazard ratio of 3.3 (CI 1.4, 9.6).
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Cytochrome P450-metabolized drugs : Monitor patients for potential interactions when administering with EGRIFTA SV . ( 7.1 ) Glucocorticoids : Patients receiving glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in maintenance or stress doses following initiation of EGRIFTA SV. ( 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 SV 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 SV 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 SV 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 SV. 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 ▾
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 SV 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 SV is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue EGRIFTA SV.
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 SV 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 SV.
8.4Pediatric Use The safety and effectiveness of EGRIFTA SV in pediatric patients have not been established. In pediatric patients with open epiphyses, treatment with EGRIFTA SV may result in linear growth acceleration and excessive growth. EGRIFTA SV 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 SV in patients greater than 65 years of age.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary EGRIFTA SV 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 SV is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue EGRIFTA SV.
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 SV 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 ▾
8.4Pediatric Use The safety and effectiveness of EGRIFTA SV in pediatric patients have not been established. In pediatric patients with open epiphyses, treatment with EGRIFTA SV may result in linear growth acceleration and excessive growth. EGRIFTA SV is not indicated for use in pediatric patients with open or closed epiphyses.
🧓 Geriatric Use ▾
8.5Geriatric Use There is no information on the use of EGRIFTA SV in patients greater than 65 years of age.
🧬 Clinical Pharmacology ▾
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 1.4 mg of EGRIFTA SV (2 mg/vial formulation) in healthy subjects, the mean [coefficient of variation (CV)] AUC 0-inf was 889.1 (57%) pg . h/mL.
The mean (CV) C max value was 2956.1 (47%) pg/mL and the median T max was 0.15 h. The systemic exposure (C max and AUCs) of tesamorelin is similar between the 1.4 mg dose of EGRIFTA SV (2 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 1.4 mg dose of EGRIFTA SV (2 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 (t 1/2 ) of tesamorelin was 8 minutes in healthy subjects after single dose subcutaneous administration of the 1.4 mg of EGRIFTA SV (2 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 anti-drug ant… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING EGRIFTA SV (tesamorelin) for injection is supplied as a white to off-white lyophilized powder in a 2 mg single-dose vial with a diluent of 10 mL vial of Sterile Water for Injection. EGRIFTA SV (NDC 62064-241-30) is available in a package comprised of two boxes, containing 30 (thirty) 2 mg single-dose vials of EGRIFTA SV in the Medication Box and 30 single-dose 10 mL bottles of Sterile Water for Injection diluent with a 30-day supply of disposable syringes and needles in the Injection Box.
Store EGRIFTA SV 2 mg vial at room temperature at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect EGRIFTA SV from light by keeping in the original box until time of use. Store the Injection box (containing Sterile Water for Injection, syringes and needles) at room temperature at 20°C to 25°C (68°F to 77°F).
📋 Description ▾
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 SV (tesamorelin) for injection is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. Each single-dose vial of EGRIFTA SV contains tesamorelin 2 mg (equivalent to approximately 2.2 mg of tesamorelin acetate) and the following inactive ingredients: 0.78 mg histidine, USP, 20 mg mannitol, USP, 0.05 mg polysorbate 20, NF and 10 mg sucrose, NF.
Hydrochloric acid may be used to adjust the pH. The pH of EGRIFTA SV is between 4.5 and 7.4. After reconstitution with 0.5 mL of Sterile Water for Injection, resultant concentration is 2 mg/0.5 mL and the solution is clear and colorless.
Structural Formula
💬 Information for Patients ▾
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 SV 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 SV 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 SV 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 SV. Advise patients to seek prompt medical attention and to immediately discontinue treatment with EGRIFTA SV if a reaction occurs [see Warnings and Precautions ( 5.5 )]. Injection Site Reactions Inform patients that injection site reactions may occur with EGRIFTA SV, 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 SV 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 SV should be instructed not to breastfeed [see Use in Specific Populations ( 8.2 )] .
Administration Counsel patients that they should never share an EGRIFTA SV 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 SV ® is a registered 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. image description
🧬 Pharmacokinetics ▾
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 1.4 mg of EGRIFTA SV (2 mg/vial formulation) in healthy subjects, the mean [coefficient of variation (CV)] AUC 0-inf was 889.1 (57%) pg . h/mL.
The mean (CV) C max value was 2956.1 (47%) pg/mL and the median T max was 0.15 h. The systemic exposure (C max and AUCs) of tesamorelin is similar between the 1.4 mg dose of EGRIFTA SV (2 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 1.4 mg dose of EGRIFTA SV (2 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 (t 1/2 ) of tesamorelin was 8 minutes in healthy subjects after single dose subcutaneous administration of the 1.4 mg of EGRIFTA SV (2 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 ▾
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 ▾
14 CLINICAL STUDIES The safety and effectiveness of EGRIFTA SV (2 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 1.4 mg EGRIFTA SV dose (2 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/mm 3 ; 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/mm 3 ; 83% had undetectable viral load (<50 copies/mL); and 44% randomized to EGRIFTA and 40% randomized to placebo had impaired glu… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
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 ▾
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 ▾
PATIENT INFORMATION EGRIFTA SV ® (eh-GRIF-tuh ESS-vee) (tesamorelin) for injection for subcutaneous use 2 mg vial Read the Patient Information that comes with EGRIFTA SV before you start to take EGRIFTA SV 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 SV ? EGRIFTA SV is an injectable prescription medicine used to reduce the excess stomach-area (abdominal) fat in HIV-infected adult patients with lipodystrophy. EGRIFTA SV is a growth hormone-releasing factor (GHRF).
The long-term safety of EGRIFTA SV on the heart and blood vessels (cardiovascular) is not known. EGRIFTA SV is not for weight loss management. It is not known whether taking EGRIFTA SV helps improve how well you take (compliance with) antiretroviral medicines.
It is not known if EGRIFTA SV is safe and effective in children. EGRIFTA SV is not recommended to be used in children with open or closed bone growth plates (epiphyses). Who should not use EGRIFTA SV?
Do not use EGRIFTA SV 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 SV. are allergic to tesamorelin or any of the ingredients in EGRIFTA SV. See the end of this leaflet for a complete list of ingredients in EGRIFTA SV. are pregnant or plan to become pregnant.
EGRIFTA SV can harm your unborn baby. If you become pregnant, stop using EGRIFTA SV and talk with your healthcare provider. What should I tell my healthcare provider before using EGRIFTA SV?
Before using EGRIFTA SV, 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 SV 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 SV 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 SV. 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 SV? Read the detailed “Instructions for Use” that comes with EGRIFTA SV before you start using it. Your healthcare provider will show you how to inject EGRIFTA SV.
Use EGRIFTA SV exactly as your healthcare provider tells you to use it. Inject EGRIFTA SV 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 SV into scar tissue, bruises or your belly button. Do not share your EGRIFTA SV 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 SV? EGRIFTA SV may cause serious side effects, including: increase risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using EGRIFTA SV 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 SV. swelling (fluid retention). EGRIFTA SV can cause swelling in some parts of your body. Call your healthcare provider if you have swelling, an increase in joint pain or pain or numbness in your hands or wrist (carpal tunnel s… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
Instructions for Use EGRIFTA SV ® (eh-GRIF-tuh ESS-vee) (tesamorelin) for injection for subcutaneous use This Instructions for Use contains step-by-step information on how to use the 2 mg vial of EGRIFTA SV. Each 2 mg vial of EGRIFTA SV must be mixed with 0.5 mL of the Sterile Water for Injection provided in the Injection Box given to you by the pharmacy. Use only one EGRIFTA SV 2 mg vial from the Medication Box to prepare your dose.
The recommended dose of EGRIFTA SV is 1.4 mg (0.35 mL). Be sure that you read, understand, and follow this Instructions for Use before using EGRIFTA SV. Your healthcare provider should show you how to mix and inject EGRIFTA SV before you inject it for the first time.
Ask your healthcare provider if you have any questions. Keep this Instructions for Use in case you need to look at it again later. Important information for use of EGRIFTA SV Do not use a syringe or needle more than 1 time.
Do not share your 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. If you are missing any supplies from the boxes given to you by the pharmacy or if any of the supplies look damaged, call your pharmacist or contact toll-free at 1-833-23THERA (1-833-238-4372) right away.
Preparing for your EGRIFTA SV injection Step 1: Find a well-lit, clean, and flat surface, such as a table. Step 2: Gather your supplies: Medication Box that contains 30 EGRIFTA SV 2 mg single-dose vials Injection Box that contains the following: 30 single-dose 10 mL bottles of Sterile Water for Injection, used for mixing 60 sterile 1 mL syringes 60 sterile 1" 20-gauge needles, used for mixing 30 sterile ½” 30-gauge needles, used for injection Other Supplies Needed Two alcohol pads One sterile gauze One adhesive bandage Sharps disposal container or a puncture resistant container for throwing away used needles and syringes after you are done with them.
(See “ How should I dispose of the used syringes, needles, bottles and vials? ” ) For each injection using EGRIFTA SV 2 mg vial you will need: (See Figure A ) Figure A Step 3: Take out the following from the Injection Box: One Sterile Water for Injection bottle Two 1 mL syringes Two 1" 20-gauge needles used for mixing One ½" 30-gauge needle used for injection Step 4: Take 1 vial of EGRIFTA SV 2 mg from the Medication Box. Step 5: Prepare to use your supplies: Wash your hands with soap and water. Dry your hands with a clean towel.
Take off the plastic caps from the EGRIFTA SV 2 mg vial and the Sterile Water for Injection bottle. Clean the rubber stoppers on the top of the EGRIFTA SV 2 mg vial and Sterile Water for Injection bottle with an alcohol pad. How to mix EGRIFTA SV 2 mg vial Step 1: Place a 1" 20-gauge needle used for mixing, with its protective needle cap in place, onto a 1 mL syringe.
Hold the syringe firmly and twist the needle cap clockwise (to the right) until it closes securely. (See Figure B ) Figure B Step 2: Carefully remove the protective needle cap by pulling it straight off. Do not twist the needle cap.
Insert the needle through the rubber stopper of the Sterile Water for Injection bottle. (See Figure C ) Figure C Step 3: With the needle still in the Sterile Water for Injection bottle, turn the bottle and syringe upside down. Pull back the plunger until the Sterile Water reaches the 0.5 mL mark on the syringe.
(See Figure D ) Figure D Step 4: Remove the syringe with needle attached from the Sterile Water bottle.Throw away the bottle containing the unused Sterile Water for Injection. (See “ How should I dispose of the used syringes, needles, bottles and vials? ”) Insert the needle into the rubber stopper of the EGRIFTA SV 2 mg vial. With the needle at a slight angle, slowly push the plunger of the syringe all the way down so that the Sterile Water goes down the inside wall of the EGRIFTA SV 2 mg vial instead of directly onto the powder to avoid foaming.
(See Figure E ) Figure… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
Principal Display Panel - Medication Box MEDICATION BOX (Box 1 of 2) NDC 62064-241-30 2 mg/vial Rx only EGRIFTA SV ® (tesamorelin) for injection 2 mg/vial For subcutaneous injection only Important: Refer to Patient Instructions for Use Use only 1 vial of EGRIFTA SV 2 mg to prepare the recommended dose of 1.4 mg (0.35 mL of the reconstituted solution). READ BEFORE OPENING BOX: This is the MEDICATION BOX – it contains 30 vials of EGRIFTA SV 2 mg/vial and the Patient Instructions for Use. You will also need the INJECTION BOX for EGRIFTA SV – it contains syringes and other materials needed for reconstitution and administration.
Protect from light. Keep in original box. Store at room temperature at 20°C to 25°C (68°F to 77°F) EGRIFTA SV ® is a registered trademark of Theratechnologies Inc.
Principal Display Panel - Medication Box
Principal Display Panel - Injection Box INJECTION BOX (Box 2 of 2) For use only with EGRIFTA SV ® 2 mg/vial (tesamorelin) for injection 2 mg/vial For mixing, refer to Patient Instructions for Use included in the EGRIFTA SV 2 mg/vial Medication Box. Rx only READ BEFORE OPENING BOX This is your INJECTION BOX for EGRIFTA SV (tesamorelin) for injection 2 mg/vial. This box contains sterile syringes, Sterile Water for Injection USP, and materials needed for injecting EGRIFTA SV .
Note this INJECTION BOX does NOT contain your EGRIFTA SV 2 mg/vial medication. Before removing contents, make sure you also have the EGRIFTA SV 2 mg/vial MEDICATION BOX. Contents of INJECTION BOX: a) 30 single-dose, 10 mL bottles of Sterile Water for Injection b) 60 sterile 1mL syringes c) 60 sterile 1" 20-gauge needles, used for mixing d) 30 sterile ½" 30-gauge needles, used for injection Store at controlled room temperature 20°C to 25°C (68°F to 77°F) Made in USA Manufactured by: Theratechnologies Inc., 2015 Peel Street, Suite 1100, Montréal, Québec, Canada H3A 1T8 US Licence No.
2091 for Theratechnologies Inc. Principal Display Panel - Injection Box
Principal Display Panel - 2 mg Vial Label 2 mg/vial EGRIFTA SV ® (tesamorelin) for injection Rx only STERILE Store at 20°C to 25°C (68° to 77°F) For subcutaneous injection only Each vial contains 2 mg of tesamorelin Single-Dose Vial - Discard Unused Portion Mfd. By Theratechnologies Inc. US License No. 2091 Principal Display Panel - 2 mg Vial Label
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