Egrifta Sv

Tesamorelin · Kit · Subcutaneous

Prescription (Rx)

Uses

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

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 ) 2.1 Dosage 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. 2.2 Reconstitution 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

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 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 ) 5.1 Increased 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. 5.2 Elevated 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. 5.3 Fluid 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. 5.4 Glucose 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. 5.5 Hypersensitivity Reactions Hypersensitivity reactions occurred in 4% of patients treated with EGRIFTA in clinical trials. Reactions included pruritus, erythema, flushing, urticaria, and rash. In cases of suspected hypersensitivity reactions, advise patients to seek prompt medical attention and immediately discontinue treatment with EGRIFTA SV. 5.6 Injection Site Reactions EGRIFTA SV treatment may cause injection site reactions, including injection site erythema, pruritus, pain, irritation, and bruising. The incidence of injection site reactions was 25% in EGRIFTA treated patients and 14% in placebo-treated patients during the first 26 weeks of treatment in clinical trials. Rotate injection sites to different areas of the abdomen to decrease injection site reactions [see Dosage and Administration ( 2.1 )]. 5.7 Increased Mortality in Patients with Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic amounts of growth hormone. EGRIFTA SV is a growth hormone-releasing hormone (GHRH) and since it stimulates growth hormone production, consider discontinuing EGRIFTA SV in critically ill patients.

Side effects

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 6.1 Clinical 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

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 ) 7.1 Cytochrome 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. 7.2 Glucocorticoids 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

Lactation: HIV-1 infected mothers should not breastfeed to avoid potential postnatal transmission of HIV-1. ( 8.2 ) 8.1 Pregnancy 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. 8.2 Lactation 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. 8.4 Pediatric 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. 8.5 Geriatric Use There is no information on the use of EGRIFTA SV in patients greater than 65 years of age.

Pregnancy

8.1 Pregnancy 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

8.4 Pediatric 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

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

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

Mechanism of action

12.1 Mechanism 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

(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).

Patient 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

Label text from the FDA structured product label by Theratechnologies Inc. (revised Jul 29, 2026). Long sections are shortened; the complete label is on DailyMed.

Egrifta Sv NDC products (1)

NDC	Strength & form	Labeler	Type
62064-241	Kit	Theratechnologies Inc.	BLA

Frequently asked questions

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Egrifta Sv is listed by 1 labeler in the FDA NDC directory, including Theratechnologies Inc..