Egrifta Sv

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.

• 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 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 ]

  , injected subcutaneously once daily.
  
  • Inject EGRIFTA SV into the abdomen. Rotate injection sites to different areas of the abdomen

  [see Warnings and Precautions ]

  . Do not inject into scar tissue, bruises or the navel.
  ).
• The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily. (
  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 ]

  , injected subcutaneously once daily.
  
  • Inject EGRIFTA SV into the abdomen. Rotate injection sites to different areas of the abdomen

  [see Warnings and Precautions ]

  . Do not inject into scar tissue, bruises or the navel.
  )
• Inject EGRIFTA SV into the abdomen, rotating injection sites. (
  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 ]

  , injected subcutaneously once daily.
  
  • Inject EGRIFTA SV into the abdomen. Rotate injection sites to different areas of the abdomen

  [see Warnings and Precautions ]

  . Do not inject into scar tissue, bruises or the navel.
  ,
  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 ].
  )
• Use only the diluent provided, Sterile Water for Injection, to reconstitute EGRIFTA SV. (
  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.
  )
• 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 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.
  )
• Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless and without particulate matter. (
  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.
  )
• Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent. (
  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.
  )

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.

• Lactation:
  HIV-1 infected mothers should not breastfeed to avoid potential postnatal transmission of HIV-1. (
  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.
  )

• 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 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 ]

  .

  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.
  )
• 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 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.
  )
• Fluid retention:
  May occur with EGRIFTA SV and may include edema, arthralgia, and carpal tunnel syndrome. (
  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.
  )
• Glucose intolerance or diabetes mellitus:
  May develop with EGRIFTA SV use. Evaluate glucose prior to and during therapy.  (
  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_1clevel ≥ 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.
  )
• Hypersensitivity reactions:
  Have occurred in clinical trials. Advise patients to seek immediate medical attention and discontinue treatment if suspected. (
  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.
  )
• Increased mortality in patients with acute critical illness:
  Consider discontinuation in critically ill patients
  .
  (
  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.
  )